A Pilot Study to Evaluate the Anabolic Effect of Testosterone on Muscles of the Pelvic Floor in Older Women With Stress Urinary Incontinence
Brigham and Women's Hospital
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.
Description
The investigators are conducting a 12-week double-blind, randomized-controlled, proof-of-concept pilot trial to determine the anabolic effect of testosterone therapy on pelvic floor muscles in postmenopausal women, 60 years and older, with stress urinary incontinence. The first aim is to compare the efficacy of testosterone supplementation versus placebo on the volume of levator ani muscles of the pelvic floor, assessed by magnetic resonance imaging (MRI). The second aim is to assess the efficacy of testosterone supplementation in improving indices of urodynamic function (i.e., bladder, urethr…
Eligibility
- Age range
- 60+ years
- Sex
- Female
- Healthy volunteers
- No
Inclusion Criteria: * 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. Exclusion Criteria: * • 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 * Previo…
Interventions
- DrugTestosterone cypionate
weekly by intramuscular injection
- DrugPlacebo
weekly by intramuscular injection
Location
- Brigham and Women's HospitalBoston, Massachusetts