Urge Urinary Incontinence Clinical Trial
Official title:
Further Enhancing Non-pharmacologic Therapy for Incontinence
Verified date | August 2017 |
Source | University of Pittsburgh |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 123 |
Est. completion date | September 2016 |
Est. primary completion date | September 2016 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 60 Years and older |
Eligibility |
Inclusion Criteria: - 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. Exclusion Criteria: - significant mental impairment [mini mental status exam (MMSE) = 20) - urethral obstruction - history of bladder cancer - spinal cord lesions - multiple sclerosis - pelvic radiation - 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. |
Country | Name | City | State |
---|---|---|---|
United States | Geriatric Continence Research Unit, NE547 Montefiore UPMC | Pittsburgh | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
University of Pittsburgh | National Institute on Aging (NIA), National Institutes of Health (NIH) |
United States,
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. — View Citation
Resnick NM. Improving treatment of urinary incontinence. JAMA. 1998 Dec 16;280(23):2034-5. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Percentage reduction in urge incontinence episodes at 12 weeks | 12 weeks | ||
Secondary | Various urodynamic parameters such as, e.g.: | 12 weeks | ||
Secondary | Increase in functional bladder capacity at 12 weeks | 12 weeks | ||
Secondary | Volume at first detrusor overactivity at 12 weeks | 12 weeks | ||
Secondary | Improvement in QoL at 12 weeks | 12 weeks |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT01786967 -
Understanding the Response to Fesoterodine Through Genetic Evaluation in the Elderly (URGE)
|
Phase 3 | |
Enrolling by invitation |
NCT01940367 -
Electrical Nerve Stimulation for Overactive Bladder a Comparison of Treatments
|
N/A | |
Recruiting |
NCT00437528 -
Safety and Applicability Study of a Novel Heat Flow Sensor Unit for Measuring Urinary Bladder Capacity
|
Phase 1 | |
Completed |
NCT04525105 -
SMAD2, SMAD3 AND TGF-β GENE EXPRESSION IN URGE URINARY INCONTINENCE
|
||
Terminated |
NCT02129816 -
Bryophyllum Pinnatum Versus Solifenacin Versus Placebo for Overactive Bladder
|
Phase 2/Phase 3 | |
Terminated |
NCT01366066 -
Transcutaneous Mechanical Nerve Stimulation in the Treatment of Incontinence
|
Phase 3 | |
Completed |
NCT01559389 -
Incontinence & Intimate Partners: Assessing the Contribution of Treatment
|
Phase 4 | |
Completed |
NCT01166438 -
Anticholinergic vs. Botox Comparison Study
|
Phase 3 | |
Completed |
NCT00909181 -
Study of Topically Administered Oxybutynin Gel in Patients With Urge Incontinence
|
Phase 3 | |
Terminated |
NCT03923348 -
Pelvic Floor Muscle Training With Leva System for Urge Incontinence
|
N/A | |
Completed |
NCT01445834 -
Age-stratified Outcome of Pelvic Floor Muscle Exercise for Urinary Incontinence
|
N/A | |
Completed |
NCT00498888 -
The Long Term Outcomes of Rehabilitation and Drug Treatment for in Urgency Urinary Incontinence
|
N/A | |
Terminated |
NCT00373789 -
Refractory Urge Incontinence and Botox Injections
|
Phase 3 | |
Recruiting |
NCT01737411 -
Surgical vs. Medical Treatment of Urge Urinary Incontinence in Women
|
Phase 1/Phase 2 | |
Recruiting |
NCT00770406 -
Intravesical Instillation of Botulinum Toxin Type A to Patients With Urge Urinary Incontinence
|
Phase 1/Phase 2 | |
Completed |
NCT00862745 -
Bringing Simple Urge Incontinence Diagnosis & Treatment to Providers (BRIDGES)
|
Phase 4 | |
Completed |
NCT02311634 -
A Comparison of Electrical Pudendal Nerve Stimulation and Transvaginal Electrical Stimulation for Urge Incontinence
|
N/A | |
Completed |
NCT01672190 -
Lessening Incontinence by Learning Yoga
|
N/A | |
Completed |
NCT01619995 -
Brain Imaging Plus Urodynamics to Investigate the Brain's Control of the Bladder
|
N/A |