The Anabolic Effect of Testosterone on Pelvic Floor Muscles

NCT ID: NCT06111209

Last Updated: 2025-05-14

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-02-15
• Study Completion Date: 2026-05-31

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.

Detailed 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, 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).

Conditions

Stress Urinary Incontinence; Menopause

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Testosterone

Testosterone Cypionate 25-mg weekly by intramuscular injection

Group Type: ACTIVE_COMPARATOR

Testosterone cypionate

Intervention Type: DRUG

weekly by intramuscular injection

Placebo

Placebo intramuscular injections weekly

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

weekly by intramuscular injection

Interventions

Testosterone cypionate

weekly by intramuscular injection

Intervention Type: DRUG

Placebo

weekly by intramuscular injection

Intervention Type: DRUG

Eligibility Criteria

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
• 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
• Presence of metallic implants (pacemakers, aneurysm clips, etc.) that preclude the patient from undergoing MRI

• Minimum Eligible Age: 60 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

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

NIH

Sponsor Role: collaborator

Brigham and Women's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Shalendar Bhasin, MD

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Grace Huang, MD

Role: PRINCIPAL_INVESTIGATOR

Brigham and Women's Hospital

Locations

Brigham and Women's Hospital

Boston, Massachusetts, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Shalender Bhasin, MB,BS

Role: CONTACT

sbhasin@bwh.harvard.edu

617-525-9150

Facility Contacts

Shalender Bhasin, MB, BS

Role: primary

sbhasin@bwh.harvard.edu

617-525-9150

Nancy Latham, PhD

Role: backup

nklatham@bwh.harvard.edu

6179999195

Other Identifiers

R01DK136904

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2023P002632

Identifier Type: -

Identifier Source: org_study_id