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

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ClinicalTrials.gov Identifier: NCT03147599
Recruitment Status : Unknown
Verified May 2017 by Abdelwahab Hashem, Mansoura University.
Recruitment status was:  Recruiting
First Posted : May 10, 2017
Last Update Posted : May 17, 2017
Sponsor:
Information provided by (Responsible Party):
Abdelwahab Hashem, Mansoura University

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.

Condition or disease Intervention/treatment Phase
Oncology Incontinence Incontinence, Daytime Urinary Incontinence, Nighttime Urinary Bladder Cancer Orthotopic Neobladder Drug: Coloverin Drug: Placebo Phase 4

Detailed Description:

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
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 Controlled Study
Estimated Study Start Date : May 15, 2017
Estimated Primary Completion Date : December 1, 2017
Estimated Study Completion Date : December 1, 2017

Arm Intervention/treatment
Active Comparator: Mebeverine
Coloverin (Mebeverine hydrochloride 135 mg)
Drug: Coloverin
Mebeverine hydrochloride 135 mg
Other Name: Mebeverine hydrochloride

Placebo Comparator: Placebo
Placebo
Drug: Placebo
Placebo




Primary Outcome Measures :
  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 Outcome Measures :
  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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  1. Upper urinary tract deterioration
  2. Uncontrolled diabetes mellitus
  3. Evident local or pelvic recurrence
  4. Adjuvant chemotherapy
  5. Chronic retention
  6. Pouch stones
  7. Urethral stricture or urethro-ileal maldirection
  8. Sensitivity to Mebeverine
  9. Untreated chronic constipation
  10. Active symptomatic urinary infection

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03147599


Contacts
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Contact: Abdelwahab R. Hashem, Msc 01069678979 ext 002 abdelwahab_hashem@yahoo.com
Contact: Mohammed H. Zahran, MD 01063338690 ext 002 zahranmha@yahoo.com

Locations
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Egypt
Urology and Nephrology Center Recruiting
Mansoura, Aldakahlia, Egypt, 35516
Contact: Abdelwahab R. Hashem, Msc    00201069678979    abdelwahab_hashem@yahoo.com   
Contact: Mohammed H. Zahran, MD    00201063338690    zahranmha@yahoo.com   
Sponsors and Collaborators
Mansoura University
Investigators
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Study Chair: Hassan Abol-Enein, MD Urology and Nephrology Center
Study Director: Ahmed Mosbah, MD Urology and Nephrology Center
Principal Investigator: Ahmed Elhussein, MBBCH Urology and Nephrology Center
Principal Investigator: Ahmed Elkarta, MBBCH Urology and Nephrology Center
Principal Investigator: Mohamed Soltan, MBBCH Urology and Nephrology Center

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Responsible Party: Abdelwahab Hashem, Urology Msc, Oncology fellow at Urology and Nephrology Center, Principal Investigator, Mansoura University
ClinicalTrials.gov Identifier: NCT03147599    
Other Study ID Numbers: R/17.02.32
First Posted: May 10, 2017    Key Record Dates
Last Update Posted: May 17, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: meta-analyses by contact the Prof. Hassan Abol-Enein, MD, Phd (Study Chair)

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Abdelwahab Hashem, Mansoura University:
Mebeverine
Incontinence
Orthotopic Neobladder
Additional relevant MeSH terms:
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Diurnal Enuresis
Nocturnal Enuresis
Enuresis
Urologic Diseases
Urination Disorders
Behavioral Symptoms
Elimination Disorders
Mental Disorders
Mebeverine
Alverine
Anticonvulsants
Parasympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs