Comparing Approaches to Treat Older Adult Women's Urge Incontinence: Pilot Feasibility and Randomized Controlled Trial (SHUW)
Comparing Mindfulness-Based Stress Reduction With the Health Enhancement Program in the Treatment of Urinary Urge Incontinence in Older Adult Women: A Pilot Feasibility and Randomized Controlled Trial
Přehled studie
Postavení
Postavení
Podmínky
Podmínky
Intervence / Léčba
Intervence / Léčba
Detailní popis
The overarching goal of this research is to evaluate potential treatment options for older women with symptoms of urinary urge incontinence, with a specific focus on Mindfulness-Based Stress Reduction, a promising therapeutic approach in preliminary studies and one increasingly used to treat symptoms associated with brain-visceral interactions. Feasibility and preliminary efficacy will be tested in two randomized study arms: a Mindfulness-Based Stress Reduction intervention group and a Health Enhancement Program intervention comparison group.
This research study will explore the feasibility and preliminary efficacy of treating urinary urge incontinence in older adult women with mindfulness-based stress reduction in comparison to the health enhancement program through a randomized controlled pilot study. Feasibility determinants will include both research feasibility (recruitment, retention, treatment fidelity) and intervention feasibility (acceptability, tolerability, treatment adherence). Clinical outcomes to evaluate preliminary intervention efficacy will include severity of urinary urge incontinence symptoms, bother of urinary urge incontinence symptoms, perceived stress, and perceived level of self-efficacy of self-management of urinary urge incontinence symptoms. Preliminary efficacy of the intervention will also be evaluated with the Patient Global Impression of Improvement, a process measure that rates the patient's "response of a condition to a therapy" (Ryan, n.d., p. 1).
This combined pilot feasibility study and randomized controlled trial will evaluate specific factors crucial to the success of a large trial to evaluate the effect of Mindfulness-Based Stress Reduction on urinary urge incontinence in older adult women. Moore (2011) recommended that the pilot study design parallel the future larger study, particularly when evaluating feasibility in the pilot study. The capacity for hypothesis testing, or establishing causal inference is limited in a pilot study due to insufficient power; however, the information from efficacy testing is vital in informing future larger scale clinical trials. This study will serve as a necessary step for the development of effectiveness trials of Mindfulness-Based Stress Reduction in treatment of urinary urge incontinence in older adult women by informing and guiding evaluation, implementation, and dissemination.
Typ studie
Typ studie
Zápis (Aktuální)
Zápis
Fáze
Fáze
- Nelze použít
Kontakty a umístění
Studijní místa
-
-
Utah
-
Salt Lake City, Utah, Spojené státy, 84112
- University of Utah
-
-
Kritéria účasti
Kritéria způsobilosti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
Inclusion Criteria:
The following eligibility criteria must be met for the potential participant to be considered for enrollment.
- The study is enrolling older adult women, with urinary urge incontinence.
- They cannot be currently treating their urinary urge incontinence with medication as this will confound results.
- Women who have attempted more extreme treatments and are still experiencing urinary urge incontinence will not be considered as potential participants, as it is unlikely that mindfulness-based stress reduction would treat urinary urge incontinence that is refractory to that degree.
- Participants must be English speaking, as the interventions and homework will be delivered in English.
- postmenopausal women
- Urge predominant urinary incontinence, defined as score of ≥ 3 (moderate to severe urinary incontinence) on the Incontinence Severity Index
- Urge predominant urinary incontinence as determined by question 3 on the 3 Incontinence Questions. The 3 Incontinence Questions has been shown to be a quick and accurate way of diagnosing stress, urge or mixed incontinence in most cases
- Has experienced urinary urge incontinence symptoms for at least three months
- Committed to attend 8 weekly sessions and one half day retreat between weeks 6 and 7
- No pharmacologic therapy for urinary urge incontinence within three weeks of enrollment and no plan to initiate such medications during the 8 week active treatment
- If on hormone therapy or vaginal estrogen, plan to remain on it for the duration of the study; if not on it, no plan to initiate
- No previous intradetrusor Botox injection for urinary urge incontinence and no plan to receive it during the intervention
- No previous neurostimulation for urinary urge incontinence and no plan to receive it during the intervention English speaking
- A score of >24 on the Montreal Cognitive Assessment
Exclusion Criteria:
The following exclusions are applied, as they could seriously limit participation or confound participant response to the intervention:
- Predominantly stress, mixed, or other type of incontinence as determined by question 3 on the 3 Incontinence Questions
- Currently taking medications for Alzheimer's disease or other dementias; these medications could interfere with their participation
- Known neurologic disease acknowledged to impact bladder function including Parkinson's disease, spinal cord injury, or stroke affecting urinary control; these diseases provide cause for urinary urge incontinence and as such the participant would be unlikely to benefit from the intervention
- Current symptomatic urinary tract infection that has not resolved prior to the start of intervention
- Current bladder infection that has not resolved prior to the start of intervention
- Use of an assistive device for ambulation (such as a cane, walker, or wheelchair) and feels that difficulties with bladder management are related to the slowed time in visiting the restroom ("Was urinary urge incontinence a problem before you began using the assistive device?")
- Functionally incontinent, in other words, having a mental or physical condition that prevents a person from visiting the restroom in time
- Ever diagnosed with interstitial cystitis
- Self-report of vaginal bulge protruding outside of the vagina
- Past participation in a formal program of mindfulness-based stress reduction
- Substantial, uncorrected hearing loss
- Substantial, uncorrected vision loss
- Limitations that preclude completing study questionnaires or surveys, such as difficulties with reading and writing or a cognitive impairment
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Jiný
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Singl
Počet zbraní
Zbraně a zásahy
Skupina účastníků / ArmSkupina účastníků / Arm |
Intervence / LéčbaIntervence / Léčba |
|---|---|
|
Experimentální: Mindfulness-Based Stress Reduction
8 week manualized, standardized mindfulness-based stress reduction program taught by a certified Mindfulness-Based Stress Reduction instructor
|
This experimental arm presents the actual Mindfulness-Based Stress Reduction program as developed in the late seventies and early eighties in its original eight week format
|
|
Aktivní komparátor: Health Enhancement Program
8 week manualized, standardized health enhancement program, taught by a certified health education specialist
|
This active comparison arm presents the official Health Enhancement Program in its eight week format as developed by MacCoon in 2009.
|
Co je měření studie?
Primární výstupní opatření
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Number of potential participants contacted
Časové okno: 10 weeks
|
number of people who contacted PI during recruitment process, including the place they heard about the study
|
10 weeks
|
|
number of enrolled participants completing the study
Časové okno: 12 weeks
|
number of participants who attended at least five of nine classes number of excused absences number of unexcused absences
|
12 weeks
|
|
percentage of course content delivered during intervention
Časové okno: 44 weeks
|
weekly interventionist report on what was taught participants perception of course content delivered measured by a checklist of concepts covered in the weekly interventions at study completion
|
44 weeks
|
|
positive or negative coded responses to the question "How did it go today?"
Časové okno: 8 weeks
|
data coded from two participants' responses after each class in each arm
|
8 weeks
|
|
number of participants who completed each week's homework practice
Časové okno: 8 weeks
|
participants mark on homework practice log and submit weekly
|
8 weeks
|
|
number of participants recruited for enrollment
Časové okno: 10 weeks
|
potential participants who were interested in the study
|
10 weeks
|
|
number of potential participants who are eligible to enroll
Časové okno: 10 weeks
|
number of people who passed the screening process via calls or emails
|
10 weeks
|
|
consent rate
Časové okno: 10 weeks
|
number of participants who are willing to sign consent document at enrollment interview; number who pass the Montreal Cognitive Assessment and are willing to sign consent document
|
10 weeks
|
|
number of participants enrolled
Časové okno: 10 weeks
|
number of people who enrolled into the study
|
10 weeks
|
|
number of dropouts due to stated distress from or dislike of either intervention experience (as opposed to someone needing to withdraw due to a family emergency or illness)
Časové okno: 8 weeks
|
participant self-report of what made the intervention challenging - why they were unable or unwilling to complete the course
|
8 weeks
|
|
- number of minutes of homework practice each week
Časové okno: 8 weeks
|
totaled from daily numbers reported by participant
|
8 weeks
|
Sekundární výstupní opatření
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
change in symptom severity
Časové okno: 16 weeks, 6 months
|
measured by the Incontinence Severity Index
|
16 weeks, 6 months
|
|
change in symptom bother
Časové okno: 16 weeks, 6 months
|
measured by the Overactive Bladder questionnaire, short form
|
16 weeks, 6 months
|
|
change in perceived stress
Časové okno: 16 weeks, 6 months
|
measured by the Perceived Stress Scale
|
16 weeks, 6 months
|
|
change in perceived self-efficacy
Časové okno: 16 weeks, 6 months
|
measured by the Geriatric Self Efficacy Index for Urinary Incontinence
|
16 weeks, 6 months
|
|
self report of rate and trajectory of change in participant impression of improvement
Časové okno: 16 weeks, 6 months
|
measured by the Patient Global Impression of Improvement
|
16 weeks, 6 months
|
Spolupracovníci a vyšetřovatelé
Sponzor
Sponzor
Vyšetřovatelé
Vyšetřovatelé
- Vrchní vyšetřovatel: Katarina F Felsted, MS, University of Utah
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Začátek studia
Primární dokončení (Aktuální)
Primární dokončení
Dokončení studie (Aktuální)
Dokončení studie
Termíny zápisu do studia
První předloženo
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
První zveřejněno
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Poslední zveřejněná aktualizace
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
Další identifikační čísla studie
- 00095461
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Studuje produkt zařízení regulovaný americkým úřadem FDA
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 Mindfulness-Based Stress Reduction
-
NCT05500794NáborPsoriáza | Pruritus | Atopická dermatitida
-
NCT06512844Dokončeno
-
NCT06734767Zápis na pozvánku
-
NCT07410572Dokončeno
-
NCT05121116DokončenoDeprese | Snížení stresu založeného na všímavosti
-
NCT00826475Dokončeno
-
NCT03839589DokončenoVšímavost | Emocionální pohoda
-
NCT03141190DokončenoStres | Chirurgická operace | Syndrom vyhoření
-
NCT05017974DokončenoSpát | Související s těhotenstvím