The Anabolic Effect of Testosterone on Pelvic Floor Muscles

Last updated: May 9, 2025
Sponsor: Brigham and Women's Hospital
Overall Status: Active - Recruiting

Phase

2

Condition

Enuresis

Urinary Incontinence

Menopause

Treatment

Placebo

Testosterone cypionate

Clinical Study ID

NCT06111209
2023P002632
R01DK136904
  • Ages > 60
  • Female

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Women, age 60 years and older.

  • Medically documented pure stress urinary incontinence on physical exam or urodynamictesting.

  • Normal mammogram within the last 12 months

  • Endometrial thickness of ≤4 mm in women with an intact uterus assessed byendometrial ultrasound.

  • Ability and willingness to provide informed consent.

Exclusion

Exclusion Criteria:

  • • Medically documented urge or mixed urinary incontinence (stress and urge) onphysical exam or urodynamic testing.

  • Participating in pelvic floor muscle training (PFMT) therapy currently or inthe past 3 months

  • Previous pelvic surgery (i.e., hysterectomy, pelvic organ prolapse repair,mid-urethral sling placement, injection of urethral bulking agents) orradiation treatment to the pelvis.

  • History of ≥ Grade 3 pelvic organ prolapse

  • Neurologic disorder causing UI or bladder dysfunction (i.e., multiplesclerosis, 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 >40kg/m2

  • Uncontrolled hypertension defined as an average of two blood pressure readingsof greater than 160/100.

  • Subjects who are on insulin therapy will be excluded.

  • Uncontrolled congestive heart failure

  • Myocardial infarction, acute coronary syndrome, revascularization surgery orstroke within 6 months

  • History of pulmonary embolism, deep vein thrombosis or a genetic thromboembolicdisorder

  • History of bipolar disorder, schizophrenia or untreated major depression

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

Study Design

Total Participants: 30
Treatment Group(s): 2
Primary Treatment: Placebo
Phase: 2
Study Start date:
February 15, 2025
Estimated Completion Date:
May 31, 2026

Study 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).

Connect with a study center

  • Brigham and Women's Hospital

    Boston, Massachusetts 02115
    United States

    Active - Recruiting

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