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

Not Applicable
Completed
Conditions
Voiding Disorders
Interventions
Registration Number
NCT04064619
Lead Sponsor
Beni-Suef University
Brief Summary

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.

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

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
60
Inclusion Criteria
  • OAB patients.
  • Recently diagnosed.
Exclusion Criteria
  • Previous trials of treatment
  • UTI, stones, tumors, or Infravesical obstruction.

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
sudden stoppingSolifenacin Succinate 5 MGpatients were followed up after 1 and 3 months from stopping the drug,
WeaningSolifenacin Succinate 5 MGpatients were followed up after 1and 3 months from the end of gradual weaning
Primary Outcome Measures
NameTimeMethod
improvement1 month

decrease voiding times

Secondary Outcome Measures
NameTimeMethod
recurrence of symptoms3 months

increase in voiding times after improvement

Trial Locations

Locations (1)

Beni-Suef University

🇪🇬

Banī Suwayf, Beni-Suef, Egypt

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