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

Not Applicable

Completed

• Conditions: Stress Urinary Incontinence

• Registration Number: NCT04340323
• Lead Sponsor: Pavol Jozef Safarik University

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

Study Timeline

• Study First Submitted: 2020-04-03
• Study First Submitted QC: 2020-04-07
• Study First Posted: 2020-04-09
• Study Start: 2020-05-02
• Primary Completion: 2021-12-01
• Study Completion: 2022-01-26
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-01
• Last Update Posted: 2022-03-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 86

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change in incontinence episode frequency (IEF) over one week.	change in incontinence episode frequency over 12 weeks of treatment	Change in the number of urinary leakages during the day, measured by the voiding diary.

Secondary Outcome Measures

Name	Time	Method
Change in incontinence quality of life	Change in incontinence quality of life over 12 weeks of treatment	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 patient global impression	Change in patient global impression over 12 weeks of treatment	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 performance and endurance of pelvic floor muscles	Change in performance and endurance of pelvic floor muscles over 12 weeks of treatment	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.
Change in hiatal area (HA, in cm2) during the Valsalva manoeuvre, assessed by 3D ultrasound	Change in hiatal area (HA, in cm2) during the Valsalva manoeuvre, assessed by 3D ultrasound over 12 weeks of treatment	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.

Trial Locations

Locations (1)

Pavol Jozef Safarik University, Faculty of Medicine; 🇸🇰 Kosice, Slovakia