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

Beni-Suef University

Status: Completed

Conditions: Voiding Disorders

Treatments: Drug: Solifenacin Succinate 5 MG

Study type: Interventional

Funder types: Other

Identifiers

NCT04064619

Anticholinergic weaning

Details and patient eligibility

About

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.

Full 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

Enrollment: 60 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• OAB patients.
• Recently diagnosed.

Exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

60 participants in 2 patient groups

sudden stopping

Active Comparator group

Description:

patients were followed up after 1 and 3 months from stopping the drug,

Treatment:

Drug: Solifenacin Succinate 5 MG

Weaning

Experimental group

Description:

patients were followed up after 1and 3 months from the end of gradual weaning

Treatment:

Drug: Solifenacin Succinate 5 MG