Yoga and Vibration Training for Stress Urinary Incontinence in Women

NCT06705283 | Recruiting

• 1 other identifier: 78/30
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Urinary Incontinence

Keywords

urinary incontinence; yoga; whole body vibration training; pelvic floor muscle; quality of life

Outcome Measures

Primary Outcomes (6)

• pelvic floor muscle strength test

  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

  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

  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

  • 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

  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

  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

Study Arms (3)

yoga group

EXPERIMENTAL

This is a group where yoga and home exercise (pelvic floor muscle training) will be done together.

Procedure: yoga and home exercise

whole body vibration training (WBVT) group

EXPERIMENTAL

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

home exercise group

ACTIVE COMPARATOR

This is a group where pelvic floor muscle training will be done.

Procedure: home exercise group

Interventions

yoga and home exercise PROCEDURE

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)

yoga group

whole body vibration training and home exercise PROCEDURE

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).

whole body vibration training (WBVT) group

home exercise group PROCEDURE

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.

home exercise group

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Suleyman Demirel University: lead

Study Sites (1)

Suleyman Demirel University

Isparta, 32100, Turkey (Türkiye)

RECRUITING

Related Publications (12)

• Rocha F, Carvalho J, Jorge Natal R, Viana R. Evaluation of the pelvic floor muscles training in older women with urinary incontinence: a systematic review. Porto Biomed J. 2018 Jul 18;3(2):e9. doi: 10.1016/j.pbj.0000000000000009. eCollection 2018 Oct.

  PMID: 31595241 RESULT

• Abrams P, Cardozo L, Fall M, Griffiths D, Rosier P, Ulmsten U, Van Kerrebroeck P, Victor A, Wein A; Standardisation Sub-Committee of the International Continence Society. The standardisation of terminology in lower urinary tract function: report from the standardisation sub-committee of the International Continence Society. Urology. 2003 Jan;61(1):37-49. doi: 10.1016/s0090-4295(02)02243-4. No abstract available.

  PMID: 12559262 RESULT

• Bo K, Nygaard IE. Is Physical Activity Good or Bad for the Female Pelvic Floor? A Narrative Review. Sports Med. 2020 Mar;50(3):471-484. doi: 10.1007/s40279-019-01243-1.

  PMID: 31820378 RESULT

• Ghaderi F, Kharaji G, Hajebrahimi S, Pashazadeh F, Berghmans B, Pourmehr HS. Physiotherapy in Patients with Stress Urinary Incontinence: A Systematic Review and Meta-analysis. Urol Res Pract. 2023 Sep;49(5):293-306. doi: 10.5152/tud.2023.23018.

  PMID: 37877877 RESULT

• Krhut J, Zachoval R, Smith PP, Rosier PF, Valansky L, Martan A, Zvara P. Pad weight testing in the evaluation of urinary incontinence. Neurourol Urodyn. 2014 Jun;33(5):507-10. doi: 10.1002/nau.22436. Epub 2013 Jun 24.

  PMID: 23797972 RESULT

• Shin DC, Shin SH, Lee MM, Lee KJ, Song CH. Pelvic floor muscle training for urinary incontinence in female stroke patients: a randomized, controlled and blinded trial. Clin Rehabil. 2016 Mar;30(3):259-67. doi: 10.1177/0269215515578695. Epub 2015 Apr 10.

  PMID: 25862769 RESULT

• Cam C, Sakalli M, Ay P, Cam M, Karateke A. Validation of the short forms of the incontinence impact questionnaire (IIQ-7) and the urogenital distress inventory (UDI-6) in a Turkish population. Neurourol Urodyn. 2007;26(1):129-33. doi: 10.1002/nau.20292.

  PMID: 17083117 RESULT

• Yesil H, Akkoc Y, Karapolat H, Guler A, Sungur U, Evyapan D, Gokcay F. Reliability and validity of the Turkish version of the Danish Prostatic Symptom Score to assess lower urinary tract symptoms in stroke patients. NeuroRehabilitation. 2017;41(2):429-435. doi: 10.3233/NRE-162136.

  PMID: 28946578 RESULT

• Dumoulin C, Cacciari LP, Hay-Smith EJC. Pelvic floor muscle training versus no treatment, or inactive control treatments, for urinary incontinence in women. Cochrane Database Syst Rev. 2018 Oct 4;10(10):CD005654. doi: 10.1002/14651858.CD005654.pub4.

  PMID: 30288727 RESULT

• Farzinmehr A, Moezy A, Koohpayehzadeh J, Kashanian M. A Comparative Study of Whole Body Vibration Training and Pelvic Floor Muscle Training on Women's Stress Urinary Incontinence: Three- Month Follow- Up. J Family Reprod Health. 2015 Nov;9(4):147-54.

  PMID: 27047560 RESULT

• Kannan P, Hsu WH, Suen WT, Chan LM, Assor A, Ho CM. Yoga and Pilates compared to pelvic floor muscle training for urinary incontinence in elderly women: A randomised controlled pilot trial. Complement Ther Clin Pract. 2022 Feb;46:101502. doi: 10.1016/j.ctcp.2021.101502. Epub 2021 Oct 26.

  PMID: 34763295 RESULT

• Lopes-Souza P, Dionello CF, Bernardes-Oliveira CL, Moreira-Marconi E, Marchon RM, Teixeira-Silva Y, Paineiras-Domingos LL, da Cunha Sa-Caputo D, Xavier VL, Bergmann A, Klumb EM, Bernardo-Filho M. Effects of 12-week whole-body vibration exercise on fatigue, functional ability and quality of life in women with systemic lupus erythematosus: A randomized controlled trial. J Bodyw Mov Ther. 2021 Jul;27:191-199. doi: 10.1016/j.jbmt.2021.01.015. Epub 2021 Jan 27.

  PMID: 34391233 RESULT

MeSH Terms

Conditions

Urinary Incontinence

Interventions

Yoga

Condition Hierarchy (Ancestors)

Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Spiritual Therapies; Exercise Movement Techniques; Physical Therapy Modalities

Study Officials

• Zeliha Baskurt, Prof

  Suleyman Demirel University

  STUDY DIRECTOR

Central Study Contacts

Pinar Yasar, MSc

CONTACT

+90 535 014 53 40; pinarergoz@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 19, 2024
• First Posted: November 26, 2024
• Study Start: November 1, 2024
• Primary Completion: November 30, 2025
• Study Completion (Estimated): June 15, 2026
• Last Updated: November 26, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)