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OncologyPhase 4NCT03147599

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

A Phase 4 study testing Coloverin in people with Oncology and Incontinence, run by Mansoura University at 1 site in Egypt.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Coloverin
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
110 participants
Where
1 siteEgypt
Study dates
15 May 2017to 1 May 2019
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • Upper urinary tract deterioration
  • Uncontrolled diabetes mellitus
  • Evident local or pelvic recurrence
  • Adjuvant chemotherapy
  • Chronic retention
  • Pouch stones
Show all 10Show fewer
  • Urethral stricture or urethro-ileal maldirection
  • Sensitivity to Mebeverine
  • Untreated chronic constipation
  • Active symptomatic urinary infection

Trial locations and contacts

1 site in 1 country.

Egypt1 site
  • Urology and Nephrology Center

    Al Mansurah, Aldakahlia, 35516

Other trials in Egypt

About this study

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 Controlled Study

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.

Read the 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.

Being tested
Coloverin, Placebo
Keywords
Mebeverine, Incontinence, Orthotopic Neobladder
Medical subject headings
Neoplasms, Diurnal Enuresis, Nocturnal Enuresis, Urinary Bladder Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ColoverinDrug

    Also called Mebeverine hydrochloride

    Mebeverine hydrochloride 135 mg

  • PlaceboDrug

    Placebo

Study groups in NCT03147599
Study groupRoleWhat they receive
MebeverineActive comparatorColoverin (Mebeverine hydrochloride 135 mg)
Receives: Drug: Coloverin
PlaceboPlacebo comparatorPlacebo
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Outcome Measure by standardized continence questionnaire

    Measured: 10 months

Secondary outcomes (2)
  1. Effect of mebeverine on patient quality of life by assessing patient quality of life measured by quality of life questionnaire

    Outcome Measure by quality of life questionnaire

    Measured: 10 months

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

    Outcome Measure by pressure change measurement in centimetre of water.

    Measured: 10 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 May 2017
  2. Study start15 May 2017
  3. Primary completion1 May 2019
  4. Study completion1 May 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
110 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03147599
Sponsor's protocol ID
R/17.02.32
Status last verified
May 2017
First submitted
15 Mar 2017
Last updated
30 Jun 2020
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: meta-analyses by contact the Prof. Hassan Abol-Enein, MD, Phd (Study Chair)

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Coloverin in people with Oncology and Incontinence, run by Mansoura University at 1 site in Egypt.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Effect of mebeverine on daytime and nocturnal incontinence by assessing continence status measured by standardized continence questionnaire (time frame: 10 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jun 2020.

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