NCT04064619

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2018

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 2, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 2, 2019

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

August 20, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 22, 2019

Completed
Last Updated

August 22, 2019

Status Verified

August 1, 2019

Enrollment Period

1.6 years

First QC Date

August 20, 2019

Last Update Submit

August 20, 2019

Conditions

Voiding Disorders

Keywords

OAB

Outcome Measures

Primary Outcomes (1)

  • improvement

    decrease voiding times

    1 month

Secondary Outcomes (1)

  • recurrence of symptoms

    3 months

Study Arms (2)

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

Solifenacin Succinate 5 MGDRUG

gradual weaning of drug vs. stopping

Also known as: vesicare
Weaningsudden stopping

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • OAB patients.
  • Recently diagnosed.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beni-Suef University

Banī Suwayf, Beni Suweif Governorate, 11371, Egypt

Location

MeSH Terms

Interventions

Solifenacin Succinate

Intervention Hierarchy (Ancestors)

QuinuclidinesHeterocyclic Compounds, Bridged-RingHeterocyclic CompoundsTetrahydroisoquinolinesIsoquinolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • Ahmed Abdelbary, MD

    Beni-Suef University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor

Study Record Dates

First Submitted

August 20, 2019

First Posted

August 22, 2019

Study Start

January 1, 2018

Primary Completion

August 2, 2019

Study Completion

August 2, 2019

Last Updated

August 22, 2019

Record last verified: 2019-08

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)