A Pilot Study to Evaluate the Anabolic Effect of Testosterone on Muscles of the Pelvic Floor in Older Women With Stress Urinary Incontinence
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Change in pelvic floor muscle volume
研究概览
简要总结
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.
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •• 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/
- •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
研究组 & 干预措施
Placebo
Placebo intramuscular injections weekly
干预措施: Placebo (Drug)
Testosterone
Testosterone Cypionate 25-mg weekly by intramuscular injection
干预措施: Testosterone cypionate (Drug)
结局指标
主要结局
Change in pelvic floor muscle volume
时间窗: 12 weeks
volume of levator ani muscles of the pelvic floor, assessed by magnetic resonance imaging (MRI)
次要结局
- Change in abdominal leak point pressure(12 weeks)
- Change in bladder pressure(12 weeks)
- Change in post void residual urine volume(12 weeks)
- Change in urine flow rate(12 weeks)
- Change in quality of life(12 weeks)
- Change in urinary symptoms(12 weeks)
研究者
Shalendar Bhasin, MD
Principal Investigator
Brigham and Women's Hospital