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

NCT04298671 | Completed

• 1 other identifier: STUDY00020675
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 1

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.

Conditions

Stress Urinary Incontinence

Keywords

Yoga; Pilates; Rhabdosphincter

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• Assess the change in Patient Global Impression of Improvement (PGI-I) post-intervention

  8 weeks

• Assess the change in number of incontinence episodes within a 24-hour period post-intervention using a 24-hour voiding diary.

  8 weeks

• Assess the effect of the intervention on the levator hiatus area and anteroposterior diameter using transperineal ultrasound.

  8 weeks

• Assess the effect of the intervention on the degree of bladder neck descent using transperineal ultrasound.

  8 weeks

Study Arms (1)

Yoga-Pilates Group

EXPERIMENTAL

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

Interventions

Yoga-Pilates BEHAVIORAL

As above

Yoga-Pilates Group

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Oregon Health and Science University: lead

Study Sites (1)

Oregon Health & Science University

Portland, Oregon, 97239, United States

Location

MeSH Terms

Conditions

Urinary Incontinence, Stress

Condition Hierarchy (Ancestors)

Urinary Incontinence; 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

Study Officials

• Sara Cichowski, MD

  Oregon Health and Science University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Pre/Post

Study Record Dates

• First Submitted: March 2, 2020
• First Posted: March 6, 2020
• Study Start: October 13, 2020
• Primary Completion: December 31, 2021
• Study Completion: January 31, 2022
• Last Updated: July 14, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)