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

I

Izmir University of Economics

Status

Completed

Conditions

Stress Urinary Incontinence (SUI)

Treatments

Device: Inspiratory Muscle Training (IMT)
Device: Sham IMT

Study type

Interventional

Funder types

Other

Identifiers

NCT06842979
2023/16-03

Details and patient eligibility

About

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.

Full 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.

Enrollment

22 patients

Sex

Female

Ages

25 to 50 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

22 participants in 2 patient groups

Study Group
Experimental group
Description:
Patients who perform inspiratory muscle training (IMT) with %60 loading
Treatment:
Device: Inspiratory Muscle Training (IMT)
Sham Group
Sham Comparator group
Description:
Patients who perform Sham IMT
Treatment:
Device: Sham IMT

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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