Autologous Bone Marrow-derived Mesenchymal Stem Cells Versus Tension-free Vaginal Tape for Treatment of Female Stress Urinary Incontinence: An Open-label Clinical Trial
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- change in cough test & urodynamic study as a measure of efficacy of treatment
研究概览
简要总结
This study evaluates the effectiveness of mesenchymal stem cells in treatment of stress urinary incontinence due to intrinsic sphincter deficiency; in which the problem is weakness or damage of the sphincter muscle responsible for continence. Mesenchymal stem cells are undifferentiated cells which can undergo self-renewal & differentiation into other cell types like muscle cells; thus can be used to regenerate the damaged sphincter muscles. In this study mesenchymal stem cells will be obtained from bone marrow from the patient, processed, & then re-injected periurethrally. Effectiveness will be compared to that of the surgical treatment (tension-free vaginal tape).
详细描述
** Study settings : The study is to be held at Ain-Shams University Maternity Hospital - urogynecolgy unit; recruiting the patients from the urogynecology outpatient clinic
** Sample size:
Fifty female patients with stress urinary incontinence due to intrinsic sphincter deficiency will be recruited into two groups; group A including 25 patients will be injected with stem cells, & these will be the patients refusing surgery as a primary line of treatment, or unfit for surgery. Group B; including 25 patients, will undergo the tension-free vaginal tape operation. The sample size is determined according to the following equation:
[ P1( 100-P1) + P2( 100-P2) ] / (P2 - P1)2 where; Power of the test = 80% Confidence level = 95% Alpha error = 5% Assuming success rate for the preferably used intervention "tension-free vaginal tape" in patients with intrinsic sphincter deficiency P1=80% ( Schierlitz et al, 2008).
Assuming success rate for stem cell therapy P2= 90% ( Smaldone et al, 2009).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Symptoms of stress urinary incontinence
- •Urodynamic study showing stress urinary incontinence due to intrinsic sphincter deficiency
排除标准
- •Pregnant females
- •Hypermobility of the urethra
- •Mild cases (treatment is mainly physiotherapy & pelvic floor exercises)
- •Urge incontinence / Urodynamic study showing detrusor instability
- •Current urinary infection
- •Current severe cystocele or rectocele
- •History of previous synthetic, biologic or fascial sub-urethral sling or any other surgery on external genitalia, bladder neck, bladder or urethra
- •Voiding dysfunction (post-void residual volume >100cc)
研究组 & 干预措施
Stem cells,Mesenchymal
Periurethral injection of autologous bone-marrow derived stem cells.
干预措施: Stem Cells,Mesenchymal (Biological)
surgery (TVT)
Tension-free vaginal tape operation: a midurethral sling operation
干预措施: surgery (TVT) (Procedure)
结局指标
主要结局
change in cough test & urodynamic study as a measure of efficacy of treatment
时间窗: before & after therapy each 3 months for one year (at 3m, 6m, 9m, 12m post-injection).
cough test: as positive or negative leakage with cough. Urodynamic study: changes in abdominal leak point pressure, and changes in maximum urethral closure pressure
次要结局
- Quality of life as measured by the Incontinence Quality of Life (I-QOL) Instrument Score(before & after therapy each 3 months for one year (at 3m, 6m, 9m, 12m post-injection).)
研究者
Rania Hassan Mostafa
assistant lecturer
Ain Shams Maternity Hospital