Testosterone therapy for improving pelvic floor muscle function in older women
A Pilot Study to Evaluate the Anabolic Effect of Testosterone on Muscles of the Pelvic Floor in Older Women With Stress Urinary Incontinence
This study is testing if testosterone therapy can help improve pelvic floor muscle function and reduce urinary problems in postmenopausal women aged 60 and older who experience stress urinary incontinence.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 60 Years and up |
| Sex | Female |
| Sponsor | Brigham and Women's Hospital Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Boston, Massachusetts) |
| Trial ID | NCT06111209 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effects of testosterone therapy on pelvic floor muscles in postmenopausal women aged 60 and older who suffer from stress urinary incontinence. It is a 12-week, double-blind, randomized, placebo-controlled trial designed to assess whether testosterone supplementation can enhance the volume of pelvic floor muscles and improve urinary function. The study will utilize magnetic resonance imaging (MRI) to measure muscle volume and urodynamic testing to evaluate bladder and urethral function. Additionally, participants will report their urinary symptoms and quality of life through validated questionnaires.
Who should consider this trial
Good fit: Ideal candidates are postmenopausal women aged 60 years and older with medically documented pure stress urinary incontinence.
Not a fit: Patients with urge or mixed urinary incontinence, recent pelvic floor muscle training, or significant pelvic organ prolapse may not benefit from this study.
Why it matters
Potential benefit: If successful, this therapy could significantly improve urinary function and quality of life for women suffering from stress urinary incontinence.
How similar studies have performed: While testosterone therapy for pelvic floor disorders is a relatively novel approach, previous studies have shown promising results in related areas, suggesting potential for success.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Boston, Massachusetts
- Brigham and Women's Hospital — Boston, Massachusetts, United States (Recruiting)
Study contacts
- Principal investigator: Grace Huang, MD — Brigham and Women's Hospital
- Study coordinator: Shalender Bhasin, MB,BS
- Email: sbhasin@bwh.harvard.edu
- Phone: 617-525-9150
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.