Testosterone for Stress Incontinence
Trial Summary
What is the purpose of this trial?
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.
Research Team
Grace Huang, MD
Principal Investigator
Brigham and Women's Hospital
Eligibility Criteria
This trial is for women aged 60 and older with medically confirmed stress urinary incontinence. Participants must have a normal mammogram from the last year and, if they have a uterus, an endometrial thickness of ≤4 mm. They need to be able to give informed consent.Inclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive either testosterone or placebo intramuscular injections weekly to assess the anabolic effect on pelvic floor muscles
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Testosterone cypionate
Find a Clinic Near You
Who Is Running the Clinical Trial?
Brigham and Women's Hospital
Lead Sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborator