Yoga and Vibration Training for Stress Urinary Incontinence in Women

November 21, 2024 updated by: Pinar Yasar, Suleyman Demirel University

Effects Of Yoga And Whole Body Vibration Training On Women With Stress Urinary Incontinence

This study aimed to compare the effects of yoga and Whole Body Vibration Training on pelvic floor muscle strength, severity of urinary symptoms and UI-related quality of life in women with UI.

The intervention period for the study was determined as 6 weeks. It has been decided that yoga practice will be done 3 times a week for 45 minutes, and whole body vibration training will be done for 45-55 minutes. The home exercise group will perform the planned exercise protocol every day for 6 weeks.

The results of the study will be evaluated by statistical analysis as a result of the interventions and evaluations.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

39

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Turkey
      • Isparta, Turkey, 32100
        • Recruiting
        • Suleyman Demirel University
        • Contact:
          • Pinar Yasar, MsC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Between the ages of 20-60,
  • patients with SUI or Mix UI with a predominant SUI component,
  • patients who have not received treatment with any physical therapy modality in the last 3 months,
  • patients who signed the informed consent form.

Exclusion Criteria:

  • Those with neurological diseases that may cause incontinence
  • Those with prolapse
  • Those using intrauterine devices
  • Obesity (BMI >30)
  • Patients with serious systemic diseases that prevent them from exercising (Cardiovascular disease, COPD, CVO and/or cancer)
  • Patients with pure urge or mixed UI with a predominant urge component
  • Patients with a history of thrombosis
  • Patients who engage in high-intensity sports activities for at least half an hour at least twice a week (tennis, aerobic exercise, running, exercises with body weight).
  • Patients with neurological or vestibular disease that may cause balance disorders
  • Patients with grade 3 or 4 knee and/or hip osteoarthritis
  • Patients with a history of knee and/or hip joint replacement surgery
  • Patients with kidney or gallbladder stones
  • Patients with acute disc herniation or spondylolisthesis

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: yoga group
This is a group where yoga and home exercise (pelvic floor muscle training) will be done together.
Procedure: yoga and home exercise

The intervention period for the study was determined as 6 weeks. It has been decided that yoga practice will be done 3 times a week for 45 minutes.

Poses to be practiced in the yoga group:

  1. Tadasana (mountain pose)
  2. Utkatasana (chair pose)
  3. Trikonasana (triangle pose)
  4. Malasana (squat pose):
  5. Viparita Karani Variation (legs up the wall pose)
  6. Salamba Set Bandhasana (supported bridge pose)
  7. Supta Baddha Konasana (reclining bound angle pose)
  8. Savasana (dead pose)
Experimental: whole body vibration training (WBVT) group
This is a group where whole body vibration training and home exercise (pelvic floor muscle training) will be done together.
Procedure: whole body vibration training and home exercise
A total of 40-45 minutes of training was planned for WBVT, including warm-up (10 minutes), active phase (25-30 minutes) and cooling phase (5 minutes).
Active Comparator: home exercise group
This is a group where pelvic floor muscle training will be done.
Procedure: home exercise group
Pelvic floor muscle training will be done in the home exercise group. This training will be done in the form of slow and fast contractions of the pelvic floor muscles in supine, chin up, sitting, squat and standing positions.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
pelvic floor muscle strength test
Time Frame: 6 weeks
Pelvic floor muscle strength evaluation will be performed with a perineal EMG biofeedback device with a vaginal probe. After the pressure probe is inserted into the vagina, the patient will be asked to contract the pelvic floor muscles. Contractions will be repeated 3 times and averaged. The obtained value will be recorded in cmH2O.
6 weeks
Numerical Rating Scale
Time Frame: 6 weeks
It is used for severity of urinary incontinence. The participant was asked "How much urine do you think you leak?" The question will be asked and the student will be asked to make a mark on the chart that scores between 0-10 points.0 means no urine leakage, 10 means a lot of urine leakage.
6 weeks
International Consultation of Incontinence Society-Short Form
Time Frame: 6 weeks
The scale addresses the frequency of UI and how much UI affects a person's life. There are a total of 4 questions, 3 of which are included in the scoring. A total of 0-21 points are given (0: no leakage, 1-5: mild, 6-12: moderate, 13-18: severe, 21: serious urine leakage). As the score increases, the severity of UI and the impact on quality of life increase.
6 weeks
1 hour pad test
Time Frame: 6 weeks

• Pad test is an easy-to-perform test that determines the severity of urine leakage objectively. During the implementation of this test, the protocol established by the International Continence Society will be taken as basis. The steps of the protocol are as follows: 0. min: The weight of the clean pad is weighed. It is given to the patient. After wearing the pad, the patient is asked to drink 500 ml of water in a short time.

30 min: walking and climbing stairs 45th minute: Coughing 10 times, sitting down and standing up 10 times, picking up something from the ground 10 times, jumping 10 times, washing hands under running water for 1 minute, running for 1 minute.

60th minute: Weighing the pad taken from the patient again. After the evaluation steps are completed, the amount of urine leakage is calculated by subtracting the weight of the clean pad from the weight of the used pad.
6 weeks
Incontinence Impact Questionnaire-7
Time Frame: 6 weeks
There are 7 items in the scale. Items are scored between 0-3, resulting in a total score between 0-21. It is understood that as the score obtained from the scale increases, the severity of UI complaints and quality of life decrease.
6 weeks
Urogenital Distress Inventory-6
Time Frame: 6 weeks
It consists of 6 questions. In the scoring of the scale, there are options for each item: 0: not at all, 1: slightly, 2: moderately, 3: very much. Minimum 0 - maximum 18 points can be obtained from UDI-6. The score is determined by converting the points received into a percentage. An increase in the score obtained from the scale indicates that the level of quality of life is deteriorating.
6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Suleyman Demirel University

Investigators

  • Study Director: Zeliha Baskurt, Prof, Suleyman Demirel University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2024

Primary Completion (Estimated)

November 30, 2025

Study Completion (Estimated)

June 15, 2026

Study Registration Dates

First Submitted

November 19, 2024

First Submitted That Met QC Criteria

November 21, 2024

First Posted (Estimated)

November 26, 2024

Study Record Updates

Last Update Posted (Estimated)

November 26, 2024

Last Update Submitted That Met QC Criteria

November 21, 2024

Last Verified

November 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 78/30

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

The data to be generated and/or analyzed during the current study are not publicly available due to confidentiality and ethical concerns, but are available from the corresponding author upon reasonable request.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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