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NCT Number: NCT06705283

Yoga and Vibration Training for Stress Urinary Incontinence in Women

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.

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Key information

Conditions

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

Age range

20 year–60 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Suleyman Demirel University

Isparta, 32100, Turkey (Türkiye)

Location status: Recruiting

Location contact

Pinar Yasar, MsC

CONTACT

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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:

  • Tadasana (mountain pose)
  • Utkatasana (chair pose)
  • Trikonasana (triangle pose)
  • Malasana (squat pose):
  • Viparita Karani Variation (legs up the wall pose)
  • Salamba Set Bandhasana (supported bridge pose)
  • Supta Baddha Konasana (reclining bound angle pose)
  • Savasana (dead pose)

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).

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.

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Pinar Yasar, MSc

CONTACT

[email protected]

+90 535 014 53 40

Sponsors and collaborators

Lead sponsor

Suleyman Demirel University

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Nov 26, 2024
Registry last updated
Nov 26, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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