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Yoga-Pilates Exercise & the Effects on Urethral Rhabdosphincter Morphology and Stress Urinary Incontinence (Y-PEE)

Primary Purpose

Stress Urinary Incontinence

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Yoga-Pilates
Sponsored by
Oregon Health and Science University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stress Urinary Incontinence focused on measuring Yoga, Pilates, Rhabdosphincter

Eligibility Criteria

18 Years - 89 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • English-speaking
  • >50% episodes of leakage are stress over urge incontinence on a 1-day voiding diary and/OR an answer of "when you are performing some physical activities, such as coughing, sneezing, lifting, or exercise" on the 3-Incontinence Questions (3IQ) Questionnaire
  • Access to the Internet and active email address

Exclusion Criteria:

  • Inability to perform yoga or Pilates due to mobility issues (specifically, inability to get up from chair without assistance or to get up from prone position on floor without assistance)
  • Chronic back or neck injury that would prevent yoga or Pilates
  • Dementia
  • Multiple sclerosis and other neurological disorders such as stroke
  • Engaged in yoga, Pilates, or pelvic floor physical therapy in past 6 months
  • Current pregnancy or pregnancy in the last 6 months
  • Untreated urinary tract infection (UTI), unevaluated hematuria, history of >3 diagnosed UTIs in past year
  • History of bladder or rectal fistula
  • Pelvic cancer or radiation
  • Interstitial cystitis or chronic pelvic pain
  • Congenital defect leading to urinary incontinence
  • Prior anti-incontinence or urethral surgery, prior surgery for pelvic floor disorder
  • Current symptomatic pelvic organ prolapse (Stage 2 or greater on exam, i.e. prolapse more than 1cm beyond the hymen)
  • Majority of incontinence episodes related to urgency urinary incontinence

Sites / Locations

  • Oregon Health & Science University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Yoga-Pilates Group

Arm Description

The 30-minute web-based video exercise program will combine the best yoga-Pilates exercises focused on the pelvic floor, based on prior research and expert opinion, in collaboration with yoga-Pilates instructors that participants will complete 4 times per week for 8 weeks.

Outcomes

Primary Outcome Measures

Assess the change in stress urinary incontinence severity and quality of life symptoms pre/post intervention.
The investigators hypothesize that participants will report a minimally important change score difference of -2.5 utilizing the International Consultation on Incontinence Questionnaire-Short Form (range 0-21, lower scores indicate less bother from incontinence).
Estimate the effect of an 8-week intervention on urethral rhabdosphincter morphology as measured by transperineal ultrasound.
The investigators hypothesize that this program will cause hypertrophy of the urethral rhabdosphincter with an increase in urethral cross sectional area of 0.25cm2 +/- 0.6cm2.

Secondary Outcome Measures

Assess the change in Patient Global Impression of Improvement (PGI-I) post-intervention
The investigators hypothesize that the majority of patients will report an answer of at least "a little better" on the PGI-I post-intervention (range 1-7; 1: "very much better", 2: "much better", 3: "a little better", 4: "no change", 5: "a little worse", 6: "much worse", 7: "very much worse")
Assess the change in number of incontinence episodes within a 24-hour period post-intervention using a 24-hour voiding diary.
The investigators hypothesize that the intervention will cause a change in number of incontinence episodes on a 24-hour voiding diary.
Assess the effect of the intervention on the levator hiatus area and anteroposterior diameter using transperineal ultrasound.
The investigators also hypothesize that the levator hiatus area and anteroposterior diameter will change over time due to hypertrophy of the levator muscles.
Assess the effect of the intervention on the degree of bladder neck descent using transperineal ultrasound.
The investigators hypothesize that the degree of bladder neck descent will change over time with Valsalva.

Full Information

First Posted
March 2, 2020
Last Updated
July 12, 2022
Sponsor
Oregon Health and Science University
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1. Study Identification

Unique Protocol Identification Number
NCT04298671
Brief Title
Yoga-Pilates Exercise & the Effects on Urethral Rhabdosphincter Morphology and Stress Urinary Incontinence
Acronym
Y-PEE
Official Title
Yoga-Pilates Exercise & the Effects on Urethral Rhabdosphincter Morphology and Stress Urinary Incontinence
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
October 13, 2020 (Actual)
Primary Completion Date
December 31, 2021 (Actual)
Study Completion Date
January 31, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Oregon Health and Science University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This is a prospective interventional study conducted at Oregon Health & Science University that will measure the pre- and post-intervention characteristics of women with stress urinary incontinence undergoing an 8-week home yoga-Pilates intervention. The investigators plan to deliver this method of exercise to patients through a web-based video in order to increase accessibility and compliance and decrease patient costs. The investigators will assess changes using a pre- and post-treatment 1-day voiding diary, answers to questionnaires International Consultation on Incontinence Questionnaire-Short Form and Patient Global Impression of Improvement questionnaire), transperineal ultrasound, and physical exam.
Detailed Description
Stress urinary incontinence (SUI) affects up to 1/3 of women and negatively impacts multiple aspects of a woman's life. Pelvic floor physical therapy has been shown to improve stress incontinence through multiple mechanisms, including rhabdosphincter hypertrophy. Yoga and Pilates have also been shown to improve stress incontinence but there is a key gap in understanding how yoga-Pilates impacts urethral function and if these exercises represent a viable option for treating SUI. To fill this gap a new exercise is proposed: a web-based 8-week yoga-Pilates pelvic floor workout. The investigators plan to enroll women with SUI and compare urethral rhabdosphincter cross-sectional area in a pre-post intervention study. The investigators will also administer validated quality of life and severity measures for SUI to evaluate the potential efficacy of yoga-Pilates. The overarching goal of this project is to determine how yoga-Pilates impact urethral function and if these exercises decrease SUI symptoms.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stress Urinary Incontinence
Keywords
Yoga, Pilates, Rhabdosphincter

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Pre/Post
Masking
None (Open Label)
Allocation
N/A
Enrollment
78 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Yoga-Pilates Group
Arm Type
Experimental
Arm Description
The 30-minute web-based video exercise program will combine the best yoga-Pilates exercises focused on the pelvic floor, based on prior research and expert opinion, in collaboration with yoga-Pilates instructors that participants will complete 4 times per week for 8 weeks.
Intervention Type
Behavioral
Intervention Name(s)
Yoga-Pilates
Intervention Description
As above
Primary Outcome Measure Information:
Title
Assess the change in stress urinary incontinence severity and quality of life symptoms pre/post intervention.
Description
The investigators hypothesize that participants will report a minimally important change score difference of -2.5 utilizing the International Consultation on Incontinence Questionnaire-Short Form (range 0-21, lower scores indicate less bother from incontinence).
Time Frame
8 weeks
Title
Estimate the effect of an 8-week intervention on urethral rhabdosphincter morphology as measured by transperineal ultrasound.
Description
The investigators hypothesize that this program will cause hypertrophy of the urethral rhabdosphincter with an increase in urethral cross sectional area of 0.25cm2 +/- 0.6cm2.
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Assess the change in Patient Global Impression of Improvement (PGI-I) post-intervention
Description
The investigators hypothesize that the majority of patients will report an answer of at least "a little better" on the PGI-I post-intervention (range 1-7; 1: "very much better", 2: "much better", 3: "a little better", 4: "no change", 5: "a little worse", 6: "much worse", 7: "very much worse")
Time Frame
8 weeks
Title
Assess the change in number of incontinence episodes within a 24-hour period post-intervention using a 24-hour voiding diary.
Description
The investigators hypothesize that the intervention will cause a change in number of incontinence episodes on a 24-hour voiding diary.
Time Frame
8 weeks
Title
Assess the effect of the intervention on the levator hiatus area and anteroposterior diameter using transperineal ultrasound.
Description
The investigators also hypothesize that the levator hiatus area and anteroposterior diameter will change over time due to hypertrophy of the levator muscles.
Time Frame
8 weeks
Title
Assess the effect of the intervention on the degree of bladder neck descent using transperineal ultrasound.
Description
The investigators hypothesize that the degree of bladder neck descent will change over time with Valsalva.
Time Frame
8 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
89 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: English-speaking >50% episodes of leakage are stress over urge incontinence on a 1-day voiding diary and/OR an answer of "when you are performing some physical activities, such as coughing, sneezing, lifting, or exercise" on the 3-Incontinence Questions (3IQ) Questionnaire Access to the Internet and active email address Exclusion Criteria: Inability to perform yoga or Pilates due to mobility issues (specifically, inability to get up from chair without assistance or to get up from prone position on floor without assistance) Chronic back or neck injury that would prevent yoga or Pilates Dementia Multiple sclerosis and other neurological disorders such as stroke Engaged in yoga, Pilates, or pelvic floor physical therapy in past 6 months Current pregnancy or pregnancy in the last 6 months Untreated urinary tract infection (UTI), unevaluated hematuria, history of >3 diagnosed UTIs in past year History of bladder or rectal fistula Pelvic cancer or radiation Interstitial cystitis or chronic pelvic pain Congenital defect leading to urinary incontinence Prior anti-incontinence or urethral surgery, prior surgery for pelvic floor disorder Current symptomatic pelvic organ prolapse (Stage 2 or greater on exam, i.e. prolapse more than 1cm beyond the hymen) Majority of incontinence episodes related to urgency urinary incontinence
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sara Cichowski, MD
Organizational Affiliation
Oregon Health and Science University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Oregon Health & Science University
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Yoga-Pilates Exercise & the Effects on Urethral Rhabdosphincter Morphology and Stress Urinary Incontinence

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