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

NCT03176901 | Completed

• 1 other identifier: 00095461
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

Urinary Incontinence, Urge; Urinary Incontinence in Old Age

Keywords

urinary urge incontinence; urinary incontinence; older adult women; older adults; mindfulness-based stress reduction; health enhancement program; feasibility; randomized controlled trial; complementary; integrative; therapies

Outcome Measures

Primary Outcomes (11)

• Number of potential participants contacted

  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

  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

  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?"

  data coded from two participants' responses after each class in each arm

  8 weeks

• number of participants who completed each week's homework practice

  participants mark on homework practice log and submit weekly

  8 weeks

• number of participants recruited for enrollment

  potential participants who were interested in the study

  10 weeks

• number of potential participants who are eligible to enroll

  number of people who passed the screening process via calls or emails

  10 weeks

• consent rate

  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

  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)

  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

  totaled from daily numbers reported by participant

  8 weeks

Secondary Outcomes (5)

• change in symptom severity

  16 weeks, 6 months

• change in symptom bother

  16 weeks, 6 months

• change in perceived stress

  16 weeks, 6 months

• change in perceived self-efficacy

  16 weeks, 6 months

• self report of rate and trajectory of change in participant impression of improvement

  16 weeks, 6 months

Study Arms (2)

Mindfulness-Based Stress Reduction

EXPERIMENTAL

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

Behavioral: Mindfulness-Based Stress Reduction

Health Enhancement Program

ACTIVE COMPARATOR

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

Behavioral: Health Enhancement Program

Interventions

Mindfulness-Based Stress Reduction 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

Mindfulness-Based Stress Reduction

Health Enhancement Program BEHAVIORAL

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

Health Enhancement Program

Eligibility Criteria

• Age: 55 Years - 105 Years
• Gender Eligibility Details: participants must self-identify as female to participate
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Utah: lead

Study Sites (1)

University of Utah

Salt Lake City, Utah, 84112, United States

Location

MeSH Terms

Conditions

Urinary Incontinence, Urge; Urinary Incontinence

Interventions

Mindfulness-Based Stress Reduction

Condition Hierarchy (Ancestors)

Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Mindfulness; Cognitive Behavioral Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Katarina F Felsted, MS

  University of Utah

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: This is a blinded, randomized controlled trial. Participants are blinded to condition.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Two armed study with intervention and comparison groups running parallel to one another

Study Record Dates

• First Submitted: April 27, 2017
• First Posted: June 6, 2017
• Study Start: February 3, 2017
• Primary Completion: April 12, 2018
• Study Completion: April 12, 2018
• Last Updated: February 15, 2019

Record last verified: 2019-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)