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NCT Number: NCT04340323

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

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

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Key information

Conditions

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

Age range

18 year–70 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Pavol Jozef Safarik University, Faculty of Medicine

Košice, 04001, Slovakia

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 criteria

  • 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

Treatment and study plan

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).

Primary outcomes

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

    Time frame: 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 outcomes

  1. Change in performance and endurance of pelvic floor muscles

    Time frame: 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.

  2. Change in hiatal area (HA, in cm2) during the Valsalva manoeuvre, assessed by 3D ultrasound

    Time frame: 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.

  3. Change in incontinence quality of life

    Time frame: 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).

  4. Change in patient global impression

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Pavol Jozef Safarik University

Other

Registry information

Official study title

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

Acronym: PELSTAB

Important dates

Study start
2020
Primary completion
2021
Study completion
2022
First posted
Apr 9, 2020
Registry last updated
Mar 2, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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