Fecal Incontinence
Conditions
Keywords
Device study, Pelvic floor weakness, Fecal incontinence
Brief summary
The study purpose is to gain experience with the TOPAS system, a minimally- invasively delivered self-fixating mesh for the treatment of pelvic floor weakness in women with symptoms of moderate fecal incontinence
Detailed description
This is a multi-center study under a common protocol. Approximately 20-30 patients will be enrolled across 5 sites in the U.S. The study population is females at least 21 years of age who have attempted but have not been satisfied with conservative therapy for their fecal incontinence symptoms. The study follow-up is two years.
Interventions
DEVICETOPAS
A mesh sling permanently implanted to increase pelvic floor support
Sponsors
ASTORA Women's Health
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
21 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Females at least 21 years of age who have evidence of pelvic floor weakness * Females who attempted but not been satisfied with conservative therapies such as dietary changes, dietary bulking agents, biofeedback, etc. * Subjects, who have an external anal injury, must have some voluntary sphincter control
Exclusion criteria
* Subjects who are unwilling or unable to sign an Informed Consent form * Subjects who are currently pregnant or considering future child-bearing * Subjects who are contraindicated for surgery * Subjects who are allergic to polypropylene mesh * Subjects who are enrolled in a concurrent clinical trial * Subjects with previous implantation of mesh or trauma to the pelvic area * Subjects who engage in anal receptive intercourse * Subjects with a significant evacuation disorder such as chronic constipation * Subjects with Crohn's Disease, ulcerative colitis or chronic diarrhea as the primary cause for fecal incontinence * Subjects who had a hysterectomy within 6 months prior to enrollment * Subjects with vaginal prolapse that passes the hymen * Subjects with complete rectal prolapse * Subjects with a history of pelvic radiation that compromises the anal canal * Subjects who have psychiatric disturbance or debilitation as a possible cause for fecal incontinence * Subjects with a neurological disorder such as amyotrophic lateral sclerosis, multiple sclerosis, or brain tumor as a possible cause for fecal incontinence symptoms * Subjects with an active pelvic infection or a recto-vaginal fistula * Subjects who have not had a negative screening exam for colon cancer within 10 years of enrollment * Subjects who have other inappropriate conditions as determined by the physician
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Fecal Incontinence Incidence From Baseline (Pre-treatment) Through 24 Months Post-treatment | Baseline (pre-treatment), 6 Week, 3 Month, 6 Month, 12 Month and 24 Month post-treatment | Includes solid and liquid stools, as measured by the mean rate obtained using a subject-reported bowel diary. The 3 month post-treatment visit was the primary endpoint time period. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Fecal Incontinence Symptoms as Measured by Symptom Severity Scale in Fecal Incontinence | Baseline (pre-treatment), 6 Week, 3 Month, 6 Month, 12 Month and 24 Month post-treatment | The Symptom Severity Scale in Fecal Incontinence is a subject-completed questionnaire that asks about the symptoms of fecal incontinence in the following areas: frequency, stool composition, stool amount, and degree of urgency. The total score is measured on a 0 (best) to 13 (worst) scale. Scores of 1-6, 7-10, and 11-13 were categorized as mild, moderate, and severe fecal incontinence, respectively. |
| Quality of Life Assessment as Measured by Fecal Incontinence Quality of Life | Baseline (pre-treatment), 3 Month, 6 Month, 12 Month and 24 Month post-treatment | The Fecal Incontinence Quality of Life Assessment is a subject-completed questionnaire. It is measured in each of four areas of depression (7 items), lifestyle (10 items), coping (9 items), and embarrassment (3 items). Area scores are measured on a 1 (worse) to 4 (best) scale and are each the average of their component individual item scores measured on the same scale. |
| Pain Intensity as Measured by the Pain Intensity Scale | Baseline (pre-treatment), 6 Week post-treatment | The Pain Intensity Scale is a subject completed questionnaire. Scores are measured on 0 (no pain) to 10 (worst possible pain) scale. |
| Intra- and Peri-Surgical Parameters: Length of Procedure | Duration of the device implant procedure | — |
| Intra- and Peri-Surgical Parameters: Length of Hospital Stay | Length of the hospital stay for the device implant procedure | — |
| Intra- and Peri-Surgical Parameters: Estimated Blood Loss During Implant Procedure | Duration of the device implant procedure (an average of 23 minutes) | — |
| Incidence Rate of Complications During the 24 Month Post-Treatment Follow-up Period | Through 24 month post-treatment | Complications are defined as all adverse events reported during the 24 month follow-up period including serious/non-serious events and events related/not related to the device and/or procedure. Incidence rate is calculated as: (total number of adverse events reported in the 24 month follow-up period) / (total number of subjects implanted = 29) |
| Fecal Incontinence Symptoms as Measured by the Wexner Score | Baseline (pre-treatment), 6 Week, 3 Month, 6 Month, 12 Month and 24 Month post-treatment | The Wexner Score (also known as the Cleveland Clinic Florida Incontinence Score) is a subject-completed questionnaire that asks about the frequency of incontinence to gas, liquid, solid, of the need to wear pads, and of lifestyle changes (scored on a frequency scale from 0 (=absent) to 4 (daily). An overall Wexner Score is computed from these five components and a score of 0 means perfect control and 20 means complete incontinence. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Anal Manometry: Rectal First Sensation | Baseline (pre-treatment), 6 Month post-treatment | — |
| Anal Manometry: Maximum Tolerable Volume | Baseline (pre-treatment), 6 Month post-treatment | — |
| Pudendal Nerve Terminal Motor Latency | Baseline (pre-treatment), 6 Month post-treatment | Pudendal Nerve Terminal Motor Latency is a measure of the time it takes for stimulation of the pudendal nerve to elicit contraction of the pelvic floor muscles and anal sphincter. It is a surrogate marker of pudendal nerve injuries and a means of ascertaining whether anal sphincter weakness is attributable to pudendal nerve injury, sphincter defect, or both. |
| Anal Manometry: Maximum Resting Pressure | Baseline (pre-treatment), 6 Month post-treatment | — |
| Anal Manometry: Maximum Squeeze Pressure | Baseline (pre-treatment), 6 Month post-treatment | — |
Countries
United States
Participant flow
Recruitment details
Subjects enrolled at 5 U.S. study centers (medical clinics) from September 2007 to August 2008. The maximum allowed enrollment number from one site is 12.
Pre-assignment details
After signing informed consent and prior to implant, subjects completed a 3-week bowel diary to describe the FI episodes, Fecal Incontinence Quality of Life scale, Wexner Score, Symptom Severity Scale in Fecal Incontinence, pain intensity scale, and dynamic MRI or defecography.
Participants by arm
| Arm | Count |
|---|---|
| TOPAS TOPAS AMS Pelvic Floor Repair System
TOPAS : A mesh sling permanently implanted to increase pelvic floor support | 29 |
| Total | 29 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 1 |
| Overall Study | Protocol Violation | 1 |
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | TOPAS |
|---|---|
| Age, Continuous | 60.6 years STANDARD_DEVIATION 13.9 |
| Body Mass Index | 28.1 kg/[m]^2 STANDARD_DEVIATION 7.1 |
| Colonoscopy Results Abnormal | 8 participants |
| Colonoscopy Results Normal | 15 participants |
| Colonoscopy Results Other | 0 participants |
| Colonoscopy Results Unknown | 6 participants |
| Colonoscopy within past 10 years No | 5 participants |
| Colonoscopy within past 10 years Yes | 24 participants |
| Digital Rectal Exam - Anal Resting Tone No | 2 participants |
| Digital Rectal Exam - Anal Resting Tone Yes | 27 participants |
| Digital Rectal Exam - Hemorrhoids No | 27 participants |
| Digital Rectal Exam - Hemorrhoids Yes | 2 participants |
| Digital Rectal Exam - Soft Tissue Scarring No | 24 participants |
| Digital Rectal Exam - Soft Tissue Scarring Yes | 5 participants |
| Endoanal Ultrasound/Magnetic Resonance Imaging - Extent of Sphincter Defect | 95.0 degrees STANDARD_DEVIATION 50.2 |
| Endoanal Ultrasound/Magnetic Resonance Imaging - Sphincter Defect No | 19 participants |
| Endoanal Ultrasound/Magnetic Resonance Imaging - Sphincter Defect Yes | 10 participants |
| Endoanal Ultrasound or Magnetic Resonance Imaging Completed Endoanal Ultrasound | 23 participants |
| Endoanal Ultrasound or Magnetic Resonance Imaging Completed MRI | 6 participants |
| Etiology of Fecal Incontinence Anorectal trauma | 4 participants |
| Etiology of Fecal Incontinence Congenital abnormality | 0 participants |
| Etiology of Fecal Incontinence Idiopathic/Unknown | 15 participants |
| Etiology of Fecal Incontinence Neurological | 2 participants |
| Etiology of Fecal Incontinence Obstetric trauma | 10 participants |
| Etiology of Fecal Incontinence Other | 0 participants |
| Fecal Incontinence Treatment History (failed modalities) Biofeedback | 11 participants |
| Fecal Incontinence Treatment History (failed modalities) Diet modification | 25 participants |
| Fecal Incontinence Treatment History (failed modalities) FI medication | 9 participants |
| Fecal Incontinence Treatment History (failed modalities) Other | 6 participants |
| Fecal Incontinence Treatment History (failed modalities) Pelvic surgery | 3 participants |
| Gravidity | 3.6 pregnancies STANDARD_DEVIATION 2.1 |
| Height | 164.8 cm STANDARD_DEVIATION 5.9 |
| Menopausal Status Post-menopausal | 22 participants |
| Menopausal Status Pre-menopausal | 7 participants |
| Number Cesarean Births | 0.1 deliveries STANDARD_DEVIATION 0.3 |
| Number of Vaginal Births | 2.8 deliveries STANDARD_DEVIATION 1.1 |
| Parity | 2.9 births STANDARD_DEVIATION 1.1 |
| Race/Ethnicity, Customized Other | 1 participants |
| Race/Ethnicity, Customized White / Caucasian | 28 participants |
| Sex: Female, Male Female | 29 Participants |
| Sex: Female, Male Male | 0 Participants |
| Weight | 76.3 kg STANDARD_DEVIATION 19.6 |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 22 / 29 |
| serious Total, serious adverse events | 5 / 29 |
Outcome results
Primary
Fecal Incontinence Incidence From Baseline (Pre-treatment) Through 24 Months Post-treatment
Includes solid and liquid stools, as measured by the mean rate obtained using a subject-reported bowel diary. The 3 month post-treatment visit was the primary endpoint time period.
Time frame: Baseline (pre-treatment), 6 Week, 3 Month, 6 Month, 12 Month and 24 Month post-treatment
Population: The FI Bowel Diary was completed by the number of subjects at each visit as follows:~Baseline: N=29, 6 Week: N=26, 3 Month: N=27, 6 Month: N=24, 12 Month: N=23, 24 Month: N=26
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| TOPAS | Fecal Incontinence Incidence From Baseline (Pre-treatment) Through 24 Months Post-treatment | Baseline (n = 29) | 6.9 Number of FI episodes/14 day period | Standard Deviation 5.1 |
| TOPAS | Fecal Incontinence Incidence From Baseline (Pre-treatment) Through 24 Months Post-treatment | 6 Week (n = 26) | 3.0 Number of FI episodes/14 day period | Standard Deviation 3.2 |
| TOPAS | Fecal Incontinence Incidence From Baseline (Pre-treatment) Through 24 Months Post-treatment | 3 Month (primary endpoint time period, n = 27) | 3.7 Number of FI episodes/14 day period | Standard Deviation 4.4 |
| TOPAS | Fecal Incontinence Incidence From Baseline (Pre-treatment) Through 24 Months Post-treatment | 6 Month (n = 24) | 3.7 Number of FI episodes/14 day period | Standard Deviation 5 |
| TOPAS | Fecal Incontinence Incidence From Baseline (Pre-treatment) Through 24 Months Post-treatment | 12 Month (n = 23) | 3.1 Number of FI episodes/14 day period | Standard Deviation 4.1 |
| TOPAS | Fecal Incontinence Incidence From Baseline (Pre-treatment) Through 24 Months Post-treatment | 24 Month (n = 26) | 3.5 Number of FI episodes/14 day period | Standard Deviation 3.4 |
Secondary
Fecal Incontinence Symptoms as Measured by Symptom Severity Scale in Fecal Incontinence
The Symptom Severity Scale in Fecal Incontinence is a subject-completed questionnaire that asks about the symptoms of fecal incontinence in the following areas: frequency, stool composition, stool amount, and degree of urgency. The total score is measured on a 0 (best) to 13 (worst) scale. Scores of 1-6, 7-10, and 11-13 were categorized as mild, moderate, and severe fecal incontinence, respectively.
Time frame: Baseline (pre-treatment), 6 Week, 3 Month, 6 Month, 12 Month and 24 Month post-treatment
Population: The Symptom Severity Scale in Fecal Incontinence was completed by the number of subjects at each visit as follows:~Baseline: N=29, 6 Week: N=29, 3 Month: N=26, 6 Month: N=25, 12 Month: N=25, 24 Month: N=23
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| TOPAS | Fecal Incontinence Symptoms as Measured by Symptom Severity Scale in Fecal Incontinence | Baseline (n = 29) | 10.1 units on a scale | Standard Deviation 1.4 |
| TOPAS | Fecal Incontinence Symptoms as Measured by Symptom Severity Scale in Fecal Incontinence | 6 Week (n = 29) | 7.4 units on a scale | Standard Deviation 2.4 |
| TOPAS | Fecal Incontinence Symptoms as Measured by Symptom Severity Scale in Fecal Incontinence | 3 Month (n = 26) | 7.2 units on a scale | Standard Deviation 2.7 |
| TOPAS | Fecal Incontinence Symptoms as Measured by Symptom Severity Scale in Fecal Incontinence | 6 Month (n = 25) | 7.5 units on a scale | Standard Deviation 2.8 |
| TOPAS | Fecal Incontinence Symptoms as Measured by Symptom Severity Scale in Fecal Incontinence | 12 Month (n = 25) | 8.0 units on a scale | Standard Deviation 2.7 |
| TOPAS | Fecal Incontinence Symptoms as Measured by Symptom Severity Scale in Fecal Incontinence | 24 Month (n = 23) | 8.1 units on a scale | Standard Deviation 2.4 |
Secondary
Fecal Incontinence Symptoms as Measured by the Wexner Score
The Wexner Score (also known as the Cleveland Clinic Florida Incontinence Score) is a subject-completed questionnaire that asks about the frequency of incontinence to gas, liquid, solid, of the need to wear pads, and of lifestyle changes (scored on a frequency scale from 0 (=absent) to 4 (daily). An overall Wexner Score is computed from these five components and a score of 0 means perfect control and 20 means complete incontinence.
Time frame: Baseline (pre-treatment), 6 Week, 3 Month, 6 Month, 12 Month and 24 Month post-treatment
Population: The Wexner Score was completed by the number of subjects at each visit as follows:~Baseline: N=29, 6 Week: N=29, 3 Month: N=26, 6 Month: N=25, 12 Month: N=25, 24 Month: N=23
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| TOPAS | Fecal Incontinence Symptoms as Measured by the Wexner Score | Baseline (n = 29) | 13.2 units on a scale | Standard Deviation 2.6 |
| TOPAS | Fecal Incontinence Symptoms as Measured by the Wexner Score | 6 Week (n = 29) | 7.6 units on a scale | Standard Deviation 4 |
| TOPAS | Fecal Incontinence Symptoms as Measured by the Wexner Score | 3 Month (n = 26) | 7.5 units on a scale | Standard Deviation 4.1 |
| TOPAS | Fecal Incontinence Symptoms as Measured by the Wexner Score | 6 Month (n = 25) | 8.5 units on a scale | Standard Deviation 4.4 |
| TOPAS | Fecal Incontinence Symptoms as Measured by the Wexner Score | 12 Month (n = 25) | 8.7 units on a scale | Standard Deviation 4 |
| TOPAS | Fecal Incontinence Symptoms as Measured by the Wexner Score | 24 Month (n = 23) | 9.9 units on a scale | Standard Deviation 4.4 |
Secondary
Incidence Rate of Complications During the 24 Month Post-Treatment Follow-up Period
Complications are defined as all adverse events reported during the 24 month follow-up period including serious/non-serious events and events related/not related to the device and/or procedure. Incidence rate is calculated as: (total number of adverse events reported in the 24 month follow-up period) / (total number of subjects implanted = 29)
Time frame: Through 24 month post-treatment
Population: Includes all subjects implanted with the TOPAS device
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| TOPAS | Incidence Rate of Complications During the 24 Month Post-Treatment Follow-up Period | Device and/or Procedure Related Serious Events | 0.03 events per 24 months/participant |
| TOPAS | Incidence Rate of Complications During the 24 Month Post-Treatment Follow-up Period | All Adverse Events | 2.34 events per 24 months/participant |
| TOPAS | Incidence Rate of Complications During the 24 Month Post-Treatment Follow-up Period | Device and/or Procedure-Related Adverse Events | 0.66 events per 24 months/participant |
| TOPAS | Incidence Rate of Complications During the 24 Month Post-Treatment Follow-up Period | All Serious Adverse Events | 0.17 events per 24 months/participant |
Secondary
Intra- and Peri-Surgical Parameters: Estimated Blood Loss During Implant Procedure
Time frame: Duration of the device implant procedure (an average of 23 minutes)
Population: All enrolled/implanted subjects were included in this analysis
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| TOPAS | Intra- and Peri-Surgical Parameters: Estimated Blood Loss During Implant Procedure | 15 ml | Standard Deviation 13 |
Secondary
Intra- and Peri-Surgical Parameters: Length of Hospital Stay
Time frame: Length of the hospital stay for the device implant procedure
Population: All enrolled/implanted subjects were included in this analysis
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| TOPAS | Intra- and Peri-Surgical Parameters: Length of Hospital Stay | 22.6 hours | Standard Deviation 11.6 |
Secondary
Intra- and Peri-Surgical Parameters: Length of Procedure
Time frame: Duration of the device implant procedure
Population: All enrolled/implanted subjects were included in this analysis
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| TOPAS | Intra- and Peri-Surgical Parameters: Length of Procedure | 23 minutes | Standard Deviation 8 |
Secondary
Pain Intensity as Measured by the Pain Intensity Scale
The Pain Intensity Scale is a subject completed questionnaire. Scores are measured on 0 (no pain) to 10 (worst possible pain) scale.
Time frame: Baseline (pre-treatment), 6 Week post-treatment
Population: The Pain Intensity Scale was completed by the number of subjects at each visit as follows:~Baseline: N=29, 6 Week: N=29
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| TOPAS | Pain Intensity as Measured by the Pain Intensity Scale | Baseline (n = 29) | 1.0 units on a scale | Standard Deviation 1.5 |
| TOPAS | Pain Intensity as Measured by the Pain Intensity Scale | 6 Week (n = 29) | 0.4 units on a scale | Standard Deviation 0.8 |
Secondary
Quality of Life Assessment as Measured by Fecal Incontinence Quality of Life
The Fecal Incontinence Quality of Life Assessment is a subject-completed questionnaire. It is measured in each of four areas of depression (7 items), lifestyle (10 items), coping (9 items), and embarrassment (3 items). Area scores are measured on a 1 (worse) to 4 (best) scale and are each the average of their component individual item scores measured on the same scale.
Time frame: Baseline (pre-treatment), 3 Month, 6 Month, 12 Month and 24 Month post-treatment
Population: The Fecal Incontinence Quality of Life Assessment was completed by the number of subjects at each visit as follows:~Baseline: N=29, 3 Month: N=26, 6 Month: N=25, 12 Month: N=25, 24 Month: N=23
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| TOPAS | Quality of Life Assessment as Measured by Fecal Incontinence Quality of Life | Depression - Baseline (n = 29) | 2.7 units on a scale | Standard Deviation 0.8 |
| TOPAS | Quality of Life Assessment as Measured by Fecal Incontinence Quality of Life | Depression - 3 Month (n = 26) | 3.3 units on a scale | Standard Deviation 0.7 |
| TOPAS | Quality of Life Assessment as Measured by Fecal Incontinence Quality of Life | Depression - 6 Month (n = 25) | 3.2 units on a scale | Standard Deviation 0.8 |
| TOPAS | Quality of Life Assessment as Measured by Fecal Incontinence Quality of Life | Depression - 12 Month (n = 25) | 3.3 units on a scale | Standard Deviation 0.8 |
| TOPAS | Quality of Life Assessment as Measured by Fecal Incontinence Quality of Life | Depression - 24 Month (n = 23) | 3.3 units on a scale | Standard Deviation 0.7 |
| TOPAS | Quality of Life Assessment as Measured by Fecal Incontinence Quality of Life | Lifestyle - Baseline (n = 29) | 2.7 units on a scale | Standard Deviation 0.8 |
| TOPAS | Quality of Life Assessment as Measured by Fecal Incontinence Quality of Life | Lifestyle - 3 Month (n = 26) | 3.4 units on a scale | Standard Deviation 0.7 |
| TOPAS | Quality of Life Assessment as Measured by Fecal Incontinence Quality of Life | Lifestyle - 6 Month (n = 25) | 3.4 units on a scale | Standard Deviation 0.7 |
| TOPAS | Quality of Life Assessment as Measured by Fecal Incontinence Quality of Life | Lifestyle - 12 Month (n = 25) | 3.3 units on a scale | Standard Deviation 0.8 |
| TOPAS | Quality of Life Assessment as Measured by Fecal Incontinence Quality of Life | Lifestyle - 24 Month (n = 23) | 3.5 units on a scale | Standard Deviation 0.7 |
| TOPAS | Quality of Life Assessment as Measured by Fecal Incontinence Quality of Life | Coping - Baseline (n = 29) | 1.9 units on a scale | Standard Deviation 0.5 |
| TOPAS | Quality of Life Assessment as Measured by Fecal Incontinence Quality of Life | Coping - 3 Month (n = 26) | 2.9 units on a scale | Standard Deviation 0.8 |
| TOPAS | Quality of Life Assessment as Measured by Fecal Incontinence Quality of Life | Coping - 6 Month (n = 25) | 2.8 units on a scale | Standard Deviation 0.8 |
| TOPAS | Quality of Life Assessment as Measured by Fecal Incontinence Quality of Life | Coping - 12 Month (n = 25) | 2.8 units on a scale | Standard Deviation 0.9 |
| TOPAS | Quality of Life Assessment as Measured by Fecal Incontinence Quality of Life | Coping - 24 Month (n = 23) | 2.8 units on a scale | Standard Deviation 0.9 |
| TOPAS | Quality of Life Assessment as Measured by Fecal Incontinence Quality of Life | Embarrassment - Baseline (n = 29) | 1.8 units on a scale | Standard Deviation 0.6 |
| TOPAS | Quality of Life Assessment as Measured by Fecal Incontinence Quality of Life | Embarrassment - 3 Month (n = 26) | 2.9 units on a scale | Standard Deviation 0.9 |
| TOPAS | Quality of Life Assessment as Measured by Fecal Incontinence Quality of Life | Embarrassment - 6 Month (n = 25) | 2.9 units on a scale | Standard Deviation 1 |
| TOPAS | Quality of Life Assessment as Measured by Fecal Incontinence Quality of Life | Embarrassment - 12 Month (n = 25) | 3.0 units on a scale | Standard Deviation 0.9 |
| TOPAS | Quality of Life Assessment as Measured by Fecal Incontinence Quality of Life | Embarrassment - 24 Month (n = 23) | 2.9 units on a scale | Standard Deviation 1 |
Other Pre-specified
Anal Manometry: Maximum Resting Pressure
Time frame: Baseline (pre-treatment), 6 Month post-treatment
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| TOPAS | Anal Manometry: Maximum Resting Pressure | Baseline (n = 28) | 29.2 mmHg | Standard Deviation 23.2 |
| TOPAS | Anal Manometry: Maximum Resting Pressure | 6 Month (n = 20) | 37.7 mmHg | Standard Deviation 25.8 |
Other Pre-specified
Anal Manometry: Maximum Squeeze Pressure
Time frame: Baseline (pre-treatment), 6 Month post-treatment
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| TOPAS | Anal Manometry: Maximum Squeeze Pressure | Baseline (n = 28) | 53.2 mmHg | Standard Deviation 38.7 |
| TOPAS | Anal Manometry: Maximum Squeeze Pressure | 6 Month (n = 20) | 51.8 mmHg | Standard Deviation 32.9 |
Other Pre-specified
Anal Manometry: Maximum Tolerable Volume
Time frame: Baseline (pre-treatment), 6 Month post-treatment
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| TOPAS | Anal Manometry: Maximum Tolerable Volume | Baseline (n = 26) | 115.3 cc | Standard Deviation 52.4 |
| TOPAS | Anal Manometry: Maximum Tolerable Volume | 6 Month (n = 20) | 126.3 cc | Standard Deviation 49.6 |
Other Pre-specified
Anal Manometry: Rectal First Sensation
Time frame: Baseline (pre-treatment), 6 Month post-treatment
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| TOPAS | Anal Manometry: Rectal First Sensation | Baseline (n = 29) | 37.6 cc | Standard Deviation 22.3 |
| TOPAS | Anal Manometry: Rectal First Sensation | 6 Month (n = 23) | 41.7 cc | Standard Deviation 30 |
Post Hoc
Percentage of Subjects With Greater Than or Equal to a 50 Percent Reduction in FI Episodes From Baseline
Includes solid and liquid stools, as measured by a subject-reported bowel diary
Time frame: 6 Weeks, 3 Month, 6 Month, 12 Month and 24 Month post-treatment
Population: Two subjects were enrolled who recorded no FI episodes at baseline and were excluded from this analysis. Missing data was not imputed and was considered a treatment failure.~The Bowel Diary was completed by the number of subjects at each visit as follows:~6 Week: N=24, 3 Month: N=25, 6 Month: N=22, 12 Month: N=21, 24 Month: N=24
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| TOPAS | Percentage of Subjects With Greater Than or Equal to a 50 Percent Reduction in FI Episodes From Baseline | 6 Week (n = 24) | 59.3 percentage participants |
| TOPAS | Percentage of Subjects With Greater Than or Equal to a 50 Percent Reduction in FI Episodes From Baseline | 3 Month (n = 25) | 63.0 percentage participants |
| TOPAS | Percentage of Subjects With Greater Than or Equal to a 50 Percent Reduction in FI Episodes From Baseline | 6 Month (n = 22) | 51.9 percentage participants |
| TOPAS | Percentage of Subjects With Greater Than or Equal to a 50 Percent Reduction in FI Episodes From Baseline | 12 Month (n = 21) | 40.7 percentage participants |
| TOPAS | Percentage of Subjects With Greater Than or Equal to a 50 Percent Reduction in FI Episodes From Baseline | 24 Month (n = 24) | 55.6 percentage participants |
Other Pre-specified
Pudendal Nerve Terminal Motor Latency
Pudendal Nerve Terminal Motor Latency is a measure of the time it takes for stimulation of the pudendal nerve to elicit contraction of the pelvic floor muscles and anal sphincter. It is a surrogate marker of pudendal nerve injuries and a means of ascertaining whether anal sphincter weakness is attributable to pudendal nerve injury, sphincter defect, or both.
Time frame: Baseline (pre-treatment), 6 Month post-treatment
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| TOPAS | Pudendal Nerve Terminal Motor Latency | Baseline - Left Pudendal Nerve Latency (n = 17) | 2.9 msec | Standard Deviation 2.4 |
| TOPAS | Pudendal Nerve Terminal Motor Latency | Baseline - Right Pudendal Nerve Latency (n = 16) | 3.3 msec | Standard Deviation 2.6 |
| TOPAS | Pudendal Nerve Terminal Motor Latency | 6 Month - Right Pudendal Nerve Latency (n = 10) | 3.8 msec | Standard Deviation 2.8 |
| TOPAS | Pudendal Nerve Terminal Motor Latency | 6 Month - Left Pudendal Nerve Latency (n = 12) | 3.1 msec | Standard Deviation 2.3 |