Translating Unique Learning for Incontinence Prevention

NCT ID: NCT01599715

Last Updated: 2016-05-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 647 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-09-30
• Study Completion Date: 2015-01-31

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

Conditions

Urinary Incontinence

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Instructional DVD Intervention

Participants randomized to this arm watched an eighteen minute bladder health instructional DVD at the conclusion of a successful baseline screening visit. This intervention occurred only once

Group Type: OTHER

Instructional DVD

Intervention Type: BEHAVIORAL

Participants randomized to this arm watched an eighteen minute bladder health instructional DVD at the conclusion of a successful baseline screening visit. This intervention occurred only once.

Bladder Health Class Intervention

Participants randomized to this arm attended a two-hour bladder health instruction session that reviewed 3 primary self-care techniques that have been proven to prevent or lessen the severity of urinary incontinence. This session occurred only once 1-3 weeks subsequent to a successful baseline screening visit.

Group Type: OTHER

Bladder Health Class

Intervention Type: BEHAVIORAL

Participants randomized to this arm attended a two-hour bladder health instruction session that reviewed 3 primary self-care techniques that have been proven to prevent or lessen the severity of urinary incontinence. This session occurred only once 1-3 weeks subsequent to a successful baseline screening visit.

Interventions

Instructional DVD

Participants randomized to this arm watched an eighteen minute bladder health instructional DVD at the conclusion of a successful baseline screening visit. This intervention occurred only once.

Intervention Type: BEHAVIORAL

Bladder Health Class

Participants randomized to this arm attended a two-hour bladder health instruction session that reviewed 3 primary self-care techniques that have been proven to prevent or lessen the severity of urinary incontinence. This session occurred only once 1-3 weeks subsequent to a successful baseline screening visit.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 55 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute of Nursing Research (NINR)

NIH

Sponsor Role: collaborator

University of Michigan

OTHER

Sponsor Role: lead

Responsible Party

Carolyn Sampselle

Carolyne K Davis Professor of Nursing

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Carolyn Sampselle, PHD, RN

Role: PRINCIPAL_INVESTIGATOR

University of Michigan

Locations

University of Michigan School of Nursing

Ann Arbor, Michigan, United States

University of Pennsylvania Department of Urology

Philadelphia, Pennsylvania, United States

Countries

United States

Other Identifiers

R01NR012011-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

The TULIP Project

Identifier Type: -

Identifier Source: org_study_id