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

NCT ID: NCT03176901

Last Updated: 2019-02-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-02-03
• Study Completion Date: 2018-04-12

Brief Summary

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.

Detailed Description

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.

Conditions

Urinary Incontinence, Urge; Urinary Incontinence in Old Age

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

Mindfulness-Based Stress Reduction

8 week manualized, standardized mindfulness-based stress reduction program taught by a certified Mindfulness-Based Stress Reduction instructor

Group Type: EXPERIMENTAL

Mindfulness-Based Stress Reduction

Intervention Type: BEHAVIORAL

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

Health Enhancement Program

8 week manualized, standardized health enhancement program, taught by a certified health education specialist

Group Type: ACTIVE_COMPARATOR

Health Enhancement Program

Intervention Type: BEHAVIORAL

This active comparison arm presents the official Health Enhancement Program in its eight week format as developed by MacCoon in 2009.

Interventions

Mindfulness-Based Stress Reduction

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

Intervention Type: BEHAVIORAL

Health Enhancement Program

This active comparison arm presents the official Health Enhancement Program in its eight week format as developed by MacCoon in 2009.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 55 Years
• Maximum Eligible Age: 105 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

University of Utah

OTHER

Sponsor Role: lead

Responsible Party

Katarina Felsted

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Katarina F Felsted, MS

Role: PRINCIPAL_INVESTIGATOR

University of Utah

Locations

University of Utah

Salt Lake City, Utah, United States

Countries

United States

Other Identifiers

00095461

Identifier Type: -

Identifier Source: org_study_id