Urge Urinary IncontinenceNCT00177541
Further Enhancing Non-pharmacologic Therapy for Incontinence
A study testing Biofeedback, pelvic floor muscle training, fMRI in people with Urge Urinary Incontinence, run by University of Pittsburgh at 1 site in United States.
Trial summary
To determine the mechanisms mediating the therapeutic efficacy of pelvic floor muscle exercises and biofeedback for urge urinary incontinence, as well as the characteristics of patients most likely to respond. Read more about this study
- Who is it for?
- Ages 60 years and older, women only
- Conditions the study is for
- Urge Urinary Incontinence
- What is being tested?
- Biofeedback, pelvic floor muscle training, fMRI
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 123 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2004to Sep 2016
- Phase
- Interventional
- 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 60 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ambulatory women over age 60, who are incontinent at least twice weekly for 3 months despite correction of potentially reversible causes.
- urinary incontinence (urge or predominantly urge) by clinical criteria.
- able to accurately complete a voiding diary, to perform a 24-hour pad test under direction, and to undergo instruction in biofeedback.
Who cannot join
- significant mental impairment [mini mental status exam (MMSE) ≤ 20)
- urethral obstruction
- history of bladder cancer
- spinal cord lesions
- multiple sclerosis
- pelvic radiation
Show all 13Show fewer
- interstitial cystitis
- artificial sphincter implant
- expected to have changes in medications/doses during the trial
- medically unstable
- Patients with factors that could cause transient UI [e.g., current urinary tract infection (UTI), acute confusion] will be treated in concert with the subject's primary care provider and considered for enrollment if their UI persists.
- conditions that require endocarditis prophylaxis (such as heart valve problems or bacterial endocarditis)
- being unable to undergo fMRI because of claustrophobia or any metallic objects in the body, such pacemakers, metallic prostheses, aneurism clips or others.
Trial locations and contacts
1 site in 1 country.
United States1 site
Geriatric Continence Research Unit, NE547 Montefiore UPMC
Pittsburgh, Pennsylvania, 15213
About this study
To determine the mechanisms mediating the therapeutic efficacy of pelvic floor muscle exercises and biofeedback for urge urinary incontinence, as well as the characteristics of patients most likely to respond. By identifying the key components of this treatment, we hope to simplify it and make it more easily applicable, more effective, less expensive, and thus more useful for people with urge incontinence in the future.
Read the detailed description
Urinary incontinence (UI) is prevalent and morbid in the elderly, and its associated costs exceed $26 billion annually. Although effective therapy exists, it is underutilized. This is particularly true for non-pharmacologic therapies, which are at least as effective as drugs but safer, and recommended as the initial approach by every national panel. If therapies such as biofeedback (which targets pelvic muscles and detrusor suppression) are to become more widely used, they will require simplification, fewer and briefer sessions, less expensive equipment, and less sophisticated therapists. Unfortunately, such protocols cannot yet be devised because it is unknown which components are essential. We postulate that the mechanisms mediating effectiveness can be identified and that such knowledge will make it possible to enhance efficacy and to formulate more feasible and cost-effective protocols. Since reduction in UI correlates weakly with improved quality of life, however, it is important that biofeedback's impact on life quality be assessed concomitantly to ensure that formulation of such streamlined methods does not eliminate components essential for improved quality of life, even if they have no physiological correlates. We will address these issues by treating at least 150 elderly subjects with urge UI in an 8-week course of biofeedback. We will collect clinical and quality of life data and perform extensive physiologic testing on each subject at baseline and 8 weeks later. Improvement will be correlated with change in physiologic and quality of life parameters to identify the parameters that likely mediated it. Knowledge from this study should identify predictors and mechanisms mediating success of biofeedback; suggest ways that it could be further improved; facilitate development of less expensive, quicker, and more feasible protocols to deliver it (potentially permitting application to less motivated or cognitively impaired patients); and shed insight into mechanisms that may even improve efficacy of other interventions.
- Conditions
- Urge Urinary Incontinence
- Being tested
- Biofeedback, pelvic floor muscle training, fMRI
- Keywords
- urge incontinence, biofeedback, pelvic floor muscle training, behavior modification
- Medical subject headings
- Urinary Incontinence, Urge
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biofeedback, pelvic floor muscle training, fMRIBehavioural
Biofeedback, pelvic floor muscle training, fMRI
| Study group | Role | What they receive |
|---|---|---|
| Biofeedback | Experimental | Biofeedback assisted pelvic floor muscle therapy (3 visits) Receives: Behavioral: Biofeedback, pelvic floor muscle training, fMRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage reduction in urge incontinence episodes at 12 weeks
Measured: 12 weeks
Secondary outcomes (4)
Various urodynamic parameters such as, e.g.:
Measured: 12 weeks
Increase in functional bladder capacity at 12 weeks
Measured: 12 weeks
Volume at first detrusor overactivity at 12 weeks
Measured: 12 weeks
Improvement in QoL at 12 weeks
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 posted15 Sep 2005 (estimated)
- Study startFeb 2004
- Primary completionSep 2016
- Study completionSep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Urge Urinary IncontinenceStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 123 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute on Aging (NIA)
- Responsible party
- Principal investigator, Neil Resnick, University of Pittsburgh
- Investigators
- Neil M Resnick, MD, Principal investigator, University of PittsburghBecky Clarkson, PhD, Study director, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00177541
- Sponsor's protocol ID
- 5R01AG020629-02
- Other IDs
- 5R01AG020629-02
- Status last verified
- Aug 2017
- First submitted
- 13 Sep 2005
- Last updated
- 8 Aug 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Burgio KL, Locher JL, Goode PS, Hardin JM, McDowell BJ, Dombrowski M, Candib D. Behavioral vs drug treatment for urge urinary incontinence in older women: a randomized controlled trial. JAMA. 1998 Dec 16;280(23):1995-2000. doi: 10.1001/jama.280.23.1995.
PubMed 9863850Resnick NM. Improving treatment of urinary incontinence. JAMA. 1998 Dec 16;280(23):2034-5. doi: 10.1001/jama.280.23.2034. No abstract available.
PubMed 9863856Resnick NM, Perera S, Tadic S, Organist L, Riley MA, Schaefer W, Griffiths D. What predicts and what mediates the response of urge urinary incontinence to biofeedback? Neurourol Urodyn. 2013 Jun;32(5):408-15. doi: 10.1002/nau.22347. Epub 2012 Nov 20.
PubMed 23168606
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Further Enhancing Non-pharmacologic Therapy for Incontinence
- ClinicalTrials.gov ID
- NCT00177541
- Acronym / sponsor ID
- 5R01AG020629-02
- Conditions
- Urge Urinary Incontinence
- Keywords
- urge incontinence, biofeedback, pelvic floor muscle training, behavior modification
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 123 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute on Aging (NIA)
- Study start
- Feb 2004
- Primary completion
- Sep 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 15 Sep 2005 (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.
To determine the mechanisms mediating the therapeutic efficacy of pelvic floor muscle exercises and biofeedback for urge urinary incontinence, as well as the characteristics of patients most likely to respond. By identifying the key components of this treatment, we hope to simplify it and make it more easily applicable, more effective, less expensive, and thus more useful for people with urge incontinence in the future.
Detailed description
Urinary incontinence (UI) is prevalent and morbid in the elderly, and its associated costs exceed $26 billion annually. Although effective therapy exists, it is underutilized. This is particularly true for non-pharmacologic therapies, which are at least as effective as drugs but safer, and recommended as the initial approach by every national panel. If therapies such as biofeedback (which targets pelvic muscles and detrusor suppression) are to become more widely used, they will require simplification, fewer and briefer sessions, less expensive equipment, and less sophisticated therapists. Unfortunately, such protocols cannot yet be devised because it is unknown which components are essential. We postulate that the mechanisms mediating effectiveness can be identified and that such knowledge will make it possible to enhance efficacy and to formulate more feasible and cost-effective protocols. Since reduction in UI correlates weakly with improved quality of life, however, it is important that biofeedback's impact on life quality be assessed concomitantly to ensure that formulation of such streamlined methods does not eliminate components essential for improved quality of life, even if they have no physiological correlates. We will address these issues by treating at least 150 elderly subjects with urge UI in an 8-week course of biofeedback. We will collect clinical and quality of life data and perform extensive physiologic testing on each subject at baseline and 8 weeks later. Improvement will be correlated with change in physiologic and quality of life parameters to identify the parameters that likely mediated it. Knowledge from this study should identify predictors and mechanisms mediating success of biofeedback; suggest ways that it could be further improved; facilitate development of less expensive, quicker, and more feasible protocols to deliver it (potentially permitting application to less motivated or cognitively impaired patients); and shed insight into mechanisms that may even improve efficacy of other interventions.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Biofeedback | Experimental | Behavioral: Biofeedback, pelvic floor muscle training, fMRIBiofeedback assisted pelvic floor muscle therapy (3 visits) |
Who may qualify
- Ages
- 60 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- ambulatory women over age 60, who are incontinent at least twice weekly for 3 months despite correction of potentially reversible causes.
- urinary incontinence (urge or predominantly urge) by clinical criteria.
- able to accurately complete a voiding diary, to perform a 24-hour pad test under direction, and to undergo instruction in biofeedback.
Key exclusion criteria (13 listed)
- significant mental impairment [mini mental status exam (MMSE) ≤ 20)
- urethral obstruction
- history of bladder cancer
- spinal cord lesions
- multiple sclerosis
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 |
|---|---|---|
| Biofeedback, pelvic floor muscle training, fMRIBiofeedback, pelvic floor muscle training, fMRI | Behavioural | Biofeedback |
Primary outcome
Percentage reduction in urge incontinence episodes at 12 weeks
Time frame: 12 weeks
4 secondary outcomes
Various urodynamic parameters such as, e.g.:
Time frame: 12 weeks
Increase in functional bladder capacity at 12 weeks
Time frame: 12 weeks
Volume at first detrusor overactivity at 12 weeks
Time frame: 12 weeks
Improvement in QoL at 12 weeks
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 8 Aug 2017.
- Background: PubMed 9863850Burgio KL, Locher JL, Goode PS, Hardin JM, McDowell BJ, Dombrowski M, Candib D. Behavioral vs drug treatment for urge urinary incontinence in older women: a randomized controlled trial. JAMA. 1998 Dec 16;280(23):1995-2000. doi: 10.1001/jama.280.23.1995.
- Background: PubMed 9863856Resnick NM. Improving treatment of urinary incontinence. JAMA. 1998 Dec 16;280(23):2034-5. doi: 10.1001/jama.280.23.2034. No abstract available.
- Derived from this study: PubMed 23168606Resnick NM, Perera S, Tadic S, Organist L, Riley MA, Schaefer W, Griffiths D. What predicts and what mediates the response of urge urinary incontinence to biofeedback? Neurourol Urodyn. 2013 Jun;32(5):408-15. doi: 10.1002/nau.22347. Epub 2012 Nov 20.
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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.
Neil M Resnick, MD principal investigator
University of Pittsburgh
Becky Clarkson, PhD study director
University of Pittsburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Biofeedback, pelvic floor muscle training, fMRI in people with Urge Urinary Incontinence, run by University of Pittsburgh at 1 site in United States.
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 13 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 8 Aug 2017. 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 United States. 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.
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?
Percentage reduction in urge incontinence episodes at 12 weeks (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 NCT00177541, which also lists 3 linked publications.
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 8 Aug 2017.