Effect of Long Acting Anticholinergic on Nocturnal Incontinence After Radical Cystectomy and Orthotopic Neobladder

NCT02877901 | Completed Phase 2

• 1 other identifier: Zahran MH17082016
• Study Type: interventional
• Target: 120
• Locations: 0 countries
• Sites: N/A

Brief Summary

It is a prospective randomized- placebo control crossover study to evaluate the effect of long acting tolterodine (anticholinergic) in improving and treating nocturnal incontinence in patient after radical cystectomy and orthotopic urinary diversion. patients will be randomly allocated into two groups. one will receive the drug and the other will receive placebo. continence status will be evaluated before and 4 weeks after treatment by the number of pads used and the ICIQ-UI short form questionnaire. This is followed by two weeks of drug washout then reevaluation of the continence status and each group will be crossed over and lastly will be evaluated again.

Conditions

Nocturnal Incontinence

Outcome Measures

Primary Outcomes (1)

• improvement of nocturnal incontinence

  the score of ICIQ- UI short form questionnaire

  10 weeks

Study Arms (2)

tolterodine-treated group

ACTIVE COMPARATOR

they will receive long acting tolterodine 4 mg at bedtime for 4 weeks. After that re-evaluation. then stop medication for two weeks (washout period).

Drug: long acting tolterodine 4 mg

placebo-control group

PLACEBO COMPARATOR

they will receive placebo at bedtime for 4 weeks. After that re-evaluation. then stop for two weeks (washout period). Then re-evaluate the nocturnal incontinence status and crosed over to receive long acting tolterodine 4 mg for 4 weeks. at the end the nocturnal incontinence status will be evaluated

Drug: placebo

Interventions

long acting tolterodine 4 mg DRUG

receive one tablet at bed time for 4 weeks

tolterodine-treated group

placebo DRUG

one tablet at bed time

placebo-control group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients who passed at least one year follow up after the procedure.
• Patients who have no symptoms or signs of oncological failure (local recurrence or distant metastasis).
• Presence of NI with normal daytime continence assessed by the Arabic version of short form International Consultation on Incontinence questionnaire (ICIQ-UI Short Form).18
• Normal renal function (eGFR ˃50 ml/min /1.73m2) calculated by the Modification Of Diet in Renal Disease study equation.
• Ability to provide informed consent.

You may not qualify if:

• Patients who did not pass one year postoperative.
• Presence of oncological failure.
• Totally continent patient or who has daytime incontinence or chronic urine retention.
• Impaired renal function.
• Uncontrolled DM or hypertension.

Sponsors & Collaborators

• Mansoura University: lead

Related Publications (1)

• Zahran MH, Harraz AM, Taha DE, Nabeeh H, El Hefnawy AS, Ali-El-Dein B. The short-term effects of tolterodine on nocturnal incontinence after ileal orthotopic neobladder: a randomised crossover placebo-controlled study. BJU Int. 2019 Oct;124(4):679-686. doi: 10.1111/bju.14769. Epub 2019 Apr 22.

  PMID: 30946525 DERIVED

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lecturer of urology

Study Record Dates

• First Submitted: August 17, 2016
• First Posted: August 24, 2016
• Study Start: May 1, 2016
• Primary Completion: November 1, 2017
• Study Completion: December 1, 2017
• Last Updated: December 27, 2017

Record last verified: 2017-12