Effects of Home-based High-intensity Inspiratory Muscle Training for Stress Urinary Incontinence
NCT ID: NCT06842979
Last Updated: 2025-02-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
22 participants
INTERVENTIONAL
2023-05-29
2025-02-10
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Dynamic Neuromuscular Stabilization vs Pelvic Floor Muscle Training in Women With Stress Urinary Incontinence
NCT07075900
360 Degree Expanded Diaphragm Exercises in Women With Stress Urinary Incontinence
NCT06120699
Dynamic Neuromuscular Stabilization Exercises in Women With Urinary Incontinence
NCT07009249
Effectiveness of Pelvic Floor Muscle and Abdominal Training in Women With Stress Urinary Incontinence
NCT03401983
Laser Therapy and Pelvic Floor Muscle Training for Stress Urinary Incontinence
NCT07319247
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Study Group
Patients who perform inspiratory muscle training (IMT) with %60 loading
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.
Sham Group
Patients who perform Sham IMT
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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.
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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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
25 Years
50 Years
FEMALE
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Izmir University of Economics
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Ridvan Aktan
Asst. Prof., PhD
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
RIDVAN AKTAN, Asst. Prof.
Role: PRINCIPAL_INVESTIGATOR
Izmir University of Economics
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Izmir University of Economics
Izmir, Balçova, Turkey (Türkiye)
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2023/16-03
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.