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Completed

NCT Number: NCT06842979

Effects of Home-based High-intensity Inspiratory Muscle Training for Stress Urinary Incontinence

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Inspiratory Muscle Training (IMT)

Device

The IMT protocol will consist of home-based high-intensity daily training - two cycles of 30 breaths with a 1-min rest between sets, twice a day for 8 weeks using an IMT Threshold device (Threshold IMT Philips® Respironics, Inc). The intensity of the training will be set to 60% of each patient's maximal inspiratory pressure measured and adjusted weekly based on the modified Borg scale from 4 to 6 regarding respiratory effort performed during the session. Patients were also informed to perform knack maneuver in daily activities that may cause sudden intra-abdominal pressure overload.

Sham IMT

Device

The IMT protocol will consist of home-based daily training - two cycles of 30 breaths with a 1-min rest between sets, twice a day for 8 weeks using an IMT Threshold device (Threshold IMT Philips® Respironics, Inc). The intensity of the training will be set to the lowest intensity of the IMT Threshold device. Patients were also informed to perform knack maneuver in daily activities that may cause sudden intra-abdominal pressure overload.

Primary outcomes

  1. 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.
  2. 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

  1. Urogenital Distress Inventory-Short Form

    Time frame: 8 weeks

    Urinary symptom was assessed with the Urogenital Distress Inventory-Short Form (range: 0-100) Higher values on this scale indicate worse symptoms.

  2. International Consultation on Incontinence Questionnaire-Short Form

    Time frame: 8 weeks

    Urinary incontinence symptom and its effect on the quality of life was assessed with the International Consultation on Incontinence Questionnaire-Short Form (range: 0-21) Higher values on this scale indicate worse symptoms.

  3. Incontinence Severity Index

    Time frame: 8 weeks

    Urinary incontinence severity was assessed with the Incontinence Severity Index (range: 1-12). Higher values on this scale indicate worse symptoms.

  4. Inspiratory muscle strength

    Time frame: 8 weeks

    The Inspiratory muscle strength was evaluated by maximum inspiratory pressure which was assessed with a digital mouth pressure meter device (MicroRPM, Micro Medical Ltd., Rochester, Kent, United Kingdom), and recorded in cmH2O (centimeter-water).

Sponsors and collaborators

Lead sponsor

Izmir University of Economics

Other

Registry information

Official study 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

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Feb 24, 2025
Registry last updated
Feb 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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