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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
60
300 mcg testosterone patches or placebo applied twice weekly
Placebo patch
Charles R. Drew University of Medicine and Science
Los Angeles, California, United States
Our primary outcome measure is the change in levator ani muscle volume with correlation in improvement in stress incontinence.
This outcome will be assessed by MRI, urodynamic studies and pad tests.
Time frame: 36 weeks
Change in urethral pressure profile.
This outcome will be evaluated with urodynamic measurement of urethral pressure (in cm H2O) along the urethra.
Time frame: 36 weeks
Change in pelvic floor muscle strength.
This outcome will be measured with a perineometer.
Time frame: 36 weeks
Change in amounts of urinary leakage.
This will be measured with the Pad Test ( in a 24 hour period).
Time frame: 36 weeks
Change in subjective quality of life as it relates to incontinence.
This outcome will be measured with a validated questionnaire and compared with the baseline before treatment.
Time frame: 36 weeks
Change in hormone levels including total and free testosterone, dihydrotestosterone (DHT), estradiol 17 B, sex hormone binding globulin (SHBG).
These will be measured at the baseline (before treatment) and then every four weeks during the treatment and recovery periods and compared with the baseline.
Time frame: 36 weeks
Change in laboratory values.
The blood sample will be collected for laboratory measurement (CBC, chem 20, lipid profile) at the baseline (before treatment) and then every four weeks during the treatment and recovery periods and compared with the baseline.
Time frame: 36 weeks
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