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

NCT04340323 | Completed

• 1 other identifier: 3545/2020/ODDZ-06621
• Study Type: interventional
• Target: 86
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Stress Urinary Incontinence

Keywords

Stress urinary incontinence;; 2D/3D ultrasound; Pelvic floor muscle training

Outcome Measures

Primary Outcomes (1)

• Change in incontinence episode frequency (IEF) over one week.

  Change in the number of urinary leakages during the day, measured by the voiding diary.

  change in incontinence episode frequency over 12 weeks of treatment

Secondary Outcomes (4)

• Change in performance and endurance of pelvic floor muscles

  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

  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

  Change in incontinence quality of life over 12 weeks of treatment

• Change in patient global impression

  Change in patient global impression over 12 weeks of treatment

Study Arms (2)

Group A-intensive exercise group

EXPERIMENTAL

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. 1. Educating probands about anatomy, physiology and pelvic floor muscle function. 2. Training of pelvic floor muscles in different positions. 3. Training of pelvic floor muscles with six stabilization exercises - activation of deep trunk muscles.

Other: Pelvic Floor Muscle Training (PFMT)

Group B-low-intensity exercise group

ACTIVE COMPARATOR

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. 1. Educating probands about anatomy, physiology and pelvic floor muscle function. 2. Training of pelvic floor muscles in different positions. 3. Training of pelvic floor muscles with six stabilization exercises - activation of deep trunk muscles.

Other: Pelvic Floor Muscle Training (PFMT)

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).

Group A-intensive exercise group; Group B-low-intensity exercise group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Pavol Jozef Safarik University: lead

Study Sites (1)

Pavol Jozef Safarik University, Faculty of Medicine

Košice, 04001, Slovakia

Location

Related Publications (2)

• Hay-Smith EJC, Starzec-Proserpio M, Moller B, Aldabe D, Cacciari L, Pitangui ACR, Vesentini G, Woodley SJ, Dumoulin C, Frawley HC, Jorge CH, Morin M, Wallace SA, Weatherall M. Comparisons of approaches to pelvic floor muscle training for urinary incontinence in women. Cochrane Database Syst Rev. 2024 Dec 20;12(12):CD009508. doi: 10.1002/14651858.CD009508.pub2.

  PMID: 39704322 DERIVED

• 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.

  PMID: 32702912 DERIVED

MeSH Terms

Conditions

Urinary Incontinence, Stress

Condition Hierarchy (Ancestors)

Urinary Incontinence; Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Peter Urdzik, prof.MD,PhD

  Pavol Jozef Safarik University, Faculty of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Faculty of Medicine

Study Record Dates

• First Submitted: April 3, 2020
• First Posted: April 9, 2020
• Study Start: May 2, 2020
• Primary Completion: December 1, 2021
• Study Completion: January 26, 2022
• Last Updated: March 2, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

SL (1)