Clinical trial NCT04340323: The Effect of Pelvic Floor Muscle Training With Stabilization Exercises With Various Intensity in Women With Stress Urinary Incontinence
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stress Urinary Incontinence
Keywords: Stress urinary incontinence;
2D/3D ultrasound
Pelvic floor muscle training
Lead sponsor: Pavol Jozef Safarik University
Sponsor class: OTHER
First posted: 2020-04-09
Enrollment: 86
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will evaluate the safety, tolerability and efficacy of high- and low-intensity PFMT with stabilization exercises in women with SUI

Detailed description: 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

Eligibility criteria: Inclusion Criteria:

1. Willing to provide written informed consent
2. Over 18 years old and experiencing uncomplicated SUI
3. Score on the International Consultation on Urinary Incontinence Questionnaire of ≥ 6 points
4. Symptoms of urinary incontinence for at least three consecutive months
5. Degree of pelvic organ prolapse, stage ≤ 2
6. Willingness to accept the randomization process and fully participate in tests

Exclusion Criteria:

1. History of anti-incontinence surgery in the past 12 months
2. History of pelvic prolapse repair or urethral surgery in the past 12 months
3. History of PFMT in the past 12 months
4. History of interstitial cystitis or bladder-related pain
5. Chronic severe constipation
6. Clinically significant renal or hepatic impairment
7. Clinically significant heart impairment
8. Pregnant, lactating or actively trying to become pregnant
9. Positive urinary tract infection
10. Use of rehabilitation aids (pessaries, urethral plugs, vaginal beads, etc.)
11. Insufficient understanding of pelvic floor exercises and/or omitting exercises
12. Incomplete questionnaire
13. Refusal to participate in the study

Primary outcomes:
measure: Change in incontinence episode frequency (IEF) over one week.
timeFrame: change in incontinence episode frequency over 12 weeks of treatment
Secondary outcomes:
measure: Change in performance and endurance of pelvic floor muscles
timeFrame: Change in performance and endurance of pelvic floor muscles over 12 weeks of treatment
measure: Change in hiatal area (HA, in cm2) during the Valsalva manoeuvre, assessed by 3D ultrasound
timeFrame: Change in hiatal area (HA, in cm2) during the Valsalva manoeuvre, assessed by 3D ultrasound over 12 weeks of treatment
measure: Change in incontinence quality of life
timeFrame: Change in incontinence quality of life over 12 weeks of treatment
measure: Change in patient global impression
timeFrame: Change in patient global impression over 12 weeks of treatment
Other outcomes:
Locations:
city: Kosice
country: Slovakia
facility: Pavol Jozef Safarik University, Faculty of Medicine
Study officials:
affiliation: Pavol Jozef Safarik University, Faculty of Medicine
name: Peter Urdzik, prof.MD,PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.