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

Pavol Jozef Safarik University86 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Stress Urinary Incontinence

Interventions

Pelvic Floor Muscle Training (PFMT)OTHER

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).

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

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

Locations (1)

Pavol Jozef Safarik University, Faculty of Medicine

Košice, Slovakia

Outcomes

Primary Outcomes

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

Secondary Outcomes

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

Data from ClinicalTrials.gov

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