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The purpose of this study is to assess and to compare the efficacy of a face to face versus a remote physiotherapy instruction session about pelvic floor muscle (PFM) function, including teaching women how to contract their PFM and how to perceive a correct PFM contraction. Study participants will be randomly assigned to participate in one of the three study groups: Group 1 will receive face to face instructions, Group 2 will receive real time remote instructions and Group 3 will not receive any instruction. The primary outcome measure is PFM function assessed using the modified Oxford Scale.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Face to face intervention group | Active Comparator | This group will be composed of participants who will receive face to face physiotherapy instruction session. |
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| Remote intervention group | Experimental | This group will be composed of participants who will receive real time remote physiotherapy instruction session. |
|
| Control group | Active Comparator | This group will be composed of participants who will not receive any type of physiotherapy instruction session during the period of the study. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Face to face intervention group | Other | Participants of this group will participate in a one 15 minutes face to face session where they will receive information about anatomy, functions and dysfunctions of the pelvic floor. During the session, some teaching materials will be used (an anatomical model, prototype simulator of the functions of the PFM, posters, videos and images), in order to facilitate the learning of women about how to contract their PFM and how to avoid urinary loss by contracting their muscles. At the end of the session, the participants will have time to ask their questions and will receive a home booklet reinforcing the information given during the session including instructions for them to perform a PFM contraction during daily live situations that generate an increased intra-abdominal pressure, such as coughing, sneezing, weight lifting and other activities, as well as strategies to inhibit urge urinary incontinence (UI). |
| Measure | Description | Time Frame |
|---|---|---|
| Change in contraction capacity | The Modified Oxford Scale will be used to assess change in the capacity to perform a PFM contraction through vaginal palpation. The Modified Oxford Scale is a categorical variable with 6 possible answers ranging from 0 to 5. High scores of Modified Oxford Scale mean better PFM function and lower scores mean worse PFM function. | At baseline, immediately after intervention and 20 days after the intervention. |
| Change in self-perception of the PFM | The Modified Oxford Scale will be used to assess change in the participants' self-perception of their contraction after vaginal palpation. The Modified Oxford Scale is a categorical variable with 6 possible answers ranging from 0 to 5. High scores of Modified Oxford Scale mean better PFM function and lower scores mean worse PFM function. | At baseline, immediately after intervention and 20 days after the intervention. |
| Measure | Description | Time Frame |
|---|---|---|
| Self-report of UI symptoms | Reports of UI symptoms will be evaluated through the International Consultation on Incontinence Questionnaire - Short Form. Participants who report having had no urinary leakage in the last four weeks will be considered continents. The International Consultation on Incontinence Questionnaire score can range from 0 (when there is no report of urinary leakage, with no impact on quality of life) to 21 (highest in UI severity and maximum impact on quality of life). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Cristine H Jorge | University of Sao Paulo | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of São Paulo | Ribeirão Preto | São Paulo | 14026956 | Brazil |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28681849 | Background | Aoki Y, Brown HW, Brubaker L, Cornu JN, Daly JO, Cartwright R. Urinary incontinence in women. Nat Rev Dis Primers. 2017 Jul 6;3:17042. doi: 10.1038/nrdp.2017.42. | |
| 27918122 | Background | Bo K, Frawley HC, Haylen BT, Abramov Y, Almeida FG, Berghmans B, Bortolini M, Dumoulin C, Gomes M, McClurg D, Meijlink J, Shelly E, Trabuco E, Walker C, Wells A. An International Urogynecological Association (IUGA)/International Continence Society (ICS) joint report on the terminology for the conservative and nonpharmacological management of female pelvic floor dysfunction. Neurourol Urodyn. 2017 Feb;36(2):221-244. doi: 10.1002/nau.23107. Epub 2016 Dec 5. |
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|
| Remote intervention group | Other | Participants of this group will be referred to a room with a computer (inside the rehabilitation center) to participate in a one 15 minutes real time remote session, where they will receive information about anatomy, functions and dysfunctions of the pelvic floor. During the session, some teaching materials will be used (an anatomical model, prototype simulator of the functions of the PFM, posters, videos and images), in order to facilitate the learning of women about how to contract their PFM and how to avoid urinary loss by contracting their muscles. At the end of the session, the participants will have time to ask their questions and will receive a home booklet reinforcing the information given during the session including instructions for them to perform a PFM contraction during daily live situations that generate an increased intra-abdominal pressure, such as coughing, sneezing, weight lifting and other activities, as well as strategies to inhibit urge UI. |
|
| Control group | Other | Participants of this group will be assessed in the same time points of the participants of the two other groups. They will not receive any intervention or information about pelvic floor anatomy, functions and dysfunctions of the pelvic floor, however after the last assessment (20 days after) for ethical reasons they will receive the same intervention. |
|
| At baseline and 20 days after the intervention. |
| Assessment of the usefulness of teaching resources | The usefulness of teaching resources will be evaluated by the numerical visual scale and by a questionnaire developed by the researchers. In the post-intervention evaluation of face to face intervention group and remote intervention group, the numerical visual scale and the questionnaire will be presented to the participants and then they will be asked to evaluate and mark on the line the point corresponding to the degree of satisfaction/usefulness of the resources. Scores closer to 0 correspond to no satisfaction with the resources used in the instruction session about pelvic floor and scores closer to 10 correspond to satisfaction with the resources used. | Immediately after intervention |
| Satisfaction with the orientations | Satisfaction with the instructions received during the session will be evaluated by the numerical visual scale. In the post-intervention evaluation, face to face intervention group and remote intervention group will be asked to evaluate and mark on the line the point corresponding to the degree of satisfaction with the guidelines given in the session. Scores closer to 0 correspond to no satisfaction with the instruction received during session about pelvic floor and scores closer to 10 correspond to satisfaction with the instruction received during session about pelvic floor. | Immediately after intervention |
| System usability assessment | The usability of the system used to carry out the remote intervention group session will be evaluated through the systems usability scale. The system usability assessment score can range from 0 (the lower the score, the greater the usability problems of the system used) to 100 (the higher the score, the lower the usability problems of the system used). | Immediately after intervention |
| 30704907 | Background | Cacciari LP, Dumoulin C, Hay-Smith EJ. Pelvic floor muscle training versus no treatment, or inactive control treatments, for urinary incontinence in women: a cochrane systematic review abridged republication. Braz J Phys Ther. 2019 Mar-Apr;23(2):93-107. doi: 10.1016/j.bjpt.2019.01.002. Epub 2019 Jan 22. |
| 32387004 | Background | Dantas LO, Barreto RPG, Ferreira CHJ. Digital physical therapy in the COVID-19 pandemic. Braz J Phys Ther. 2020 Sep-Oct;24(5):381-383. doi: 10.1016/j.bjpt.2020.04.006. Epub 2020 May 1. No abstract available. |
| 29574170 | Background | de Andrade RL, Bo K, Antonio FI, Driusso P, Mateus-Vasconcelos ECL, Ramos S, Julio MP, Ferreira CHJ. An education program about pelvic floor muscles improved women's knowledge but not pelvic floor muscle function, urinary incontinence or sexual function: a randomised trial. J Physiother. 2018 Apr;64(2):91-96. doi: 10.1016/j.jphys.2018.02.010. Epub 2018 Mar 21. |
| 30467764 | Background | de Freitas LM, Bo K, Fernandes ACNL, Uechi N, Duarte TB, Ferreira CHJ. Pelvic floor muscle knowledge and relationship with muscle strength in Brazilian women: a cross-sectional study. Int Urogynecol J. 2019 Nov;30(11):1903-1909. doi: 10.1007/s00192-018-3824-y. Epub 2018 Nov 22. |
| 32986147 | Background | Ferreira CHJ, Driusso P, Haddad JM, Pereira SB, Fernandes ACNL, Porto D, Reis BM, Mascarenhas LR, Brito LGO, Ferreira EAG. A guide to physiotherapy in urogynecology for patient care during the COVID-19 pandemic. Int Urogynecol J. 2021 Jan;32(1):203-210. doi: 10.1007/s00192-020-04542-8. Epub 2020 Sep 28. |
| 34147398 | Background | Fernandes ACNL, Palacios-Cena D, Hay-Smith J, Pena CC, Sidou MF, de Alencar AL, Ferreira CHJ. Women report sustained benefits from attending group-based education about pelvic floor muscles: a longitudinal qualitative study. J Physiother. 2021 Jul;67(3):210-216. doi: 10.1016/j.jphys.2021.06.010. Epub 2021 Jun 17. |
| 16299815 | Background | Frawley HC, Galea MP, Phillips BA, Sherburn M, Bo K. Reliability of pelvic floor muscle strength assessment using different test positions and tools. Neurourol Urodyn. 2006;25(3):236-242. doi: 10.1002/nau.20201. |
| 19937315 | Background | Haylen BT, de Ridder D, Freeman RM, Swift SE, Berghmans B, Lee J, Monga A, Petri E, Rizk DE, Sand PK, Schaer GN. An International Urogynecological Association (IUGA)/International Continence Society (ICS) joint report on the terminology for female pelvic floor dysfunction. Int Urogynecol J. 2010 Jan;21(1):5-26. doi: 10.1007/s00192-009-0976-9. Epub 2009 Nov 25. |
| 23183454 | Background | Hay-Smith J, Herderschee R, Dumoulin C, Herbison P. Comparisons of approaches to pelvic floor muscle training for urinary incontinence in women: an abridged Cochrane systematic review. Eur J Phys Rehabil Med. 2012 Dec;48(4):689-705. |
| 17059650 | Background | Hui E, Lee PS, Woo J. Management of urinary incontinence in older women using videoconferencing versus conventional management: a randomized controlled trial. J Telemed Telecare. 2006;12(7):343-7. doi: 10.1258/135763306778682413. |
| 7732416 | Background | Laycock J. Pelvic muscle exercises: physiotherapy for the pelvic floor. Urol Nurs. 1994 Sep;14(3):136-40. No abstract available. |
| 16326162 | Background | Liao YM, Dougherty MC, Liou YS, Tseng IJ. Pelvic floor muscle training effect on urinary incontinence knowledge, attitudes, and severity: an experimental study. Int J Nurs Stud. 2006 Jan;43(1):29-37. doi: 10.1016/j.ijnurstu.2005.01.004. |
| 29429823 | Background | Mateus-Vasconcelos ECL, Brito LGO, Driusso P, Silva TD, Antonio FI, Ferreira CHJ. Effects of three interventions in facilitating voluntary pelvic floor muscle contraction in women: a randomized controlled trial. Braz J Phys Ther. 2018 Sep-Oct;22(5):391-399. doi: 10.1016/j.bjpt.2017.12.006. Epub 2018 Feb 3. |
| 9670874 | Background | Miller JM, Ashton-Miller JA, DeLancey JO. A pelvic muscle precontraction can reduce cough-related urine loss in selected women with mild SUI. J Am Geriatr Soc. 1998 Jul;46(7):870-4. doi: 10.1111/j.1532-5415.1998.tb02721.x. |
| 17762378 | Background | Nelson ME, Rejeski WJ, Blair SN, Duncan PW, Judge JO, King AC, Macera CA, Castaneda-Sceppa C. Physical activity and public health in older adults: recommendation from the American College of Sports Medicine and the American Heart Association. Med Sci Sports Exerc. 2007 Aug;39(8):1435-45. doi: 10.1249/mss.0b013e3180616aa2. |
| 29320966 | Background | Scott Kruse C, Karem P, Shifflett K, Vegi L, Ravi K, Brooks M. Evaluating barriers to adopting telemedicine worldwide: A systematic review. J Telemed Telecare. 2018 Jan;24(1):4-12. doi: 10.1177/1357633X16674087. Epub 2016 Oct 16. |
| 20970839 | Background | Smith AL, Nissim HA, Le TX, Khan A, Maliski SL, Litwin MS, Sarkisian CA, Raz S, Rodriguez LV, Anger JT. Misconceptions and miscommunication among aging women with overactive bladder symptoms. Urology. 2011 Jan;77(1):55-9. doi: 10.1016/j.urology.2010.07.460. Epub 2010 Oct 23. |
| 17876492 | Background | Talasz H, Himmer-Perschak G, Marth E, Fischer-Colbrie J, Hoefner E, Lechleitner M. Evaluation of pelvic floor muscle function in a random group of adult women in Austria. Int Urogynecol J Pelvic Floor Dysfunct. 2008 Jan;19(1):131-5. doi: 10.1007/s00192-007-0404-y. Epub 2007 Sep 18. |
| 24337586 | Background | Tibaek S, Dehlendorff C. Pelvic floor muscle function in women with pelvic floor dysfunction: a retrospective chart review, 1992-2008. Int Urogynecol J. 2014 May;25(5):663-9. doi: 10.1007/s00192-013-2277-6. Epub 2013 Dec 12. |
| 31737927 | Background | Uechi N, Fernandes ACNL, Bo K, de Freitas LM, de la Ossa AMP, Bueno SM, Ferreira CHJ. Do women have an accurate perception of their pelvic floor muscle contraction? A cross-sectional study. Neurourol Urodyn. 2020 Jan;39(1):361-366. doi: 10.1002/nau.24214. Epub 2019 Nov 18. |
| 39704322 | Derived | Hay-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. |
| ID | Term |
|---|---|
| D014549 | Urinary Incontinence |
| ID | Term |
|---|---|
| D014555 | Urination Disorders |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D059411 | Lower Urinary Tract Symptoms |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D035061 | Control Groups |
| ID | Term |
|---|---|
| D015340 | Epidemiologic Research Design |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D012107 | Research Design |
| D008722 | Methods |
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