Stress Urinary Incontinence Clinical Trial
Official title:
Testosterone Replacement in Postmenopausal Women With Stress Urinary Incontinence
The overall objective of this study is to establish if testosterone replacement in
post-menopausal women with low testosterone levels and stress urinary incontinence (SUI) will
lead to improvement in symptoms of SUI.
This study is a prospective, randomized, double-blind, placebo-controlled, parallel-group,
clinical trial and will involve sixty (60) post-menopausal women with clinically diagnosed
stress urinary incontinence and low testosterone concentrations. These subjects will enter
the control period, which involves the baseline measurements of pelvic floor muscle volume
and strength, amounts of urine leakage in 24-hour period, urodynamic parameters, and quality
of life using Incontinence Impact Questionnaire and Urogenital Distress Inventory. Subjects
are then randomly assigned to either placebo (30 subjects) or 300 mcg/twice-weekly
testosterone patch (30 subjects) group. Both the subjects and investigators will be blinded.
The duration of the testosterone/control study will be 36 weeks, with weeks 1-3
screening/control period, 4-28 application of placebo or testosterone patches and 29-36
recovery time/assessment of effects.
Primary Outcome Measure:
Our primary outcome measure is the change in levator ani muscle volume with correlation in
improvement in stress incontinence. These will be assessed by MRI, urodynamic studies and pad
tests. [Time Frame: 36 weeks]
Secondary Outcome Measures:
Our secondary outcome measures are: [Time Frame: 36 weeks]
1. Change in urodynamic measurements including urethral pressure profile, cough stress
profile, maximum urethral closure pressure, Valsalva leak point pressure, and pressure
transmission ratios.
2. Change in pelvic floor muscle strength as measured with a perineometer.
3. Change in amounts of urinary leakage (in a 24 hour period) using the Pad Test.
4. Change in subjective quality of life as it relates to incontinence using the
Incontinence Impact Questionnaire, Urogenital Distress Inventory and Incontinence Diary.
5. Change in hormone levels including total and free testosterone, dihydrotestosterone
(DHT), estradiol 17 B, and sex hormone binding globulin (SHBG).
6. Change in complete blood count, chem 20, lipid profile (total cholesterol, triglyceride,
HDL, LDL) and physical examination as compared to the baseline before treatment.
;
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