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

Voiding Disorders Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04064619
• Other study ID #: Anticholinergic weaning
• Status: Completed
• Phase: N/A
• Start date: January 1, 2018
• Est. completion date: August 2, 2019

Study information

• Verified date: August 2019
• Source: Beni-Suef University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: August 2, 2019
• Est. primary completion date: August 2, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• OAB patients.

• Recently diagnosed.

Exclusion Criteria:

• Previous trials of treatment

• UTI, stones, tumors, or Infravesical obstruction.

Related Conditions & MeSH terms

• Recurrence
• Voiding Disorders

Intervention

Drug:
• Solifenacin Succinate 5 MG
gradual weaning of drug vs. stopping

Locations

Country	Name	City	State
Egypt	Beni-Suef University	Bani Suwayf	Beni-Suef

Sponsors (1)

Lead Sponsor	Collaborator
Beni-Suef University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	improvement	decrease voiding times	1 month
Secondary	recurrence of symptoms	increase in voiding times after improvement	3 months