Clinical trial NCT06842979: Effects of Home-based High-intensity Inspiratory Muscle Training for Stress Urinary Incontinence
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stress Urinary Incontinence (SUI)
Keywords: inspiratory muscle training
stress urinary incontinence
pelvic floor muscle
telerehabilitation
Lead sponsor: Izmir University of Economics
Sponsor class: OTHER
First posted: 2025-02-24
Enrollment: 22
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This study was designed as a prospective and Randomized Controlled experimental study. Participants were randomly divided into two groups in a 1:1 ratio; the study group and the control group.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change of Pelvic floor muscle functions with Pressure feedbacks
timeFrame: 8 weeks
measure: Change of Pelvic floor muscle functions with Manual muscle test
timeFrame: 8 weeks
Secondary outcomes:
measure: Urogenital Distress Inventory-Short Form
timeFrame: 8 weeks
measure: International Consultation on Incontinence Questionnaire-Short Form
timeFrame: 8 weeks
measure: Incontinence Severity Index
timeFrame: 8 weeks
measure: Inspiratory muscle strength
timeFrame: 8 weeks
Other outcomes:
Locations:
city: İzmir
country: Turkey
facility: Izmir University of Economics
state: Balçova
Study officials:
affiliation: Izmir University of Economics
name: RIDVAN AKTAN, Asst. Prof.
role: PRINCIPAL_INVESTIGATOR
References:
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