Clinical trial NCT04298671: Yoga-Pilates Exercise & the Effects on Urethral Rhabdosphincter Morphology and Stress Urinary Incontinence
Official title: Yoga-Pilates Exercise & the Effects on Urethral Rhabdosphincter Morphology and Stress Urinary Incontinence
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stress Urinary Incontinence
Keywords: Yoga
Pilates
Rhabdosphincter
Lead sponsor: Oregon Health and Science University
Sponsor class: OTHER
First posted: 2020-03-06
Enrollment: 78
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Pre/Post
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Assess the change in stress urinary incontinence severity and quality of life symptoms pre/post intervention.
timeFrame: 8 weeks
measure: Estimate the effect of an 8-week intervention on urethral rhabdosphincter morphology as measured by transperineal ultrasound.
timeFrame: 8 weeks
Secondary outcomes:
measure: Assess the change in Patient Global Impression of Improvement (PGI-I) post-intervention
timeFrame: 8 weeks
measure: Assess the change in number of incontinence episodes within a 24-hour period post-intervention using a 24-hour voiding diary.
timeFrame: 8 weeks
measure: Assess the effect of the intervention on the levator hiatus area and anteroposterior diameter using transperineal ultrasound.
timeFrame: 8 weeks
measure: Assess the effect of the intervention on the degree of bladder neck descent using transperineal ultrasound.
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Portland
country: United States
facility: Oregon Health & Science University
state: Oregon
Study officials:
affiliation: Oregon Health and Science University
name: Sara Cichowski, MD
role: PRINCIPAL_INVESTIGATOR
References: