Translating Unique Learning for Incontinence Prevention (TULIP)
Translating Unique Learning for Incontinence Prevention for Women Over the Age of 55
연구 개요
상태
상태
정황
정황
개입 / 치료
개입 / 치료
상세 설명
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:
- 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
Exclusion:
- 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
연구 유형
연구 유형
등록 (실제)
등록
단계
단계
- 2 단계
연락처 및 위치
연구 장소
-
-
Michigan
-
Ann Arbor, Michigan, 미국, 48109
- University of Michigan School of Nursing
-
-
Pennsylvania
-
Philadelphia, Pennsylvania, 미국, 19104
- University of Pennsylvania Department of Urology
-
-
참여기준
자격 기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 방지
- 할당: 무작위
- 중재 모델: 단일 그룹 할당
- 마스킹: 하나의
팔의 수
무기와 개입
참가자 그룹 / 팔참가자 그룹 / 팔 |
개입 / 치료개입 / 치료 |
|---|---|
|
다른: 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
|
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.
|
|
다른: 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.
|
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.
|
연구는 무엇을 측정합니까?
주요 결과 측정
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Translating Unique Learning for Incontinence Prevention (TULIP)
기간: 5 years
|
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
|
공동 작업자 및 조사자
협력자
협력자
수사관
수사관
- 수석 연구원: Carolyn Sampselle, PHD, RN, University of Michigan
연구 기록 날짜
연구 주요 날짜
연구 시작
연구 시작
기본 완료 (실제)
기본 완료
연구 완료 (실제)
연구 완료
연구 등록 날짜
최초 제출
최초 제출
QC 기준을 충족하는 최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
처음 게시됨
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
마지막 업데이트 게시됨
QC 기준을 충족하는 마지막 업데이트 제출
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
키워드
기타 연구 ID 번호
기타 연구 ID 번호
- The TULIP Project
- R01NR012011-01 (미국 NIH 보조금/계약)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
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