Compare Sudden Stopping and Weaning of Anticholinergics i... | NCT04064619

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

NCT04064619

Sponsor

Beni-Suef University

Status

Completed

Last Update Posted

Aug 22, 2019Actual

Enrollment

60Actual

Phase

Not Applicable

Conditions

Voiding Disorders

Interventions

Solifenacin Succinate 5 MG

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2018Actual

Primary Completion Date

Aug 2, 2019Actual

Completion Date

Aug 2, 2019Actual

First Submitted Date

Aug 20, 2019

First Submission Date that Met QC Criteria

Aug 20, 2019

First Posted Date

Aug 22, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 20, 2019

Last Update Posted Date

Aug 22, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

60Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
sudden stopping	Active Comparator	patients were followed up after 1 and 3 months from stopping the drug,	Drug: Solifenacin Succinate 5 MG
Weaning	Experimental	patients were followed up after 1and 3 months from the end of gradual weaning	Drug: Solifenacin Succinate 5 MG

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Solifenacin Succinate 5 MG	Drug	gradual weaning of drug vs. stopping	Weaning sudden stopping

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
improvement	decrease voiding times	1 month

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

OAB patients.
Recently diagnosed.

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Ahmed Abdelbary, MD	Beni-Suef University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Beni-Suef University		Banī Suwayf	Beni Suweif Governorate	11371	Egypt

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000069464	Solifenacin Succinate

Ancestor Terms

ID	Term
D011812	Quinuclidines
D006572	Heterocyclic Compounds, Bridged-Ring
D006571	Heterocyclic Compounds
D044005	Tetrahydroisoquinolines

Browse Leaves

Not provided

Browse Branches

Not provided

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.