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

Stress Urinary Incontinence Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04340323
• Other study ID #: 3545/2020/ODDZ-06621
• Status: Completed
• Phase: N/A
• Start date: May 2, 2020
• Est. completion date: January 26, 2022

Study information

• Verified date: March 2022
• Source: Pavol Jozef Safarik University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 86
• Est. completion date: January 26, 2022
• Est. primary completion date: December 1, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Enuresis
• Stress Urinary Incontinence
• Urinary Incontinence
• Urinary Incontinence, Stress

Intervention

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).

Locations

Country	Name	City	State
Slovakia	Pavol Jozef Safarik University, Faculty of Medicine	Kosice

Sponsors (1)

Lead Sponsor	Collaborator
Pavol Jozef Safarik University

Country where clinical trial is conducted

Slovakia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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 performance and endurance of pelvic floor muscles over 12 weeks of treatment
Secondary	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 hiatal area (HA, in cm2) during the Valsalva manoeuvre, assessed by 3D ultrasound over 12 weeks of treatment
Secondary	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 incontinence quality of life over 12 weeks of treatment
Secondary	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.	Change in patient global impression over 12 weeks of treatment