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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04064619
Recruitment Status : Completed
First Posted : August 22, 2019
Last Update Posted : August 22, 2019
Sponsor:
Information provided by (Responsible Party):
Ahmed M Abdelbary, MD, 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.

Condition or disease Intervention/treatment Phase
Voiding Disorders Drug: Solifenacin Succinate 5 MG Not Applicable

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

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Study Type : Interventional  (Clinical Trial)
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.
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 : January 1, 2018
Actual Primary Completion Date : August 2, 2019
Actual Study Completion Date : August 2, 2019

Resource links provided by the National Library of Medicine


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 Name: 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 Name: vesicare




Primary Outcome Measures :
  1. improvement [ Time Frame: 1 month ]
    decrease voiding times


Secondary Outcome Measures :
  1. recurrence of symptoms [ Time Frame: 3 months ]
    increase in voiding times after improvement



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • OAB patients.
  • Recently diagnosed.

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04064619


Locations
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Egypt
Beni-Suef University
Banī Suwayf, Beni-Suef, Egypt, 11371
Sponsors and Collaborators
Beni-Suef University
Investigators
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Principal Investigator: Ahmed Abdelbary, MD Beni-Suef University
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Responsible Party: Ahmed M Abdelbary, MD, Associate professor, Beni-Suef University
ClinicalTrials.gov Identifier: NCT04064619    
Other Study ID Numbers: Anticholinergic weaning
First Posted: August 22, 2019    Key Record Dates
Last Update Posted: August 22, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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, Beni-Suef University:
OAB
Additional relevant MeSH terms:
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Recurrence
Disease Attributes
Pathologic Processes
Solifenacin Succinate
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Urological Agents