Bowel Incontinence, Fecal Incontinence
Conditions
Brief summary
This study is a multi-center, randomized clinical trial of women with refractory accidental bowel leakage (ABL) symptoms who have failed to achieve satisfactory symptom control from 2 first-line treatments for ABL: supervised pelvic muscle training (PMT) and constipating medication. The purpose of this study is to compare percutaneous tibial nerve stimulation (PTNS) to a validated sham to determine if PTNS is effective for the treatment of fecal incontinence (FI) in women. The investigators will test the null hypothesis that change from baseline in St. Mark's (Vaizey) score after 12 weeks of stimulation is not significantly different in women with symptomatic ABL receiving PTNS treatments compared to women receiving sham PTNS treatments.
Detailed description
The overarching goal of this randomized clinical trial is to determine if PTNS is more effective than sham PTNS for the treatment of FI in women after 12 weeks of treatment and 1 year after initiating treatment. This is a two-part trial with a Run-In Phase prior to randomization. The trial has the following primary aim: To determine whether the change from baseline in St. Mark's (Vaizey) score in women with symptomatic ABL undergoing PTNS differs from sham after 12 weeks of stimulation. Additional secondary aims include: 1. To compare changes from baseline in self-reported functional outcomes after 12 weekly stimulation sessions in both PTNS and sham groups in Part 1. 2. To determine whether symptom relief amongst study responders can be sustained for one year with maintenance treatments in Part II. 3. To determine the impact of completing a bowel diary and receiving education on FI on symptom severity. 4. To determine the ability of the PFDN ABL phone app bowel diary to detect changes from baseline in fecal incontinence episodes recorded to after 12 weeks of stimulation sessions. 5. To determine the association between St. Mark's score and both fat and fiber intake alone and in combination.
Interventions
DEVICEES-130
The ES-130 device will be used for the indication of Posterior Tibial Nerve Stimulation for the treatment of fecal incontinence using the FDA-approved protocol for treatment of urge urinary incontinence (UUI) in the PFDN NOTABLe study. There is no PTNS device cleared by the FDA for the indication of FI treatment; therefore, this is considered an investigational device.
Sponsors
University of Alabama at Birmingham
University of California, San Diego
Duke University
Women and Infants Hospital of Rhode Island
RTI International
University of Pennsylvania
University of Pittsburgh
Kaiser Permanente
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
University of Texas Southwestern Medical Center
NICHD Pelvic Floor Disorders Network
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Masking description
Participants will remain masked to subject treatment assignment throughout the trial. To maintain masking of participants, the duration of treatment sessions for both the PTNS and sham groups will be 30 minutes and will be conducted with subjects in a supine position with the knees comfortably abducted and flexed. The leg and foot involved in treatment will be obscured from the subject's view with a portable anesthesia drape frame to which an exam sheet will be secured.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Women ≥ 18 years of age * FI symptoms ≥ 3 months * Baseline St. Mark's score of ≥ 12 * Attended ≥ 2 supervised PMT for ABL * Intolerance, unwillingness, or inadequate response to constipating medications * Current negative colon cancer screening based on the USPSTF's recommendation for colorectal cancer screening (2016)
Exclusion criteria
* Previous PTNS treatment * History of uncontrolled diarrhea in the past 3 months (usual or most common stool type over the preceding 3 months of 7 on the Bristol Stool Form Scale) * History of severe constipation in the past 3 months (usual or most common stool type over the preceding 3 months of 1 on the Bristol Stool Form Scale) * History of inflammatory bowel disease (includes Crohn's disease and ulcerative colitis, but does not include irritable bowel disease) * Unrepaired rectovaginal fistula/chronic 4th degree laceration * Full thickness rectal prolapse * History of congenital anorectal malformation * History of bowel resection surgery for any indication * Minor anal procedures within 6 months for treatment of ABL (injection of bulking agent or radiofrequency energy) or ligation of hemorrhoids * Prior pelvic or abdominal radiation * Diagnosis of cancer of the descending colon or anus * Diagnosis of cancer in the region where the PTNS or sham needles or surface electrodes would be placed * Pacemaker, implantable defibrillator * Current use of Interstim sacral nerve stimulator or TENS in the pelvic region, back, or legs * Clinically significant neurological disorders known to affect anal continence * Coagulopathy * Severe peripheral edema preventing accurate placement of PTNS needles * Chronic swollen, infected, inflamed skin or skin eruptions (e.g., phlebitis, thrombophlebitis, varicose veins) in the region where the PTNS or sham needles or surface electrodes would be placed * Metal implant in foot/toes near TENS electrode location * Marked sensory deficit (numbness) of feet or ankles in the region where the PTNS or sham needles or surface electrodes would be placed * Childbirth within the last 3 months * Pregnant or planning to become pregnant during the study duration 1 year; a urine pregnancy test will be performed and must be negative by the first intervention visit if the participant is of childbearing potential * Unwilling to use acceptable form of contraceptive if the participant is of childbearing potential * Participation in another intervention trial impacting bowel function * Inability to provide informed consent, complete questionnaires independently, or to attend intervention sessions * Unable or unwilling to complete the bowel diary in Run-In Phase (valid diary defined as data from ≥ 10 of 14 days with minimum of 3 consecutive days per week) * Unwilling to download bowel diary app onto smartphone if the participant owns a smartphone * Visual impairment prohibiting reading the paper diary, the smart phone screen * Unable to speak, read, or write in English or Spanish at a basic level
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline St. Mark's (Vaizey) Score | 4, 8, and 12 Weeks | The primary outcome measure is the change from baseline in St. Mark's (Vaizey) Score 12 weeks after treatment initiation to compare the outcomes of post-tibial nerve stimulation (PTNS) versus sham stimulation. The St. Mark's (Vaizey) score, published in 1999, is commonly used in clinical studies and reports and was based on the Jorge-Wexner score but added two further items for assessment: the use of constipating medication and the presence of fecal urgency. Minimum score is 0 = perfect continence; maximum score is 24 = totally incontinent. Change from baseline is calculated as Week \[4, 8, or 12\] Score minus the score at baseline. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline Number of Fecal Incontinence Events Per Week | 8 and 12 Weeks | Based on data collected from participant-completed diaries at baseline, 8, and 12 weeks, the outcome variable is computed as the difference in number of fecal incontinence episodes per week at 8 and 12 weeks and the number of fecal incontinence episodes at baseline. |
| Change From Baseline Number of Urge Fecal Incontinence Events Per Week | 8 and 12 Weeks | Based on data collected from participant-completed diaries at baseline, 8, and 12 weeks, the outcome variable is computed as the difference in number of urge fecal incontinence episodes per week at 8 and 12 weeks and the number of urge fecal incontinence episodes at baseline. |
| Change From Baseline Number of Bowel Movements Per Week | 8 and 12 Weeks | Based on data collected from participant-completed diaries at baseline, 8, and 12 weeks, the outcome variable is computed as the difference in number of bowel movements per week at 8 and 12 weeks and the number of bowel movements at baseline. |
| Change From Baseline Number of Urge Bowel Movements Per Week | 8 and 12 Weeks | Based on data collected from participant-completed diaries at baseline, 8, and 12 weeks, the outcome variable is computed as the difference in number of urge bowel movements per week at 8 and 12 weeks and the number of urge bowel movements at baseline. |
| Responder to Treatment | 4, 8, and 12 Weeks | Responder status is based on the primary chnage from St. Mark's Score. A responder is defined as any particpant with at least a 4 point reduction in score compared to their baseline score |
| 50% Improvement in Fecal Incontinence Episodes Per Week | 8 and 12 Weeks | Based on data collected from participant-completed diaries at baseline, 8, and 12 weeks, the outcome is calculated as any participant with a 50% reduction in fecal incontinence episodes per week at 8 and 12 weeks compared to the fecal incontinence episodes at baseline |
| 75% Improvement in Fecal Incontinence Episodes Per Week | 8 and 12 Weeks | Based on data collected from participant-completed diaries at baseline, 8, and 12 weeks, the outcome is calculated as any participant with a 75% reduction in fecal incontinence episodes per week at 8, and 12 weeks compared to the fecal incontinence episodes at baseline. |
| Patient Global Impression-Improvement | 4, 8, and 12 Weeks | The Patient Global Impression of Improvement (PGI-I) is a patient-reported measure of perceived improvement with treatment, as assessed on a scale of 1 (very much better) to 7 (very much worse). Included here are participants who had improvement as indicated by a rating of 1 (very much better) or 2 (much better) |
| Change From Baseline Number of Days Without Fecal Incontinence Episodes Per Week | 8 and 12 Weeks | Based on data collected from participant-completed diaries at baseline, 8, and 12 weeks, the outcome variable is computed as the difference in number of days without fecal incontinence episodes per week at 8 and 12 weeks and the number of days without fecal incontinence episodes at baseline. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline FIQL Coping Score | 8 and 12 Weeks | The FIQL Coping Score is a subscale of the validated Fecal Incontinence Quality of Life (FIQL) questionnaire which assesses the impact of accidental bowel leakage on quality of life. Minimum score is 1 = lower functional quality of life; maximum score is 5 = higher functional quality of life. Change from baseline is calculated as Week \[8 or 12\] Score minus the score at baseline. |
| Change From Baseline FIQL Depression Score | 8 and 12 Weeks | The FIQL Depression Score is a subscale of the validated Fecal Incontinence Quality of Life (FIQL) questionnaire which assesses the impact of accidental bowel leakage on quality of life. Minimum score is 1 = lower functional quality of life; maximum score is 5 = higher functional quality of life. Change from baseline is calculated as Week \[8 or 12\] Score minus the score at baseline. |
| Change From Baseline FIQL Embarrassment Score | 8 and 12 Weeks | The FIQL Embarrassment Score is a subscale of the validated Fecal Incontinence Quality of Life (FIQL) questionnaire which assesses the impact of accidental bowel leakage on quality of life. Minimum score is 1 = lower functional quality of life; maximum score is 5 = higher functional quality of life. Change from baseline is calculated as Week \[8 or 12\] Score minus the score at baseline. |
| Change From Baseline FISI Patient Score | 8 and 12 Weeks | The FISI Patient Score is a summary score of the validated Fecal Incontinence Severity Index questionnaire which provides a summary metric of the severity of fecal incontinence from the patient's perspective. Minimum score is 0 = no fecal incontinence; maximum score is 61 = very severe fecal incontinence. Change from baseline is calculated as Week \[8 or 12\] Score minus the score at baseline. |
| Change From Baseline FISI Doctor Score | 8 and 12 Weeks | The FISI Doctor Score is a summary score of the validated Fecal Incontinence Severity Index questionnaire which provides a summary metric of the severity of fecal incontinence from the doctor's perspective. Minimum score is 0 = no fecal incontinence; maximum score is 57 = very severe fecal incontinence. Change from baseline is calculated as Week \[8 or 12\] Score minus the score at baseline. |
| Change From Baseline MMHQ Incontinence Impact Score | 8 and 12 Weeks | The MMHQ Incontinence Impact Score is a subscale of the validated Modified-Manchester Health questionnaire (MMHq) which provides a health-related quality of life rating. Minimum score is 0 = high quality of life; maximum score is 100 = low quality of life. Change from baseline is calculated as Week \[8 or 12\] Score minus the score at baseline. |
| Change From Baseline MMHQ Role Limitations Score | 8 and 12 Weeks | The MMHQ Role Limitations Score is a subscale of the validated Modified-Manchester Health questionnaire (MMHq) which provides a health-related quality of life rating. Minimum score is 0 = high quality of life; maximum score is 100 = low quality of life. Change from baseline is calculated as Week \[8 or 12\] Score minus the score at baseline. |
| Change From Baseline MMHQ Physical Limitations Score | 8 and 12 Weeks | The MMHQ Physical Limitations Score is a subscale of the validated Modified-Manchester Health questionnaire (MMHq) which provides a health-related quality of life rating. Minimum score is 0 = high quality of life; maximum score is 100 = low quality of life. Change from baseline is calculated as Week \[8 or 12\] Score minus the score at baseline. |
| Change From Baseline MMHQ Social Limitations Score | 8 and 12 Weeks | The MMHQ Social Limitations Score is a subscale of the validated Modified-Manchester Health questionnaire (MMHq) which provides a health-related quality of life rating. Minimum score is 0 = high quality of life; maximum score is 100 = low quality of life. Change from baseline is calculated as Week \[8 or 12\] Score minus the score at baseline. |
| Change From Baseline MMHQ Personal Relationship Score | 8 and 12 Weeks | The MMHQ Personal Relationship Score is a subscale of the validated Modified-Manchester Health questionnaire (MMHq) which provides a health-related quality of life rating. Minimum score is 0 = high quality of life; maximum score is 100 = low quality of life. Change from baseline is calculated as Week \[8 or 12\] Score minus the score at baseline. |
| Change From Baseline PISQ-IR SA-GQR Score | 12 Weeks | The Pelvic Organ Prolapse Incontinence Sexual Questionnaire, IUGA-revised measures the impact of incontinence symptoms on sexual function and satisfaction. The Sexually Active-Global Quality Rating (SA-GQR) ranges from 1 to 4.75 with higher scores indicating greater sexual function. The outcome is calculated as the difference in score at 12 weeks and the score at baseline. |
| Change From Baseline MMHQ Emotional Function Score | 8 and 12 Weeks | The MMHQ Emotional Function Score is a subscale of the validated Modified-Manchester Health questionnaire (MMHq) which provides a health-related quality of life rating. Minimum score is 0 = high quality of life; maximum score is 100 = low quality of life. Change from baseline is calculated as Week \[8 or 12\] Score minus the score at baseline. |
| Change From Baseline MMHQ Sleep/Energy Score | 8 and 12 Weeks | The MMHQ Sleep/Energy Score is a subscale of the validated Modified-Manchester Health questionnaire (MMHq) which provides a health-related quality of life rating. Minimum score is 0 = high quality of life; maximum score is 100 = low quality of life. Change from baseline is calculated as Week \[8 or 12\] Score minus the score at baseline. |
| Change From Baseline MMHQ Severity Measures Score | 8 and 12 Weeks | The MMHQ Severity Measures Score is a subscale of the validated Modified-Manchester Health questionnaire (MMHq) which provides a health-related quality of life rating. Minimum score is 0 = high quality of life; maximum score is 100 = low quality of life. Change from baseline is calculated as Week \[8 or 12\] Score minus the score at baseline. |
| Change From Baseline PISQ-IR SA-CI Score | 12 Weeks | The Pelvic Organ Prolapse Incontinence Sexual Questionnaire, IUGA-revised measures the impact of incontinence symptoms on sexual function and satisfaction. The Sexually Active-Condition Impact (SA-CI) ranges from 1 to 4 with higher scores indicating greater sexual function. The outcome is calculated as the difference in score at 12 weeks and the score at baseline. |
| Change From Baseline CRAIQ Score | 8 and 12 Weeks | The Pelvic Floor Impact Questionnaire short form (PFIQ-7) measuring the impact of bladder, bowel, and vaginal symptoms on a woman's daily activities, relationships and emotions is composed of 3 scales of 7 questions each: the Urinary Impact Questionnaire (UIQ; range 0-100), the Pelvic Organ Prolapse Impact Questionnaire (POPIQ; range 0-100), and the Colorectal-Anal Impact Questionnaire (CRAIQ; range 0-100). Scores are calculated by multiplying the mean value of all answered questions for a scale by 100 divided by 3. The range of responses is: 0-100 with 0 (least negative impact) to 100 (most negative impact). Change = (Week \[8, 12\] Score - Baseline Score). Lower scores indicate better function / fewer symptoms. |
| Change From Baseline POPIQ Score | 8 and 12 Weeks | The Pelvic Floor Impact Questionnaire short form (PFIQ-7) measuring the impact of bladder, bowel, and vaginal symptoms on a woman's daily activities, relationships and emotions is composed of 3 scales of 7 questions each: the Urinary Impact Questionnaire (UIQ; range 0-100), the Pelvic Organ Prolapse Impact Questionnaire (POPIQ; range 0-100), and the Colorectal-Anal Impact Questionnaire (CRAIQ; range 0-100). Scores are calculated by multiplying the mean value of all answered questions for a scale by 100 divided by 3. The range of responses is: 0-100 with 0 (least negative impact) to 100 (most negative impact). Change = (Week \[8, 12\] Score - Baseline Score). Lower scores indicate better function / fewer symptoms. |
| Change From Baseline UIQ Score | 8 and 12 Weeks | The Pelvic Floor Impact Questionnaire short form (PFIQ-7) measuring the impact of bladder, bowel, and vaginal symptoms on a woman's daily activities, relationships and emotions is composed of 3 scales of 7 questions each: the Urinary Impact Questionnaire (UIQ; range 0-100), the Pelvic Organ Prolapse Impact Questionnaire (POPIQ; range 0-100), and the Colorectal-Anal Impact Questionnaire (CRAIQ; range 0-100). Scores are calculated by multiplying the mean value of all answered questions for a scale by 100 divided by 3. The range of responses is: 0-100 with 0 (least negative impact) to 100 (most negative impact). Change = (Week \[8, 12\] Score - Baseline Score). Lower scores indicate better function / fewer symptoms. |
| Change From Baseline PFIQ Score | 8 and 12 Weeks | The Pelvic Floor Impact Questionnaire short form (PFIQ-7) measuring the impact of bladder, bowel, and vaginal symptoms on a woman's daily activities, relationships and emotions is composed of 3 scales of 7 questions each: the Urinary Impact Questionnaire (UIQ; range 0-100), the Pelvic Organ Prolapse Impact Questionnaire (POPIQ; range 0-100), and the Colorectal-Anal Impact Questionnaire (CRAIQ; range 0-100). Scores are calculated by multiplying the mean value of all answered questions for a scale by 100 divided by 3. The range of responses is: 0-100 with 0 (least negative impact) to 100 (most negative impact). Change = (Week \[8, 12\] Score - Baseline Score). Lower scores indicate better function / fewer symptoms. |
| Change From Baseline PAC-SYM Abdominal Score | 12 Weeks | The Patient Assessment of Constipation - Symptom (PAC-SYM) ia a validated form measuring the frequency and severity of chronic constipation. It consists of an overall score (range: 0-4) consisting of 3 subscales across 12 question: the Abdominal score (range 0-4), the Rectal Score (range 0-4), and the Stool Score (range 0-4). Scores are calculated as the mean of non-mising responses. The range of responses is: 0-4 with 0 (Absent) to 4 (Very sever). Change = (Week 12 Score - Baseline Score). Lower scores indicate less severe constipation. |
| Change From Baseline PAC-SYM Rectal Score | 12 Weeks | The Patient Assessment of Constipation - Symptom (PAC-SYM) ia a validated form measuring the frequency and severity of chronic constipation. It consists of an overall score (range: 0-4) consisting of 3 subscales across 12 question: the Abdominal score (range 0-4), the Rectal Score (range 0-4), and the Stool Score (range 0-4). Scores are calculated as the mean of non-mising responses. The range of responses is: 0-4 with 0 (Absent) to 4 (Very sever). Change = (Week 12 Score - Baseline Score). Lower scores indicate less severe constipation. |
| Change From Baseline PAC-SYM Stool Score | 12 Weeks | The Patient Assessment of Constipation - Symptom (PAC-SYM) ia a validated form measuring the frequency and severity of chronic constipation. It consists of an overall score (range: 0-4) consisting of 3 subscales across 12 question: the Abdominal score (range 0-4), the Rectal Score (range 0-4), and the Stool Score (range 0-4). Scores are calculated as the mean of non-mising responses. The range of responses is: 0-4 with 0 (Absent) to 4 (Very sever). Change = (Week 12 Score - Baseline Score). Lower scores indicate less severe constipation. |
| Change From Baseline PAC-SYM Total Score | 12 Weeks | The Patient Assessment of Constipation - Symptom (PAC-SYM) is a validated form measuring the frequency and severity of chronic constipation. It consists of an overall score (range: 0-4) consisting of 3 subscales across 12 question: the Abdominal score (range 0-4), the Rectal Score (range 0-4), and the Stool Score (range 0-4). Scores are calculated as the mean of non-missing responses. The range of responses is: 0-4 with 0 (Absent) to 4 (Very severe). Change = (Week 12 Score - Baseline Score). Lower scores indicate less severe constipation. |
| Change From Baseline PISQ-IR NSA-PR Score | 12 Weeks | The Pelvic Organ Prolapse Incontinence Sexual Questionnaire, IUGA-revised measures the impact of incontinence symptoms on sexual function and satisfaction. The Not Sexually Active-Partner Related (NSA-PR) ranges from 1 to 4 with higher scores indicating greater sexual function. The outcome is calculated as the difference in score at 12 weeks and the score at baseline. |
| Change From Baseline PISQ-IR NSA-CS Score | 12 Weeks | The Pelvic Organ Prolapse Incontinence Sexual Questionnaire, IUGA-revised measures the impact of incontinence symptoms on sexual function and satisfaction. The Not Sexually Active-Condition Specific (NSA-CS) ranges from 1 to 4 with higher scores indicating greater sexual function. The outcome is calculated as the difference in score at 12 weeks and the score at baseline. |
| Change From Baseline ABLe Liquid Score | 8 and 12 Weeks | The ABLE Liquid Score is a subscale of the validated Accidental Bowel Leakage Evaluation (ABLE) questionnaire which assesses the impact and severity of the leakage of liquid stool. Minimum score is 0 = no problem with liquid stool leakage; maximum score is 4 = frequent, bothersome leakage of large amounts of liquid stool. Change from baseline is calculated as Week \[8 or 12\] Score minus the score at baseline. |
| Change From Baseline PISQ-IR NSA-CI Score | 12 Weeks | The Pelvic Organ Prolapse Incontinence Sexual Questionnaire, IUGA-revised measures the impact of incontinence symptoms on sexual function and satisfaction. The Not Sexually Active-Condition Impact (NSA-CI) ranges from 1 to 4 with higher scores indicating greater sexual function. The outcome is calculated as the difference in score at 12 weeks and the score at baseline. |
| Change From Baseline PISQ-IR SA-AO Score | 12 Weeks | The Pelvic Organ Prolapse Incontinence Sexual Questionnaire, IUGA-revised measures the impact of incontinence symptoms on sexual function and satisfaction. The Sexually Active-Arousal Orgasm (SA-AO) ranges from 1 to 5 with higher scores indicating greater sexual function. The outcome is calculated as the difference in score at 12 weeks and the score at baseline. |
| Change From Baseline PISQ-IR SA-PR Score | 12 Weeks | The Pelvic Organ Prolapse Incontinence Sexual Questionnaire, IUGA-revised measures the impact of incontinence symptoms on sexual function and satisfaction. The Sexually Active-Partner Related (SA-PR) ranges from 1 to 4 with higher scores indicating greater sexual function. The outcome is calculated as the difference in score at 12 weeks and the score at baseline. |
| Change From Baseline PISQ-IR SA-CS Score | 12 Weeks | The Pelvic Organ Prolapse Incontinence Sexual Questionnaire, IUGA-revised measures the impact of incontinence symptoms on sexual function and satisfaction. The Sexually Active-Condition Specific (SA-CS) ranges from 1 to 5 with higher scores indicating greater sexual function. The outcome is calculated as the difference in score at 12 weeks and the score at baseline. |
| Change From Baseline PISQ-IR SA-D Score | 12 Weeks | The Pelvic Organ Prolapse Incontinence Sexual Questionnaire, IUGA-revised measures the impact of incontinence symptoms on sexual function and satisfaction. The Sexually Active-Desire (SA-D) ranges from 1 to 5 with higher scores indicating greater sexual function. The outcome is calculated as the difference in score at 12 weeks and the score at baseline. |
| Change From Baseline PISQ-IR SA-AVG Score | 12 Weeks | The Pelvic Organ Prolapse Incontinence Sexual Questionnaire, IUGA-revised measures the impact of incontinence symptoms on sexual function and satisfaction. The Sexually Active-Average (SA-AVG) ranges from 1 to 5 with higher scores indicating greater sexual function. The outcome is calculated as the difference in score at 12 weeks and the score at baseline. |
| Change From Baseline FIAI Hygiene Index Score | 12 Weeks | The Fecal Incontinence Adaptation Index (FIAI) is a validated form which measures the adaptation behavios resulting from fecal incontinence. It consists of two subscales: Hygiene (range: 0-100) and Avoidance (range: 0-100). Scores are cal calculated as the average of the non-missing responses multiplied by 25. The outcome is calculated as the difference in score at 12 weeks and the score at baseline. |
| Change From Baseline FIAI Avoidance Index Score | 12 Weeks | The Fecal Incontinence Adaptation Index (FIAI) is a validated form which measures the adaptation behavios resulting from fecal incontinence. It consists of two subscales: Hygiene (range: 0-100) and Avoidance (range: 0-100). Scores are cal calculated as the average of the non-missing responses multiplied by 25. The outcome is calculated as the difference in score at 12 weeks and the score at baseline. |
| Change From Baseline SF-12 Aggregate Physical Score | 12 Weeks | The 12-Item Short-Form Health Survey (SF-12) is a validated survey which assesses overall physical and mental health. The Aggregate Physical Score ranges from 24 to 56.6 with higher scores indicating greater physical health. The outcome is calculated as the difference in score at 12 weeks and the score at baseline. |
| Change From Baseline SF-12 Aggregate Mental Score | 12 Weeks | The 12-Item Short-Form Health Survey (SF-12) is a validated survey which assesses overall physical and mental health. The Aggregate Mental Score ranges from 19.06 to 60.86 with higher scores indicating greater mental health. The outcome is calculated as the difference in score at 12 weeks and the score at baseline |
| Change From Baseline PISQ-IR NSA-GQA Score | 12 Weeks | The Pelvic Organ Prolapse Incontinence Sexual Questionnaire, IUGA-revised measures the impact of incontinence symptoms on sexual function and satisfaction. The Not Sexually Active-Global Quality Rating (NSA-GQA) ranges from 1 to 4.5 with higher scores indicating greater sexual function. The outcome is calculated as the difference in score at 12 weeks and the score at baseline. |
| Change From Baseline ABLe Solid Score | 8 and 12 Weeks | The ABLE Solid Score is a subscale of the validated Accidental Bowel Leakage Evaluation (ABLE) questionnaire which assesses the impact and severity of the leakage of solid stool. Minimum score is 0 = no problem with solid stool leakage; maximum score is 4 = frequent, bothersome leakage of large amounts of solid stool. Change from baseline is calculated as Week \[8 or 12\] Score minus the score at baseline. |
| Change From Baseline ABLe Mucus Score | 8 and 12 Weeks | The ABLE Mucus Score is a subscale of the validated Accidental Bowel Leakage Evaluation (ABLE) questionnaire which assesses the impact and severity of the leakage of mucus from the rectum. Minimum score is 0 = no problem with mucus leakage from the rectum; maximum score is 4 = frequent, bothersome leakage of large amounts of mucus from the rectum. Change from baseline is calculated as Week \[8 or 12\] Score minus the score at baseline. |
| Change From Baseline ABLe Gas Score | 8 and 12 Weeks | The ABLE Gas Score is a subscale of the validated Accidental Bowel Leakage Evaluation (ABLE) questionnaire which assesses the impact and severity of the leakage of gas from the rectum. Minimum score is 0 = no problem with gas leakage from the rectum; maximum score is 4 = frequent and bothersome leakage of gas from the rectum. Change from baseline is calculated as Week \[8 or 12\] Score minus the score at baseline. |
| Change From Baseline ABLe Predictability/Awareness Score | 8 and 12 Weeks | The ABLE Predictability/Awareness Score is a subscale of the validated Accidental Bowel Leakage Evaluation (ABLE) questionnaire which assesses the predictability of bowel leakage events. Minimum score is 0 = no problems with leakage; maximum score is 4 = leakage without awareness or predictability. Change from baseline is calculated as Week \[8 or 12\] Score minus the score at baseline. |
| Change From Baseline ABLe Control Score | 8 and 12 Weeks | The ABLE Control Score is a subscale of the validated Accidental Bowel Leakage Evaluation (ABLE) questionnaire which assesses the ability to control bowel movements. Minimum score is 0 = no problems with urgency to empty bowels wthout warning; maximum score is 4 = frequent and bothersome urgency to empty bowels wthout warning. |
| Change From Baseline ABLe Ancillary Bowel Symptoms Score | 8 and 12 Weeks | The ABLE Ancillary Bowel Symptoms Score is a subscale of the validated Accidental Bowel Leakage Evaluation (ABLE) questionnaire which assesses the frequency and impact of ancially bowel symptoms. Minimum score is 0 = no problems with pain or incomplete emptying; maximum score is 4 = frequent and bothersome pain or incomplete emptying. |
| Change From Baseline ABLe Overall Score | 8 and 12 Weeks | The ABLE Overall Score is the summary score of the validated Accidental Bowel Leakage Evaluation (ABLE) questionnaire which assesses the frequency and impact of accidental bowel leakage and related symptoms. Minimum score is 0 = no problems with bowel leakage and related symptoms; maximum score is 4 = frequent and bothersome problems with bowel leakage and related symptoms. |
| Patient Global Symptom Control | Baseline and 4, 8, and 12 Weeks | The Patient Global Symptom Control (PGSC) is a patient-reported measure of perceived agreement that symptoms are under control, as assessed on a scale of 1 (Disagree Strongly) to 5 (Agree Strongly). Included here are participants who had reported disagreements as indicated by a rating of 1 (Disagree Strongly) or 2 (Disagree) |
| Change From Baseline FIQL Lifestyle Score | 8 and 12 Weeks | The FIQL Lifestyle Score is a subscale of the validated Fecal Incontinence Quality of Life (FIQL) questionnaire which assesses the impact of accidental bowel leakage on quality of life. Minimum score is 1 = lower functional quality of life; maximum score is 5 = higher functional quality of life. Change from baseline is calculated as Week \[8 or 12\] Score minus the score at baseline. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| PTNS PTNS treatment entails insertion of a 36 gauge needle electrode at a 60 degree angle 3-4 cm deep towards the tibial nerve, approximately 5 cm or 3 finger breadths cephalad to the medial malleolus and posterior to the tibia. The PTNS grounding electrode, placed near the calcaneus and the needle electrode will be connected to the ES-130 device pulse generator.
ES-130: The ES-130 device will be used for the indication of Posterior Tibial Nerve Stimulation for the treatment of fecal incontinence using the FDA-approved protocol for treatment of urge urinary incontinence (UUI) in the PFDN NOTABLe study. There is no PTNS device cleared by the FDA for the indication of FI treatment; therefore, this is considered an investigational device. | 111 |
| Sham Sham treatment will use the Streitberger acupuncture placebo needle in the same location as the needle electrode for PTNS. The sham uses an active gel surface electrode pad placed on the bottom of the foot just below the fifth (smallest) toe. This location is not part of the acupuncture nerve pathway connected to the bladder, pelvis or any major organs. Electrical current is delivered to this pad via a TENS unit resulting in sensory stimulation.
ES-130: The ES-130 device will be used for the indication of Posterior Tibial Nerve Stimulation for the treatment of fecal incontinence using the FDA-approved protocol for treatment of urge urinary incontinence (UUI) in the PFDN NOTABLe study. There is no PTNS device cleared by the FDA for the indication of FI treatment; therefore, this is considered an investigational device. | 55 |
| Total | 166 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 3 | 1 |
Baseline characteristics
| Characteristic | PTNS | Sham | Total |
|---|---|---|---|
| Age, Continuous | 63.5 years STANDARD_DEVIATION 12 | 63.8 years STANDARD_DEVIATION 11 | 63.6 years STANDARD_DEVIATION 12 |
| Body Mass Index | 29.2 kg/m^2 STANDARD_DEVIATION 7 | 29.7 kg/m^2 STANDARD_DEVIATION 6 | 29.4 kg/m^2 STANDARD_DEVIATION 7 |
| Current Smoker No | 102 Participants | 50 Participants | 152 Participants |
| Current Smoker Yes | 9 Participants | 5 Participants | 14 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 10 Participants | 6 Participants | 16 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 99 Participants | 49 Participants | 148 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 2 Participants | 0 Participants | 2 Participants |
| Ever Pregnant No | 4 Participants | 5 Participants | 9 Participants |
| Ever Pregnant Yes | 107 Participants | 50 Participants | 157 Participants |
| Menstrual Status not sure | 8 Participants | 2 Participants | 10 Participants |
| Menstrual Status post-menopausal | 92 Participants | 49 Participants | 141 Participants |
| Menstrual Status pre-menopausal | 11 Participants | 4 Participants | 15 Participants |
| Number of Cesarean Deliveries | 0 deliveries per participant | 0 deliveries per participant | 0 deliveries per participant |
| Number of Vaginal Deliveries | 2 deliveries per participant | 2 deliveries per participant | 2 deliveries per participant |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) Black or African American | 10 Participants | 9 Participants | 19 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 3 Participants | 4 Participants | 7 Participants |
| Race (NIH/OMB) White | 95 Participants | 39 Participants | 134 Participants |
| Sex/Gender, Customized Female | 111 Participants | 55 Participants | 166 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 1 / 111 | 0 / 55 |
| other Total, other adverse events | 72 / 111 | 30 / 55 |
| serious Total, serious adverse events | 4 / 111 | 2 / 55 |
Outcome results
Primary
Change From Baseline St. Mark's (Vaizey) Score
The primary outcome measure is the change from baseline in St. Mark's (Vaizey) Score 12 weeks after treatment initiation to compare the outcomes of post-tibial nerve stimulation (PTNS) versus sham stimulation. The St. Mark's (Vaizey) score, published in 1999, is commonly used in clinical studies and reports and was based on the Jorge-Wexner score but added two further items for assessment: the use of constipating medication and the presence of fecal urgency. Minimum score is 0 = perfect continence; maximum score is 24 = totally incontinent. Change from baseline is calculated as Week \[4, 8, or 12\] Score minus the score at baseline.
Time frame: 4, 8, and 12 Weeks
Population: An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| PTNS | Change From Baseline St. Mark's (Vaizey) Score | Week 4 | -2.8 units on a scale |
| PTNS | Change From Baseline St. Mark's (Vaizey) Score | Week 8 | -4.3 units on a scale |
| PTNS | Change From Baseline St. Mark's (Vaizey) Score | Week 12 | -5.3 units on a scale |
| Sham | Change From Baseline St. Mark's (Vaizey) Score | Week 4 | -3.3 units on a scale |
| Sham | Change From Baseline St. Mark's (Vaizey) Score | Week 8 | -4.1 units on a scale |
| Sham | Change From Baseline St. Mark's (Vaizey) Score | Week 12 | -3.9 units on a scale |
Secondary
50% Improvement in Fecal Incontinence Episodes Per Week
Based on data collected from participant-completed diaries at baseline, 8, and 12 weeks, the outcome is calculated as any participant with a 50% reduction in fecal incontinence episodes per week at 8 and 12 weeks compared to the fecal incontinence episodes at baseline
Time frame: 8 and 12 Weeks
Population: An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| PTNS | 50% Improvement in Fecal Incontinence Episodes Per Week | Week 8 | >= 50% Improvement | 38 Participants |
| PTNS | 50% Improvement in Fecal Incontinence Episodes Per Week | Week 8 | < 50% Improvement | 61 Participants |
| PTNS | 50% Improvement in Fecal Incontinence Episodes Per Week | Week 12 | >= 50% Improvement | 51 Participants |
| PTNS | 50% Improvement in Fecal Incontinence Episodes Per Week | Week 12 | < 50% Improvement | 46 Participants |
| Sham | 50% Improvement in Fecal Incontinence Episodes Per Week | Week 12 | < 50% Improvement | 29 Participants |
| Sham | 50% Improvement in Fecal Incontinence Episodes Per Week | Week 8 | >= 50% Improvement | 14 Participants |
| Sham | 50% Improvement in Fecal Incontinence Episodes Per Week | Week 12 | >= 50% Improvement | 19 Participants |
| Sham | 50% Improvement in Fecal Incontinence Episodes Per Week | Week 8 | < 50% Improvement | 35 Participants |
Secondary
75% Improvement in Fecal Incontinence Episodes Per Week
Based on data collected from participant-completed diaries at baseline, 8, and 12 weeks, the outcome is calculated as any participant with a 75% reduction in fecal incontinence episodes per week at 8, and 12 weeks compared to the fecal incontinence episodes at baseline.
Time frame: 8 and 12 Weeks
Population: An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| PTNS | 75% Improvement in Fecal Incontinence Episodes Per Week | Week 8 | >= 75% Improvement | 19 Participants |
| PTNS | 75% Improvement in Fecal Incontinence Episodes Per Week | Week 8 | < 75% Improvement | 80 Participants |
| PTNS | 75% Improvement in Fecal Incontinence Episodes Per Week | Week 12 | >= 75% Improvement | 32 Participants |
| PTNS | 75% Improvement in Fecal Incontinence Episodes Per Week | Week 12 | < 75% Improvement | 65 Participants |
| Sham | 75% Improvement in Fecal Incontinence Episodes Per Week | Week 12 | < 75% Improvement | 35 Participants |
| Sham | 75% Improvement in Fecal Incontinence Episodes Per Week | Week 8 | >= 75% Improvement | 10 Participants |
| Sham | 75% Improvement in Fecal Incontinence Episodes Per Week | Week 12 | >= 75% Improvement | 13 Participants |
| Sham | 75% Improvement in Fecal Incontinence Episodes Per Week | Week 8 | < 75% Improvement | 39 Participants |
Secondary
Change From Baseline Number of Bowel Movements Per Week
Based on data collected from participant-completed diaries at baseline, 8, and 12 weeks, the outcome variable is computed as the difference in number of bowel movements per week at 8 and 12 weeks and the number of bowel movements at baseline.
Time frame: 8 and 12 Weeks
Population: An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| PTNS | Change From Baseline Number of Bowel Movements Per Week | Week 8 | -1.8 episodes per week |
| PTNS | Change From Baseline Number of Bowel Movements Per Week | Week 12 | -1.8 episodes per week |
| Sham | Change From Baseline Number of Bowel Movements Per Week | Week 8 | -0.2 episodes per week |
| Sham | Change From Baseline Number of Bowel Movements Per Week | Week 12 | -1.5 episodes per week |
Secondary
Change From Baseline Number of Days Without Fecal Incontinence Episodes Per Week
Based on data collected from participant-completed diaries at baseline, 8, and 12 weeks, the outcome variable is computed as the difference in number of days without fecal incontinence episodes per week at 8 and 12 weeks and the number of days without fecal incontinence episodes at baseline.
Time frame: 8 and 12 Weeks
Population: An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| PTNS | Change From Baseline Number of Days Without Fecal Incontinence Episodes Per Week | Week 8 | 1 episodes per week |
| PTNS | Change From Baseline Number of Days Without Fecal Incontinence Episodes Per Week | Week 12 | 1.3 episodes per week |
| Sham | Change From Baseline Number of Days Without Fecal Incontinence Episodes Per Week | Week 8 | 0.8 episodes per week |
| Sham | Change From Baseline Number of Days Without Fecal Incontinence Episodes Per Week | Week 12 | 0.8 episodes per week |
Secondary
Change From Baseline Number of Fecal Incontinence Events Per Week
Based on data collected from participant-completed diaries at baseline, 8, and 12 weeks, the outcome variable is computed as the difference in number of fecal incontinence episodes per week at 8 and 12 weeks and the number of fecal incontinence episodes at baseline.
Time frame: 8 and 12 Weeks
Population: An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| PTNS | Change From Baseline Number of Fecal Incontinence Events Per Week | Week 8 | -2.4 episodes per week |
| PTNS | Change From Baseline Number of Fecal Incontinence Events Per Week | Week 12 | -2.3 episodes per week |
| Sham | Change From Baseline Number of Fecal Incontinence Events Per Week | Week 8 | -1.6 episodes per week |
| Sham | Change From Baseline Number of Fecal Incontinence Events Per Week | Week 12 | -2.1 episodes per week |
Secondary
Change From Baseline Number of Urge Bowel Movements Per Week
Based on data collected from participant-completed diaries at baseline, 8, and 12 weeks, the outcome variable is computed as the difference in number of urge bowel movements per week at 8 and 12 weeks and the number of urge bowel movements at baseline.
Time frame: 8 and 12 Weeks
Population: An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| PTNS | Change From Baseline Number of Urge Bowel Movements Per Week | Week 8 | -1.9 episodes per week |
| PTNS | Change From Baseline Number of Urge Bowel Movements Per Week | Week 12 | -2.3 episodes per week |
| Sham | Change From Baseline Number of Urge Bowel Movements Per Week | Week 8 | -1.1 episodes per week |
| Sham | Change From Baseline Number of Urge Bowel Movements Per Week | Week 12 | -2.2 episodes per week |
Secondary
Change From Baseline Number of Urge Fecal Incontinence Events Per Week
Based on data collected from participant-completed diaries at baseline, 8, and 12 weeks, the outcome variable is computed as the difference in number of urge fecal incontinence episodes per week at 8 and 12 weeks and the number of urge fecal incontinence episodes at baseline.
Time frame: 8 and 12 Weeks
Population: An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| PTNS | Change From Baseline Number of Urge Fecal Incontinence Events Per Week | Week 8 | -1.3 episodes per week |
| PTNS | Change From Baseline Number of Urge Fecal Incontinence Events Per Week | Week 12 | -1.1 episodes per week |
| Sham | Change From Baseline Number of Urge Fecal Incontinence Events Per Week | Week 8 | -0.4 episodes per week |
| Sham | Change From Baseline Number of Urge Fecal Incontinence Events Per Week | Week 12 | -0.8 episodes per week |
Secondary
Patient Global Impression-Improvement
The Patient Global Impression of Improvement (PGI-I) is a patient-reported measure of perceived improvement with treatment, as assessed on a scale of 1 (very much better) to 7 (very much worse). Included here are participants who had improvement as indicated by a rating of 1 (very much better) or 2 (much better)
Time frame: 4, 8, and 12 Weeks
Population: An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| PTNS | Patient Global Impression-Improvement | Week 4 | Improved | 20 Participants |
| PTNS | Patient Global Impression-Improvement | Week 4 | No improvement | 83 Participants |
| PTNS | Patient Global Impression-Improvement | Week 8 | Improved | 36 Participants |
| PTNS | Patient Global Impression-Improvement | Week 8 | No improvement | 70 Participants |
| PTNS | Patient Global Impression-Improvement | Week 12 | Improved | 47 Participants |
| PTNS | Patient Global Impression-Improvement | Week 12 | No improvement | 56 Participants |
| Sham | Patient Global Impression-Improvement | Week 12 | Improved | 21 Participants |
| Sham | Patient Global Impression-Improvement | Week 4 | Improved | 13 Participants |
| Sham | Patient Global Impression-Improvement | Week 8 | No improvement | 33 Participants |
| Sham | Patient Global Impression-Improvement | Week 4 | No improvement | 37 Participants |
| Sham | Patient Global Impression-Improvement | Week 12 | No improvement | 33 Participants |
| Sham | Patient Global Impression-Improvement | Week 8 | Improved | 17 Participants |
Secondary
Responder to Treatment
Responder status is based on the primary chnage from St. Mark's Score. A responder is defined as any particpant with at least a 4 point reduction in score compared to their baseline score
Time frame: 4, 8, and 12 Weeks
Population: An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| PTNS | Responder to Treatment | Week 8 | Non-responder | 51 Participants |
| PTNS | Responder to Treatment | Week 12 | Non-responder | 40 Participants |
| PTNS | Responder to Treatment | Week 4 | Responder | 39 Participants |
| PTNS | Responder to Treatment | Week 8 | Responder | 54 Participants |
| PTNS | Responder to Treatment | Week 4 | Non-responder | 63 Participants |
| PTNS | Responder to Treatment | Week 12 | Responder | 64 Participants |
| Sham | Responder to Treatment | Week 12 | Non-responder | 28 Participants |
| Sham | Responder to Treatment | Week 8 | Non-responder | 23 Participants |
| Sham | Responder to Treatment | Week 4 | Non-responder | 26 Participants |
| Sham | Responder to Treatment | Week 12 | Responder | 26 Participants |
| Sham | Responder to Treatment | Week 4 | Responder | 24 Participants |
| Sham | Responder to Treatment | Week 8 | Responder | 29 Participants |
Other Pre-specified
Change From Baseline ABLe Ancillary Bowel Symptoms Score
The ABLE Ancillary Bowel Symptoms Score is a subscale of the validated Accidental Bowel Leakage Evaluation (ABLE) questionnaire which assesses the frequency and impact of ancially bowel symptoms. Minimum score is 0 = no problems with pain or incomplete emptying; maximum score is 4 = frequent and bothersome pain or incomplete emptying.
Time frame: 8 and 12 Weeks
Population: An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| PTNS | Change From Baseline ABLe Ancillary Bowel Symptoms Score | Week 8 | -0.4 units on a scale |
| PTNS | Change From Baseline ABLe Ancillary Bowel Symptoms Score | Week 12 | -0.7 units on a scale |
| Sham | Change From Baseline ABLe Ancillary Bowel Symptoms Score | Week 8 | -0.3 units on a scale |
| Sham | Change From Baseline ABLe Ancillary Bowel Symptoms Score | Week 12 | -0.4 units on a scale |
Other Pre-specified
Change From Baseline ABLe Control Score
The ABLE Control Score is a subscale of the validated Accidental Bowel Leakage Evaluation (ABLE) questionnaire which assesses the ability to control bowel movements. Minimum score is 0 = no problems with urgency to empty bowels wthout warning; maximum score is 4 = frequent and bothersome urgency to empty bowels wthout warning.
Time frame: 8 and 12 Weeks
Population: An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| PTNS | Change From Baseline ABLe Control Score | Week 8 | -0.3 units on a scale |
| PTNS | Change From Baseline ABLe Control Score | Week 12 | -0.6 units on a scale |
| Sham | Change From Baseline ABLe Control Score | Week 8 | -0.3 units on a scale |
| Sham | Change From Baseline ABLe Control Score | Week 12 | -0.6 units on a scale |
Other Pre-specified
Change From Baseline ABLe Gas Score
The ABLE Gas Score is a subscale of the validated Accidental Bowel Leakage Evaluation (ABLE) questionnaire which assesses the impact and severity of the leakage of gas from the rectum. Minimum score is 0 = no problem with gas leakage from the rectum; maximum score is 4 = frequent and bothersome leakage of gas from the rectum. Change from baseline is calculated as Week \[8 or 12\] Score minus the score at baseline.
Time frame: 8 and 12 Weeks
Population: An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| PTNS | Change From Baseline ABLe Gas Score | Week 8 | -0.3 units on a scale |
| PTNS | Change From Baseline ABLe Gas Score | Week 12 | -0.4 units on a scale |
| Sham | Change From Baseline ABLe Gas Score | Week 8 | -0.2 units on a scale |
| Sham | Change From Baseline ABLe Gas Score | Week 12 | -0.4 units on a scale |
Other Pre-specified
Change From Baseline ABLe Liquid Score
The ABLE Liquid Score is a subscale of the validated Accidental Bowel Leakage Evaluation (ABLE) questionnaire which assesses the impact and severity of the leakage of liquid stool. Minimum score is 0 = no problem with liquid stool leakage; maximum score is 4 = frequent, bothersome leakage of large amounts of liquid stool. Change from baseline is calculated as Week \[8 or 12\] Score minus the score at baseline.
Time frame: 8 and 12 Weeks
Population: An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| PTNS | Change From Baseline ABLe Liquid Score | Week 8 | -0.3 units on a scale |
| PTNS | Change From Baseline ABLe Liquid Score | Week 12 | -0.6 units on a scale |
| Sham | Change From Baseline ABLe Liquid Score | Week 8 | -0.5 units on a scale |
| Sham | Change From Baseline ABLe Liquid Score | Week 12 | -0.7 units on a scale |
Other Pre-specified
Change From Baseline ABLe Mucus Score
The ABLE Mucus Score is a subscale of the validated Accidental Bowel Leakage Evaluation (ABLE) questionnaire which assesses the impact and severity of the leakage of mucus from the rectum. Minimum score is 0 = no problem with mucus leakage from the rectum; maximum score is 4 = frequent, bothersome leakage of large amounts of mucus from the rectum. Change from baseline is calculated as Week \[8 or 12\] Score minus the score at baseline.
Time frame: 8 and 12 Weeks
Population: An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| PTNS | Change From Baseline ABLe Mucus Score | Week 8 | -0.5 units on a scale |
| PTNS | Change From Baseline ABLe Mucus Score | Week 12 | -0.7 units on a scale |
| Sham | Change From Baseline ABLe Mucus Score | Week 8 | -0.4 units on a scale |
| Sham | Change From Baseline ABLe Mucus Score | Week 12 | -0.4 units on a scale |
Other Pre-specified
Change From Baseline ABLe Overall Score
The ABLE Overall Score is the summary score of the validated Accidental Bowel Leakage Evaluation (ABLE) questionnaire which assesses the frequency and impact of accidental bowel leakage and related symptoms. Minimum score is 0 = no problems with bowel leakage and related symptoms; maximum score is 4 = frequent and bothersome problems with bowel leakage and related symptoms.
Time frame: 8 and 12 Weeks
Population: An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| PTNS | Change From Baseline ABLe Overall Score | Week 8 | -0.4 units on a scale |
| PTNS | Change From Baseline ABLe Overall Score | Week 12 | -0.7 units on a scale |
| Sham | Change From Baseline ABLe Overall Score | Week 8 | -0.3 units on a scale |
| Sham | Change From Baseline ABLe Overall Score | Week 12 | -0.4 units on a scale |
Other Pre-specified
Change From Baseline ABLe Predictability/Awareness Score
The ABLE Predictability/Awareness Score is a subscale of the validated Accidental Bowel Leakage Evaluation (ABLE) questionnaire which assesses the predictability of bowel leakage events. Minimum score is 0 = no problems with leakage; maximum score is 4 = leakage without awareness or predictability. Change from baseline is calculated as Week \[8 or 12\] Score minus the score at baseline.
Time frame: 8 and 12 Weeks
Population: An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| PTNS | Change From Baseline ABLe Predictability/Awareness Score | Week 8 | 0 units on a scale |
| PTNS | Change From Baseline ABLe Predictability/Awareness Score | Week 12 | -0.2 units on a scale |
| Sham | Change From Baseline ABLe Predictability/Awareness Score | Week 8 | 0 units on a scale |
| Sham | Change From Baseline ABLe Predictability/Awareness Score | Week 12 | 0 units on a scale |
Other Pre-specified
Change From Baseline ABLe Solid Score
The ABLE Solid Score is a subscale of the validated Accidental Bowel Leakage Evaluation (ABLE) questionnaire which assesses the impact and severity of the leakage of solid stool. Minimum score is 0 = no problem with solid stool leakage; maximum score is 4 = frequent, bothersome leakage of large amounts of solid stool. Change from baseline is calculated as Week \[8 or 12\] Score minus the score at baseline.
Time frame: 8 and 12 Weeks
Population: An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| PTNS | Change From Baseline ABLe Solid Score | Week 8 | -0.5 units on a scale |
| PTNS | Change From Baseline ABLe Solid Score | Week 12 | -0.7 units on a scale |
| Sham | Change From Baseline ABLe Solid Score | Week 8 | -0.4 units on a scale |
| Sham | Change From Baseline ABLe Solid Score | Week 12 | -0.7 units on a scale |
Other Pre-specified
Change From Baseline CRAIQ Score
The Pelvic Floor Impact Questionnaire short form (PFIQ-7) measuring the impact of bladder, bowel, and vaginal symptoms on a woman's daily activities, relationships and emotions is composed of 3 scales of 7 questions each: the Urinary Impact Questionnaire (UIQ; range 0-100), the Pelvic Organ Prolapse Impact Questionnaire (POPIQ; range 0-100), and the Colorectal-Anal Impact Questionnaire (CRAIQ; range 0-100). Scores are calculated by multiplying the mean value of all answered questions for a scale by 100 divided by 3. The range of responses is: 0-100 with 0 (least negative impact) to 100 (most negative impact). Change = (Week \[8, 12\] Score - Baseline Score). Lower scores indicate better function / fewer symptoms.
Time frame: 8 and 12 Weeks
Population: An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| PTNS | Change From Baseline CRAIQ Score | Week 8 | -12.9 units on a scale |
| PTNS | Change From Baseline CRAIQ Score | Week 12 | -19.1 units on a scale |
| Sham | Change From Baseline CRAIQ Score | Week 8 | -12.8 units on a scale |
| Sham | Change From Baseline CRAIQ Score | Week 12 | -14.5 units on a scale |
Other Pre-specified
Change From Baseline FIAI Avoidance Index Score
The Fecal Incontinence Adaptation Index (FIAI) is a validated form which measures the adaptation behavios resulting from fecal incontinence. It consists of two subscales: Hygiene (range: 0-100) and Avoidance (range: 0-100). Scores are cal calculated as the average of the non-missing responses multiplied by 25. The outcome is calculated as the difference in score at 12 weeks and the score at baseline.
Time frame: 12 Weeks
Population: An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| PTNS | Change From Baseline FIAI Avoidance Index Score | -12.8 units on a scale |
| Sham | Change From Baseline FIAI Avoidance Index Score | -6.4 units on a scale |
Other Pre-specified
Change From Baseline FIAI Hygiene Index Score
The Fecal Incontinence Adaptation Index (FIAI) is a validated form which measures the adaptation behavios resulting from fecal incontinence. It consists of two subscales: Hygiene (range: 0-100) and Avoidance (range: 0-100). Scores are cal calculated as the average of the non-missing responses multiplied by 25. The outcome is calculated as the difference in score at 12 weeks and the score at baseline.
Time frame: 12 Weeks
Population: An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| PTNS | Change From Baseline FIAI Hygiene Index Score | -10.2 units on a scale |
| Sham | Change From Baseline FIAI Hygiene Index Score | -2.8 units on a scale |
Other Pre-specified
Change From Baseline FIQL Coping Score
The FIQL Coping Score is a subscale of the validated Fecal Incontinence Quality of Life (FIQL) questionnaire which assesses the impact of accidental bowel leakage on quality of life. Minimum score is 1 = lower functional quality of life; maximum score is 5 = higher functional quality of life. Change from baseline is calculated as Week \[8 or 12\] Score minus the score at baseline.
Time frame: 8 and 12 Weeks
Population: An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| PTNS | Change From Baseline FIQL Coping Score | Week 8 | 0.4 units on a scale |
| PTNS | Change From Baseline FIQL Coping Score | Week 12 | 0.6 units on a scale |
| Sham | Change From Baseline FIQL Coping Score | Week 8 | 0.4 units on a scale |
| Sham | Change From Baseline FIQL Coping Score | Week 12 | 0.5 units on a scale |
Other Pre-specified
Change From Baseline FIQL Depression Score
The FIQL Depression Score is a subscale of the validated Fecal Incontinence Quality of Life (FIQL) questionnaire which assesses the impact of accidental bowel leakage on quality of life. Minimum score is 1 = lower functional quality of life; maximum score is 5 = higher functional quality of life. Change from baseline is calculated as Week \[8 or 12\] Score minus the score at baseline.
Time frame: 8 and 12 Weeks
Population: An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| PTNS | Change From Baseline FIQL Depression Score | Week 8 | 0.3 units on a scale |
| PTNS | Change From Baseline FIQL Depression Score | Week 12 | 0.5 units on a scale |
| Sham | Change From Baseline FIQL Depression Score | Week 8 | 0.2 units on a scale |
| Sham | Change From Baseline FIQL Depression Score | Week 12 | 0.2 units on a scale |
Other Pre-specified
Change From Baseline FIQL Embarrassment Score
The FIQL Embarrassment Score is a subscale of the validated Fecal Incontinence Quality of Life (FIQL) questionnaire which assesses the impact of accidental bowel leakage on quality of life. Minimum score is 1 = lower functional quality of life; maximum score is 5 = higher functional quality of life. Change from baseline is calculated as Week \[8 or 12\] Score minus the score at baseline.
Time frame: 8 and 12 Weeks
Population: An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| PTNS | Change From Baseline FIQL Embarrassment Score | Week 8 | 0.4 units on a scale |
| PTNS | Change From Baseline FIQL Embarrassment Score | Week 12 | 0.7 units on a scale |
| Sham | Change From Baseline FIQL Embarrassment Score | Week 8 | 0.4 units on a scale |
| Sham | Change From Baseline FIQL Embarrassment Score | Week 12 | 0.4 units on a scale |
Other Pre-specified
Change From Baseline FIQL Lifestyle Score
The FIQL Lifestyle Score is a subscale of the validated Fecal Incontinence Quality of Life (FIQL) questionnaire which assesses the impact of accidental bowel leakage on quality of life. Minimum score is 1 = lower functional quality of life; maximum score is 5 = higher functional quality of life. Change from baseline is calculated as Week \[8 or 12\] Score minus the score at baseline.
Time frame: 8 and 12 Weeks
Population: An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| PTNS | Change From Baseline FIQL Lifestyle Score | Week 8 | 0.3 units on a scale |
| PTNS | Change From Baseline FIQL Lifestyle Score | Week 12 | 0.6 units on a scale |
| Sham | Change From Baseline FIQL Lifestyle Score | Week 8 | 0.4 units on a scale |
| Sham | Change From Baseline FIQL Lifestyle Score | Week 12 | 0.4 units on a scale |
Other Pre-specified
Change From Baseline FISI Doctor Score
The FISI Doctor Score is a summary score of the validated Fecal Incontinence Severity Index questionnaire which provides a summary metric of the severity of fecal incontinence from the doctor's perspective. Minimum score is 0 = no fecal incontinence; maximum score is 57 = very severe fecal incontinence. Change from baseline is calculated as Week \[8 or 12\] Score minus the score at baseline.
Time frame: 8 and 12 Weeks
Population: An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| PTNS | Change From Baseline FISI Doctor Score | Week 8 | -5 units on a scale |
| PTNS | Change From Baseline FISI Doctor Score | Week 12 | -7.4 units on a scale |
| Sham | Change From Baseline FISI Doctor Score | Week 8 | -6.3 units on a scale |
| Sham | Change From Baseline FISI Doctor Score | Week 12 | -7 units on a scale |
Other Pre-specified
Change From Baseline FISI Patient Score
The FISI Patient Score is a summary score of the validated Fecal Incontinence Severity Index questionnaire which provides a summary metric of the severity of fecal incontinence from the patient's perspective. Minimum score is 0 = no fecal incontinence; maximum score is 61 = very severe fecal incontinence. Change from baseline is calculated as Week \[8 or 12\] Score minus the score at baseline.
Time frame: 8 and 12 Weeks
Population: An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| PTNS | Change From Baseline FISI Patient Score | Week 8 | -4.9 units on a scale |
| PTNS | Change From Baseline FISI Patient Score | Week 12 | -7.5 units on a scale |
| Sham | Change From Baseline FISI Patient Score | Week 8 | -5.9 units on a scale |
| Sham | Change From Baseline FISI Patient Score | Week 12 | -6.7 units on a scale |
Other Pre-specified
Change From Baseline MMHQ Emotional Function Score
The MMHQ Emotional Function Score is a subscale of the validated Modified-Manchester Health questionnaire (MMHq) which provides a health-related quality of life rating. Minimum score is 0 = high quality of life; maximum score is 100 = low quality of life. Change from baseline is calculated as Week \[8 or 12\] Score minus the score at baseline.
Time frame: 8 and 12 Weeks
Population: An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| PTNS | Change From Baseline MMHQ Emotional Function Score | Week 8 | -7.2 units on a scale |
| PTNS | Change From Baseline MMHQ Emotional Function Score | Week 12 | -14.4 units on a scale |
| Sham | Change From Baseline MMHQ Emotional Function Score | Week 8 | -4.6 units on a scale |
| Sham | Change From Baseline MMHQ Emotional Function Score | Week 12 | -7.4 units on a scale |
Other Pre-specified
Change From Baseline MMHQ Incontinence Impact Score
The MMHQ Incontinence Impact Score is a subscale of the validated Modified-Manchester Health questionnaire (MMHq) which provides a health-related quality of life rating. Minimum score is 0 = high quality of life; maximum score is 100 = low quality of life. Change from baseline is calculated as Week \[8 or 12\] Score minus the score at baseline.
Time frame: 8 and 12 Weeks
Population: An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| PTNS | Change From Baseline MMHQ Incontinence Impact Score | Week 8 | -9.4 units on a scale |
| PTNS | Change From Baseline MMHQ Incontinence Impact Score | Week 12 | -17.2 units on a scale |
| Sham | Change From Baseline MMHQ Incontinence Impact Score | Week 8 | -11.3 units on a scale |
| Sham | Change From Baseline MMHQ Incontinence Impact Score | Week 12 | -15.9 units on a scale |
Other Pre-specified
Change From Baseline MMHQ Personal Relationship Score
The MMHQ Personal Relationship Score is a subscale of the validated Modified-Manchester Health questionnaire (MMHq) which provides a health-related quality of life rating. Minimum score is 0 = high quality of life; maximum score is 100 = low quality of life. Change from baseline is calculated as Week \[8 or 12\] Score minus the score at baseline.
Time frame: 8 and 12 Weeks
Population: An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| PTNS | Change From Baseline MMHQ Personal Relationship Score | Week 8 | -5 units on a scale |
| PTNS | Change From Baseline MMHQ Personal Relationship Score | Week 12 | -6.2 units on a scale |
| Sham | Change From Baseline MMHQ Personal Relationship Score | Week 8 | -2.2 units on a scale |
| Sham | Change From Baseline MMHQ Personal Relationship Score | Week 12 | -11.4 units on a scale |
Other Pre-specified
Change From Baseline MMHQ Physical Limitations Score
The MMHQ Physical Limitations Score is a subscale of the validated Modified-Manchester Health questionnaire (MMHq) which provides a health-related quality of life rating. Minimum score is 0 = high quality of life; maximum score is 100 = low quality of life. Change from baseline is calculated as Week \[8 or 12\] Score minus the score at baseline.
Time frame: 8 and 12 Weeks
Population: An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| PTNS | Change From Baseline MMHQ Physical Limitations Score | Week 8 | -10.3 units on a scale |
| PTNS | Change From Baseline MMHQ Physical Limitations Score | Week 12 | -20.4 units on a scale |
| Sham | Change From Baseline MMHQ Physical Limitations Score | Week 8 | -3.8 units on a scale |
| Sham | Change From Baseline MMHQ Physical Limitations Score | Week 12 | -10.6 units on a scale |
Other Pre-specified
Change From Baseline MMHQ Role Limitations Score
The MMHQ Role Limitations Score is a subscale of the validated Modified-Manchester Health questionnaire (MMHq) which provides a health-related quality of life rating. Minimum score is 0 = high quality of life; maximum score is 100 = low quality of life. Change from baseline is calculated as Week \[8 or 12\] Score minus the score at baseline.
Time frame: 8 and 12 Weeks
Population: An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| PTNS | Change From Baseline MMHQ Role Limitations Score | Week 8 | -9.8 units on a scale |
| PTNS | Change From Baseline MMHQ Role Limitations Score | Week 12 | -17.5 units on a scale |
| Sham | Change From Baseline MMHQ Role Limitations Score | Week 8 | -3.1 units on a scale |
| Sham | Change From Baseline MMHQ Role Limitations Score | Week 12 | -9.9 units on a scale |
Other Pre-specified
Change From Baseline MMHQ Severity Measures Score
The MMHQ Severity Measures Score is a subscale of the validated Modified-Manchester Health questionnaire (MMHq) which provides a health-related quality of life rating. Minimum score is 0 = high quality of life; maximum score is 100 = low quality of life. Change from baseline is calculated as Week \[8 or 12\] Score minus the score at baseline.
Time frame: 8 and 12 Weeks
Population: An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| PTNS | Change From Baseline MMHQ Severity Measures Score | Week 8 | -9.1 units on a scale |
| PTNS | Change From Baseline MMHQ Severity Measures Score | Week 12 | -17 units on a scale |
| Sham | Change From Baseline MMHQ Severity Measures Score | Week 8 | -10.7 units on a scale |
| Sham | Change From Baseline MMHQ Severity Measures Score | Week 12 | -11.8 units on a scale |
Other Pre-specified
Change From Baseline MMHQ Sleep/Energy Score
The MMHQ Sleep/Energy Score is a subscale of the validated Modified-Manchester Health questionnaire (MMHq) which provides a health-related quality of life rating. Minimum score is 0 = high quality of life; maximum score is 100 = low quality of life. Change from baseline is calculated as Week \[8 or 12\] Score minus the score at baseline.
Time frame: 8 and 12 Weeks
Population: An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| PTNS | Change From Baseline MMHQ Sleep/Energy Score | Week 8 | -7.2 units on a scale |
| PTNS | Change From Baseline MMHQ Sleep/Energy Score | Week 12 | -11 units on a scale |
| Sham | Change From Baseline MMHQ Sleep/Energy Score | Week 8 | -4.3 units on a scale |
| Sham | Change From Baseline MMHQ Sleep/Energy Score | Week 12 | -6.4 units on a scale |
Other Pre-specified
Change From Baseline MMHQ Social Limitations Score
The MMHQ Social Limitations Score is a subscale of the validated Modified-Manchester Health questionnaire (MMHq) which provides a health-related quality of life rating. Minimum score is 0 = high quality of life; maximum score is 100 = low quality of life. Change from baseline is calculated as Week \[8 or 12\] Score minus the score at baseline.
Time frame: 8 and 12 Weeks
Population: An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| PTNS | Change From Baseline MMHQ Social Limitations Score | Week 8 | -9.6 units on a scale |
| PTNS | Change From Baseline MMHQ Social Limitations Score | Week 12 | -14.8 units on a scale |
| Sham | Change From Baseline MMHQ Social Limitations Score | Week 8 | -1.8 units on a scale |
| Sham | Change From Baseline MMHQ Social Limitations Score | Week 12 | -8.6 units on a scale |
Other Pre-specified
Change From Baseline PAC-SYM Abdominal Score
The Patient Assessment of Constipation - Symptom (PAC-SYM) ia a validated form measuring the frequency and severity of chronic constipation. It consists of an overall score (range: 0-4) consisting of 3 subscales across 12 question: the Abdominal score (range 0-4), the Rectal Score (range 0-4), and the Stool Score (range 0-4). Scores are calculated as the mean of non-mising responses. The range of responses is: 0-4 with 0 (Absent) to 4 (Very sever). Change = (Week 12 Score - Baseline Score). Lower scores indicate less severe constipation.
Time frame: 12 Weeks
Population: An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| PTNS | Change From Baseline PAC-SYM Abdominal Score | -0.4 units on a scale |
| Sham | Change From Baseline PAC-SYM Abdominal Score | -0.2 units on a scale |
Other Pre-specified
Change From Baseline PAC-SYM Rectal Score
The Patient Assessment of Constipation - Symptom (PAC-SYM) ia a validated form measuring the frequency and severity of chronic constipation. It consists of an overall score (range: 0-4) consisting of 3 subscales across 12 question: the Abdominal score (range 0-4), the Rectal Score (range 0-4), and the Stool Score (range 0-4). Scores are calculated as the mean of non-mising responses. The range of responses is: 0-4 with 0 (Absent) to 4 (Very sever). Change = (Week 12 Score - Baseline Score). Lower scores indicate less severe constipation.
Time frame: 12 Weeks
Population: An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| PTNS | Change From Baseline PAC-SYM Rectal Score | -0.1 units on a scale |
| Sham | Change From Baseline PAC-SYM Rectal Score | -0.1 units on a scale |
Other Pre-specified
Change From Baseline PAC-SYM Stool Score
The Patient Assessment of Constipation - Symptom (PAC-SYM) ia a validated form measuring the frequency and severity of chronic constipation. It consists of an overall score (range: 0-4) consisting of 3 subscales across 12 question: the Abdominal score (range 0-4), the Rectal Score (range 0-4), and the Stool Score (range 0-4). Scores are calculated as the mean of non-mising responses. The range of responses is: 0-4 with 0 (Absent) to 4 (Very sever). Change = (Week 12 Score - Baseline Score). Lower scores indicate less severe constipation.
Time frame: 12 Weeks
Population: An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| PTNS | Change From Baseline PAC-SYM Stool Score | -0.3 units on a scale |
| Sham | Change From Baseline PAC-SYM Stool Score | -0.2 units on a scale |
Other Pre-specified
Change From Baseline PAC-SYM Total Score
The Patient Assessment of Constipation - Symptom (PAC-SYM) is a validated form measuring the frequency and severity of chronic constipation. It consists of an overall score (range: 0-4) consisting of 3 subscales across 12 question: the Abdominal score (range 0-4), the Rectal Score (range 0-4), and the Stool Score (range 0-4). Scores are calculated as the mean of non-missing responses. The range of responses is: 0-4 with 0 (Absent) to 4 (Very severe). Change = (Week 12 Score - Baseline Score). Lower scores indicate less severe constipation.
Time frame: 12 Weeks
Population: An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| PTNS | Change From Baseline PAC-SYM Total Score | -0.3 units on a scale |
| Sham | Change From Baseline PAC-SYM Total Score | -0.2 units on a scale |
Other Pre-specified
Change From Baseline PFIQ Score
The Pelvic Floor Impact Questionnaire short form (PFIQ-7) measuring the impact of bladder, bowel, and vaginal symptoms on a woman's daily activities, relationships and emotions is composed of 3 scales of 7 questions each: the Urinary Impact Questionnaire (UIQ; range 0-100), the Pelvic Organ Prolapse Impact Questionnaire (POPIQ; range 0-100), and the Colorectal-Anal Impact Questionnaire (CRAIQ; range 0-100). Scores are calculated by multiplying the mean value of all answered questions for a scale by 100 divided by 3. The range of responses is: 0-100 with 0 (least negative impact) to 100 (most negative impact). Change = (Week \[8, 12\] Score - Baseline Score). Lower scores indicate better function / fewer symptoms.
Time frame: 8 and 12 Weeks
Population: An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| PTNS | Change From Baseline PFIQ Score | Week 8 | -19.4 units on a scale |
| PTNS | Change From Baseline PFIQ Score | Week 12 | -31.5 units on a scale |
| Sham | Change From Baseline PFIQ Score | Week 8 | -28.1 units on a scale |
| Sham | Change From Baseline PFIQ Score | Week 12 | -30.7 units on a scale |
Other Pre-specified
Change From Baseline PISQ-IR NSA-CI Score
The Pelvic Organ Prolapse Incontinence Sexual Questionnaire, IUGA-revised measures the impact of incontinence symptoms on sexual function and satisfaction. The Not Sexually Active-Condition Impact (NSA-CI) ranges from 1 to 4 with higher scores indicating greater sexual function. The outcome is calculated as the difference in score at 12 weeks and the score at baseline.
Time frame: 12 Weeks
Population: An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed. This measure was only collected for participants that were not sexually active.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| PTNS | Change From Baseline PISQ-IR NSA-CI Score | 0.4 units on a scale |
| Sham | Change From Baseline PISQ-IR NSA-CI Score | 0.3 units on a scale |
Other Pre-specified
Change From Baseline PISQ-IR NSA-CS Score
The Pelvic Organ Prolapse Incontinence Sexual Questionnaire, IUGA-revised measures the impact of incontinence symptoms on sexual function and satisfaction. The Not Sexually Active-Condition Specific (NSA-CS) ranges from 1 to 4 with higher scores indicating greater sexual function. The outcome is calculated as the difference in score at 12 weeks and the score at baseline.
Time frame: 12 Weeks
Population: An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed. This measure was only collected from participants that were not sexually active.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| PTNS | Change From Baseline PISQ-IR NSA-CS Score | 0.2 units on a scale |
| Sham | Change From Baseline PISQ-IR NSA-CS Score | 0.2 units on a scale |
Other Pre-specified
Change From Baseline PISQ-IR NSA-GQA Score
The Pelvic Organ Prolapse Incontinence Sexual Questionnaire, IUGA-revised measures the impact of incontinence symptoms on sexual function and satisfaction. The Not Sexually Active-Global Quality Rating (NSA-GQA) ranges from 1 to 4.5 with higher scores indicating greater sexual function. The outcome is calculated as the difference in score at 12 weeks and the score at baseline.
Time frame: 12 Weeks
Population: An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed. This measure was only collected from participants that were not sexually active.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| PTNS | Change From Baseline PISQ-IR NSA-GQA Score | 0.4 units on a scale |
| Sham | Change From Baseline PISQ-IR NSA-GQA Score | 0.3 units on a scale |
Other Pre-specified
Change From Baseline PISQ-IR NSA-PR Score
The Pelvic Organ Prolapse Incontinence Sexual Questionnaire, IUGA-revised measures the impact of incontinence symptoms on sexual function and satisfaction. The Not Sexually Active-Partner Related (NSA-PR) ranges from 1 to 4 with higher scores indicating greater sexual function. The outcome is calculated as the difference in score at 12 weeks and the score at baseline.
Time frame: 12 Weeks
Population: An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed. This measure was only collected from participants that were not sexually active.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| PTNS | Change From Baseline PISQ-IR NSA-PR Score | 0.1 units on a scale |
| Sham | Change From Baseline PISQ-IR NSA-PR Score | -0.1 units on a scale |
Other Pre-specified
Change From Baseline PISQ-IR SA-AO Score
The Pelvic Organ Prolapse Incontinence Sexual Questionnaire, IUGA-revised measures the impact of incontinence symptoms on sexual function and satisfaction. The Sexually Active-Arousal Orgasm (SA-AO) ranges from 1 to 5 with higher scores indicating greater sexual function. The outcome is calculated as the difference in score at 12 weeks and the score at baseline.
Time frame: 12 Weeks
Population: An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed. This measure is only calculated for participants that were sexually active.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| PTNS | Change From Baseline PISQ-IR SA-AO Score | 0.2 units on a scale |
| Sham | Change From Baseline PISQ-IR SA-AO Score | 0.2 units on a scale |
Other Pre-specified
Change From Baseline PISQ-IR SA-AVG Score
The Pelvic Organ Prolapse Incontinence Sexual Questionnaire, IUGA-revised measures the impact of incontinence symptoms on sexual function and satisfaction. The Sexually Active-Average (SA-AVG) ranges from 1 to 5 with higher scores indicating greater sexual function. The outcome is calculated as the difference in score at 12 weeks and the score at baseline.
Time frame: 12 Weeks
Population: An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed. This measure was only collected from participants that were sexually active.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| PTNS | Change From Baseline PISQ-IR SA-AVG Score | 0.2 units on a scale |
| Sham | Change From Baseline PISQ-IR SA-AVG Score | 0.3 units on a scale |
Other Pre-specified
Change From Baseline PISQ-IR SA-CI Score
The Pelvic Organ Prolapse Incontinence Sexual Questionnaire, IUGA-revised measures the impact of incontinence symptoms on sexual function and satisfaction. The Sexually Active-Condition Impact (SA-CI) ranges from 1 to 4 with higher scores indicating greater sexual function. The outcome is calculated as the difference in score at 12 weeks and the score at baseline.
Time frame: 12 Weeks
Population: An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed. This measure was only collected from participants that were sexually active.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| PTNS | Change From Baseline PISQ-IR SA-CI Score | 0.4 units on a scale |
| Sham | Change From Baseline PISQ-IR SA-CI Score | 0.3 units on a scale |
Other Pre-specified
Change From Baseline PISQ-IR SA-CS Score
The Pelvic Organ Prolapse Incontinence Sexual Questionnaire, IUGA-revised measures the impact of incontinence symptoms on sexual function and satisfaction. The Sexually Active-Condition Specific (SA-CS) ranges from 1 to 5 with higher scores indicating greater sexual function. The outcome is calculated as the difference in score at 12 weeks and the score at baseline.
Time frame: 12 Weeks
Population: An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed. This measure was only collected from participants that were sexually active.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| PTNS | Change From Baseline PISQ-IR SA-CS Score | 0.3 units on a scale |
| Sham | Change From Baseline PISQ-IR SA-CS Score | 0.5 units on a scale |
Other Pre-specified
Change From Baseline PISQ-IR SA-D Score
The Pelvic Organ Prolapse Incontinence Sexual Questionnaire, IUGA-revised measures the impact of incontinence symptoms on sexual function and satisfaction. The Sexually Active-Desire (SA-D) ranges from 1 to 5 with higher scores indicating greater sexual function. The outcome is calculated as the difference in score at 12 weeks and the score at baseline.
Time frame: 12 Weeks
Population: An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed. This measure was only collected from participants that were sexually active.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| PTNS | Change From Baseline PISQ-IR SA-D Score | 0.0 units on a scale |
| Sham | Change From Baseline PISQ-IR SA-D Score | 0.2 units on a scale |
Other Pre-specified
Change From Baseline PISQ-IR SA-GQR Score
The Pelvic Organ Prolapse Incontinence Sexual Questionnaire, IUGA-revised measures the impact of incontinence symptoms on sexual function and satisfaction. The Sexually Active-Global Quality Rating (SA-GQR) ranges from 1 to 4.75 with higher scores indicating greater sexual function. The outcome is calculated as the difference in score at 12 weeks and the score at baseline.
Time frame: 12 Weeks
Population: An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed. This measure was only collected from participants that were sexually active.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| PTNS | Change From Baseline PISQ-IR SA-GQR Score | 0.3 units on a scale |
| Sham | Change From Baseline PISQ-IR SA-GQR Score | 0.4 units on a scale |
Other Pre-specified
Change From Baseline PISQ-IR SA-PR Score
The Pelvic Organ Prolapse Incontinence Sexual Questionnaire, IUGA-revised measures the impact of incontinence symptoms on sexual function and satisfaction. The Sexually Active-Partner Related (SA-PR) ranges from 1 to 4 with higher scores indicating greater sexual function. The outcome is calculated as the difference in score at 12 weeks and the score at baseline.
Time frame: 12 Weeks
Population: An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed. This measure is only collected from participants that were sexually active.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| PTNS | Change From Baseline PISQ-IR SA-PR Score | 0.1 units on a scale |
| Sham | Change From Baseline PISQ-IR SA-PR Score | 0.0 units on a scale |
Other Pre-specified
Change From Baseline POPIQ Score
The Pelvic Floor Impact Questionnaire short form (PFIQ-7) measuring the impact of bladder, bowel, and vaginal symptoms on a woman's daily activities, relationships and emotions is composed of 3 scales of 7 questions each: the Urinary Impact Questionnaire (UIQ; range 0-100), the Pelvic Organ Prolapse Impact Questionnaire (POPIQ; range 0-100), and the Colorectal-Anal Impact Questionnaire (CRAIQ; range 0-100). Scores are calculated by multiplying the mean value of all answered questions for a scale by 100 divided by 3. The range of responses is: 0-100 with 0 (least negative impact) to 100 (most negative impact). Change = (Week \[8, 12\] Score - Baseline Score). Lower scores indicate better function / fewer symptoms.
Time frame: 8 and 12 Weeks
Population: An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| PTNS | Change From Baseline POPIQ Score | Week 8 | -3.3 units on a scale |
| PTNS | Change From Baseline POPIQ Score | Week 12 | -5.2 units on a scale |
| Sham | Change From Baseline POPIQ Score | Week 8 | -5.1 units on a scale |
| Sham | Change From Baseline POPIQ Score | Week 12 | -5.6 units on a scale |
Other Pre-specified
Change From Baseline SF-12 Aggregate Mental Score
The 12-Item Short-Form Health Survey (SF-12) is a validated survey which assesses overall physical and mental health. The Aggregate Mental Score ranges from 19.06 to 60.86 with higher scores indicating greater mental health. The outcome is calculated as the difference in score at 12 weeks and the score at baseline
Time frame: 12 Weeks
Population: An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| PTNS | Change From Baseline SF-12 Aggregate Mental Score | 0.9 units on a scale |
| Sham | Change From Baseline SF-12 Aggregate Mental Score | -0.7 units on a scale |
Other Pre-specified
Change From Baseline SF-12 Aggregate Physical Score
The 12-Item Short-Form Health Survey (SF-12) is a validated survey which assesses overall physical and mental health. The Aggregate Physical Score ranges from 24 to 56.6 with higher scores indicating greater physical health. The outcome is calculated as the difference in score at 12 weeks and the score at baseline.
Time frame: 12 Weeks
Population: An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| PTNS | Change From Baseline SF-12 Aggregate Physical Score | 2.6 units on a scale |
| Sham | Change From Baseline SF-12 Aggregate Physical Score | 2.1 units on a scale |
Other Pre-specified
Change From Baseline UIQ Score
The Pelvic Floor Impact Questionnaire short form (PFIQ-7) measuring the impact of bladder, bowel, and vaginal symptoms on a woman's daily activities, relationships and emotions is composed of 3 scales of 7 questions each: the Urinary Impact Questionnaire (UIQ; range 0-100), the Pelvic Organ Prolapse Impact Questionnaire (POPIQ; range 0-100), and the Colorectal-Anal Impact Questionnaire (CRAIQ; range 0-100). Scores are calculated by multiplying the mean value of all answered questions for a scale by 100 divided by 3. The range of responses is: 0-100 with 0 (least negative impact) to 100 (most negative impact). Change = (Week \[8, 12\] Score - Baseline Score). Lower scores indicate better function / fewer symptoms.
Time frame: 8 and 12 Weeks
Population: An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| PTNS | Change From Baseline UIQ Score | Week 8 | -3.3 units on a scale |
| PTNS | Change From Baseline UIQ Score | Week 12 | -7.2 units on a scale |
| Sham | Change From Baseline UIQ Score | Week 8 | -10.2 units on a scale |
| Sham | Change From Baseline UIQ Score | Week 12 | -10.5 units on a scale |
Other Pre-specified
Patient Global Symptom Control
The Patient Global Symptom Control (PGSC) is a patient-reported measure of perceived agreement that symptoms are under control, as assessed on a scale of 1 (Disagree Strongly) to 5 (Agree Strongly). Included here are participants who had reported disagreements as indicated by a rating of 1 (Disagree Strongly) or 2 (Disagree)
Time frame: Baseline and 4, 8, and 12 Weeks
Population: An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| PTNS | Patient Global Symptom Control | Baseline | No Control | 18 Participants |
| PTNS | Patient Global Symptom Control | Baseline | Control | 93 Participants |
| PTNS | Patient Global Symptom Control | Week 4 | No Control | 46 Participants |
| PTNS | Patient Global Symptom Control | Week 4 | Control | 59 Participants |
| PTNS | Patient Global Symptom Control | Week 8 | No Control | 70 Participants |
| PTNS | Patient Global Symptom Control | Week 8 | Control | 36 Participants |
| PTNS | Patient Global Symptom Control | Week 12 | No Control | 82 Participants |
| PTNS | Patient Global Symptom Control | Week 12 | Control | 22 Participants |
| Sham | Patient Global Symptom Control | Week 12 | Control | 14 Participants |
| Sham | Patient Global Symptom Control | Baseline | No Control | 10 Participants |
| Sham | Patient Global Symptom Control | Week 8 | No Control | 33 Participants |
| Sham | Patient Global Symptom Control | Baseline | Control | 44 Participants |
| Sham | Patient Global Symptom Control | Week 12 | No Control | 40 Participants |
| Sham | Patient Global Symptom Control | Week 4 | No Control | 25 Participants |
| Sham | Patient Global Symptom Control | Week 8 | Control | 19 Participants |
| Sham | Patient Global Symptom Control | Week 4 | Control | 25 Participants |