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

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.

Study Overview

• Status: Completed
• Conditions: Stress Urinary Incontinence
• Intervention / Treatment: Behavioral: Yoga-Pilates

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.

• Study Type: Interventional
• Enrollment (Actual): 78
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Oregon
    • Portland, Oregon, United States, 97239
      • Oregon Health & Science University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 89 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Yoga-Pilates Group; 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.	Behavioral: Yoga-Pilates; As above

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	8 weeks
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.	8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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")	8 weeks
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.	8 weeks
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.	8 weeks
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.	8 weeks

Collaborators and Investigators

• Sponsor: Oregon Health and Science University
• Investigators: Principal Investigator: Sara Cichowski, MD, Oregon Health and Science University

Study record dates

Study Major Dates

• Study Start (Actual): October 13, 2020
• Primary Completion (Actual): December 31, 2021
• Study Completion (Actual): January 31, 2022

Study Registration Dates

• First Submitted: March 2, 2020
• First Submitted That Met QC Criteria: March 3, 2020
• First Posted (Actual): March 6, 2020

Study Record Updates

• Last Update Posted (Actual): July 14, 2022
• Last Update Submitted That Met QC Criteria: July 12, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Keywords: Yoga; Pilates; Rhabdosphincter
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Urologic Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Urination Disorders; Elimination Disorders; Urinary Incontinence; Enuresis; Urinary Incontinence, Stress
• Other Study ID Numbers: STUDY00020675

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No