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

Primary Purpose

Stress Urinary Incontinence

Status
Completed
Phase
Not Applicable
Locations
Slovakia
Study Type
Interventional
Intervention
Pelvic Floor Muscle Training (PFMT)
Sponsored by
Pavol Jozef Safarik University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stress Urinary Incontinence focused on measuring Stress urinary incontinence;, 2D/3D ultrasound, Pelvic floor muscle training

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)FemaleDoes not accept 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

Sites / Locations

  • Pavol Jozef Safarik University, Faculty of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Group A-intensive exercise group

Group B-low-intensity exercise group

Arm 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.

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.

Outcomes

Primary Outcome Measures

Change in incontinence episode frequency (IEF) over one week.
Change in the number of urinary leakages during the day, measured by the voiding diary.

Secondary Outcome Measures

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.
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.
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).
Change in patient global impression
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.

Full Information

First Posted
April 3, 2020
Last Updated
March 1, 2022
Sponsor
Pavol Jozef Safarik University
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1. Study Identification

Unique Protocol Identification Number
NCT04340323
Brief Title
The Effect of Pelvic Floor Muscle Training With Stabilization Exercises With Various Intensity in Women With Stress Urinary Incontinence
Acronym
PELSTAB
Official 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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
May 2, 2020 (Actual)
Primary Completion Date
December 1, 2021 (Actual)
Study Completion Date
January 26, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Pavol Jozef Safarik University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stress Urinary Incontinence
Keywords
Stress urinary incontinence;, 2D/3D ultrasound, Pelvic floor muscle training

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
86 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group A-intensive exercise group
Arm Type
Experimental
Arm 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.
Arm Title
Group B-low-intensity exercise group
Arm Type
Active Comparator
Arm 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.
Intervention Type
Other
Intervention Name(s)
Pelvic Floor Muscle Training (PFMT)
Intervention Description
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 Outcome Measure Information:
Title
Change in incontinence episode frequency (IEF) over one week.
Description
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 Outcome Measure Information:
Title
Change in performance and endurance of pelvic floor muscles
Description
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
Title
Change in hiatal area (HA, in cm2) during the Valsalva manoeuvre, assessed by 3D ultrasound
Description
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
Title
Change in incontinence quality of life
Description
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
Title
Change in patient global impression
Description
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.
Time Frame
Change in patient global impression over 12 weeks of treatment

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter Urdzik, prof.MD,PhD
Organizational Affiliation
Pavol Jozef Safarik University, Faculty of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Pavol Jozef Safarik University, Faculty of Medicine
City
Kosice
ZIP/Postal Code
04001
Country
Slovakia

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
32702912
Citation
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.
Results Reference
derived

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

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