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

Sponsor

Pavol Jozef Safarik University (Other)

Overall Status

Completed

CT.gov ID

NCT04340323

Collaborator

(none)

Enrollment

Location

Arms

20.8

Actual Duration (Months)

4.1

Patients Per Site Per Month

Study Details

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

Condition or Disease	Intervention/Treatment	Phase
Stress Urinary Incontinence	Other: Pelvic Floor Muscle Training (PFMT)	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

86 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Treatment

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

Actual Study Start Date :

May 2, 2020

Actual Primary Completion Date :

Dec 1, 2021

Actual Study Completion Date :

Jan 26, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Group A-intensive exercise group 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.	Other: Pelvic Floor Muscle Training (PFMT) 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).
Active Comparator: Group B-low-intensity exercise group 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.	Other: Pelvic Floor Muscle Training (PFMT) 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).

Arm

Intervention/Treatment

Experimental: Group A-intensive exercise group

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.

Other: Pelvic Floor Muscle Training (PFMT)

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).

Active Comparator: Group B-low-intensity exercise group

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.

Other: Pelvic Floor Muscle Training (PFMT)

Outcome Measures

Primary Outcome Measures

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

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.
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Pavol Jozef Safarik University, Faculty of Medicine	Kosice		Slovakia	04001

Sponsors and Collaborators

Pavol Jozef Safarik University

Investigators

Principal Investigator: Peter Urdzik, prof.MD,PhD, Pavol Jozef Safarik University, Faculty of Medicine

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Peter Urdzik, Faculty of Medicine, Pavol Jozef Safarik University

ClinicalTrials.gov Identifier:

NCT04340323

Other Study ID Numbers:

3545/2020/ODDZ-06621

First Posted:

Apr 9, 2020

Last Update Posted:

Mar 2, 2022

Last Verified:

Mar 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Peter Urdzik, Faculty of Medicine, Pavol Jozef Safarik University

Stress urinary incontinence;

2D/3D ultrasound

Pelvic floor muscle training

Additional relevant MeSH terms:

Urinary Incontinence

Enuresis

Urinary Incontinence, Stress

Study Results

No Results Posted as of Mar 2, 2022