Outcome
Type |
Measure |
Description |
Time frame |
Safety issue |
Primary |
Change in Patient Global Impression of Improvement (PGI-I) score at 16 weeks (4 weeks post-initial treatment). |
The primary outcome will be the average change in patients' PGI-I scores from baseline to 16 weeks 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. |
16 weeks ( 4 weeks 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. |
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. |
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. |
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. |
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. |
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. |
6 months and 36 months post-initial treatment |
|
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). |
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. |
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. |
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. |
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. |
6 months and 36 months post-initial treatment |
|