Skip to main content
OpenTrials
Completed

NCT Number: NCT03147599

Mebeverine For 1st Year Daytime And Nocturnal Incontinence After Orthotopic W-Ileal Neobladders

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.

Completed

Looking for future studies?

Notify Me

Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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

Treatment and study plan

Coloverin

Drug

Mebeverine hydrochloride 135 mg

Other names: Mebeverine hydrochloride

Placebo

Drug

Placebo

Primary outcomes

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

    Time frame: 10 months

    Outcome Measure by standardized continence questionnaire

Secondary outcomes

  1. Effect of mebeverine on patient quality of life by assessing patient quality of life measured by quality of life questionnaire

    Time frame: 10 months

    Outcome Measure by quality of life questionnaire

  2. Effect of mebeverine on orthotopic w-ileal neobladders urodynamics by assessing simple urodynamic parameter

    Time frame: 10 months

    Outcome Measure by pressure change measurement in centimetre of water.

Sponsors and collaborators

Lead sponsor

Mansoura University

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
May 10, 2017
Registry last updated
Jun 30, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.