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Comparing Approaches to Treat Older Adult Women's Urge Incontinence: Pilot Feasibility and Randomized Controlled Trial (SHUW)

11 febbraio 2019 aggiornato da: Katarina Felsted, University of Utah

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

The purpose of this study is to examine the feasibility of conducting a pilot randomized controlled trial comparing mindfulness-based stress reduction with the health enhancement program on symptoms of urinary urge incontinence in older adult women, and to establish preliminary efficacy of these two approaches on symptoms of urinary urge incontinence.

Panoramica dello studio

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Effettivo)

25

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

    • Utah
      • Salt Lake City, Utah, Stati Uniti, 84112
        • University of Utah

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

Da 55 anni a 105 anni (Adulto, Adulto più anziano)

Accetta volontari sani

Sessi ammissibili allo studio

Femmina

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Altro
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Separare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: 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
Comparatore attivo: 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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Number of potential participants contacted
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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?"
Lasso di tempo: 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
Lasso di tempo: 8 weeks
participants mark on homework practice log and submit weekly
8 weeks
number of participants recruited for enrollment
Lasso di tempo: 10 weeks
potential participants who were interested in the study
10 weeks
number of potential participants who are eligible to enroll
Lasso di tempo: 10 weeks
number of people who passed the screening process via calls or emails
10 weeks
consent rate
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 8 weeks
totaled from daily numbers reported by participant
8 weeks

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
change in symptom severity
Lasso di tempo: 16 weeks, 6 months
measured by the Incontinence Severity Index
16 weeks, 6 months
change in symptom bother
Lasso di tempo: 16 weeks, 6 months
measured by the Overactive Bladder questionnaire, short form
16 weeks, 6 months
change in perceived stress
Lasso di tempo: 16 weeks, 6 months
measured by the Perceived Stress Scale
16 weeks, 6 months
change in perceived self-efficacy
Lasso di tempo: 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
Lasso di tempo: 16 weeks, 6 months
measured by the Patient Global Impression of Improvement
16 weeks, 6 months

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Investigatori

  • Investigatore principale: Katarina F Felsted, MS, University of Utah

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

3 febbraio 2017

Completamento primario (Effettivo)

12 aprile 2018

Completamento dello studio (Effettivo)

12 aprile 2018

Date di iscrizione allo studio

Primo inviato

27 aprile 2017

Primo inviato che soddisfa i criteri di controllo qualità

1 giugno 2017

Primo Inserito (Effettivo)

6 giugno 2017

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

15 febbraio 2019

Ultimo aggiornamento inviato che soddisfa i criteri QC

11 febbraio 2019

Ultimo verificato

1 febbraio 2019

Maggiori informazioni

Termini relativi a questo studio

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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