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| ID | Type | Description | Link |
|---|---|---|---|
| R01DK136904 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
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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.
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 postmenopausal women, 60 years and older, with stress urinary incontinence. The first aim is to compare the efficacy of testosterone supplementation versus placebo on the volume of levator ani muscles of the pelvic floor, assessed by magnetic resonance imaging (MRI). The second aim is to assess the efficacy of testosterone supplementation in improving indices of urodynamic function (i.e., bladder, urethra, and sphincter function), assessed by urodynamic testing. These urodynamic measures include Valsava leak point pressure, urethral pressure profile, cystometry and electromyography. As an exploratory aim, the efficacy of testosterone treatment relative to placebo will be assessed using self-reported urinary symptoms assessed by the Urogenital Distress Inventory (UDI) and quality of life assessed by the Incontinence Impact Questionnaire (IIQ).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Testosterone | Active Comparator | Testosterone Cypionate 25-mg weekly by intramuscular injection |
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| Placebo | Placebo Comparator | Placebo intramuscular injections weekly |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Testosterone cypionate | Drug | weekly by intramuscular injection |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change in pelvic floor muscle volume | volume of levator ani muscles of the pelvic floor, assessed by magnetic resonance imaging (MRI) | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in abdominal leak point pressure | abdominal leak point pressure will be measured by a urodynamic function study | 12 weeks |
| Change in urine flow rate | urine flow rate will be measured by urodynamic function a study |
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Inclusion Criteria:
Exclusion Criteria:
• Medically documented urge or mixed urinary incontinence (stress and urge) on physical exam or urodynamic testing.
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| Name | Affiliation | Role |
|---|---|---|
| Grace Huang, MD | Brigham and Women's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Brigham and Women's Hospital | Boston | Massachusetts | 02115 | United States |
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| ID | Term |
|---|---|
| D014550 | Urinary Incontinence, Stress |
| D059952 | Pelvic Floor Disorders |
| ID | Term |
|---|---|
| D014549 | Urinary Incontinence |
| D014555 | Urination Disorders |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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| ID | Term |
|---|---|
| C016131 | testosterone 17 beta-cypionate |
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| Placebo |
| Drug |
weekly by intramuscular injection |
|
| 12 weeks |
| Change in bladder pressure | bladder pressure will be measured during filling, storage and voiding by urodynamic study | 12 weeks |
| Change in post void residual urine volume | post void residual urine volume will be measured using bladder ultrasound | 12 weeks |
| Change in urinary symptoms | self-reported urinary symptoms will be assessed by the Urogenital Distress Inventory (UDI). Total score ranges from 6-24 with higher scores indicating higher severity of symptoms | 12 weeks |
| Change in quality of life | quality of life will be assessed by the Incontinence Impact Questionnaire (IIQ). Total score ranges from 0-21 with higher scores indicating worse impact on quality of life. | 12 weeks |
| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D059411 | Lower Urinary Tract Symptoms |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D011248 | Pregnancy Complications |