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Urinary IncontinenceNCT06705283

Yoga and Vibration Training for Stress Urinary Incontinence in Women

A study testing yoga and home exercise, whole body vibration training and home exercise and home exercise group in people with Urinary Incontinence, run by Suleyman Demirel University at 1 site in Turkey (Türkiye).

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 20 to 60 years, women onlyHealthy volunteers can take part
Conditions the study is for
Urinary Incontinence
What is being tested?
yoga and home exercise, whole body vibration training and home exercise and home exercise group
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
39 participants
Where
1 siteTurkey (Türkiye)
Study dates
1 Nov 2024to 15 Jun 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 60 years
  • Women only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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.

Who cannot join

  • 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
Show all 13Show fewer
  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Turkey (Türkiye)1 site, 1 recruiting
  • Suleyman Demirel University

    Isparta, 32100

    Pinar Yasar, MsC

    Recruiting

Other trials in Turkey (Türkiye)

About this study

Official title: 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.

Being tested
yoga and home exercise, whole body vibration training and home exercise, home exercise group
Keywords
urinary incontinence, yoga, whole body vibration training, pelvic floor muscle, quality of life
Medical subject headings
Urinary Incontinence

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • yoga and home exerciseProcedure or surgery

    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)
  • whole body vibration training and home exerciseProcedure or surgery

    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 groupProcedure or surgery

    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.

Study groups in NCT06705283
Study groupRoleWhat they receive
yoga groupExperimentalThis is a group where yoga and home exercise (pelvic floor muscle training) will be done together.
Receives: Procedure: yoga and home exercise
whole body vibration training (WBVT) groupExperimentalThis is a group where whole body vibration training and home exercise (pelvic floor muscle training) will be done together.
Receives: Procedure: whole body vibration training and home exercise
home exercise groupActive comparatorThis is a group where pelvic floor muscle training will be done.
Receives: Procedure: home exercise group

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 6 weeks

  2. 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.

    Measured: 6 weeks

  3. 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.

    Measured: 6 weeks

  4. 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.

    Measured: 6 weeks

  5. 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.

    Measured: 6 weeks

  6. 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.

    Measured: 6 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Nov 2024
  2. Study start1 Nov 2024
  3. Primary completion30 Nov 2025 (estimated)
  4. Study completion15 Jun 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
39 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06705283
Sponsor's protocol ID
78/30
Status last verified
Nov 2024
First submitted
19 Nov 2024
Last updated
26 Nov 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: 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.

Publications

  • 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.

    PubMed 31595241
  • 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.

    PubMed 12559262
  • 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.

    PubMed 31820378
  • 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.

    PubMed 37877877
  • 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.

    PubMed 23797972
  • 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.

    PubMed 25862769
  • 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.

    PubMed 17083117
  • 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.

    PubMed 28946578
  • 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.

    PubMed 30288727
  • 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.

    PubMed 27047560
  • 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.

    PubMed 34763295
  • 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.

    PubMed 34391233

Questions about this trial

What is this clinical trial studying?

A study testing yoga and home exercise, whole body vibration training and home exercise and home exercise group in people with Urinary Incontinence, run by Suleyman Demirel University at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 26 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Pinar Yasar, MSc (+90 535 014 53 40, pinarergoz@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

pelvic floor muscle strength test (time frame: 6 weeks). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06705283, which also lists 12 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Nov 2024.

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