Yoga and Vibration Training for Stress Urinary Incontinence in Women

Not Applicable

Recruiting

• Conditions: Urinary Incontinence

• Registration Number: NCT06705283
• Lead Sponsor: Suleyman Demirel University

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-11
• Study Start: 2024-11-01
• Study First Submitted: 2024-11-19
• Study First Submitted QC: 2024-11-21
• Last Update Submitted: 2024-11-21
• Study First Posted: 2024-11-26
• Last Update Posted: 2024-11-26
• Primary Completion: 2025-11-30
• Study Completion: 2026-06-15

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 39

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
pelvic floor muscle strength test	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.
Numerical Rating Scale	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.
International Consultation of Incontinence Society-Short Form	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.
1 hour pad test	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.
Incontinence Impact Questionnaire-7	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.
Urogenital Distress Inventory-6	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.

Trial Locations

Locations (1)

Suleyman Demirel University; 🇹🇷 Isparta, Turkey