NCT03116087

Testosterone Replacement in Postmenopausal Women With Stress Urinary Incontinence

Completed NA Last updated 9 August 2018

What this trial tests

NA trial testing Testosterone patch in Stress Urinary Incontinence in 60 participants. Completed in 31 May 2018.

Timeline

1 March 2007

Primary endpoint
31 May 2018

31 May 2018

Quick facts

Lead sponsor	Charles Drew University of Medicine and Science
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	60
Start date	1 March 2007
Primary completion	31 May 2018
Estimated completion	31 May 2018
Sites	1 location across United States

Drugs / interventions tested

• Testosterone patch
• Placebo

Conditions studied

• Stress Urinary Incontinence — all drugs for Stress Urinary Incontinence →

Sponsor

Charles Drew University of Medicine and Science

Who can join

Adults 45 to 75, female only, with Stress Urinary Incontinence. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Pharmacotherapy in Stress Urinary Incontinence; A Literature Review.
   Tabei SS, Baas W, Mahdy A. · · 2024 · cited 5× · PMID 38727982 · DOI 10.1007/s11934-024-01205-9