- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT01599715
Translating Unique Learning for Incontinence Prevention (TULIP)
Translating Unique Learning for Incontinence Prevention for Women Over the Age of 55
Přehled studie
Postavení
Podmínky
Intervence / Léčba
Detailní popis
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
Typ studie
Zápis (Aktuální)
Fáze
- Fáze 2
Kontakty a umístění
Studijní místa
-
-
Michigan
-
Ann Arbor, Michigan, Spojené státy, 48109
- University of Michigan School of Nursing
-
-
Pennsylvania
-
Philadelphia, Pennsylvania, Spojené státy, 19104
- University of Pennsylvania Department of Urology
-
-
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
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
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Prevence
- Přidělení: Randomizované
- Intervenční model: Přiřazení jedné skupiny
- Maskování: Singl
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
|
Jiný: 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.
|
|
Jiný: 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.
|
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Translating Unique Learning for Incontinence Prevention (TULIP)
Časové okno: 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
|
Spolupracovníci a vyšetřovatelé
Sponzor
Spolupracovníci
Vyšetřovatelé
- Vrchní vyšetřovatel: Carolyn Sampselle, PHD, RN, University of Michigan
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia
Primární dokončení (Aktuální)
Dokončení studie (Aktuální)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Odhad)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Odhad)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- The TULIP Project
- R01NR012011-01 (Grant/smlouva NIH USA)
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
Popis plánu IPD
Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .
Klinické studie na Instructional DVD
-
The Miriam HospitalNational Institute of Mental Health (NIMH); Brown University; University of Rochester a další spolupracovníciDokončenoHIV infekce | Pohlavně přenosné nemoci | HIVSpojené státy
-
VA Office of Research and DevelopmentDokončeno
-
Case Comprehensive Cancer CenterAmerican Cancer Society, Inc.; Consumer Wellness Solutions; North Carolina Tobacco...Dokončeno
-
The University of Hong KongThe Boys' and Girls' Clubs Association of Hong KongDokončeno
-
University of Texas Southwestern Medical CenterAgency for Healthcare Research and Quality (AHRQ)DokončenoNovotvary prsu | Novotvary plic | Novotvary tlustého střevaSpojené státy
-
AmgenDokončeno
-
IRCSS Istituto Dermopatico dell'Immacolata, Fondazione...Ministry of Health, Italy; Centro di Eccellenza per la Cultura e la Ricerca...DokončenoSklerodermie, systémová
-
University of RochesterThe Commonwealth Fund; Academic Pediatric AssociationDokončeno
-
Fred Hutchinson Cancer CenterNational Cancer Institute (NCI)Dokončeno
-
University of DelawareNational Institute on Drug Abuse (NIDA)DokončenoSyndrom získané immunití nedostatečnisti | Hepatitida C | Virus lidské imunodeficienceSpojené státy