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This study will evaluate the safety, tolerability and efficacy of high- and low-intensity PFMT with stabilization exercises in women with SUI
This is a randomized interventional parallel study to evaluate the effect of PFMT with stabilization exercises of high and low intensity in women with SUI
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A-intensive exercise group | Experimental | Dosage of intensive exercise group - 12 weeks, five times a week for 30 minutes per day; five times with education by a physiotherapist, followed by continuation at home. PFMT with lumbopelvic stabilization. Exercise up to five times a week for up to 30 minutes per day, after initial training with a physiotherapist.
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| Group B-low-intensity exercise group | Active Comparator | Dosage of low-intensity exercise group - 12 weeks, twice a week for 15 minutes per day; five times with physiotherapist education, followed by continuation at home. PFMT with lumbopelvic stabilization. Exercise up to five times a week for up to 30 minutes per day, after initial training with a physiotherapist.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pelvic Floor Muscle Training (PFMT) | Other | The method of first choice in SUI treatment according to the International Continence Society (ICS) is training of the pelvic floor muscles. Pelvic floor muscle training (PFMT) is a method based on scientific evidence, defined by the ICS as repeated selective voluntary contraction and relaxation of specific pelvic floor muscles. It is important to train the strength and endurance of the pelvic floor muscles but also their relaxation (Abrams, 2018; Arnold, 2014; Bo, 2013). |
| Measure | Description | Time Frame |
|---|---|---|
| Change in incontinence episode frequency (IEF) over one week. | Change in the number of urinary leakages during the day, measured by the voiding diary. | change in incontinence episode frequency over 12 weeks of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Change in performance and endurance of pelvic floor muscles | Performance on five-degree scale of 0-5 is used (no contraction, weak contraction, normal contraction, strong contraction, very strong contraction). Endurance - the patient is requested to perform a maximum voluntary contraction of the pelvic floor and the contraction weakening time is measured. Time is given in seconds, for a maximum of 10 seconds. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Peter Urdzik, prof.MD,PhD | Pavol Jozef Safarik University, Faculty of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pavol Jozef Safarik University, Faculty of Medicine | Košice | 04001 | Slovakia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39704322 | Derived | Hay-Smith EJC, Starzec-Proserpio M, Moller B, Aldabe D, Cacciari L, Pitangui ACR, Vesentini G, Woodley SJ, Dumoulin C, Frawley HC, Jorge CH, Morin M, Wallace SA, Weatherall M. Comparisons of approaches to pelvic floor muscle training for urinary incontinence in women. Cochrane Database Syst Rev. 2024 Dec 20;12(12):CD009508. doi: 10.1002/14651858.CD009508.pub2. | |
| 32702912 |
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| Change in performance and endurance of pelvic floor muscles over 12 weeks of treatment |
| Change in hiatal area (HA, in cm2) during the Valsalva manoeuvre, assessed by 3D ultrasound | Examination will be carried out using a ultrasound console, volume contrast imaging software and a 3D/4D 4-8 MHz probe in the midsagittal plane. Examination will take place with an empty bladder in the lithotomy position. The probe will be placed longitudinally on the perineum. A 3D image will be taken at rest, at maximum contraction and at the Valsalva manoeuvre. The amount of hiatial space at the Valsalva manoeuvre will be measured in cm2. | Change in hiatal area (HA, in cm2) during the Valsalva manoeuvre, assessed by 3D ultrasound over 12 weeks of treatment |
| Change in incontinence quality of life | Urinary Incontinence Quality of Life Scale (I-QoL) The I-QoL is composed of three subscales (avoidance and limiting behaviour; psychosocial impact; social embarrassment) and comprises 22 questions with a total score in the range from 0 (worst quality of life) to 100 (best quality of life). | Change in incontinence quality of life over 12 weeks of treatment |
| Change in patient global impression | Patient Global Impression of Improvement Scale (PGI-I) The PGI-I evaluates the status of urination problems compared to the patient's condition before treatment in the study. Patient impressions are evaluated according to the following scores: 1, much better; 2, quite better; 3, a little better; 4, no change; 5, a little worse; 6, a lot worse; 7, definitely worse. | Change in patient global impression over 12 weeks of treatment |
| Hagovska M, Urdzik P, Svihra J. A randomized interventional parallel study to evaluate the effect of pelvic floor muscle training with stabilization exercises of high and low intensity in women with stress urinary incontinence: The PELSTAB study. Medicine (Baltimore). 2020 Jul 17;99(29):e21264. doi: 10.1097/MD.0000000000021264. |
| ID | Term |
|---|---|
| D014550 | Urinary Incontinence, Stress |
| ID | Term |
|---|---|
| D014549 | Urinary Incontinence |
| D014555 | Urination Disorders |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D059411 | Lower Urinary Tract Symptoms |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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