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

NCT06842979 | Completed

• 1 other identifier: 2023/16-03
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

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.

Conditions

Stress Urinary Incontinence (SUI)

Keywords

inspiratory muscle training; stress urinary incontinence; pelvic floor muscle; telerehabilitation

Outcome Measures

Primary Outcomes (2)

• Change of Pelvic floor muscle functions with Pressure feedbacks

  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.

  8 weeks

• Change of Pelvic floor muscle functions with Manual muscle test

  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.

  8 weeks

Secondary Outcomes (4)

• 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

Study Arms (2)

Study Group

EXPERIMENTAL

Patients who perform inspiratory muscle training (IMT) with %60 loading

Device: Inspiratory Muscle Training (IMT)

Sham Group

SHAM COMPARATOR

Patients who perform Sham IMT

Device: Sham IMT

Interventions

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.

Study Group

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.

Sham Group

Eligibility Criteria

• Age: 25 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Izmir University of Economics: lead

Study Sites (1)

Izmir University of Economics

Izmir, Balçova, 35330, Turkey (Türkiye)

Location

Related Publications (12)

• Haylen BT, de Ridder D, Freeman RM, Swift SE, Berghmans B, Lee J, Monga A, Petri E, Rizk DE, Sand PK, Schaer GN. An International Urogynecological Association (IUGA)/International Continence Society (ICS) joint report on the terminology for female pelvic floor dysfunction. Int Urogynecol J. 2010 Jan;21(1):5-26. doi: 10.1007/s00192-009-0976-9. Epub 2009 Nov 25.

  PMID: 19937315 BACKGROUND

• Hodges PW, Gandevia SC. Changes in intra-abdominal pressure during postural and respiratory activation of the human diaphragm. J Appl Physiol (1985). 2000 Sep;89(3):967-76. doi: 10.1152/jappl.2000.89.3.967.

  PMID: 10956340 BACKGROUND

• Talasz H, Kofler M, Kalchschmid E, Pretterklieber M, Lechleitner M. Breathing with the pelvic floor? Correlation of pelvic floor muscle function and expiratory flows in healthy young nulliparous women. Int Urogynecol J. 2010 Apr;21(4):475-81. doi: 10.1007/s00192-009-1060-1. Epub 2009 Dec 8.

  PMID: 19997721 BACKGROUND

• Talasz H, Kremser C, Kofler M, Kalchschmid E, Lechleitner M, Rudisch A. Phase-locked parallel movement of diaphragm and pelvic floor during breathing and coughing-a dynamic MRI investigation in healthy females. Int Urogynecol J. 2011 Jan;22(1):61-8. doi: 10.1007/s00192-010-1240-z. Epub 2010 Aug 31.

  PMID: 20809211 BACKGROUND

• Al-Bilbeisi F, McCOOL FD. Diaphragm recruitment during nonrespiratory activities. Am J Respir Crit Care Med. 2000 Aug;162(2 Pt 1):456-9. doi: 10.1164/ajrccm.162.2.9908059.

  PMID: 10934070 BACKGROUND

• CAMPBELL EJ, GREEN JH. The variations in intra-abdominal pressure and the activity of the abdominal muscles during breathing; a study in man. J Physiol. 1953 Nov 28;122(2):282-90. doi: 10.1113/jphysiol.1953.sp004999. No abstract available.

  PMID: 13118539 BACKGROUND

• Neumann P, Gill V. Pelvic floor and abdominal muscle interaction: EMG activity and intra-abdominal pressure. Int Urogynecol J Pelvic Floor Dysfunct. 2002;13(2):125-32. doi: 10.1007/s001920200027.

  PMID: 12054180 BACKGROUND

• Sapsford RR, Hodges PW, Richardson CA, Cooper DH, Markwell SJ, Jull GA. Co-activation of the abdominal and pelvic floor muscles during voluntary exercises. Neurourol Urodyn. 2001;20(1):31-42. doi: 10.1002/1520-6777(2001)20:13.0.co;2-p.

  PMID: 11135380 BACKGROUND

• Saunders SW, Rath D, Hodges PW. Postural and respiratory activation of the trunk muscles changes with mode and speed of locomotion. Gait Posture. 2004 Dec;20(3):280-90. doi: 10.1016/j.gaitpost.2003.10.003.

  PMID: 15531175 BACKGROUND

• Azevedo IG, Sousa SLO, Viana ESR, Dantas DS, Maciel ACC, Da Camara SMA. Relationship between symptomatic pelvic organ prolapse and respiratory muscle strength in middle-aged and older women in Northeast Brazil: a cross-sectional study. Physiother Theory Pract. 2021 Jun;37(6):755-761. doi: 10.1080/09593985.2019.1642428. Epub 2019 Jul 11.

  PMID: 31294670 BACKGROUND

• Hodges PW, Sapsford R, Pengel LH. Postural and respiratory functions of the pelvic floor muscles. Neurourol Urodyn. 2007;26(3):362-71. doi: 10.1002/nau.20232.

  PMID: 17304528 BACKGROUND

• Deffieux X, Hubeaux K, Porcher R, Ismael SS, Raibaut P, Amarenco G. Pelvic floor muscle activity during coughing: altered pattern in women with stress urinary incontinence. Urology. 2007 Sep;70(3):443-7; discussion 447-8. doi: 10.1016/j.urology.2007.03.084.

  PMID: 17905093 BACKGROUND

MeSH Terms

Conditions

Urinary Incontinence, Stress

Condition Hierarchy (Ancestors)

Urinary Incontinence; Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• RIDVAN AKTAN, Asst. Prof.

  Izmir University of Economics

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Asst. Prof., PhD

Model Details: 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.

Study Record Dates

• First Submitted: February 11, 2025
• First Posted: February 24, 2025
• Study Start: May 29, 2023
• Primary Completion: February 3, 2025
• Study Completion: February 10, 2025
• Last Updated: February 24, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)