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

Sponsor
Beni-Suef University (Other)
Overall Status
Completed
CT.gov ID
NCT04064619
Collaborator
(none)
60
Enrollment
1
Location
2
Arms
19
Actual Duration (Months)
3.2
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Solifenacin Succinate 5 MG
 N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
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.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.
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Recurrence of Symptoms of Overactive Bladder After Weaning Versus Sudden Stopping of Anticholinergics
Actual Study Start Date :
Jan 1, 2018
Actual Primary Completion Date :
Aug 2, 2019
Actual Study Completion Date :
Aug 2, 2019

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. improvement [1 month]

      decrease voiding times

    Secondary Outcome Measures

    1. recurrence of symptoms [3 months]

      increase in voiding times after improvement

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • OAB patients.

    • Recently diagnosed.

    Exclusion Criteria:

    • Previous trials of treatment

    • UTI, stones, tumors, or Infravesical obstruction.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Beni-Suef University Banī Suwayf Beni-Suef Egypt 11371

    Sponsors and Collaborators

    • Beni-Suef University

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Ahmed M Abdelbary, MD, Associate professor, Beni-Suef University
    ClinicalTrials.gov Identifier:
    NCT04064619
    Other Study ID Numbers:
    • Anticholinergic weaning
    First Posted:
    Aug 22, 2019
    Last Update Posted:
    Aug 22, 2019
    Last Verified:
    Aug 1, 2019
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    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
    Keywords provided by Ahmed M Abdelbary, MD, Associate professor, Beni-Suef University
    OAB
    Additional relevant MeSH terms:
    Recurrence
    Solifenacin Succinate

    Study Results

    No Results Posted as of Aug 22, 2019