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.
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
- Conditions the study is for
- Oncology, Incontinence, Incontinence, Daytime Urinary
- 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.
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.
- Conditions
- Oncology, Incontinence, Incontinence, Daytime Urinary, Incontinence, Nighttime Urinary, Bladder Cancer, Orthotopic Neobladder
- 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 group | Role | What they receive |
|---|---|---|
| Mebeverine | Active comparator | Coloverin (Mebeverine hydrochloride 135 mg) Receives: Drug: Coloverin |
| Placebo | Placebo comparator | Placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
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
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.
- First posted10 May 2017
- Study start15 May 2017
- Primary completion1 May 2019
- Study completion1 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OncologyStudies of the same condition, open and under way.
- More trials run by Mansoura UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Abdelwahab Hashem, Mansoura University
- Investigators
- Hassan Abol-Enein, MD, Study chair, Urology and Nephrology CenterAhmed Mosbah, MD, Study director, Urology and Nephrology CenterAhmed Elhussein, MBBCH, Principal investigator, Urology and Nephrology CenterAhmed Elkarta, MBBCH, Principal investigator, Urology and Nephrology CenterMohamed Soltan, MBBCH, Principal investigator, Urology and Nephrology Center
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)
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03147599
- Acronym / sponsor ID
- R/17.02.32
- Conditions
- Oncology, Incontinence, Incontinence, Daytime Urinary, Incontinence, Nighttime Urinary, Bladder Cancer, Orthotopic Neobladder
- Keywords
- Mebeverine, Incontinence, Orthotopic Neobladder
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 15 May 2017 (actual)
- Primary completion
- 1 May 2019 (actual)
- Study completion
- 1 May 2019 (actual)
- First posted
- 10 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mebeverine | Active comparator | Drug: ColoverinColoverin (Mebeverine hydrochloride 135 mg) |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Men 18 years or older
- ONB within 1 year post-surgery.
Key exclusion criteria (10 listed)
- Upper urinary tract deterioration
- Uncontrolled diabetes mellitus
- Evident local or pelvic recurrence
- Adjuvant chemotherapy
- Chronic retention
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ColoverinAlso: Mebeverine hydrochlorideMebeverine hydrochloride 135 mg | Drug | Mebeverine |
| PlaceboPlacebo | Drug | Placebo |
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
2 secondary outcomes
Effect of mebeverine on patient quality of life by assessing patient quality of life measured by quality of life questionnaire
Time frame: 10 months
Effect of mebeverine on orthotopic w-ileal neobladders urodynamics by assessing simple urodynamic parameter
Time frame: 10 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2020.
- Individual participant dataSharing planned: Yes. meta-analyses by contact the Prof. Hassan Abol-Enein, MD, Phd (Study Chair)
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hassan Abol-Enein, MD study chair
Urology and Nephrology Center
Ahmed Mosbah, MD study director
Urology and Nephrology Center
Ahmed Elhussein, MBBCH principal investigator
Urology and Nephrology Center
1 site in 1 country: see every site and its status.
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.