Burning Vagina, Dyspareunia, Genitourinary System; Disorder, Female, Irritation; Vagina, Menopause Related Conditions, Stress Urinary Incontinence, Urinary Bladder, Overactive, Urinary Incontinence, Urinary Tract Infections
Conditions
Keywords
Laser Therapy
Brief summary
This is a prospective observational study of women undergoing vaginal treatment with the fractional carbon dioxide (fCO2) laser for various urogenital symptoms.
Detailed description
Fractional carbon dioxide (fCO2) laser treatment of the vaginal tissue has been proposed as a treatment for various genitourinary symptoms, including vaginal itching, burning, dryness, dyspareunia (difficult or painful sexual intercourse), dysuria (painful or difficult urination), nocturia (waking at night to urinate), incontinence (the involuntary loss of urine), urine frequency, urine urgency, and urinary tract infection (UTI). Case report and case series data suggest that laser treatment of the vaginal tissues is well tolerated by patients and does not pose serious risks to the patient. Several case series demonstrate improvements in vulvovaginal and urinary symptoms, and in sexual function. However, these studies are from a select few centers, are small, and are also biased in that the laser treatment is only available to patients who are able to pay for it. Additionally, most studies report only on vulvovaginal symptoms, despite increasing use of laser for urinary symptoms. Several recent editorials have called for larger studies with longer follow-up and high quality outcome measures. This study has been designed to address these needs. This is a prospective observational study of women undergoing vaginal treatment with the fCO2 laser for a wide range of patients with vulvovaginal, sexual and/or urologic complaints. The effects of fCO2 therapy will be evaluated by various physical assessments and patient questionnaires.
Interventions
DEVICEfCO2 Laser Therapy Group
Women enrolled in the study will receive three treatments with the fractional carbon dioxide (fCO2) laser. The interval between treatments is approximately six weeks. Intra-vaginal laser treatments will be delivered at 8 points at each level of the vaginal wall.
Sponsors
Corewell Health East
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
1. Female 2. 18 years of age or greater and 90 years of age or less 3. One or more of the following indications for fCO2 laser treatment: 1. Genitourinary symptoms of menopause, including after natural, medical- induced or surgical menopause 2. Vaginal dryness, burning, itching or dyspareunia not related to menopause 3. Stress urinary incontinence 4. Recurrent urinary tract infections (UTIs), defined as 4 or more in a year 5. Overactive bladder 4. Must sign the informed consent 5. Must be willing to comply with the study protocol
Exclusion criteria
1. Contraindications to fCO2 laser treatment, such as: 1. Currently implanted synthetic pelvic mesh, sling or tape 2. Current or previous genital cancers 3. Radiation to the vaginal or colo-rectal tissue 4. Currently pregnant or less than 3 months following pregnancy 5. Undiagnosed vaginal or cervical lesions 2. Patients who have received vaginal fCO2 laser treatment within the past 12 months 3. Patients treated with vaginal estrogen within the past 3 months 4. Patients with undiagnosed vaginal bleeding 5. Active vulvar or vaginal infection, including herpes, candidiasis, etc. 6. Current urinary tract infection (UTI), confirmed by positive urine culture and patient-reported symptoms 7. Pelvic or vaginal surgery with the past 9 months 8. Pelvic organ prolapse beyond the introitus 9. Patient possesses any other characteristics that, per the investigator's judgment, deems them unsuitable (i.e. may increase the patient's risk, may affect the conduct of the study etc.) for the treatment and/or study 10. Participation in an investigational trial that used a study treatment, medication and/or biologic within 6 months or less prior to the date of the screening visit
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patient Global Impression of Improvement (PGI-I) Score at 4 Weeks After Initial Treatment | 4 weeks post-initial treatment | PGI-I score is recorded 4 weeks after initial treatment completion. The PGI-I asks the patient to "check the box that best describes how your urinary and/or vaginal symptoms are now, compared with how you symptoms were before you began this study." There are 7 possible responses ranging from 1 to 7, where 1 is "Very Much Better", 2 is "Much Better, 3 is "A Little Bit Better", 4 is "No Change", 5 is "A Little Worse", 6 is "Much Worse", and 7 is "Very Much Worse". A score from 1 to 3 would indicate improvement. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Vaginal pH and Overall Vaginal Health on Physical Exam as Measured by the Vaginal Health Inventory Score (VHIS) at 6 Months Post-initial Treatment. | 6 months post-initial treatment | The Vaginal Health Inventory Score (VHIS) is an assessment tool, used by providers, to determine if vaginal atrophy is present. Providers perform a vaginal exam and give a score of 1-5 (abnormal to normal, respectively) on each of the following vaginal parameters: elasticity, secretion/fluid volume, vaginal pH, integrity of the epithelium, and lubrication/moisture of the vaginal wall. The total VHIS score is a sum of the individual scores of these 5 vaginal parameters. The minimum score is 5 and the maximum score is 25. A score of 5-14 indicates the presence of vaginal atrophy, while a score of 15-25 indicates normal healthy vaginal tissue. For this outcome measure we reported the change in VHIS between 6 months and baseline. A positive number means that vaginal tissue is healthier at 6 months compared to baseline. |
| Change in Urinary Symptoms Specifically Stress Urinary Incontinence Score as Measured by the Questionnaire for Urinary Incontinence Diagnosis (QUID) at 6 Months Post-initial Treatment. | 6 months post-initial treatment | The Questionnaire for Urinary Incontinence Diagnosis (QUID) consists of 2 sections: section 1 are three questions related to stress urinary incontinence (SUI) and section 2 are three questions related to Urge Urinary Incontinence (UUI). This outcome measure is focused on the SUI score only (QUID-SUI). Patients are asked how often they leak urine in three different situations. Responses range from 0 = none of the time, to 5 = all of the time. The total QUID-SUI score ranges from 0 - 15, with a higher score meaning more frequent urinary leakage in response to a stress event (e.g. cough, lifting, exercise). Here we report the change in QUID-SUI score from 6 months to baseline. A negative number means the QUID stress urinary incontinence score has gone down and severity of SUI his better at 6 months compared to baseline. |
| Change in Overactive Bladder (OAB) Symptoms, Specifically Symptom Bother as Measured by the Overactive Bladder Questionnaire-Short Form (OAB-q SF) at 6 Months After Initial Treatment. | 6 months post-initial treatment | For this outcome measure, we used the OAB-q SF, which consists of two scales assessing symptom bother and health-related quality of life (HR-QOL) in patients with OAB. In this outcome measure we specifically look at the symptom bother scale that consists of 6 questions. Each question asks about the level of bother related to a specific symptom (e.g. urgency, frequency, nighttime urination and leakage). The patient rates the degree of bother on a 6-point scale with 1 = Not at all and 6 = A very great deal. The scores of the 6 questions are added and converted to a 100-point scale. The symptom bother score ranges from 0-100. A higher score is associated with a high degree of bother. For this outcome measure, we report the change in the mean symptom bother scale from 6 months to baseline. A negative change means that the degree of symptom bother decreased at 6 months compared to before treatment. |
| Change in Number of Voids as Recorded on Voiding Diary at 6 Months Post-initial Treatment. | 6 months post-initial treatment | A 3-day voiding diary will be completed by the patient and evaluated to describe urinary frequency (number of voids) and incontinence episodes. The change in number of voids over a 3 day period at 6 months minus baseline will be measured. A negative number means the number of voids went down compared to baseline. |
| Change in Sexual Function, Including Dyspareunia Symptoms, as Measured by the Female Sexual Function Inventory (FSFI) at 6 Months Post-initial Treatment. | 6 months post-initial treatment | The FSFI consists of 6 subscales related to sexual desire (2 Qs scale 1 worst - 5 best), arousal (4Qs 0 worst - 5 best), lubrication (4Qs 0 worst-5 best), orgasm (3Qs 0 worst - 5 best), satisfaction ( 3Qs 0 worst - 5 best), and pain (3 Qs 0 worst - 5 best). Higher scores indicate higher sexual functioning. Scores range from 2-36. A score of 26.55 has been clinically selected as the cut-off for sexual dysfunction. Scores below this value indicate sexual dysfunction. The overall change is measured at 6 months minus baseline. A positive score means the sexual dysfunction symptoms are getting worse. Only people that had sexual activity were included. |
| Frequency of Urinary Tract Infection (UTI) Occurrences, as Measured by a Positive Urine Culture Test at 6 Months Post-initial Treatment. | 6 months post-initial treatment | A clean catch urine specimen will be collected at each visit. A positive urine dipstick test will have the presence of leukocytes and nitrites accompanied by symptoms (dysuria, bladder pain, and/or urinary frequency) and will be sent for a culture. A positive urine culture has the presence of bacterial growth. Only patients that reported recurrent UTI's - 4 or more in the past year (i.e. had 4 or more positive urine cultures in a year) at baseline with an occurrence of a positive urine culture at or before 6 months post-initial treatment will be counted. |
| Change in Mental Health Status as Measured by the Generalized Anxiety Disorder Questionnaire (GAD-7) at 6 Months Post-initial Treatment. | 6 months post-initial treatment | The GAD-7 is a self-reported questionnaire for screening and measuring severity of generalized anxiety disorder. There are 7 questions total asking how often the patient has been bothered by certain problems over the past 2 weeks. Each answer is scored on a scale from 0 = not at all to 3 = nearly every day. All scores are added up to calculate the total score which ranges from 0 - 21. Total scores greater than or equal to 10 indicate moderate anxiety and further assessment is recommended. In this outcome measure we report the change in GAD-7 score between 6 months and baseline. A negative number means a reduction in GAD-7 score and therefore a reduction in anxiety/depression at 6 months compared to before treatment. |
| Change in Mental Health Status as Measured by the Patient Health Questionnaire (PHQ-8) at 6 Months Post-initial Treatment. | 6 months post-initial treatment | The PHQ-8 is an eight-item questionnaire that measures the severity of depression symptoms over the past 2 weeks. For each of the questions, the patient is asked the rate how often they are bothered by a specific problem (e.g. sleep disturbance, fatigue, appetite change, low-self esteem, poor concentration). Each question is scored from 0 = not at all to 3 = nearly every day. The scores of each question are added together to form the total score, which ranges from 0 - 24. The higher the score, the more severe depressive symptoms are. A score of 10 or greater is commonly used to indicate the presence of clinically significant depressive symptoms. Here we report the change in score between 6 months and baseline. A negative number means there is a reduction in PHQ8 score at 6 months compared to before treatment and therefore a reduction in depression. |
| Change in Life and Sexual Impact of Vulvovaginal Skin Symptoms as Measured by the Incontinence Quality of Life Questionnaire (I-QOL) at 6 Months. | 6 months post-initial treatment | The Incontinence Quality of Life Questionnaire (I-QOL) is a validated tool to assess the impact of urinary incontinence problems. The I-QOL has 22 incontinent-specific quality of life items. The 22 items are broken down into 3 subscales: Avoidance and Limiting Behaviors Score (8 of the 22 items), Psychosocial Impacts Score (9 of the 22 items), and Social Embarrassment Score (5 of the 22 items). Each question has a five-point ordinal response scale: 1= Extremely, 2= Quite a Bit, 3= Moderately, 4= A Little, and 5= Not at All. All 22 items are summed up, and the sum is converted to a 100-point scale. The range of the score is 0-100, with a high score indicating a better quality of life. In this outcome measure we report the change in the I-QOL score at 6 months minus the score at baseline. A positive score indicates that the quality of life improved at 6 months compared to before treatment. |
| The Presence of Lactobacillus, Assessed by Vaginal Swab at 6 Months. | 6 months post-initial treatment | A vaginal exam is completed at 6 months. In some cases the 6 month visit was completed remotely and thus a vaginal exam was not completed. Presence or absence of lactobacillus will be collected by the physician via a vaginal swab and assessed under the microscope of the patients that had a vaginal exam completed. This is the total number of patients positive for lactobacillus at 6 months. |
| Change in Patient Global Impression of Improvement (PGI-I) Score at 36 Months. | 36 months post-initial treatment | The average change in patients' PGI-I scores from baseline to 6 months and 36 months post-treatment. The PGI-I asks the patient to "check the one number that best describes how your urinary tract condition is now compared with how it was before your treatment." There are 7 possible responses ranging from 1 to 7, where 1 is "Very Much Better" and 7 is "Very Much Worse". A lower score would represent improvement and a favorable outcome. |
| Change in Vaginal pH and Overall Vaginal Health on Physical Exam as Measured by the Vaginal Health Inventory Score (VHIS) at 36 Month Post-initial Treatment. | 36 months post-initial treatment | The Vaginal Health Inventory Score (VHIS) is an assessment tool, used by providers, to determine if vaginal atrophy is present. Providers perform a vaginal exam and give a score of 1-5 (abnormal to normal, respectively) on each of the following vaginal parameters: elasticity, secretion/fluid volume, vaginal pH, integrity of the epithelium, and lubrication/moisture of the vaginal wall. The total VHIS score is a sum of the individual scores of these 5 vaginal parameters. The scale ranges from 5-25. A score of 5-14 indicates the presence of vaginal atrophy, while a score of 15-25 indicates normal/healthy vaginal tissue. For this outcome measure we reported the change in VHIS between 36 months and baseline. A positive number means that vaginal tissue is healthier at 36 months compared to baseline. |
| Change in Urinary Symptoms, Specifically Stress Urinary Incontinence as Measured by the Questionnaire for Urinary Incontinence Diagnosis (QUID) at 36 Months Post-inital Treatment. | 36 months post-initial treatment | The Questionnaire for Urinary Incontinence Diagnosis (QUID) consists of 2 sections: section 1 are three questions related to stress urinary incontinence (SUI) and section 2 are three questions related to Urge Urinary Incontinence (UUI). This outcome measure is focused on the SUI score only (QUID-SUI). Patients are asked how often they leak urine in three different situations. Responses range from 0 = none of the time, to 5 = all of the time. The total QUID-SUI score ranges from 0 - 15, with a higher score meaning more frequent urinary leakage in response to a stress event (e.g. cough, lifting, exercise). Here we report the change in QUID-SUI score from 36 months to baseline. A negative number means the QUID stress urinary incontinence score has gone down and severity of SUI his better at 36 months compared to baseline. |
| Change in Urinary Symptoms Specifically Urge Urinary Incontinence Score as Measured by the Questionnaire for Urinary Incontinence Diagnosis (QUID) at 6 Months Post-initial Treatment. | 6 months post-initial treatment | The Questionnaire for Urinary Incontinence Diagnosis (QUID) consists of 2 sections: section 1 are three questions related to stress urinary incontinence (SUI) and section 2 are three questions related to Urge Urinary Incontinence (UUI). This outcome measure is focused on the UUI score only (QUID-UUI). Patients are asked how often they leak urine in three different situations related to urgency. Responses range from 0 = none of the time, to 5 = all of the time. The total QUID-UUI score ranges from 0 - 15, with a higher score meaning more frequent urinary leakage due to urgency. Here we report the change in QUID-UUI score from 6 months to baseline. A negative number means the QUID urge urinary incontinence score has gone down and severity of UUI has improved at 6 months compared to before treatment. |
| Change in Urinary Symptoms Specifically Urge Urinary Incontinence Score as Measured by the Questionnaire for Urinary Incontinence Diagnosis (QUID) at 36 Months Post-initial Treatment. | 36 months post-initial treatment | The Questionnaire for Urinary Incontinence Diagnosis (QUID) consists of 2 sections: section 1 are three questions related to stress urinary incontinence (SUI) and section 2 are three questions related to Urge Urinary Incontinence (UUI). This outcome measure is focused on the UUI score only (QUID-UUI). Patients are asked how often they leak urine in three different situations related to urgency. Responses range from 0 = none of the time, to 5 = all of the time. The total QUID-UUI score ranges from 0 - 15, with a higher score meaning more frequent urinary leakage due to urgency. Here we report the change in QUID-UUI score from 36 months to baseline. A negative number means the QUID urge urinary incontinence score has gone down and severity of UUI has improved at 36 months compared to before treatment. |
| Change in Overactive Bladder (OAB) Symptoms, Specifically Health-related Quality of Life (HR-QOL) as Measured by the Overactive Bladder Questionnaire-Short Form (OAB-q SF) at 36 Months Post-initial Treatment. | 36 months post-initial treatment | For this outcome measure, we used the OAB-q SF, which consists of two scales assessing symptom bother and health-related quality of life (HR-QOL) in patients with OAB. In this outcome measure we specifically look at the health-related quality of life (HR-QOL) scale that consists of 13 questions. Each question asks how the patient's quality of life has been impacted. The patient rates the degree of impact on a 6-point scale with 1 = Not at all and 6 = A very great deal. The scores of the 13 questions are added and converted to a 100-point scale. The HR-QOL score ranges from 0-100. A higher score is associated with a better quality of life. For this outcome measure, we report the change in the mean HR-QOL score for 36 months minus baseline. A positive change means that the quality of life became better by 36 months as compared to before treatment. |
| Change in Overactive Bladder (OAB) Symptoms, Specifically Symptom Bother as Measured by the Overactive Bladder Questionnaire-Short Form (OAB-q SF) at 36 Months Post-initial Treatment. | 36 months post-initial treatment | For this outcome measure, we used the OAB-q SF, which consists of two scales assessing symptom bother and health-related quality of life (HR-QOL) in patients with OAB. In this outcome measure we specifically look at the symptom bother scale that consists of 6 questions. Each question asks about the level of bother related to a specific symptom (e.g. urgency, frequency, nighttime urination and leakage). The patient rates the degree of bother on a 6-point scale with 1 = Not at all and 6 = A very great deal. The scores of the 6 questions are added and converted to a 100-point scale. The symptom bother score ranges from 0-100. A higher score is associated with a high degree of bother. For this outcome measure, we report the change in the mean symptom bother scale from 36 months to baseline. A negative change means that the degree of symptom bother decreased at 36 months compared to before treatment. |
| Change in Overactive Bladder (OAB) Symptoms, Specifically Health-related Quality of Life (HR-QOL) as Measured by the Overactive Bladder Questionnaire-Short Form (OAB-q SF) at 6 Months Post-initial Treatment. | 6 months post-initial treatment | For this outcome measure, we used the OAB-q SF, which consists of two scales assessing symptom bother and health-related quality of life (HR-QOL) in patients with OAB. In this outcome measure we specifically look at the health-related quality of life (HR-QOL) scale that consists of 13 questions. Each question asks how the patient's quality of life has been impacted. The patient rates the degree of impact on a 6-point scale with 1 = Not at all and 6 = A very great deal. The scores of the 13 questions are added and converted to a 100-point scale. The HR-QOL score ranges from 0-100. A higher score is associated with a better quality of life. For this outcome measure, we report the change in the mean HR-QOL score for 6 months minus baseline. A positive change means that the quality of life became better by 6 months as compared to before treatment. |
| Change in Number of Voids as Recorded on Voiding Diary at 36 Months Post-initial Treatment. | 36 months post-initial treatment | A 3-day voiding diary will be completed by the patient and evaluated to describe urinary frequency (number of voids) and incontinence episodes. The change in number of voids over a 3 day period at 36 months minus baseline will be measured. A negative number means the number of voids went down compared to baseline. |
| Change in Number of Stress Urinary Incontinence Events as Recorded on Voiding Diary at 6 Months Post-initial Treatment. | 6 months post-initial treatment | A 3-day voiding diary will be completed by the patient and evaluated to describe incontinence episodes (number of stress urinary incontinence occurrences). The change in number of stress urinary incontinence episodes over a 3 day period at 6 months minus baseline will be measured. A negative number means the number of stress urinary incontinence events went down compared to baseline. |
| Change in Number of Stress Urinary Incontinence Events as Recorded on Voiding Diary at 36 Months Post-initial Treatment. | 36 months post-initial treatment | A 3-day voiding diary will be completed by the patient and evaluated to describe incontinence episodes (number of stress urinary incontinence occurrences). The change in number of stress urinary incontinence episodes over a 3 day period at 36 months minus baseline will be measured. A negative number means the number of stress urinary incontinence events went down compared to baseline. |
| Change in Number of Urge Urinary Incontinence Events as Recorded on Voiding Diary at 6 Months Post-initial Treatment. | 6 months post-initial treatment | A 3-day voiding diary will be completed by the patient and evaluated to describe incontinence episodes (number of urge urinary incontinence events). The change in number of urge urinary incontinence events over a 3 day period at 6 months minus baseline will be measured. A negative number means the number of urge urinary incontinence events went down compared to baseline. |
| Change in Number of Urge Urinary Incontinence Events as Recorded on Voiding Diary at 36 Months Post-initial Treatment. | 36 months post-initial treatment | A 3-day voiding diary will be completed by the patient and evaluated to describe incontinence episodes (number of urge urinary incontinence events). The change in number of urge urinary incontinence events over a 3 day period at 36 months minus baseline will be measured. A negative number means the number of urge urinary incontinence events went down compared to baseline. |
| Change in Mental Health Status as Measured by the Generalized Anxiety Disorder Questionnaire (GAD-7) at 36 Months Post-initial Treatment. | 36 months post-initial treatment | The GAD-7 is a self-reported questionnaire for screening and measuring severity of generalized anxiety disorder. There are 7 questions total asking how often the patient has been bothered by certain problems over the past 2 weeks. Each answer is scored on a scale from 0 = not at all to 3 = nearly every day. All scores are added up to calculate the total score which ranges from 0 - 21. Total scores greater than or equal to 10 indicate moderate anxiety and further assessment is recommended. In this outcome measure we report the change in GAD-7 score between 36 months and baseline. A negative number means a reduction in GAD-7 score and therefore a reduction in anxiety/depression at 36 months compared to before treatment. |
| Change in Mental Health Status as Measured by the Patient Health Questionnaire (PHQ-8) at 36 Months Post-initial Treatment. | 36 months post-initial treatment | The PHQ-8 is an eight-item questionnaire that measures the severity of depression symptoms over the past 2 weeks. For each of the questions, the patient is asked the rate how often they are bothered by a specific problem (e.g. sleep disturbance, fatigue, appetite change, low-self esteem, poor concentration). Each question is scored from 0 = not at all to 3 = nearly every day. The scores of each question are added together to form the total score, which ranges from 0 - 24. The higher the score, the more severe depressive symptoms are. A score of 10 or greater is commonly used to indicate the presence of clinically significant depressive symptoms. Here we report the change in score between 36 months and baseline. A negative number means there is a reduction in PHQ8 score at 36 months compared to before treatment and therefore a reduction in depression. |
| Change in Sexual Function, Including Dyspareunia Symptoms, as Measured by the Female Sexual Function Inventory (FSFI) at 36 Months Post-initial Treatment. | 36 months post-initial treatment | The FSFI consists of 6 subscales related to sexual desire (2 Qs scale 1 worst - 5 best), arousal (4Qs 0 worst - 5 best), lubrication (4Qs 0 worst-5 best), orgasm (3Qs 0 worst - 5 best), satisfaction ( 3Qs 0 worst - 5 best), and pain (3 Qs 0 worst - 5 best). Higher scores indicate higher sexual functioning. Scores range from 2-36. A score of 26.55 has been clinically selected as the cut-off for sexual dysfunction. Scores below this value indicate sexual dysfunction. The change is measured as the difference at 36 months minus baseline. A positive score means the sexual dysfunction symptoms are getting worse. Only people that had sexual activity were included. |
| Frequency of Urinary Tract Infection (UTI) Occurrences, as Measured by a Positive Urine Culture Test at 36 Months Post-initial Treatment. | 36 months post-initial treatment | A clean catch urine specimen will be collected at each visit. A positive urine dipstick test will have the presence of leukocytes and nitrites accompanied by symptoms (dysuria, bladder pain, and/or urinary frequency) and will be sent for a culture. A positive urine culture has the presence of bacterial growth. Only patients that reported recurrent UTI's - 4 or more in the past year (i.e. had 4 or more positive urine cultures in a year) at baseline with an occurrence of a positive urine culture after 6 months but before or at 36 months post-initial treatment will be counted. |
| The Presence of Lactobacillus, Assessed by Vaginal Swab at 36 Months. | 36 months post-initial treatment | A vaginal exam is completed at 36 months. In some cases the 36 month visit was completed remotely and thus a vaginal exam was not completed. Presence or absence of lactobacillus will be collected by the physician via a vaginal swab and assessed under the microscope of the patients that had a vaginal exam completed. This is the total number of patients positive for lactobacillus at 36 months. |
| Change in Patient Global Impression of Improvement (PGI-I) Score at 6 Months After Initial Treatment | 6 months post-initial treatment | The average change in patients' PGI-I scores from baseline to 6 months and 36 months post-treatment. The PGI-I asks the patient to "check the one number that best describes how your urinary tract condition is now compared with how it was before your treatment." There are 7 possible responses ranging from 1 to 7, where 1 is "Very Much Better" and 7 is "Very Much Worse". A lower score would represent improvement and a favorable outcome. |
| Change in Life and Sexual Impact of Vulvovaginal Skin Symptoms as Measured by the Incontinence Quality of Life Questionnaire (I-QOL) at 36 Months. | 36 months post-initial treatment | The Incontinence Quality of Life Questionnaire (I-QOL) is a validated tool to assess the impact of urinary incontinence problems. The I-QOL has 22 incontinent-specific quality of life items all having the following five-point ordinal response scale: 1= Extremely, 2= Quite a Bit, 3= Moderately, 4= A Little, and 5= Not at All. All 22 items are summed up, and the sum is converted to a 100-point scale. The range of the score is 0-100, with a high score indicating a better quality of life. In this outcome measure we report the change in the I-QOL score at 36 months minus the score at baseline. A positive score indicates that the quality of life improved at 36 months compared to before treatment. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORKenneth Peters, MD
Corewell Health William Beaumont University Hospital
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| fCO2 Laser Therapy Group Women treated with the fCO2 laser
fCO2 Laser Therapy Group: Women enrolled in the study will receive three treatments with the fractional carbon dioxide (fCO2) laser. The interval between treatments is approximately six weeks. Intra-vaginal laser treatments will be delivered at 8 points at each level of the vaginal wall. | 80 |
| Total | 80 |
Baseline characteristics
| Characteristic | fCO2 Laser Therapy Group |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 16 Participants |
| Age, Categorical Between 18 and 65 years | 84 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 98 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 9 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 90 Participants |
| Region of Enrollment United States | 100 participants |
| Sex: Female, Male Female | 100 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 81 |
| other Total, other adverse events | 64 / 81 |
| serious Total, serious adverse events | 0 / 81 |
Outcome results
Primary
Patient Global Impression of Improvement (PGI-I) Score at 4 Weeks After Initial Treatment
PGI-I score is recorded 4 weeks after initial treatment completion. The PGI-I asks the patient to check the box that best describes how your urinary and/or vaginal symptoms are now, compared with how you symptoms were before you began this study. There are 7 possible responses ranging from 1 to 7, where 1 is Very Much Better, 2 is Much Better, 3 is A Little Bit Better, 4 is No Change, 5 is A Little Worse, 6 is Much Worse, and 7 is Very Much Worse. A score from 1 to 3 would indicate improvement.
Time frame: 4 weeks post-initial treatment
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| fCO2 Laser Therapy Group | Patient Global Impression of Improvement (PGI-I) Score at 4 Weeks After Initial Treatment | 2.66 score on a scale | Standard Deviation 0.88 |
Secondary
Change in Frequency of UTI Occurrences, as Measured by a Positive Urine Culture Test.
A clean catch urine specimen will be collected at each visit. A positive urine dipstick test will have the presence of leukocytes and nitrites accompanied by symptoms (dysuria, bladder pain, and/or urinary frequency).
Time frame: 6 months and 36 months post-initial treatment
Secondary
Change in Life and Sexual Impact of Vulvovaginal Skin Symptoms.
The Incontinence Quality of Life Questionnaire (I-QOL) is a validated tool to assess the impact of urinary incontinence problems. The I-QOL has 22 incontinent-specific quality of life items all having the following five-point ordinal response scale: 1= Extremely, 2= Quite a Bit, 3= Moderately, 4= A Little, and 5= Not at All. Total I-QOL is a combined score of all items. All 22 items are summed to calculate a total I-QOL score, ranging from 22 to 110, with a high score indicating a better quality of life. The 22 items are broken down into 3 subscales: Avoidance and Limiting Behaviors Score (8 of the 22 items), Psychosocial Impacts Score (9 of the 22 items), and Social Embarrassment Score (5 of the 22 items). Scores are summed based on the same 5-point scale. 1= Extremely, 2= Quite a Bit, 3= Moderately, 4= A Little, and 5= Not at All. A high score indicates a better quality of life.
Time frame: 6 months and 36 months post-initial treatment
Secondary
Change in Mental Health Status as Measured by the Generalized Anxiety Disorder Questionnaire (GAD-7).
The GAD-7 is a self-reported questionnaire for screening and measuring severity of generalized anxiety disorder. There are 7 questions total, each answer is scored on a scale from 0 = not at all to 3 = nearly every day. Scores greater than or equal to 10 indicate moderate anxiety and further assessment is recommended.
Time frame: 6 months and 36 months post-initial treatment
Secondary
Change in Mental Health Status as Measured by the Patient Health Questionnaire (PHQ-8).
The PHQ-8 is an eight item questionnaire that is a valid diagnostic and severity measure for depressive disorders. Each question is scored from 0 = not at all to 3 = nearly every day. A score of 10 or greater is considered major depression and a score of 20 or more as severe major depression.
Time frame: 6 months and 36 months post-initial treatment
Secondary
Change in Overactive Bladder (OAB) Symptoms as Measured by the Overactive Bladder Questionnaire-Short Form (OAB-q SF).
The OAB-q SF consists of two scales assessing symptom bother and health-related quality of life (HR-QOL) in patients with OAB. Each question is rated on a 6 point scale with 1 = Not at all and 6 = A very great deal.
Time frame: 6 months and 36 months post-initial treatment
Secondary
Change in Patient Global Impression of Improvement (PGI-I) Score
The average change in patients' PGI-I scores from baseline to 6 months and 36 months post-treatment. The PGI-I asks the patient to check the one number that best describes how your urinary tract condition is now compared with how it was before your treatment. There are 7 possible responses ranging from 1 to 7, where 1 is Very Much Better and 7 is Very Much Worse. A lower score would represent improvement and a favorable outcome.
Time frame: 6 months and 36 months post-initial treatment
Secondary
Change in Sexual Function, Including Dyspareunia Symptoms, as Measured by the Female Sexual Function Inventory (FSFI).
The FSFI consists of 6 subscales related to sexual desire (2 Qs scale 1 worst - 5 best), arousal (4Qs 0 worst - 5 best), lubrication (4Qs 0 worst-5 best), orgasm (3Qs 0 worst - 5 best), satisfaction ( 3Qs 0 worst - 5 best), and pain (3 Qs 0 worst - 5 best). Higher scores indicate higher sexual functioning. Scores range from 2-36. A score of 26.55 has been clinically selected as the cut-off for sexual dysfunction. Scores below this value indicate sexual dysfunction.
Time frame: 6 months and 36 months post-initial treatment
Secondary
Change in the Presence of Lactobacillus, Assessed by Vaginal Swab.
Presence or absence of lactobacillus will be collected by the physician via a vaginal swab and assessed under the microscope.
Time frame: 6 months and 36 months post-initial treatment
Secondary
Change in Urinary Symptoms as Measured by the Questionnaire for Urinary Incontinence Diagnosis (QUID).
Patients will complete the QUID, which consists of 6 questions. Responses to the questions indicate the frequency of urinary incontinence. Scores are: 0 (none of the time), 1 (rarely), 2 (once in awhile), 3 (often), 4 (most of the time), or 5 (all of the time). Responses to items 1, 2, and 3 are summed for the Stress Urinary Incontinence Score. Responses to items 4, 5, and 6 are summed for the Urge Incontinence Score.
Time frame: 6 months and 36 months post-initial treatment
Secondary
Change in Vaginal pH and Overall Vaginal Health on Physical Exam as Measured by the Vaginal Health Inventory Score (VHIS).
The Vaginal Health Inventory Score (VHIS) is an assessment tool, used by providers, to determine if vaginal atrophy is present. Providers perform a vaginal exam and give a score of 1-5 (abnormal to normal, respectively) on each of the following vaginal parameters: elasticity, secretion/fluid volume, vaginal pH, integrity of the epithelium, and lubrication/moisture of the vaginal wall. A VHIS score less than 15 is indicative of vaginal atrophy.
Time frame: 6 months and 36 months post-initial treatment
Secondary
Change in Voiding Diaries.
A 3-day voiding diary will be completed by the patient and evaluated to describe urinary frequency and incontinence episodes.
Time frame: 6 months and 36 months post-initial treatment