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临床试验/NCT03147599
NCT03147599已完成4 期

Mebeverine For Daytime And Nocturnal Incontinence and After Orthotopic W-Ileal Neobladders - Assessment Of Efficacy And Quality Of Life Effect Within 1 Year Post-Surgery: A Randomized Controlled Study

Mansoura University1 个研究点 分布在 1 个国家目标入组 110 人开始时间: 2017年5月15日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
入组人数
110
试验地点
1
主要终点
Effect of mebeverine on daytime and nocturnal incontinence by assessing continence status measured by standardized continence questionnaire

研究概览

简要总结

A randomized controlled trial to assess clinically the efficacy of the selective ileum spasmolytic mebeverine on daytime incontinence and nocturnal enuresis of orthotopic w-ileal neobladders and quality of life effect within 1 year post-surgery.

详细描述

In appropriately selected patients an orthotopic neobladder (ONB) permits the elimination of an external stoma and preservation of body image without compromising cancer control after radical cystectomy. Voiding dysfunction (VD) following ONB can be divided into failure to empty bladder or failure to store urine. Failure to empty bladder by angulation of urethra is the most common cause. Failure to store urine can occur during daytime, night-time or both. VD that persists beyond 6 to 12 months warrants urodynamics evaluation to determine the cause and suggest plane of therapy. Voiding dysfunction has a detrimental impact on quality of life.

Among the various bowel segments studied, the ileum is ideal for ONB creation. A spherical reservoir, reconfigured from a de-tubularized ileal segment, offers the most desirable attributes like, adequate capacity, low intraluminal pressure, and good compliance. The patient of ONB reported 4-25% rate of clean intermittent self-catheterisation (CISC) for incomplete emptying. Daytime incontinence was present in 13% of patients. The rate of nocturnal incontinence is usually higher in the range of 15-40% in recent metanalysis. The success of ONB rely on detubularization of intestinal segment, sufficient capacity and proper configuration and position in the pelvis. Adequate capacity is achieved by using sufficient length, folding, and creation an ellipsoid or spherical configuration. The ONB should hold approximately 500 cc of urine at low pressure (at < 15 cm H2O), empty completely (< 100 cc urine), four to five times daily and allow the patient to sleep without awakening, while maintain normal body image

loss of the vesico-urethral reflex 'guarding reflex' in which increased urethral sphincter tone parallel to bladder distension, decreased patient vigilance during sleep resulting in reduced muscle tone and urethral closing pressure, decreased sensitivity of the membranous urethra after radical cystectomy, involuntary high-amplitude contractions of the reservoir secondary to bowel peristalsis and shifting of free water from the reservoir wall into the hyperosmolar urine are the main factor causing global and nocturnal polyuria in patient with ONB. Final, there is also evidence suggesting an increase in bowel activity during sleep. Maximum urethral closing pressure (MUCP) is the primary component responsible for daytime continence in patients with an ONB. However, Koraitim et al. suggest that nocturnal incontinence depends on three reservoir parameters: maximal contraction amplitude, baseline reservoir pressure at mid capacity, and MUCP.

Mebeverine is a derivative of reserpine, which has relatively specific effects on smooth muscle cells without atropine-like side effects in humans. It directly blocks voltage-operated sodium channels and inhibits intracellular calcium accumulation. It is three times more potent than papaverine in inhibiting the peristaltic reflex of the ileum.

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
Single (Participant)

入排标准

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

入选标准

  • Men 18 years or older
  • ONB within 1 year post-surgery.

排除标准

  • Upper urinary tract deterioration
  • Uncontrolled diabetes mellitus
  • Evident local or pelvic recurrence
  • Adjuvant chemotherapy
  • Chronic retention
  • Pouch stones
  • Urethral stricture or urethro-ileal maldirection
  • Sensitivity to Mebeverine
  • Untreated chronic constipation
  • Active symptomatic urinary infection

研究组 & 干预措施

Mebeverine

Active Comparator

Coloverin (Mebeverine hydrochloride 135 mg)

干预措施: Coloverin (Drug)

Placebo

Placebo Comparator

Placebo

干预措施: Placebo (Drug)

结局指标

主要结局

Effect of mebeverine on daytime and nocturnal incontinence by assessing continence status measured by standardized continence questionnaire

时间窗: 10 months

Outcome Measure by standardized continence questionnaire

次要结局

  • Effect of mebeverine on patient quality of life by assessing patient quality of life measured by quality of life questionnaire(10 months)
  • Effect of mebeverine on orthotopic w-ileal neobladders urodynamics by assessing simple urodynamic parameter(10 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Abdelwahab Hashem

Urology Msc, Oncology fellow at Urology and Nephrology Center, Principal Investigator

Mansoura University

研究点 (1)

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