The Effect of Pelvic Floor Muscle Training With Stabilization Exercises With Various Intensity in Women With Stress Urinary Incontinence (PELSTAB)

Pavol Jozef Safarik University

Status: Completed

Conditions: Stress Urinary Incontinence

Treatments: Other: Pelvic Floor Muscle Training (PFMT)

Study type: Interventional

Funder types: Other

Identifiers

NCT04340323

3545/2020/ODDZ-06621

Details and patient eligibility

About

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

Full 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

Enrollment: 86 patients

Sex: Female

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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86 participants in 2 patient groups

Group A-intensive exercise group

Experimental group

Description:

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. Educating probands about anatomy, physiology and pelvic floor muscle function. Training of pelvic floor muscles in different positions. Training of pelvic floor muscles with six stabilization exercises - activation of deep trunk muscles.

Treatment:

Other: Pelvic Floor Muscle Training (PFMT)

Group B-low-intensity exercise group

Active Comparator group

Description:

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. Educating probands about anatomy, physiology and pelvic floor muscle function. Training of pelvic floor muscles in different positions. Training of pelvic floor muscles with six stabilization exercises - activation of deep trunk muscles.

Treatment:

Other: Pelvic Floor Muscle Training (PFMT)