Clinical Trial: Mebeverine For Daytime And Nocturnal Incontinence and After Orthotopic W-Ileal Neobladders

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official 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 Cross-over Contr

Brief Summary: 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.

Detailed Summary:

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 r
Sponsor: Mansoura University

Current Primary Outcome: 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


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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
  • 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.


Original Secondary Outcome: Same as current

Information By: Mansoura University

Dates:
Date Received: March 15, 2017
Date Started: May 15, 2017
Date Completion: December 1, 2017
Last Updated: May 16, 2017
Last Verified: May 2017