NCT01423838

Brief Summary

Null hypothesis of the trial is that there is no difference between solifenacin and oxybutynin with respect to efficacy, side effects, patient satisfaction and quality of life measures in patients with overactive bladder.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
500

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Sep 2011

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

August 25, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 26, 2011

Completed
6 days until next milestone

Study Start

First participant enrolled

September 1, 2011

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2012

Completed
Last Updated

August 26, 2011

Status Verified

August 1, 2011

Enrollment Period

1 year

First QC Date

August 25, 2011

Last Update Submit

August 25, 2011

Conditions

Overactive Bladder

Keywords

Overactive bladderSolifenacinOxybutynin

Outcome Measures

Primary Outcomes (1)

  • Degree of improvement in overactive bladder symptoms

    The main symptoms of overactive bladder are frequency, urgency, urge incontinence and nocturia (if any). The primary outcome of the trial will be comparison of the improvement of these symptoms in terms of number and severity between two study groups.

    2 months

Secondary Outcomes (1)

  • To compare the degree of side effects between two study groups

    2 months

Study Arms (2)

Solifenacin

ACTIVE COMPARATOR

Anticholinergic molecule used in the treatment of overactive bladder.

Drug: Solifenacin

Oxybutynin

ACTIVE COMPARATOR

Anticholinergic molecule used in the treatment of overactive bladder.

Drug: Oxybutynin

Interventions

SolifenacinDRUG

5 mg, oral, once in a day

Also known as: Kinzy
Solifenacin
OxybutyninDRUG

5 mg, oral, three times in a day

Also known as: Uropan
Oxybutynin

Eligibility Criteria

Age18 Years - 70 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Turkish Republic Ministry of Health Adana Numune Training and Research Hospital

Adana, 01150, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Urinary Bladder, Overactive

Interventions

Solifenacin Succinateoxybutynin

Condition Hierarchy (Ancestors)

Urinary Bladder DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesLower Urinary Tract SymptomsUrological ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

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

Study Officials

  • Murat Api, M.D., Ph.D.

    Turkish Republic Ministry of Health Adana Numune Training and Research Hospital

    STUDY DIRECTOR

Central Study Contacts

Murat Api, M.D., PhD.

CONTACT

+905424241807muratapi@hotmail.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor, M.D., Ph.D.

Study Record Dates

First Submitted

August 25, 2011

First Posted

August 26, 2011

Study Start

September 1, 2011

Primary Completion

September 1, 2012

Study Completion

September 1, 2012

Last Updated

August 26, 2011

Record last verified: 2011-08

Locations

TU(1)