Translating Unique Learning for Incontinence Prevention (TULIP)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Carolyn Sampselle, University of Michigan
ClinicalTrials.gov Identifier:
NCT01599715
First received: May 14, 2012
Last updated: June 21, 2013
Last verified: June 2013
  Purpose

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.


Condition Intervention Phase
Urinary Incontinence
Behavioral: DVD Group
Behavioral: Bladder Health Class
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Prevention
Official Title: Translating Unique Learning for Incontinence Prevention for Women Over the Age of 55

Resource links provided by NLM:


Further study details as provided by University of Michigan:

Primary Outcome Measures:
  • Translating Unique Learning for Incontinence Prevention (TULIP) [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    Prevention study for Urinary Incontinence in women over the age of 55 who are fully continent (do not leak urine at all) or mildly continent (leak small drops of urine on occasion). This study will measure the effectiveness of 2 interventions: a bladder health instruction session or Bladder Health DVD administration.


Estimated Enrollment: 600
Study Start Date: September 2010
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Behavioral Intervention
There is no control group in the study, however, both interventions will teach self-care practices that have been proven to prevent or lessen the severity of urinary incontinence.
Behavioral: DVD Group
Participants could be instructed to watch an 18 minute bladder health instructional DVD at the conclusion of a successful baseline screening visit. This intervention session will occur only once.
Behavioral: Bladder Health Class
Participants could be assigned to a two-hour bladder health instruction session that will review 3 primary self-care techniques that have been proven to prevent or lessen the severity of urinary incontinence. This session occurs only once 1-3 weeks after a successful baseline screening visit.

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

Ages Eligible for Study:   55 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01599715

Locations
United States, Michigan
University of Michigan School of Nursing
Ann Arbor, Michigan, United States, 48109
United States, Pennsylvania
University of Pennsylvania Department of Urology
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
University of Michigan
Investigators
Principal Investigator: Carolyn Sampselle, PHD, RN University of Michigan
  More Information

No publications provided

Responsible Party: Carolyn Sampselle, Carolyne K Davis Professor of Nursing, University of Michigan
ClinicalTrials.gov Identifier: NCT01599715     History of Changes
Other Study ID Numbers: The TULIP Project, R01NR012011-01
Study First Received: May 14, 2012
Last Updated: June 21, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Michigan:
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

Additional relevant MeSH terms:
Urinary Incontinence
Urination Disorders
Urologic Diseases
Urological Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on July 23, 2014