Actively Recruiting
The Anabolic Effect of Testosterone on Pelvic Floor Muscles
Led by Brigham and Women's Hospital · Updated on 2025-05-14
30
Participants Needed
1
Research Sites
67 weeks
Total Duration
On this page
Sponsors
B
Brigham and Women's Hospital
Lead Sponsor
N
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
The Anabolic Effect of Testosterone on Pelvic Floor Muscles
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Women aged 60 years and older
- Medically documented pure stress urinary incontinence confirmed by physical exam or urodynamic testing
- Normal mammogram within the last 12 months
- Endometrial thickness of 4 mm or less in women with an intact uterus, confirmed by ultrasound
- Ability and willingness to give informed consent
You will not qualify if you...
- Diagnosed urge or mixed urinary incontinence
- Currently or recently (within 3 months) participating in pelvic floor muscle training therapy
- Previous pelvic surgery or radiation treatment to the pelvis
- History of grade 3 or higher pelvic organ prolapse
- Neurologic disorders causing urinary incontinence or bladder dysfunction
- Current urinary tract infection
- History of breast or endometrial cancer
- Use of systemic estrogen therapy in the past 3 months
- Baseline hematocrit over 48%, serum creatinine over 2.5 mg/dL, HbA1c over 8.0%, or BMI over 40 kg/m2
- Uncontrolled hypertension with blood pressure readings over 160/100
- Use of insulin therapy
- Uncontrolled congestive heart failure
- Recent myocardial infarction, acute coronary syndrome, revascularization surgery, or stroke within 6 months
- History of pulmonary embolism, deep vein thrombosis, or genetic thromboembolic disorder
- History of bipolar disorder, schizophrenia, or untreated major depression
- Presence of metallic implants preventing MRI scanning
AI-Screening
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Trial Site Locations
Total: 1 location
1
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
Actively Recruiting
Research Team
S
Shalender Bhasin, MB,BS
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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