Effects of Home-based Telerehabilitation-assisted High-intensity Inspiratory Muscle Training on Pelvic Floor Muscle Function and Urinary Symptoms in Women With Stress Urinary Incontinence: A Randomized Controlled Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 22
- Locations
- 1
- Primary Endpoint
- Change of Pelvic floor muscle functions with Pressure feedbacks
Study Overview
Brief Summary
Strengthening the diaphragm muscle, the roof of the pelvic floor muscles (PFM), may be an alternative intervention in patients suffering from stress urinary incontinence (SUI). This study aims to investigate the effects of home-based telerehabilitation-assisted high-intensity inspiratory muscle training (IMT) on PFM function and urinary symptoms in women with SUI.
Detailed Description
The IMT protocol consisted of home-based high-intensity daily training - two cycles of 30 breaths with a 1-minute rest between sets, twice a day for 8 weeks using an IMT Threshold device (Threshold IMT Philips® Respironics, Inc). The IMT was performed twice a day, 7 days/week, for 8 weeks. The study group performed IMT at 60% of their baseline MIP and was adjusted weekly based on the modified Borg scale from 4 to 6 regarding respiratory effort performed during the session, while the control group performed a sham-IMT without applied resistance. Patients are evaluated before the inspiratory muscle training and after 8 weeks of training.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 25 Years to 50 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Diagnosed with stress urinary incontinence by a specialized Urologist
- •Being female aged between 25 and 50 years
- •To have the ability to access and use technological devices required by the study
- •Being able to read and write
- •Volunteering to research
Exclusion Criteria
- •Inability of the participant to understand or perform the procedures proposed during the evaluations or training program.
- •Active urinary tract infection,
- •pelvic organ prolapse stage 2 and more according to the pelvic organ prolapse staging system (Pelvic Organ Prolapse Quantification System (POP-Q))
- •Fecal incontinence,
- •Any neurogenic dysfunction of the lower urinary tract
- •Conservative or surgical treatment of urinary incontinence in the last 12 months
- •Previous pelvic floor training
- •Less than three months after pregnancy or postpartum
- •Having undergone any pelvic floor surgery (hysterectomy, etc.)
- •Radiotherapy treatment in the last 12 months
- •Severe low back pain or pelvic pain
- •Lower extremity orthopaedic problems that may affect the pelvic structure (such as lower extremity inequality, total hip arthroplasty)
- •Having any chronic respiratory disease
- •Having any neurological disease
- •Being in menopause
- •Latex allergy
Arms & Interventions
Study Group
Patients who perform inspiratory muscle training (IMT) with %60 loading
Intervention: Inspiratory Muscle Training (IMT) (Device)
Sham Group
Patients who perform Sham IMT
Intervention: Sham IMT (Device)
Outcomes
Primary Outcomes
Change of Pelvic floor muscle functions with Pressure feedbacks
Time Frame: 8 weeks
Pressure feedbacks: Pelvic muscle functions were evaluated with pressure feedback of pelvic muscle using a biofeedback device (Myomed 932®- Enraf-Nonius, Delf, The Netherlands), and recorded in hPa (Hectopascal). - Manual muscle test: Manual muscle test was evaluated using the modified Oxford Scale that ranges from 1 to 5. Higher values on this scale indicate better muscle strength.
Change of Pelvic floor muscle functions with Manual muscle test
Time Frame: 8 weeks
The manual muscle test was evaluated using the modified Oxford Scale, which ranges from 1 to 5. Higher values on this scale indicate better muscle strength.
Secondary Outcomes
- Urogenital Distress Inventory-Short Form(8 weeks)
- International Consultation on Incontinence Questionnaire-Short Form(8 weeks)
- Incontinence Severity Index(8 weeks)
- Inspiratory muscle strength(8 weeks)
Investigators
Ridvan Aktan
Asst. Prof., PhD
Izmir University of Economics