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

Study Overview
=================
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

Official Title
-----------------
Recurrence of Symptoms of Overactive Bladder After Weaning Versus Sudden Stopping of Anticholinergics

Conditions
-----------------
Voiding Disorders

Intervention / Treatment
-----------------
* Drug: Solifenacin Succinate 5 MG


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: OAB patients. Recently diagnosed. Exclusion Criteria: Previous trials of treatment UTI, stones, tumors, or Infravesical obstruction.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: sudden stopping<br>patients were followed up after 1 and 3 months from stopping the drug, | Drug: Solifenacin Succinate 5 MG<br>* gradual weaning of drug vs. stopping<br>* Other names: vesicare;|
| Experimental: Weaning<br>patients were followed up after 1and 3 months from the end of gradual weaning | Drug: Solifenacin Succinate 5 MG<br>* gradual weaning of drug vs. stopping<br>* Other names: vesicare;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| improvement | decrease voiding times | 1 month | 

Secondary Outcome Measures

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

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
OAB