An interventional study of Pelvic Floor Muscle Training (PFMT) in Stress Urinary Incontinence, sponsored by Pavol Jozef Safarik University. Completed at 1 site in Slovakia. Open to female participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2022-03-02.
Sponsored by Pavol Jozef Safarik University · Not applicable, Interventional, and Treatment
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
1,363 studies on the registry are indexed under Urinary Incontinence; 228 are open to participants now.
This study's enrollment of 86 is above the median of 66 across 1,011 interventional studies indexed under Urinary Incontinence.
Browse Urinary Incontinence studies →Pavol Jozef Safarik University is the lead sponsor of 14 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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. 1. Educating probands about anatomy, physiology and pelvic floor muscle function. 2. Training of pelvic floor muscles in different positions. 3. Training of pelvic floor muscles with six stabilization exercises - activation of deep trunk muscles.
Other: Pelvic Floor Muscle Training (PFMT)
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. 1. Educating probands about anatomy, physiology and pelvic floor muscle function. 2. Training of pelvic floor muscles in different positions. 3. Training of pelvic floor muscles with six stabilization exercises - activation of deep trunk muscles.
Other: Pelvic Floor Muscle Training (PFMT)
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).
Change in incontinence episode frequency (IEF) over one week.
Change in the number of urinary leakages during the day, measured by the voiding diary.
Time frame: change in incontinence episode frequency over 12 weeks of treatment
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.
Time frame: 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.
Time frame: 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).
Time frame: 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.
Time frame: Change in patient global impression over 12 weeks of treatment
Plan to share: No
This study is completed, as verified in Mar 2022. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Pavol Jozef Safarik University