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临床试验/NCT00472069
NCT00472069已完成1 期

EVALUATION Of A NEW THERAPEUTIC STRATEGY FOR URETHRAL SPHINCTER INSUFFICIENCY BASED ON THE INTRA-URETHRAL IMPLANTATION OF AUTOLOGOUS MYOFIBERS WITH THEIR SATELLITE CELLS

Assistance Publique - Hôpitaux de Paris2 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2007年4月最近更新:
适应症

试验速览

阶段
1 期
状态
已完成
入组人数
10
试验地点
2
主要终点
Clinical tolerance and feasibility of a new therapeutic strategy for stress urinary incontinence based on intra urethral myofiber implantation of autologous myofibers with their satellite cells

研究概览

简要总结

Stress urinary incontinence is a frequent condition that can be caused by urethral sphincter insufficiency and results in a dramatic deterioration of the quality of life. We developed a new therapeutic strategy for stress urinary incontinence based on the implantation myofibers with their satellite cells in the urethra. The aim of this procedure is to generate functional tissue acting like a new sphincter in the urethra

详细描述

stress urinary incontinence is a frequent condition that can be caused by urethral sphincter insufficiency and results in a dramatic deterioration of the quality of life. We developed a new therapeutic strategy for stress urinary incontinence based on the implantation myofibers with their satellite cells. The principle of this procedure relies on the activation in vivo of the satellite cells present around each myofibers. Satellite cell activation is concomitant with myofiber death that occurs after their implantation. Activated satellite proliferate and fuse to form myotubes replacing the parental myofibers thus leading to the reconstitution of the muscle mass that was initially implanted. Preliminary studies in the pig showed the regenerated muscle tissue in the urethra was innervated by urethral nerves and developed tonic contractions acting like a new sphincter. This procedure does not include a phase of satellite cell amplification ex vivo, as standard methods of satellite cell transfer, and rather relies on the natural myogenic capacities of these cells. Thus, the procedure of cell transfer into the urethra is considerably simplified and can be performed in one step in the operating room.This therapeutic strategy could represent an alternative to the artificial urinary sphincter.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
40 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Men or women from 40 to 75 years old, suffering from urinary incontinence since at least 6 months and candidate for a surgical treatment (artificial urinary sphincter, synthetic compressive tapes or adjustable balloons).
  • The myofiber implantation procedure will be proposed after failure of pelvic floor exercises.
  • The observation of urine leakage during cough in consultation or during urodynamic (with absence of abnormal vesical contraction) and a score MHU > 2 (domain of stress urinary incontinence) will be considered as the main diagnostic criteria.
  • An urethral closure pressure lower than 40 cm H20 will be the main urodynamic diagnostic criterion
  • For women: a negative BONNEY test, and Qtip test<40° (c.f. annex) demonstrating the absence of vesica-urethral hypermobility.
  • 24 hours Pad test > 20g.

排除标准

  • Incapacity to answer the questionnaires of evaluation.
  • History of pelvic radiotherapy.
  • Disorder of hemostasis.
  • Untreated urinary infection.
  • Genetically determined or acquired muscular disease.
  • Neurological disorder (Parkinson's disease, multiple sclerosis, spina BIFIDA, medullary traumatism).
  • The patients suffering from stress urinary incontinence due to vesica-urethral hypermobility (positive BONNEY test and Qtip test >40°) will not be included in the study because the referenced treatment is the implantation of a vaginal tape supporting the urethra.
  • Incomplete vesical emptying. Residual volume > 20% of the urinated volume with a micturition >150cc.
  • Dysuria: maximum urinary flow < 12 ml/sec, IPSS score>7 or score (men) or MHU dysuria domain none equal to 0 at woman.
  • Vesical instability (bladder contraction > 10 cm H20 during the vesical filling of the cysto-manometry). bladder capacity (B3) < 300 DC.
  • Urethral Stenosis (ureterocystoscopy).
  • Previous surgeries for urinary incontinence do not constitute a criterion of exclusion.
  • Pregnancy or intention of pregnancy throughout study. A test of pregnancy will be carried out with the visit of inclusion.
  • Urethral diverticulum.

结局指标

主要结局

Clinical tolerance and feasibility of a new therapeutic strategy for stress urinary incontinence based on intra urethral myofiber implantation of autologous myofibers with their satellite cells

时间窗: 3 months

次要结局

  • Effects of this treatment on urinary continence in order to consider a phase II later on.(3 months)

研究者

申办方类型
Other

研究点 (2)

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