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

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

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.

Study Overview

• Status: Completed
• Conditions: Stress Urinary Incontinence (SUI)
• Intervention / Treatment: Device: Inspiratory Muscle Training (IMT); Device: Sham IMT

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 Type: Interventional
• Enrollment (Actual): 22
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Balçova
    • İzmir, Balçova, Turkey, 35330
      • Izmir University of Economics

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Sham Comparator: Sham Group; Patients who perform Sham IMT	Device: Sham IMT; 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.
Experimental: Study Group; Patients who perform inspiratory muscle training (IMT) with %60 loading	Device: Inspiratory Muscle Training (IMT); 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Urogenital Distress Inventory-Short Form	Urinary symptom was assessed with the Urogenital Distress Inventory-Short Form (range: 0-100) Higher values on this scale indicate worse symptoms.	8 weeks
International Consultation on Incontinence Questionnaire-Short Form	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.	8 weeks
Incontinence Severity Index	Urinary incontinence severity was assessed with the Incontinence Severity Index (range: 1-12). Higher values on this scale indicate worse symptoms.	8 weeks
Inspiratory muscle strength	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).	8 weeks

Collaborators and Investigators

• Sponsor: Izmir University of Economics
• Investigators: Principal Investigator: RIDVAN AKTAN, Asst. Prof., Izmir University of Economics

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): May 29, 2023
• Primary Completion (Actual): February 3, 2025
• Study Completion (Actual): February 10, 2025

Study Registration Dates

• First Submitted: February 11, 2025
• First Submitted That Met QC Criteria: February 19, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 19, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Keywords: inspiratory muscle training; stress urinary incontinence; pelvic floor muscle; telerehabilitation
• Additional Relevant MeSH Terms: Urogenital Diseases; Mental Disorders; Pathologic Processes; Male Urogenital Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urination Disorders; Lower Urinary Tract Symptoms; Urological Manifestations; Behavioral Symptoms; Elimination Disorders; Respiratory Tract Diseases; Respiration Disorders; Urinary Incontinence; Enuresis; Urinary Incontinence, Stress; Respiratory Aspiration
• Other Study ID Numbers: 2023/16-03

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No