A Phase 2 interventional study of Testosterone cypionate and Placebo in Stress Urinary Incontinence and Menopause, sponsored by Brigham and Women's Hospital. Active, not recruiting at 1 site in United States. Open to female participants aged 60 Years and older. Per ClinicalTrials.gov, last updated 2026-06-26.
Sponsored by Brigham and Women's Hospital · Phase 2, Interventional, and Treatment
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.
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, urethra, and sphincter function), assessed by urodynamic testing. These urodynamic measures include Valsava leak point pressure, urethral pressure profile, cystometry and electromyography. As an exploratory aim, the efficacy of testosterone treatment relative to placebo will be assessed using self-reported urinary symptoms assessed by the Urogenital Distress Inventory (UDI) and quality of life assessed by the Incontinence Impact Questionnaire (IIQ).
658 studies on the registry are indexed under Urinary Incontinence, Stress; 123 are open to participants now.
This study's planned enrollment of 30 is below the median of 70 across 509 interventional studies indexed under Urinary Incontinence, Stress.
Browse Urinary Incontinence, Stress studies →Brigham and Women's Hospital is the lead sponsor of 1,236 studies on the registry; 224 are open to participants now.
Of its 116 completed or terminated interventional studies of FDA-regulated products, 64 (55%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Medically documented urge or mixed urinary incontinence (stress and urge) on physical exam or urodynamic testing.
Testosterone Cypionate 25-mg weekly by intramuscular injection
Drug: Testosterone cypionate
Placebo intramuscular injections weekly
Drug: Placebo
weekly by intramuscular injection
weekly by intramuscular injection
Change in pelvic floor muscle volume
volume of levator ani muscles of the pelvic floor, assessed by magnetic resonance imaging (MRI)
Time frame: 12 weeks
Change in abdominal leak point pressure
abdominal leak point pressure will be measured by a urodynamic function study
Time frame: 12 weeks
Change in urine flow rate
urine flow rate will be measured by urodynamic function a study
Time frame: 12 weeks
Change in bladder pressure
bladder pressure will be measured during filling, storage and voiding by urodynamic study
Time frame: 12 weeks
Change in post void residual urine volume
post void residual urine volume will be measured using bladder ultrasound
Time frame: 12 weeks
Change in urinary symptoms
self-reported urinary symptoms will be assessed by the Urogenital Distress Inventory (UDI). Total score ranges from 6-24 with higher scores indicating higher severity of symptoms
Time frame: 12 weeks
Change in quality of life
quality of life will be assessed by the Incontinence Impact Questionnaire (IIQ). Total score ranges from 0-21 with higher scores indicating worse impact on quality of life.
Time frame: 12 weeks
Plan to share: No
No publications or documents are linked to this record.
This study is active, not recruiting, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.
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Brigham and Women's Hospital