A Pilot Study to Evaluate the Anabolic Effect of Testosterone on Muscles of the Pelvic Floor in Older Women With Stress Urinary Incontinence

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

Stress urinary incontinence is the most common female pelvic floor disorder encountered in clinical practice with significant negative impact on quality of life. The prevalence of urinary incontinence increases with aging, and weakness of the pelvic floor muscles contributes to the development of stress urinary incontinence. Given that androgen receptors are expressed throughout the pelvic floor, the anabolic effects of androgens on pelvic floor muscles may provide a therapeutic option in women with stress urinary incontinence. The investigators are conducting a randomized, double-blind, placebo-controlled proof-of-concept trial in older postmenopausal women with stress urinary incontinence to assess whether testosterone therapy can increase pelvic floor muscles and improve urinary function.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 60
Healthy Volunteers: f
View:

• Women, age 60 years and older.

• Medically documented pure stress urinary incontinence on physical exam or urodynamic testing.

• Normal mammogram within the last 12 months

• Endometrial thickness of ≤4 mm in women with an intact uterus assessed by endometrial ultrasound.

• Ability and willingness to provide informed consent.

Locations
United States
Massachusetts
Brigham and Women's Hospital
RECRUITING
Boston
Contact Information
Primary
Shalender Bhasin, MB,BS
sbhasin@bwh.harvard.edu
617-525-9150
Time Frame
Start Date: 2025-02-15
Estimated Completion Date: 2026-05-31
Participants
Target number of participants: 30
Treatments
Active_comparator: Testosterone
Testosterone Cypionate 25-mg weekly by intramuscular injection
Placebo_comparator: Placebo
Placebo intramuscular injections weekly
Sponsors
Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Leads: Brigham and Women's Hospital

This content was sourced from clinicaltrials.gov