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

Stress Urinary Incontinence Clinical Trial

— Y-PEE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04298671
• Other study ID #: STUDY00020675
• Status: Completed
• Phase: N/A
• Start date: October 13, 2020
• Est. completion date: January 31, 2022

Study information

• Verified date: July 2022
• Source: Oregon Health and Science University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 78
• Est. completion date: January 31, 2022
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 89 Years

Eligibility

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

Related Conditions & MeSH terms

• Enuresis
• Stress Urinary Incontinence
• Urinary Incontinence
• Urinary Incontinence, Stress

Intervention

Behavioral:
• Yoga-Pilates
As above

Locations

Country	Name	City	State
United States	Oregon Health & Science University	Portland	Oregon

Sponsors (1)

Lead Sponsor	Collaborator
Oregon Health and Science University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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