Incontinence, UrinaryNCT03727269
Wii Fit Game Based Abdomino-Pelvic Training In Urinary Incontinence
A study testing Wii Fit Training Experimental Group and Conventional Training in people with Incontinence, Urinary, run by Riphah International University at 1 site in Pakistan.
Trial summary
This study is aimed to determine the effect of Wii fit based abdomino-pelvic training on strength of pelvic floor muscles and on symptoms of urinary incontinence in females. An experimental, randomized controlled trial will be performed. Read more about this study
- Who is it for?
- Ages 45 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Incontinence, Urinary
- What is being tested?
- Wii Fit Training Experimental Group and Conventional Training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 sitePakistan
- Study dates
- 15 Nov 2018to 15 Feb 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 45 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- • Females with only stress urinary incontinence (SUI).
Who cannot join
- Females with urinary tract infection.
- Females with myopathy, neurological abnormalities, cognitive or physical disorder that could hinder in training and assessment.
- Pelvic floor muscle strength 0 on Modified oxford grading scale and pelvic organ prolapse greater than or equal to 3 on pelvic organ Quantification (POP-Q) system.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Role Of Wii Fit Game Based Abdomino-Pelvic Training In Females With Urinary Incontinence
This study is aimed to determine the effect of Wii fit based abdomino-pelvic training on strength of pelvic floor muscles and on symptoms of urinary incontinence in females. An experimental, randomized controlled trial will be performed. Both reproductive and postmenopausal females with stress urinary incontinence will be included. 40 participants would be randomly distributed in experimental group (n=20) receiving wii fit based abdomino-pelvic training and control group (n=20) receiving conventional pelvic floor exercises. Pelvic floor strength would be assessed before and after by Digital method and EMG biofeedback. Urinary symptoms would be assessed by bladder diary, pad test and International consultation on Incontinence Questionnaires. Health related Quality of life questionnaire would also be used as an outcome measure. Data will be analyzed on SPSS 21 version using descriptive and inferential statistics
Read the detailed description
Loss of bladder control results causes the accidental leak of urine is called urinary incontinence. It may be slightly bothersome or totally debilitating. It may leads to embarrassment and keeps them away from enjoying many physical activities, including exercising. Urinary incontinence may develop emotional distress because of some outside factors, such as difficulty getting to standing position or only being able to walk slowly, which prevent them from getting to the toilet on time.
Old women experience urinary incontinence more than young women or young girls. Muscles in the wall of bladder contracts during urination. Sphincter muscles surrounding the urethra relax which let the urine to pass out from the body. Incontinence will occur when the muscles of bladder suddenly contracts or are not strong enough to hold back the urine. Then the urine may escape with less pressure than usual when the muscles are damaged, this causing a change in the position of the bladder.
Stress incontinence is the most common type of urinary incontinence. 80% of the females suffering from urinary incontinence have stress urinary incontinence. Obese women having greater intra-abdominal pressure leads to weakening of pelvic floor muscle which causes stress incontinence.
During pregnancy, child birth and menopause physical changes results in the weakening of muscles of bladder. As the result of physical exertions, muscles of bladder become weak that increase intra-abdominal pressure leakage may cause. Leakage may occur during coughing, sneezing or heavy lifting.
Wii fit games are computer-generated scenario that simulates experience through senses and perception. This approach is being used by physical therapist so than their patient stick to their exercise protocol and it enhance their training and functional level. Wii fit game based pelvic floor muscle exercises helps the pelvic floor muscle to strengthen by different movements such as anteversion,, retroversion, lateral tilting, truck rotation, circumduction and pelvic stabilization. video game based treatment that enhance patients' motivation, functional training and hence adherence to exercise regimen. As clinical practice in women's health physical therapy lacks options for pelvic floor muscle training and wii fit game based pelvic floor rehabilitation is an innovated method so could be a valuable adjunct in management of female urinary incontinence protocol.
- Conditions
- Incontinence, Urinary
- Being tested
- Wii Fit Training Experimental Group, Conventional Training
- Keywords
- Wii Fit, Urinary Incontinence, Females, Abdomino-Pelvic Training
- Medical subject headings
- Urinary Incontinence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Wii Fit Training Experimental GroupOther
Experimental group receiving wii fit game based abdomino-pelvic training. A specific protocol was developed by the researchers. Wii fit games which promote exercises focusing on the abdominopelvic cavity strengthening, using as a therapeutic means a Wii™ console with a Wii Fit Plus™ CD game. The protocol was design that which playing games participant perform different pelvic movements such as anteversion, retroversion, lateral tilt and circumduction that maintain trunk control and stabilization with mild abdomino-pelvic muscle activation. Duration of each game is 5 minutes with 90 seconds interval between them twice a week. After performing the sequence of virtual games, a series of abdominopelvic and lower limb muscle stretching exercises will done.
Conventional TrainingOther
Control group (n=20) receiving conventional pelvic floor exercises. Conventional exercises includes:
- Knack Maneuver (Ashton -Miller 1998, 2008)
- Pelvic floor strengthening: kegel Exercise.
- -Lumbo-Pelvic Stabilization Exercise.
- Functional Training/ PFM Contraction during ADL
- Correction of biomechanical/structural deformities
| Study group | Role | What they receive |
|---|---|---|
| Wii Fit Training Experimental Group | Experimental | receiving Wii fit based abdomino-pelvic training Receives: Other: Wii Fit Training Experimental Group |
| Conventional Training Control Group | Active comparator | receiving conventional pelvic floor exercises. Receives: Other: Conventional Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
EMG biofeedback
EMG biofeedback device shows electrical activity of pelvic floor muscles and can assist with both muscle strengthening AND relaxation training
Measured: 8 week
Secondary outcomes (1)
Michigan Incontinence Symptoms Index:
Michigan incontinence symptoms index is a clinical measure of type, severity and bother related to urinary incontinence.The M-ISI is a parsimonious measure that has established reliability and validity on several levels and complements current clinical evaluative methods for patients with urinary incontinence
Measured: 8th week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2018
- Study start15 Nov 2018
- Primary completion15 Feb 2019
- Study completion15 Feb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Incontinence, UrinaryStudies of the same condition, open and under way.
- More trials run by Riphah International UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Experimental group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- imran Amjad, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03727269
- Sponsor's protocol ID
- RiphahIU Mizna Saleh
- Status last verified
- Aug 2019
- First submitted
- 24 Oct 2018
- Last updated
- 8 Aug 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Wood LN, Anger JT. Urinary incontinence in women. BMJ. 2014 Sep 15;349:g4531. doi: 10.1136/bmj.g4531.
PubMed 25225003Hilton P. Urinary incontinence in women. Br Med J (Clin Res Ed). 1987 Aug 15;295(6595):426-32. doi: 10.1136/bmj.295.6595.426. No abstract available.
PubMed 3115486Osborn DJ, Strain M, Gomelsky A, Rothschild J, Dmochowski R. Obesity and female stress urinary incontinence. Urology. 2013 Oct;82(4):759-63. doi: 10.1016/j.urology.2013.06.020. Epub 2013 Aug 22.
PubMed 23972338Burgio KL, Matthews KA, Engel BT. Prevalence, incidence and correlates of urinary incontinence in healthy, middle-aged women. J Urol. 1991 Nov;146(5):1255-9. doi: 10.1016/s0022-5347(17)38063-1.
PubMed 1942274Dobson HD, Pearl RK, Orsay CP, Rasmussen M, Evenhouse R, Ai Z, Blew G, Dech F, Edison MI, Silverstein JC, Abcarian H. Virtual reality: new method of teaching anorectal and pelvic floor anatomy. Dis Colon Rectum. 2003 Mar;46(3):349-52. doi: 10.1097/01.DCR.0000054639.29160.9E.
PubMed 12626910Martinho NM, Silva VR, Marques J, Carvalho LC, Iunes DH, Botelho S. The effects of training by virtual reality or gym ball on pelvic floor muscle strength in postmenopausal women: a randomized controlled trial. Braz J Phys Ther. 2016 Mar 22;20(3):248-57. doi: 10.1590/bjpt-rbf.2014.0148.
PubMed 27437716Botelho S, Martinho NM, Silva VR, Marques J, Carvalho LC, Riccetto C. Virtual reality: a proposal for pelvic floor muscle training. Int Urogynecol J. 2015 Nov;26(11):1709-12. doi: 10.1007/s00192-015-2698-5. Epub 2015 Apr 30.
PubMed 25925487Steenstrup B, Giralte F, Bakker E, Grise P. [Evaluation of the electromyography activity of pelvic floor muscle during postural exercises using the Wii Fit Plus(c). Analysis and perspectives in rehabilitation]. Prog Urol. 2014 Dec;24(17):1099-105. doi: 10.1016/j.purol.2014.09.046. Epub 2014 Oct 23. French.
PubMed 25450755Elliott V, de Bruin ED, Dumoulin C. Virtual reality rehabilitation as a treatment approach for older women with mixed urinary incontinence: a feasibility study. Neurourol Urodyn. 2015 Mar;34(3):236-43. doi: 10.1002/nau.22553. Epub 2014 Jan 10.
PubMed 24415577Bertotto A, Schvartzman R, Uchoa S, Wender MCO. Effect of electromyographic biofeedback as an add-on to pelvic floor muscle exercises on neuromuscular outcomes and quality of life in postmenopausal women with stress urinary incontinence: A randomized controlled trial. Neurourol Urodyn. 2017 Nov;36(8):2142-2147. doi: 10.1002/nau.23258. Epub 2017 May 16.
PubMed 28508398Capelini MV, Riccetto CL, Dambros M, Tamanini JT, Herrmann V, Muller V. Pelvic floor exercises with biofeedback for stress urinary incontinence. Int Braz J Urol. 2006 Jul-Aug;32(4):462-8; discussion 469. doi: 10.1590/s1677-55382006000400015.
PubMed 16953917Thubert T, Deffieux X, Jousse M, Guinet-Lacoste A, Ismael SS, Amarenco G. Influence of a distraction task on pelvic floor muscle contraction. Neurourol Urodyn. 2015 Feb;34(2):139-43. doi: 10.1002/nau.22524. Epub 2014 Feb 12.
PubMed 24519688Hay-Smith EJC, Starzec-Proserpio M, Moller B, Aldabe D, Cacciari L, Pitangui ACR, Vesentini G, Woodley SJ, Dumoulin C, Frawley HC, Jorge CH, Morin M, Wallace SA, Weatherall M. Comparisons of approaches to pelvic floor muscle training for urinary incontinence in women. Cochrane Database Syst Rev. 2024 Dec 20;12(12):CD009508. doi: 10.1002/14651858.CD009508.pub2.
PubMed 39704322
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role Of Wii Fit Game Based Abdomino-Pelvic Training In Females With Urinary Incontinence
- ClinicalTrials.gov ID
- NCT03727269
- Acronym / sponsor ID
- RiphahIU Mizna Saleh
- Conditions
- Incontinence, Urinary
- Keywords
- Wii Fit, Urinary Incontinence, Females, Abdomino-Pelvic Training
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 15 Nov 2018 (actual)
- Primary completion
- 15 Feb 2019 (actual)
- Study completion
- 15 Feb 2019 (actual)
- First posted
- 1 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is aimed to determine the effect of Wii fit based abdomino-pelvic training on strength of pelvic floor muscles and on symptoms of urinary incontinence in females. An experimental, randomized controlled trial will be performed. Both reproductive and postmenopausal females with stress urinary incontinence will be included. 40 participants would be randomly distributed in experimental group (n=20) receiving wii fit based abdomino-pelvic training and control group (n=20) receiving conventional pelvic floor exercises. Pelvic floor strength would be assessed before and after by Digital method and EMG biofeedback. Urinary symptoms would be assessed by bladder diary, pad test and International consultation on Incontinence Questionnaires. Health related Quality of life questionnaire would also be used as an outcome measure. Data will be analyzed on SPSS 21 version using descriptive and inferential statistics
Detailed description
Loss of bladder control results causes the accidental leak of urine is called urinary incontinence. It may be slightly bothersome or totally debilitating. It may leads to embarrassment and keeps them away from enjoying many physical activities, including exercising. Urinary incontinence may develop emotional distress because of some outside factors, such as difficulty getting to standing position or only being able to walk slowly, which prevent them from getting to the toilet on time.
Old women experience urinary incontinence more than young women or young girls. Muscles in the wall of bladder contracts during urination. Sphincter muscles surrounding the urethra relax which let the urine to pass out from the body. Incontinence will occur when the muscles of bladder suddenly contracts or are not strong enough to hold back the urine. Then the urine may escape with less pressure than usual when the muscles are damaged, this causing a change in the position of the bladder.
Stress incontinence is the most common type of urinary incontinence. 80% of the females suffering from urinary incontinence have stress urinary incontinence. Obese women having greater intra-abdominal pressure leads to weakening of pelvic floor muscle which causes stress incontinence.
During pregnancy, child birth and menopause physical changes results in the weakening of muscles of bladder. As the result of physical exertions, muscles of bladder become weak that increase intra-abdominal pressure leakage may cause. Leakage may occur during coughing, sneezing or heavy lifting.
Wii fit games are computer-generated scenario that simulates experience through senses and perception. This approach is being used by physical therapist so than their patient stick to their exercise protocol and it enhance their training and functional level. Wii fit game based pelvic floor muscle exercises helps the pelvic floor muscle to strengthen by different movements such as anteversion,, retroversion, lateral tilting, truck rotation, circumduction and pelvic stabilization. video game based treatment that enhance patients' motivation, functional training and hence adherence to exercise regimen. As clinical practice in women's health physical therapy lacks options for pelvic floor muscle training and wii fit game based pelvic floor rehabilitation is an innovated method so could be a valuable adjunct in management of female urinary incontinence protocol.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Experimental group
| Arm | Type | Receives |
|---|---|---|
| Wii Fit Training Experimental Group | Experimental | Other: Wii Fit Training Experimental Groupreceiving Wii fit based abdomino-pelvic training |
| Conventional Training Control Group | Active comparator | Other: Conventional Trainingreceiving conventional pelvic floor exercises. |
Who may qualify
- Ages
- 45 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- • Females with only stress urinary incontinence (SUI).
Key exclusion criteria (3 listed)
- Females with urinary tract infection.
- Females with myopathy, neurological abnormalities, cognitive or physical disorder that could hinder in training and assessment.
- Pelvic floor muscle strength 0 on Modified oxford grading scale and pelvic organ prolapse greater than or equal to 3 on pelvic organ Quantification (POP-Q) system.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Wii Fit Training Experimental GroupExperimental group receiving wii fit game based abdomino-pelvic training. A specific protocol was developed by the researchers. Wii fit games which promote exercises focusing on the abdominopelvic cavity strengthening, using as a therapeutic means a Wii™ console with a Wii Fit Plus™ CD game. The protocol was design that which playing games participant perform different pelvic movements such as anteversion, retroversion, lateral tilt and circumduction that maintain trunk control and stabilization with mild abdomino-pelvic muscle activation. Duration of each game is 5 minutes with 90 seconds interval between them twice a week. After performing the sequence of virtual games, a series of abdominopelvic and lower limb muscle stretching exercises will done. | Other | Wii Fit Training Experimental Group |
| Conventional TrainingControl group (n=20) receiving conventional pelvic floor exercises. Conventional exercises includes: 1. Knack Maneuver (Ashton -Miller 1998, 2008) 2. Pelvic floor strengthening: kegel Exercise. 3. -Lumbo-Pelvic Stabilization Exercise. 4. Functional Training/ PFM Contraction during ADL 5. Correction of biomechanical/structural deformities | Other | Conventional Training Control Group |
Primary outcome
EMG biofeedback
Time frame: 8 week
EMG biofeedback device shows electrical activity of pelvic floor muscles and can assist with both muscle strengthening AND relaxation training
1 secondary outcome
Michigan Incontinence Symptoms Index:
Time frame: 8th week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2019.
- Background: PubMed 25225003Wood LN, Anger JT. Urinary incontinence in women. BMJ. 2014 Sep 15;349:g4531. doi: 10.1136/bmj.g4531.
- Background: PubMed 3115486Hilton P. Urinary incontinence in women. Br Med J (Clin Res Ed). 1987 Aug 15;295(6595):426-32. doi: 10.1136/bmj.295.6595.426. No abstract available.
- Background: PubMed 23972338Osborn DJ, Strain M, Gomelsky A, Rothschild J, Dmochowski R. Obesity and female stress urinary incontinence. Urology. 2013 Oct;82(4):759-63. doi: 10.1016/j.urology.2013.06.020. Epub 2013 Aug 22.
- Background: PubMed 1942274Burgio KL, Matthews KA, Engel BT. Prevalence, incidence and correlates of urinary incontinence in healthy, middle-aged women. J Urol. 1991 Nov;146(5):1255-9. doi: 10.1016/s0022-5347(17)38063-1.
- Background: PubMed 12626910Dobson HD, Pearl RK, Orsay CP, Rasmussen M, Evenhouse R, Ai Z, Blew G, Dech F, Edison MI, Silverstein JC, Abcarian H. Virtual reality: new method of teaching anorectal and pelvic floor anatomy. Dis Colon Rectum. 2003 Mar;46(3):349-52. doi: 10.1097/01.DCR.0000054639.29160.9E.
- Background: PubMed 27437716Martinho NM, Silva VR, Marques J, Carvalho LC, Iunes DH, Botelho S. The effects of training by virtual reality or gym ball on pelvic floor muscle strength in postmenopausal women: a randomized controlled trial. Braz J Phys Ther. 2016 Mar 22;20(3):248-57. doi: 10.1590/bjpt-rbf.2014.0148.
- Background: PubMed 25925487Botelho S, Martinho NM, Silva VR, Marques J, Carvalho LC, Riccetto C. Virtual reality: a proposal for pelvic floor muscle training. Int Urogynecol J. 2015 Nov;26(11):1709-12. doi: 10.1007/s00192-015-2698-5. Epub 2015 Apr 30.
- Background: PubMed 25450755Steenstrup B, Giralte F, Bakker E, Grise P. [Evaluation of the electromyography activity of pelvic floor muscle during postural exercises using the Wii Fit Plus(c). Analysis and perspectives in rehabilitation]. Prog Urol. 2014 Dec;24(17):1099-105. doi: 10.1016/j.purol.2014.09.046. Epub 2014 Oct 23. French.
- Background: PubMed 24415577Elliott V, de Bruin ED, Dumoulin C. Virtual reality rehabilitation as a treatment approach for older women with mixed urinary incontinence: a feasibility study. Neurourol Urodyn. 2015 Mar;34(3):236-43. doi: 10.1002/nau.22553. Epub 2014 Jan 10.
- Background: PubMed 28508398Bertotto A, Schvartzman R, Uchoa S, Wender MCO. Effect of electromyographic biofeedback as an add-on to pelvic floor muscle exercises on neuromuscular outcomes and quality of life in postmenopausal women with stress urinary incontinence: A randomized controlled trial. Neurourol Urodyn. 2017 Nov;36(8):2142-2147. doi: 10.1002/nau.23258. Epub 2017 May 16.
- Background: PubMed 16953917Capelini MV, Riccetto CL, Dambros M, Tamanini JT, Herrmann V, Muller V. Pelvic floor exercises with biofeedback for stress urinary incontinence. Int Braz J Urol. 2006 Jul-Aug;32(4):462-8; discussion 469. doi: 10.1590/s1677-55382006000400015.
- Background: PubMed 24519688Thubert T, Deffieux X, Jousse M, Guinet-Lacoste A, Ismael SS, Amarenco G. Influence of a distraction task on pelvic floor muscle contraction. Neurourol Urodyn. 2015 Feb;34(2):139-43. doi: 10.1002/nau.22524. Epub 2014 Feb 12.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
imran Amjad principal investigator
Riphah International University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Wii Fit Training Experimental Group and Conventional Training in people with Incontinence, Urinary, run by Riphah International University at 1 site in Pakistan.
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 1 inclusion and 3 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: finished, as of the sponsor's last update on 8 Aug 2019. 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 Pakistan. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
EMG biofeedback (time frame: 8 week). 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 NCT03727269, which also lists 13 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 8 Aug 2019.