The Anabolic Effect of Testosterone on Pelvic Floor Muscles

Launched by BRIGHAM AND WOMEN'S HOSPITAL · Oct 30, 2023

Keywords

ClinConnect Summary

This clinical trial is studying the effects of testosterone therapy on pelvic floor muscles in older women who experience stress urinary incontinence, a condition where urine leaks during activities like coughing or exercise. The trial aims to see if increasing testosterone levels can help strengthen these muscles and improve urinary function. It involves women aged 60 and older who have been diagnosed with this specific type of incontinence, and who meet certain health criteria, such as having a normal mammogram and specific ultrasound results.

Eligible participants will be randomly assigned to receive either testosterone or a placebo (a treatment that has no active ingredients) to see how it affects their condition. Throughout the trial, participants will be monitored to ensure their safety and to collect data on how well the treatment works. It's important to note that women with certain health issues or those who have had specific pelvic surgeries may not qualify for this study. If you're interested in this trial, it could be an opportunity to explore new treatment options for stress urinary incontinence.

Gender

FEMALE

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