The Anabolic Effect of Testosterone on Pelvic Floor Muscles

What this trial studies

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.

Conditions in scope

• Stress Urinary Incontinence
• Menopause

Interventions

• Testosterone cypionate (Drug) — weekly by intramuscular injection
• Placebo (Drug) — weekly by intramuscular injection

Who can join

Women only · Ages 60 Years and up

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
• 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

Eligibility wording paraphrased from the public record. View the full criteria on ClinicalTrials.gov before contacting a site.

Where it’s happening

Status & timeline

• Overall status: Recruiting
• Study type: Interventional
• Phase: PHASE2
• Start date: 2025-02-15
• Primary completion: 2026-03-31
• Last update posted: 2025-05-14
• First posted: 2023-11-01

Sponsor & contact

Lead sponsor: Brigham and Women's Hospital (Other)

Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

For trial site contact information, use the official record at ClinicalTrials.gov. Contact details change frequently and the public record is the source of truth.

Outcome measures

Primary outcomes

• Change in pelvic floor muscle volume (12 weeks)
  volume of levator ani muscles of the pelvic floor, assessed by magnetic resonance imaging (MRI)

Related ClearedRx care

If you’re reading this trial because you have menopause symptoms now, you don’t have to wait for a trial to access evidence-based care. ClearedRx prescribes the same FDA-approved and compounded HRT products that have been studied in trials like this one for decades.