Clinical trial NCT06705283: Yoga and Vibration Training for Stress Urinary Incontinence in Women
Official title: Effects Of Yoga And Whole Body Vibration Training On Women With Stress Urinary Incontinence
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Urinary Incontinence
Keywords: urinary incontinence
yoga
whole body vibration training
pelvic floor muscle
quality of life
Lead sponsor: Suleyman Demirel University
Sponsor class: OTHER
First posted: 2024-11-26
Enrollment: 39
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: pelvic floor muscle strength test
timeFrame: 6 weeks
measure: Numerical Rating Scale
timeFrame: 6 weeks
measure: International Consultation of Incontinence Society-Short Form
timeFrame: 6 weeks
measure: 1 hour pad test
timeFrame: 6 weeks
measure: Incontinence Impact Questionnaire-7
timeFrame: 6 weeks
measure: Urogenital Distress Inventory-6
timeFrame: 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Isparta
country: Turkey
facility: Suleyman Demirel University
Study officials:
affiliation: Suleyman Demirel University
name: Zeliha Baskurt, Prof
role: STUDY_DIRECTOR
References:
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citation: 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.
citation: 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.
citation: 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.
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citation: 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.
citation: 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.