Overactive BladderPhase 3NCT02143570
Efficacy of Darifenacin and Physiotherapy for the Treatment of Overactive Bladder in Women
A Phase 3 study testing Darifenacin and Physiotherapy in people with Overactive Bladder, run by Universidad de Valparaiso at 1 site in Chile.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 years and older, women only
- Conditions the study is for
- Overactive Bladder
- What is being tested?
- Darifenacin and Physiotherapy
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteChile
- Study dates
- May 2014to Apr 2016
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- History of pelvic radiotherapy.
- Recent pelvic surgery (<1 year).
- History of anti-incontinence surgery.
- Pregnancy.
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Overactive Bladder
- Being tested
- Darifenacin, Physiotherapy
- Keywords
- Urinary Bladder, Overactive, Darifenacin, Physiotherapy, Quality of Life
- Medical subject headings
- Urinary Bladder, Overactive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DarifenacinDrug
Also called Oralafi, Darisec, Continex, Emselex
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.
PhysiotherapyProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Darifenacin; Procedure: Physiotherapy |
| Physiotherapy | Active comparator | Patients allocated to this arm will receive a tailored pelvic floor exercise programme in addition to a matching placebo pill. Receives: Procedure: Physiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of Life
Overall quality of life as established by the Overactive Bladder Questionnaire.
Measured: 12 weeks
Secondary outcomes (2)
Overactive Bladder Symptoms
Presence of symptoms of overactive bladder, as established by the King's Health Questionnaire and the International Consultation on Incontinence Questionnaire.
Measured: 12 weeks
Adverse Events
Development of any adverse event attributable to darifenacin and as established by a standardised questionnaire.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2014 (estimated)
- Study startMay 2014
- Primary completionApr 2016
- Study completionApr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Overactive BladderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad de Valparaiso
- Sponsor type
- University, hospital or other
- Collaborators
- Recalcine (GynoPharm)
- Responsible party
- Principal investigator, Felipe Martinez, Universidad de Valparaiso
- Investigators
- Melissa Cifuentes, M.D., Principal investigator, Senior Urologist
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02143570
- Sponsor's protocol ID
- 635
- Status last verified
- Apr 2016
- First submitted
- 18 May 2014
- Last updated
- 2 May 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 37160401
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Darifenacin and Physiotherapy for the Treatment of Overactive Bladder in Women
- ClinicalTrials.gov ID
- NCT02143570
- Acronym / sponsor ID
- 635
- Conditions
- Overactive Bladder
- Keywords
- Urinary Bladder, Overactive, Darifenacin, Physiotherapy, Quality of Life
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Universidad de ValparaisoUniversity, hospital or other
- Collaborators
- Recalcine (GynoPharm)
- Study start
- May 2014
- Primary completion
- Apr 2016 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 21 May 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Darifenacin + Physiotherapy | Experimental | Drug: Darifenacin, Procedure: PhysiotherapyPatients 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. |
| Physiotherapy | Active comparator | Procedure: PhysiotherapyPatients allocated to this arm will receive a tailored pelvic floor exercise programme in addition to a matching placebo pill. |
Who may qualify
- Ages
- 16 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- History of pelvic radiotherapy.
- Recent pelvic surgery (<1 year).
- History of anti-incontinence surgery.
- Pregnancy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DarifenacinAlso: Oralafi, Darisec, Continex, EmselexDarifenacin 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. | Drug | Darifenacin + Physiotherapy |
| PhysiotherapyAll 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. | Procedure or surgery | Darifenacin + Physiotherapy, Physiotherapy |
Primary outcome
Quality of Life
Time frame: 12 weeks
Overall quality of life as established by the Overactive Bladder Questionnaire.
2 secondary outcomes
Overactive Bladder Symptoms
Time frame: 12 weeks
Adverse Events
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 May 2016.
- Derived from this study: PubMed 37160401Stoniute 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Melissa Cifuentes, M.D. principal investigator
Senior Urologist
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Darifenacin and Physiotherapy in people with Overactive Bladder, run by Universidad de Valparaiso at 1 site in Chile.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 May 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Chile. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of Life (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02143570, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 May 2016.