Compare Sudden Stopping and Weaning of Anticholinergics in Recurrence of OAB Symptoms

August 20, 2019 updated by: Ahmed M Abdelbary, MD, Beni-Suef University

Recurrence of Symptoms of Overactive Bladder After Weaning Versus Sudden Stopping of Anticholinergics

Our study included 60 patients with idiopathic OAB and treated with solifenacin 5mg twice daily for one month. After improvement of their condition, we divided the responders into 2 groups, group I stopped the drug suddenly, while group II underwent gradual weaning of the drug.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

We started an open-label, prospective, two-arm, randomized controlled trial at Beni-Suef University, from January 2018 to January 2019, including 60 patients suffering from OAB symptoms. Patients were recently diagnosed with idiopathic OAB which was not treated prior to enrollment. All participants signed written informed consents. The study protocol was approved by the ethics committee of our faculty. Patients were allocated into 2 equal groups (30 patients in each group) according to a computer-generated random numeric table after exclusion of those who are not eligible or refused to be included in the study

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
    • Beni-Suef
      • Banī Suwayf, Beni-Suef, Egypt, 11371
        • Beni-Suef University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • OAB patients.
  • Recently diagnosed.

Exclusion Criteria:

  • Previous trials of treatment
  • UTI, stones, tumors, or Infravesical obstruction.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: sudden stopping
patients were followed up after 1 and 3 months from stopping the drug,
Drug: Solifenacin Succinate 5 MG
gradual weaning of drug vs. stopping
Other Names:
  • vesicare
Experimental: Weaning
patients were followed up after 1and 3 months from the end of gradual weaning
Drug: Solifenacin Succinate 5 MG
gradual weaning of drug vs. stopping
Other Names:
  • vesicare

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
improvement
Time Frame: 1 month
decrease voiding times
1 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
recurrence of symptoms
Time Frame: 3 months
increase in voiding times after improvement
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Beni-Suef University

Investigators

  • Principal Investigator: Ahmed Abdelbary, MD, Beni-Suef University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2018

Primary Completion (Actual)

August 2, 2019

Study Completion (Actual)

August 2, 2019

Study Registration Dates

First Submitted

August 20, 2019

First Submitted That Met QC Criteria

August 20, 2019

First Posted (Actual)

August 22, 2019

Study Record Updates

Last Update Posted (Actual)

August 22, 2019

Last Update Submitted That Met QC Criteria

August 20, 2019

Last Verified

August 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Anticholinergic weaning

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Voiding Disorders

Clinical Trials on Solifenacin Succinate 5 MG

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in New Zealand

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe