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

11. februar 2019 oppdatert av: 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.

Studieoversikt

Detaljert beskrivelse

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.

Studietype

Intervensjonell

Registrering (Faktiske)

25

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

    • Utah
      • Salt Lake City, Utah, Forente stater, 84112
        • University of Utah

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

55 år til 105 år (Voksen, Eldre voksen)

Tar imot friske frivillige

Ja

Kjønn som er kvalifisert for studier

Hunn

Beskrivelse

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

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Annen
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Enkelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: 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
Aktiv komparator: 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.

Hva måler studien?

Primære resultatmål

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

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
change in symptom severity
Tidsramme: 16 weeks, 6 months
measured by the Incontinence Severity Index
16 weeks, 6 months
change in symptom bother
Tidsramme: 16 weeks, 6 months
measured by the Overactive Bladder questionnaire, short form
16 weeks, 6 months
change in perceived stress
Tidsramme: 16 weeks, 6 months
measured by the Perceived Stress Scale
16 weeks, 6 months
change in perceived self-efficacy
Tidsramme: 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
Tidsramme: 16 weeks, 6 months
measured by the Patient Global Impression of Improvement
16 weeks, 6 months

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Etterforskere

  • Hovedetterforsker: Katarina F Felsted, MS, University of Utah

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

3. februar 2017

Primær fullføring (Faktiske)

12. april 2018

Studiet fullført (Faktiske)

12. april 2018

Datoer for studieregistrering

Først innsendt

27. april 2017

Først innsendt som oppfylte QC-kriteriene

1. juni 2017

Først lagt ut (Faktiske)

6. juni 2017

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

15. februar 2019

Siste oppdatering sendt inn som oppfylte QC-kriteriene

11. februar 2019

Sist bekreftet

1. februar 2019

Mer informasjon

Begreper knyttet til denne studien

Plan for individuelle deltakerdata (IPD)

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NEI

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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