Clinical trial NCT01599715: Translating Unique Learning for Incontinence Prevention
Official title: Translating Unique Learning for Incontinence Prevention for Women Over the Age of 55
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Urinary Incontinence
Keywords: Urinary Incontinence
Weak bladder
Frequent urination
Overactive bladder
Urine leakage
Stress incontinence
Urge Incontinence
Pelvic Floor weakness
Pelvic Floor Muscle Exercises
Kegel exercises
Self-Care
Lead sponsor: University of Michigan
Sponsor class: OTHER
Collaborators: name: National Institute of Nursing Research (NINR)
First posted: 2012-05-16
Enrollment: 647
Sex: FEMALE
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: More than one in three US women suffers from the distressing, embarrassing, and often unreported problem of urinary incontinence (UI). UI severity increases with age and the financial cost exceeds $19 billion per year . The Adult Conservative Management Committee of the 2008 International Consultation on Incontinence concluded that pelvic floor muscle training (PFMT) should be offered as first line therapy to all women with stress, urge, or mixed UI; and that bladder training (BT) may be preferred to drug therapy. Conservative strategies are low risk and differ from other forms of UI management in that they do not prejudice future treatments. They also may decrease symptoms of urgency and frequency that do not entail UI, but greatly reduce the quality of life for nearly 1 in 11 US women.

Detailed description: The study will attempt to accomplish 3 aims:

Aim 1: Compare outcomes of the two-hour BH Class with the condensed DVD version.

To accomplish this aim we will conduct a comparative effectiveness trial of 600 women 55 years and older randomized to BH Class or DVD. Women will be followed for 24 months post-intervention in order to assess long-term outcomes and sustainability.

Aim 2: Conduct an economic analysis comparing the two-hour BH Class with the DVD version. Describing the costs, quality of life, and analyzing the willingness to pay and employment/ productivity data will be the primary economic focus of this study.

Aim 3: Conduct a qualitative analysis to gain insight into elements of the intervention that contribute to sustainability.

Inclusion/Exclusion Criteria

Inclusion:

1. Female, aged 55 years or older
2. An additive sum of the frequency (question 1) and volume (question 2) items from the International Consultation on Incontinence Questionnaire-Short Form is ≤5
3. Negative for demonstrable UI on the standardized Paper Towel Test
4. Willing to undergo vaginal/pelvic examination
5. Willing and able to be compliant with visit schedule and study procedures for the study duration
6. Provide written informed consent form
7. Able to understand and read English

Exclusion:

1. Non-ambulatory (patient confined to bed or wheelchair)
2. Persistent pelvic pain (defined as daily pelvic pain)
3. History of neurologic diseases (e.g. Cerebral Vasular Accident, Parkinson's disease, Multiple sclerosis, Epilepsy, Spinal cord tumor or trauma, spina bifida, current symptomatic herniated disc)
4. Actively taking UI, OAB, or any other bladder control medication.
5. Other urinary conditions or procedures that may affect continence status (e.g. history of bladder cancer, urethral diverticula, previous augmentation cystoplasty or artificial sphincter; implanted nerve stimulators for urinary symptoms, history of sling surgery for UI or prolapse)
6. Participation in another research project that may influence the results of this trial
7. Pelvic organ prolapse protruding past the introitus upon straining
8. Absolute absence of pelvic floor muscle strength manifested by zero Brink test (Brink et al., 1994 for pressure and displacement 9
9. Evidence of UTI or hematuria - Urine dipstick positive for red blood cells will exclude the participant from enrollment in the study until a microscopic urinalysis is negative. Urine dipstick positive for leukocytes plus nitrates will exclude the participant from enrollment in the study and require further evaluation for UTI.
10. History of \> 2 recurrent UTI's in the past year and no more than one UTI within 6 months
11. Post void residual \> 150 cc

Eligibility criteria: Inclusion Criteria:

1. Female, aged 55 years or older
2. An additive sum of the frequency (question 1) and volume (question 2) items from the International Consultation on Incontinence Questionnaire-Short Form is ≤5
3. Negative for demonstrable UI on the standardized Paper Towel Test
4. Willing to undergo vaginal/pelvic examination
5. Willing and able to be compliant with visit schedule and study procedures for the study duration
6. Provide written informed consent form
7. Able to understand and read English

Exclusion Criteria:

1. Non-ambulatory (patient confined to bed or wheelchair)
2. Persistent pelvic pain (defined as daily pelvic pain)
3. History of neurologic diseases (e.g. Cerebral Vasular Accident, Parkinson's disease, Multiple sclerosis, Epilepsy, Spinal cord tumor or trauma, spina bifida, current symptomatic herniated disc)
4. Actively taking UI, OAB, or any other bladder control medication.
5. Other urinary conditions or procedures that may affect continence status (e.g. history of bladder cancer, urethral diverticula, previous augmentation cystoplasty or artificial sphincter; implanted nerve stimulators for urinary symptoms, history of sling surgery for UI or prolapse)
6. Participation in another research project that may influence the results of this trial
7. Pelvic organ prolapse protruding past the introitus upon straining
8. Absolute absence of pelvic floor muscle strength manifested by zero Brink test (Brink et al., 1994 for pressure and displacement 9
9. Evidence of UTI or hematuria - Urine dipstick positive for red blood cells will exclude the participant from enrollment in the study until a microscopic urinalysis is negative. Urine dipstick positive for leukocytes plus nitrates will exclude the participant from enrollment in the study and require further evaluation for UTI.
10. History of \> 2 recurrent UTI's in the past year and no more than one UTI within 6 months
11. Post void residual \> 150 cc

Primary outcomes:
measure: Translating Unique Learning for Incontinence Prevention (TULIP)
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan School of Nursing
state: Michigan
city: Philadelphia
country: United States
facility: University of Pennsylvania Department of Urology
state: Pennsylvania
Study officials:
affiliation: University of Michigan
name: Carolyn Sampselle, PHD, RN
role: PRINCIPAL_INVESTIGATOR
References: