NCT02143570

Brief Summary

Overactive bladder is a common problem among adult women. Darifenacin is an antimuscarinic drug that is frequently used as part of the management of the condition. However, current evidence backing its use is limited. This study aims to address Darifenacin's effectiveness in adjunct to physiotherapy in treating symptoms due to overactive bladder.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
80

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started May 2014

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

May 1, 2014

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

May 18, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 21, 2014

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2016

Completed
Last Updated

May 2, 2016

Status Verified

April 1, 2016

Enrollment Period

1.9 years

First QC Date

May 18, 2014

Last Update Submit

April 29, 2016

Conditions

Overactive Bladder

Keywords

Urinary Bladder, OveractiveDarifenacinPhysiotherapyQuality of Life

Outcome Measures

Primary Outcomes (1)

  • Quality of Life

    Overall quality of life as established by the Overactive Bladder Questionnaire.

    12 weeks

Secondary Outcomes (2)

  • Overactive Bladder Symptoms

    12 weeks

  • Adverse Events

    12 weeks

Study Arms (2)

Darifenacin + Physiotherapy

EXPERIMENTAL

Patients allocated to this group will receive Darifenacin 7.5mg daily in addition to physiotherapy for 12 weeks. This dose may be increased up to 7.5mg twice daily in follow-up visits in cases of refractory symptoms.

Drug: DarifenacinProcedure: Physiotherapy

Physiotherapy

ACTIVE COMPARATOR

Patients allocated to this arm will receive a tailored pelvic floor exercise programme in addition to a matching placebo pill.

Procedure: Physiotherapy

Interventions

DarifenacinDRUG

Darifenacin will be prescribed in a starting dose of 7.5mg, once daily. This dose may be increased to 15mg a day in cases with refractory symptoms.

Also known as: Oralafi, Darisec, Continex, Emselex, Enablex
Darifenacin + Physiotherapy
PhysiotherapyPROCEDURE

All patients will received a tailored pelvic floor exercise programme as part of the standard of care of overactive bladder at the study centre. This intervention will be mainly comprised of biofeedback stimulation techniques.

Darifenacin + PhysiotherapyPhysiotherapy

Eligibility Criteria

Age16 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with overactive bladder as diagnosed and confirmed by a urologist.
  • Able to answer the ICIC, King's Health Questionnaire and Overactive Bladder Questionnaire.
  • Able and willing to receive urodynamic studies.

You may not qualify if:

  • History of pelvic radiotherapy.
  • Recent pelvic surgery (\<1 year).
  • History of anti-incontinence surgery.
  • Pregnancy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Carlos Van Buren

Valparaíso, Región de Valparaíso, 2341131, Chile

Location

Related Publications (1)

  • Stoniute A, Madhuvrata P, Still M, Barron-Millar E, Nabi G, Omar MI. Oral anticholinergic drugs versus placebo or no treatment for managing overactive bladder syndrome in adults. Cochrane Database Syst Rev. 2023 May 9;5(5):CD003781. doi: 10.1002/14651858.CD003781.pub3.

    PMID: 37160401DERIVED

MeSH Terms

Conditions

Urinary Bladder, Overactive

Interventions

darifenacinPhysical Therapy Modalities

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)

TherapeuticsRehabilitation

Study Officials

  • Melissa Cifuentes, M.D.

    Senior Urologist

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
M.D., M.Sc.

Study Record Dates

First Submitted

May 18, 2014

First Posted

May 21, 2014

Study Start

May 1, 2014

Primary Completion

April 1, 2016

Study Completion

April 1, 2016

Last Updated

May 2, 2016

Record last verified: 2016-04

Locations

CL(1)