Feasibility of transcranial direct current stimulation (tDCS) combined with pelvic floor muscle training (PFMT) in female urinary incontinence: randomized controlled trial
DOI:
https://doi.org/10.17267/2965-3738bis.2024.e5381Keywords:
Urinary Incontinence, Exercise Therapy, Electrical Stimulation Therapy, Feasibility StudiesAbstract
INTRODUCTION: Pelvic floor muscle training (PFMT) is widely regarded as the most conservative and effective non-pharmacological treatment option for women suffering from urinary incontinence (UI). Transcranial direct current stimulation (tDCS) is a non-invasive, non-pharmacological neuromodulation technique that has demonstrated promising results in a variety of medical conditions. However, there has been little research into the feasibility of tDCS as an adjunct therapy to PFMT in improving symptoms in women with UI. OBJECTIVE: To explore the feasibility (recruitment and retention) of tDCS as an adjunct therapy to PFMT to relieve symptoms of female UI. METHODS AND MATERIALS: Eleven female patients were randomly assigned to receive 12 non-consecutive sessions of PFMT combined with 20 minutes (2mA) of anodal (Cz) or sham tDCS for 4 weeks. Feasibility (primary outcome) was assessed through recruitment and retention rates. Secondary outcomes included four domains: (1) urinary leakage, (2) severity of incontinence, (3) impact on quality of life, and (4) symptoms and adverse events. RESULTS: Eleven patients were evaluated, and nine women completed the treatment protocol. The recruitment rate was 100%, and retention was 81.8%. Clinical results showed that anodal tDCS is viable as adjunctive therapy to PFMT protocol and may result in minimal clinically important differences (MCID) in UI symptoms. CONCLUSION: The high rate of recruitment and retention indicates that tDCS in combination with PFMT is a feasible adjunct therapy for female UI treatment. This research supports the recommendation for a full RCT, with prioritization of outcomes required for hypothesis testing.
References
(1) Haylen BT, Ridder D, Freeman RM, Swift SE, Berghmans B, Lee J, et al. An International Urogynecological Association (IUGA)/International Continence Society (ICS) joint report on the terminology for female pelvic floor dysfunction. Neurourol Urodyn. 2010;29(1):4-20. http://dx.doi.org/10.1002/nau.20798
(2) Aoki Y, Brown HW, Brubaker L, Cornu JN, Daly JO, Cartwright R. Urinary incontinence in women. Nat Rev Dis Primers. 2017;3:17097. http://dx.doi.org/10.1038/nrdp.2017.97
(3) Sinclair AJ, Ramsay IN. The psychosocial impact of urinary incontinence in women. Obstet Gynaecol. 2011;13(3):143-8. http://doi.wiley.com/10.1576/toag.13.3.143.27665
(4) Rubilotta E, Balzarro M, D’Amico A, Cerruto MA, Bassi S, Bovo C, et al. Pure stress urinary incontinence: analysis of prevalence, estimation of costs, and financial impact. BMC Urol. 2019;19(1):44. http://dx.doi.org/10.1186/s12894-019-0468-2
(5) Sarikaya S, Yildiz FG, Senocak C, Bozkurt OF, Karatas OF. Urinary incontinence as a cause of depression and sexual dysfunction: Questionnaire-based study. Rev Int Androl. 2020;18(2):50-4. http://dx.doi.org/10.1016/j.androl.2018.08.003
(6) Wu JM, Vaughan CP, Goode PS, Redden DT, Burgio KL, Richter HE, et al. Prevalence and Trends of Symptomatic Pelvic Floor Disorders in U.S. Women. Obstet Gynecol. 2014;123(1):141-8. https://doi.org/10.1097/aog.0000000000000057
(7) Xue K, Palmer MH, Zhou F. Prevalence and associated factors of urinary incontinence in women living in China: a literature review. BMC Urol. 2020;20(1):159. http://dx.doi.org/10.1186/s12894-020-00735-x
(8) 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;10(10):CD005654. http://dx.doi.org/10.1002/14651858.CD005654.pub4
(9) Kegel AH. Progressive resistance exercise in the functional restoration of the perineal muscles. Am J Obstet Gynecol. 1948;56(2):238-48. http://dx.doi.org/10.1016/0002-9378(48)90266-x
(10) Dumoulin C, Hay-Smith J, Frawley H, McClurg D, Alewijnse D, Bo K, et al. 2014 consensus statement on improving pelvic floor muscle training adherence: International Continence Society 2011 State-of-the-Science Seminar. Neurourol Urodyn. 2015;34(7):600-5. http://dx.doi.org/10.1002/nau.22796
(11) O’Neill AT, Hockey J, O’Brien P, Williams A, Morris TP, Khan T, et al. Knowledge of pelvic floor problems: a study of third trimester, primiparous women. Int Urogynecol J. 2017;28(1):125-9. http://dx.doi.org/10.1007/s00192-016-3087-4
(12) Ayeleke RO, Hay-Smith EJC, Omar MI. Pelvic floor muscle training added to another active treatment versus the same active treatment alone for urinary incontinence in women. Cochrane Database Syst Rev. 2015;2015(11):CD010551. http://dx.doi.org/10.1002/14651858.CD010551.pub3
(13) Tadic SD, Griffiths D, Schaefer W, Cheng CI, Resnick NM. Brain activity measured by functional magnetic resonance imaging is related to patient reported urgency urinary incontinence severity. J Urol. 2010;183(1):221-8. http://dx.doi.org/10.1016/j.juro.2009.08.155
(14) Harvie C, Weissbart SJ, Kadam-Halani P, Rao H, Arya LA. Brain activation during the voiding phase of micturition in healthy adults: A meta-analysis of neuroimaging studies. Clin Anat. 2019;32(1):13-9. https://doi.org/10.1002/ca.23244
(15) Kitta T, Mitsui T, Kanno Y, Chiba H, Moriya K, Shinohara N. Brain-bladder control network: the unsolved 21st century urological mystery. Int J Urol. 2015;22(4):342-8. https://doi.org/10.1111/iju.12721
(16) Vacher P, Charlanes A, Chesnel C, Pagès A, Malot C, Le Breton F, et al. Intérêt de la stimulation transcrânienne dans les troubles pelvi-périnéaux. Progrès en Urologie. 2019;29(7):349-59. https://doi.org/10.1016/j.purol.2019.03.001
(17) Griffiths D, Clarkson B, Tadic SD, Resnick NM. Brain Mechanisms Underlying Urge Incontinence and its Response to Pelvic Floor Muscle Training. J Urol. 2015;194(3):708-15. http://dx.doi.org/10.1016/j.juro.2015.03.102
(18) Nitsche MA, Paulus W. Excitability changes induced in the human motor cortex by weak transcranial direct current stimulation. J Physiol. 2000;527 Pt 3(Pt 3):633-9. http://dx.doi.org/10.1111/j.1469-7793.2000.t01-1-00633.x
(19) Nitsche MA, Paulus W. Sustained excitability elevations induced by transcranial DC motor cortex stimulation in humans. Neurology. 2001;57(10):1899-901. http://dx.doi.org/10.1212/wnl.57.10.1899
(20) Krishnan C, Ranganathan R, Kantak SS, Dhaher YY, Rymer WZ. Anodal transcranial direct current stimulation alters elbow flexor muscle recruitment strategies. Brain Stimul. 2014;7(3):443-50. http://dx.doi.org/10.1016/j.brs.2014.01.057
(21) Machado S, Jansen P, Almeida V, Veldema J. Is tDCS an Adjunct Ergogenic Resource for Improving Muscular Strength and Endurance Performance? A Systematic Review. Front Psychol. 2019;10:1127. http://dx.doi.org/10.3389/fpsyg.2019.01127
(22) O’Connell NE, Marston L, Spencer S, DeSouza LH, Wand BM. Non-invasive brain stimulation techniques for chronic pain. Cochrane Database Syst Rev. 2018;3:CD008208. https://doi.org/10.1002/14651858.CD008208.pub4
(23) Schabrun SM, Jones E, Cancino ELE, Hodges PW. Targeting chronic recurrent low back pain from the top-down and the bottom-up: a combined transcranial direct current stimulation and peripheral electrical stimulation intervention. Brain Stimul. 2014;7(3):451-9. http://dx.doi.org/10.1016/j.brs.2014.01.058
(24) Mendonca ME, Simis M, Grecco LC, Battistella LR, Baptista AF, Fregni F. Transcranial Direct Current Stimulation Combined with Aerobic Exercise to Optimize Analgesic Responses in Fibromyalgia: A Randomized Placebo-Controlled Clinical Trial. Front Hum Neurosci. 2016;10:68. https://doi.org/10.3389/fnhum.2016.00068
(25) Hazime FA, Baptista AF, Freitas DG, Monteiro RL, Maretto RL, Hasue RH, et al. Treating low back pain with combined cerebral and peripheral electrical stimulation: A randomized, double-blind, factorial clinical trial. Eur J Pain. 2017;21(7):1132-43. http://dx.doi.org/10.1002/ejp.1037
(26) Persu C, Chapple CR, Cauni V, Gutue S, Geavlete P. Pelvic Organ Prolapse Quantification System (POP-Q) - a new era in pelvic prolapse staging. J Med Life. 2011;4(1):75-81. Cited: PMID: 21505577.
(27) Burkhard FC, Bosch JLHR, Cruz F, Lemack GE, Nambiar AK, Thiruchelvam N, et al. EAU guidelines on Urinary incontinence in adults [Internet]. Netherlands: European Association of Urology; 2020. Available from: https://uroweb.org/eau-guidelines/discontinued-topics/urinary-incontinence
(28) Husband CJ, Wharf-Higgins J, Rhodes RE. A feasibility randomized trial of an identity-based physical activity intervention among university students. Health Psychol Behav Med. 2019;7(1):128-46. http://dx.doi.org/10.1080/21642850.2019.1600407
(29) Jackson N, Waters E, Guidelines for Systematic Reviews in Health Promotion and Public Health Taskforce. Criteria for the systematic review of health promotion and public health interventions. Health Promot Int. 2005;20(4):367-74. http://dx.doi.org/10.1093/heapro/dai022
(30) O’Sullivan R, Karantanis E, Stevermuer TL, Allen W, Moore KH. Definition of mild, moderate and severe incontinence on the 24-hour pad test. BJOG. 2004;111(8):859-62. https://doi.org/10.1111/j.1471-0528.2004.00211.x
(31) Pereira VS, Santos JYC, Correia GN, Driusso P. Translation and validation into Portuguese of a questionnaire to evaluate the severity of urinary incontinence. Rev Bras Ginecol Obstet. 2011;33(4):182-7. https://doi.org/10.1590/S0100-72032011000400006
(32) Tamanini JTN, Dambros M, D’Ancona CAL, Palma PCR, Netto Jr NR. Validation of the “International Consultation on Incontinence Questionnaire - Short Form” (ICIQ-SF) for Portuguese. Rev Saúde Pública. 2004;38(3). http://dx.doi.org/10.1590/s0034-89102004000300015
(33) Tamanini JTN, D’Ancona CAL, Botega NJ, Netto Jr NR. Validation of the Portuguese version of the King’s Health Questionnaire for urinary incontinent women. Rev Saúde Pública. 2003;37(2):203-11. https://doi.org/10.1590/S0034-89102003000200007
(34) Souza CCC, Rodrigues AM, Ferreira CE, Fonseca ESM, Bella ZIKJ, Girão MJBC, et al. Portuguese validation of the Urinary Incontinence-Specific Quality-of-Life Instrument: I-QOL. Int Urogynecol J. 2009;20(10):1183-9. http://dx.doi.org/10.1007/s00192-009-0916-8
(35) Laycock J, Jerwood D. Pelvic Floor Muscle Assessment: The PERFECT Scheme. Physiotherapy. 2001;87(12):631-42. https://doi.org/10.1016/S0031-9406(05)61108-X
(36) Frawley HC, Galea MP, Phillips BA, Sherburn M, Bø K. Reliability of pelvic floor muscle strength assessment using different test positions and tools. Neurourol Urodyn. 2006;25(3):236-42. http://dx.doi.org/10.1002/nau.20201
(37) Roza T, Mascarenhas T, Araujo M, Trindade V, Jorge RN. Oxford Grading Scale vs manometer for assessment of pelvic floor strength in nulliparous sports students. Physiotherapy. 2013;99(3):207-11. http://dx.doi.org/10.1016/j.physio.2012.05.014
(38) Brown JS, McNaughton KS, Wyman JF, Burgio KL, Harkaway R, Bergner D, et al. Measurement characteristics of a voiding diary for use by men and women with overactive bladder. Urology. 2003;61(4):802-9. http://dx.doi.org/10.1016/s0090-4295(02)02505-0
(39) Bright E, Drake MJ, Abrams P. Urinary diaries: evidence for the development and validation of diary content, format, and duration. Neurourol Urodyn. 2011;30(3):348-52. http://dx.doi.org/10.1002/nau.20994
(40) Costa LOP, Maher CG, Latimer J, Ferreira PH, Ferreira ML, Pozzi GC, et al. Clinimetric testing of three self-report outcome measures for low back pain patients in Brazil: which one is the best?. Spine. 2008;33(22):2459-63. http://dx.doi.org/10.1097/BRS.0b013e3181849dbe
(41) Gorenstein C, Andrade L. Validation of a Portuguese version of the Beck Depression Inventory and State-Trait Anxiety Inventory in Brazilian subjects. Braz J Med Biol Res. 1996;29(4):453-7. Cited: PMID: 8736107.
(42) Williams VSL, Morlock RJ, Feltner D. Psychometric evaluation of a visual analog scale for the assessment of anxiety. Health Qual Life Outcomes. 2010;8:57. http://dx.doi.org/10.1186/1477-7525-8-57
(43) Beattie P, Turner C, Dowda M, Michener L, Nelson R. The MedRisk Instrument for Measuring Patient Satisfaction With Physical Therapy Care: a psychometric analysis. J Orthop Sports Phys Ther. 2005;35(1):24-32. http://dx.doi.org/10.2519/jospt.2005.35.1.24
(44) Herwig U, Satrapi P, Schönfeldt-Lecuona C. Using the international 10-20 EEG system for positioning of transcranial magnetic stimulation. Brain Topogr. 2003;16(2):95-9. http://dx.doi.org/10.1023/b:brat.0000006333.93597.9d
(45) Carlsen AN, Eagles JS, MacKinnon CD. Transcranial direct current stimulation over the supplementary motor area modulates the preparatory activation level in the human motor system. Behav Brain Res. 2015;279:68-75. http://dx.doi.org/10.1016/j.bbr.2014.11.009
(46) Sluijs EM, Knibbe JJ. Patient compliance with exercise: Different theoretical approaches to short-term and long-term compliance. Patient Educ Couns. 1991;17(3):191-204. https://doi.org/10.1016/0738-3991(91)90060-I
(47) Howard DB, Gosling CM. A short questionnaire to identify patient characteristics indicating improved compliance to exercise rehabilitation programs: A pilot investigation. Int J Osteopath Med. 2008;11(1):7-15. https://doi.org/10.1016/j.ijosm.2007.12.002
(48) Borello-France D, Burgio KL, Goode PS, Markland AD, Kenton K, Balasubramanyam A, et al. Adherence to behavioral interventions for urge incontinence when combined with drug therapy: adherence rates, barriers, and predictors. Phys Ther. 2010;90(10):1493-505. http://dx.doi.org/10.2522/ptj.20080387
(49) O’Neill F, Sacco P, Bowden E, Asher R, Burnside G, Cox T, et al. Patient-delivered tDCS on chronic neuropathic pain in prior responders to TMS (a randomized controlled pilot study). J Pain Res. 2018;11:3117-28. http://dx.doi.org/10.2147/JPR.S186079
(50) Oláh KS, Bridges N, Denning J, Farrar DJ. The conservative management of patients with symptoms of stress incontinence: a randomized, prospective study comparing weighted vaginal cones and interferential therapy. Am J Obstet Gynecol. 1990;162(1):87-92. http://dx.doi.org/10.1016/0002-9378(90)90827-t
(51) Bø K, Talseth T, Holme I. Single blind, randomised controlled trial of pelvic floor exercises, electrical stimulation, vaginal cones, and no treatment in management of genuine stress incontinence in women. BMJ. 1999;318(7182):487-93. http://dx.doi.org/10.1136/bmj.318.7182.487
(52) Barber MD, Spino C, Janz NK, Brubaker L, Nygaard I, Nager CW, et al. The minimum important differences for the urinary scales of the Pelvic Floor Distress Inventory and Pelvic Floor Impact Questionnaire. Am J Obstet Gynecol. 2009;200(5):580.e1-7. http://dx.doi.org/10.1016/j.ajog.2009.02.007
(53) Lim R, Liong ML, Lim KK, Leong WS, Yuen KH. The Minimum Clinically Important Difference of the International Consultation on Incontinence Questionnaires (ICIQ-UI SF and ICIQ-LUTSqol). Urology. 2019;133:91-5. http://dx.doi.org/10.1016/j.urology.2019.08.004
(54) Abdel-fattah M, Barrington JW, Youssef M. The standard 1-hour pad test: does it have any value in clinical practice?. Eur Urol. 2004;46(3):377-80. http://dx.doi.org/10.1016/j.eururo.2004.04.018
(55) Dutta A, Krishnan C, Kantak SS, Ranganathan R, Nitsche MA. Recurrence quantification analysis of surface electromyogram supports alterations in motor unit recruitment strategies by anodal transcranial direct current stimulation. Restor Neurol Neurosci. 2015;33(5):663-9. http://dx.doi.org/10.3233/RNN-140469
(56) Matsumoto H, Ugawa Y. Adverse events of tDCS and tACS: A review. Clin Neurophysiol Pract. 2017;2:19-25. http://dx.doi.org/10.1016/j.cnp.2016.12.003
(57) Ramezani M, Ehsani F, Delkhosh CT, Masoudian N, Jaberzadeh S. Concurrent multi-session anodal trans-cranial direct current stimulation enhances pelvic floor muscle training effectiveness for female patients with multiple sclerosis suffering from urinary incontinence and pelvic floor dysfunction: a randomized clinical trial study. Int Urogynecol J. 2023;34:1771-9. http://dx.doi.org/10.1007/s00192-022-05429-6
Downloads
Published
Issue
Section
License
Copyright (c) 2024 Antonia Mykaele Cordeiro Brandão, Sávia Francisca Lopes Dias, Maria Gabriela Cardoso Teles Monteiro, Janaina Mayer de Oliveira Nunes, Tiago da Silva Lopes, Abrahão Fontes Baptista, Katia Nunes Sá, Fuad Ahmad Hazime
This work is licensed under a Creative Commons Attribution 4.0 International License.
This work is licensed under a Creative Commons Attribution 4.0 International License.
