Comparison of Pelvic Floor Therapy and Yoga on Stres Urinary Incontinence Incontinence

NCT ID: NCT05253898

Last Updated: 2022-03-11

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-01-18
• Study Completion Date: 2022-08-15

Brief Summary

The aim of this study is to compare the effectiveness of pelvic floor physical therapy (PFT) and therapeutic yoga training (TYT) for women who have postnatal stress urinary incontinence (SUI).

Detailed Description

32 subjects with postnatal stress urinary incontinence will be included in the study after a voluntary consent form will be filled out. Subjects will randomly be divided into two groups according to the order.

Pelvic floor physical therapy (PFT) (n=16) will be Group 1, and therapeutic yoga training (TYT) (n=16) will be the Group 2.

PFT group will be received sessions twice a week and a special home exercise program once a week for 8 weeks. Each session will include warm-up exercises, pelvic floor muscle contractions in different positions, and abdominal breathing techniques. Each session is planned for 45 minutes.

TYT group will be received sessions twice a week and a special home exercise program once a week for 8 weeks. Each session will include warm-up exercises, different asanas, and yogi breathing exercises. each session is planned for 45 minutes.

Conditions

Urinary Incontinence; Urinary Tract Disorders

Study Design

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

Study Groups

Pelvic Floor Physical Therapy

Group 1 includes a training program about correctly using pelvic floor muscles. At the first session, an educational program will be given to all women about the anatomy and function of the pelvic floor muscles. Then, the pelvic floor muscles contractions will be controlled by vaginal palpation for approximately 10 minutes.

Then it will follow with 5 minutes of warm-up exercises, 30 minutes of fast and slow pelvic floor muscles contractions in different positions, and 10 minutes of abdominal breathing, general relaxation, stretching, and cool-down exercises.

It is planned to teach contractions with internal palpation for 10 minutes before the first session to ensure that the patients' pelvic floor contractions are performed correctly. PFT treatment will be given as two sessions per week, 45 minutes, and 8 weeks as group sessions.

Group Type: ACTIVE_COMPARATOR

Pelvic floor Physical Therapy

Intervention Type: PROCEDURE

Purpose of pelvic floor muscle education program is reduce the symptoms of stress urinary incontinence and improving quality of life.

Therapeutic Yoga Training

Group 2 program includes therapeutic yoga training. It will begin with education about the positive effects of yoga on the body and pelvic floor.

Then it will follow with 5 minutes of warm-up exercises, 30 minutes of different asanas coordinated with breathing, and 10 minutes of yogi breathing and cool-down exercises.

Also, a home exercise program will be given based on yoga sessions. Participants will receive a detailed description of the home program.

Group Type: ACTIVE_COMPARATOR

Therapeutic Yoga Training

Intervention Type: PROCEDURE

Purpose of this group show the effectiveness of yoga therapy on stress urinary incontinence and quality of life.

Interventions

Pelvic floor Physical Therapy

Purpose of pelvic floor muscle education program is reduce the symptoms of stress urinary incontinence and improving quality of life.

Intervention Type: PROCEDURE

Therapeutic Yoga Training

Purpose of this group show the effectiveness of yoga therapy on stress urinary incontinence and quality of life.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Women ages between 18 and 50 years old,
• Women who have SUI 45 days and above after giving birth
• Patients who accept to join the group sessions and will participate regularly in the treatment program

Exclusion Criteria

• Women who have pelvic organ prolapsus and fecal incontinence
• Women who have undergone surgery for the lower urinary system
• Those who receive medication treatment for incontinence in the last 3 months
• Those with acute infection and bladder stones or tumors will not be included in the study.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Hasan Kalyoncu University

OTHER

Sponsor Role: lead

Responsible Party

Nergiz Sayın

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Aysenur Tuncer, PT, PhD

Role: STUDY_DIRECTOR

Hasan Kalyoncu University

Locations

Special Nova Therapy and Rehabilitation Center

Diyarbakır, , Turkey (Türkiye)

Site Status: RECRUITING

Countries

Turkey (Türkiye)

Central Contacts

Aysenur Tuncer, PT, PhD

Role: CONTACT

aysenur.tuncer@hku.edu.tr

+90-342 2118080

Nergiz Sayin, PT

Role: CONTACT

nergizsyn@gmail.com

Facility Contacts

Nergiz Sayin, PT

Role: primary

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)

Other Identifiers

2021/005

Identifier Type: -

Identifier Source: org_study_id