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

NCT ID: NCT04340323

Last Updated: 2022-03-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 86 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-05-02
• Study Completion Date: 2022-01-26

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

Conditions

Stress Urinary Incontinence

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

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.

Group Type: EXPERIMENTAL

Pelvic Floor Muscle Training (PFMT)

Intervention Type: 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 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.

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.

Group Type: ACTIVE_COMPARATOR

Pelvic Floor Muscle Training (PFMT)

Intervention Type: 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).

Interventions

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).

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Pavol Jozef Safarik University

OTHER

Sponsor Role: lead

Responsible Party

Peter Urdzik

Faculty of Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Peter Urdzik, prof.MD,PhD

Role: PRINCIPAL_INVESTIGATOR

Pavol Jozef Safarik University, Faculty of Medicine

Locations

Pavol Jozef Safarik University, Faculty of Medicine

Košice, , Slovakia

Countries

Slovakia

References

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.

Reference Type: DERIVED

PMID: 39704322 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 32702912 (View on PubMed)

Other Identifiers

3545/2020/ODDZ-06621

Identifier Type: -

Identifier Source: org_study_id