Status:
COMPLETED
The Effect of Pelvic Floor Muscle Training With Stabilization Exercises With Various Intensity in Women With Stress Urinary Incontinence
Lead Sponsor:
Pavol Jozef Safarik University
Conditions:
Stress Urinary Incontinence
Eligibility:
FEMALE
18-70 years
Phase:
NA
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
- Willing to provide written informed consent
- Over 18 years old and experiencing uncomplicated SUI
- Score on the International Consultation on Urinary Incontinence Questionnaire of ≥ 6 points
- Symptoms of urinary incontinence for at least three consecutive months
- Degree of pelvic organ prolapse, stage ≤ 2
- Willingness to accept the randomization process and fully participate in tests
Exclusion
- History of anti-incontinence surgery in the past 12 months
- History of pelvic prolapse repair or urethral surgery in the past 12 months
- History of PFMT in the past 12 months
- History of interstitial cystitis or bladder-related pain
- Chronic severe constipation
- Clinically significant renal or hepatic impairment
- Clinically significant heart impairment
- Pregnant, lactating or actively trying to become pregnant
- Positive urinary tract infection
- Use of rehabilitation aids (pessaries, urethral plugs, vaginal beads, etc.)
- Insufficient understanding of pelvic floor exercises and/or omitting exercises
- Incomplete questionnaire
- Refusal to participate in the study
Key Trial Info
Start Date :
May 2 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 26 2022
Estimated Enrollment :
86 Patients enrolled
Trial Details
Trial ID
NCT04340323
Start Date
May 2 2020
End Date
January 26 2022
Last Update
March 2 2022
Active Locations (1)
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1
Pavol Jozef Safarik University, Faculty of Medicine
Košice, Slovakia, 04001