Status:
RECRUITING
The Anabolic Effect of Testosterone on Pelvic Floor Muscles
Lead Sponsor:
Brigham and Women's Hospital
Collaborating Sponsors:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Conditions:
Stress Urinary Incontinence
Menopause
Eligibility:
FEMALE
60+ years
Phase:
PHASE2
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...
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 postmen...
Eligibility Criteria
Inclusion
- 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
- • 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
Key Trial Info
Start Date :
February 15 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 31 2026
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT06111209
Start Date
February 15 2025
End Date
May 31 2026
Last Update
May 14 2025
Active Locations (1)
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1
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115