NCT03116087

Testosterone Replacement in Postmenopausal Women With Stress Urinary Incontinence

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Charles Drew University of Medicine and Science · Academic / Other
• Sex: Female
• Age: 45 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Stress Urinary Incontinence

Interventions

Type	Name	Description
DRUG	Testosterone patch	300 mcg testosterone patches or placebo applied twice weekly
DRUG	Placebo	Placebo patch

Timeline

• Start date: 2007-03-01
• Primary completion: 2018-05-31
• Completion: 2018-05-31
• First posted: 2017-04-14
• Last updated: 2018-08-09

Locations

1 site across 1 country: United States