The Anabolic Effect of Testosterone on Pelvic Floor Muscles
Eligible age
60+ yrs
Accepts
Women
Locations
1 state
Healthy volunteers
No
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About this study
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.
Sponsor: Brigham and Women's Hospital
You may qualify if…
- ✓ 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.
You may not qualify if…
- ✕ • Medically documented urge or mixed urinary incontinence (stress and urge) on physical exam or urodynamic testing.
- ✕ Participating in pelvic floor muscle training (PFMT) therapy currently or in the past 3 months
- ✕ Previous pelvic surgery (i.e., hysterectomy, pelvic organ prolapse repair, mid-urethral sling placement, injection of urethral bulking agents) or radiation treatment to the pelvis.
- ✕ History of ≥ Grade 3 pelvic organ prolapse
- ✕ Neurologic disorder causing UI or bladder dysfunction (i.e., multiple sclerosis, Parkinson's disease, stroke, cerebral palsy, spinal cord injury)
- ✕ Current urinary tract infection
- ✕ History of breast or endometrial cancer
- ✕ Use of systemic estrogen therapy in the past 3 months
Where it's recruiting
Boston
Source: ClinicalTrials.gov · NCT06111209 · last updated 2025-05-14