Translating Unique Learning for Incontinence Prevention

NCT01599715 | Completed Phase 2 DMC

• 2 other identifiers: The TULIP ProjectR01NR012011-01
• Study Type: interventional
• Target: 647
• Locations: 1 country
• Sites: 2

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.

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

Outcome Measures

Primary Outcomes (1)

• Translating Unique Learning for Incontinence Prevention (TULIP)

  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.

  5 years

Study Arms (2)

Instructional DVD Intervention

OTHER

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

Behavioral: Instructional DVD

Bladder Health Class Intervention

OTHER

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.

Behavioral: Bladder Health Class

Interventions

Instructional DVD 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.

Instructional DVD Intervention

Bladder Health Class 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.

Bladder Health Class Intervention

Eligibility Criteria

• Age: 55 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Non-ambulatory (patient confined to bed or wheelchair)
• Persistent pelvic pain (defined as daily pelvic pain)
• 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)
• Actively taking UI, OAB, or any other bladder control medication.
• 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)
• Participation in another research project that may influence the results of this trial
• Pelvic organ prolapse protruding past the introitus upon straining
• Absolute absence of pelvic floor muscle strength manifested by zero Brink test (Brink et al., 1994 for pressure and displacement 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.
• History of \> 2 recurrent UTI's in the past year and no more than one UTI within 6 months
• Post void residual \> 150 cc

Sponsors & Collaborators

• University of Michigan: lead
• National Institute of Nursing Research (NINR): collaborator

Study Sites (2)

University of Michigan School of Nursing

Ann Arbor, Michigan, 48109, United States

Location

University of Pennsylvania Department of Urology

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Urinary Incontinence; Nocturnal Enuresis; Urinary Bladder, Overactive; Urinary Incontinence, Stress; Urinary Incontinence, Urge

Condition Hierarchy (Ancestors)

Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Enuresis; Behavioral Symptoms; Behavior; Elimination Disorders; Mental Disorders; Urinary Bladder Diseases

Study Officials

• Carolyn Sampselle, PHD, RN

  University of Michigan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Carolyne K Davis Professor of Nursing

Study Record Dates

• First Submitted: May 14, 2012
• First Posted: May 16, 2012
• Study Start: September 1, 2010
• Primary Completion: January 1, 2015
• Study Completion: January 1, 2015
• Last Updated: May 12, 2016

Record last verified: 2016-05

Data Sharing

• IPD Sharing: Will share

Locations

US (2)