Phase
Condition
Enuresis
Urinary Incontinence
Menopause
Treatment
Placebo
Testosterone cypionate
Clinical Study ID
Ages > 60 Female
Study Summary
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
Study Description
Connect with a study center
Brigham and Women's Hospital
Boston, Massachusetts 02115
United StatesActive - Recruiting
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