The Anabolic Effect of Testosterone on Pelvic Floor Muscles

NCT06111209 | Recruiting Phase 2 DMC FDA Drug

• 2 other identifiers: 2023P002632R01DK136904
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Stress Urinary Incontinence; Menopause

Keywords

stress urinary incontinence; testosterone therapy; menopause; pelvic floor disorders

Outcome Measures

Primary Outcomes (1)

• Change in pelvic floor muscle volume

  volume of levator ani muscles of the pelvic floor, assessed by magnetic resonance imaging (MRI)

  12 weeks

Secondary Outcomes (6)

• Change in abdominal leak point pressure

  12 weeks

• Change in urine flow rate

  12 weeks

• Change in bladder pressure

  12 weeks

• Change in post void residual urine volume

  12 weeks

• Change in urinary symptoms

  12 weeks

Study Arms (2)

Testosterone

ACTIVE COMPARATOR

Testosterone Cypionate 25-mg weekly by intramuscular injection

Drug: Testosterone cypionate

Placebo

PLACEBO COMPARATOR

Placebo intramuscular injections weekly

Drug: Placebo

Interventions

Testosterone cypionate DRUG

weekly by intramuscular injection

Testosterone

Placebo DRUG

weekly by intramuscular injection

Placebo

Eligibility Criteria

• Age: 60 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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
• Baseline hematocrit \>48%, serum creatinine \>2.5 mg/dL; HbA1c \>8.0%; BMI \>40 kg/m2
• Uncontrolled hypertension defined as an average of two blood pressure readings of greater than 160/100.
• Subjects who are on insulin therapy will be excluded.
• Uncontrolled congestive heart failure
• Myocardial infarction, acute coronary syndrome, revascularization surgery or stroke within 6 months
• History of pulmonary embolism, deep vein thrombosis or a genetic thromboembolic disorder
• History of bipolar disorder, schizophrenia or untreated major depression

Sponsors & Collaborators

• Brigham and Women's Hospital: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

RECRUITING

MeSH Terms

Conditions

Urinary Incontinence, Stress; Pelvic Floor Disorders

Interventions

testosterone 17 beta-cypionate

Condition Hierarchy (Ancestors)

Urinary Incontinence; Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pregnancy Complications

Study Officials

• Grace Huang, MD

  Brigham and Women's Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Shalender Bhasin, MB,BS

CONTACT

617-525-9150; sbhasin@bwh.harvard.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 18, 2023
• First Posted: November 1, 2023
• Study Start: February 15, 2025
• Primary Completion: March 31, 2026
• Study Completion (Estimated): May 31, 2026
• Last Updated: May 14, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)