Evaluation of Integrated Optimization Schemes for Female Stress Incontinence
NCT ID: NCT05053373
Last Updated: 2021-09-22
Study Results
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Basic Information
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COMPLETED
NA
358 participants
INTERVENTIONAL
2014-05-20
2017-11-21
Brief Summary
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Detailed Description
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The participated women with SUI will be recruited from four participating hospitals or through community clinics by advertising. Participated hospitals include: Yueyang Hospital of Integrated Traditional Chinese and Western Medicine Affiliated to Shanghai University of Traditional Chinese Medicine (Shanghai, China); Shaanxi Hospital of Traditional Chinese Medicine (Xi'an, China); First Teaching Hospital of Tianjin University of Traditional Chinese Medicine (Tianjin, China); and Nanjing Hospital of Chinese Medicine Affiliated to Nanjing University of Chinese Medicine (Nanjing, China).
Patients will be screened for eligibility. Chief complaint, medical history, and general characteristics (such as age, race, education level, body mass index, manner of child delivery, menopause) will be obtained. Those who met inclusion criteria and are interested in participating in the study will sign an informed consent form and then make another appointment to complete the baseline data collection, including the 72-hr bladder diary, 1-h pad test, International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF) score, the weekly mean number of urine pads used). Participants will then be assigned randomly to either a PFMT (3 sets/day for 8 weeks) + EA (3 times per week for 8 weeks) group or a PFMT + sham EA group. The primary and secondary outcome will be measured from week 2 to 32. The participant-reported severity of UI and subjective self-evaluation of therapeutic effects will be recorded. Written informed consent will be obtained from all participants before they are included in the study. All clinical investigations will be conducted according to the principles of the Declaration of Helsinki.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Electroacupuncture Added to Pelvic Floor Muscle Training
Patients will be in a prone position. Bilateral Zhongliao (BL33) and Huiyangacupoint (BL35) will be identified and punctured by an acupuncturist. The electrodes will be placed on the needle handles, and stimulate for 30 minutes at 50 Hz with a current intensity between 1 to 5 mA. PFMT will be performed 3 sets a day (morning, around noon, and night).
Electroacupuncture group
Pelvic floor muscle training
Sham Electroacupuncture Added to Pelvic Floor Muscle Training
The preparation for the patients will be the same as that for the patients who will receive EA. Whereas, instead of using real acupuncture needles, special designed placebo needles (size 0.30 × 25 mm) with the blunt-head will be used in the PFMT+sham EA group to penetrate the fixed pad to the skin surface but without skin penetration. The same procedure for deqi will be performed as in the PFMT+EA group. A special-designed cable (the intermediate wire of the cable is cut off but the appearance is normal) will be used to connect the electrodes to the electroacupuncture machine. Therefore, the electroacupuncture machine appears to work, but does not actually stimulated acupoints. The sham EA treatment will also be maintained for 30 minutes. PFMT will be performed 3 sets a day (morning, around noon, and night),
Sham electroacupuncture group
Pelvic floor muscle training
Interventions
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Electroacupuncture group
Sham electroacupuncture group
Pelvic floor muscle training
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Involuntary leakage of urine during increased intra-abdominal pressure in the absence of a bladder contraction, such as coughing, sneezing, or other physical activities
* a 1-hour pad test exceeds 1 g
* no other treatments are administered for urinary incontinence currently
Exclusion Criteria
* Subjects with pelvic organ prolapse, pregnancy, a history of pelvic surgery, chronic respiratory diseases, urinary tract infection, cardiac pacemaker installation, metal allergy, severe needle fear, and currently taking medications for SUI or psychological disorders.
40 Years
75 Years
FEMALE
No
Sponsors
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Shanghai Yueyang Integrated Medicine Hospital
OTHER
Responsible Party
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Principal Investigators
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Yuelai Chen, Doctor
Role: STUDY_CHAIR
Yueyang Hospital of Integrated Traditional Chinese and Western Medicine
Locations
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Department of Acupuncture and Moxibustion, Nanjing Hospital of Chinese Medicine, Nanjing University of Chinese Medicine
Nanjing, Jiangsu, China
Department of Acupuncture and Moxibustion, Shaanxi Hospital of Traditional Chinese Medicine
Xi'an, Shaanxi, China
Department of Acupuncture and Moxibustion, Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine
Shanghai, Shanghai Municipality, China
Department of Acupuncture and Moxibustion, First Teaching Hospital of Tianjin University of Traditional Chinese Medicine
Tianjin, Tianjin Municipality, China
Countries
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References
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Haylen BT, de Ridder D, Freeman RM, Swift SE, Berghmans B, Lee J, Monga A, Petri E, Rizk DE, Sand PK, Schaer GN; International Urogynecological Association; International Continence Society. 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. doi: 10.1002/nau.20798.
Minassian VA, Bazi T, Stewart WF. Clinical epidemiological insights into urinary incontinence. Int Urogynecol J. 2017 May;28(5):687-696. doi: 10.1007/s00192-017-3314-7. Epub 2017 Mar 20.
Lukacz ES, Santiago-Lastra Y, Albo ME, Brubaker L. Urinary Incontinence in Women: A Review. JAMA. 2017 Oct 24;318(16):1592-1604. doi: 10.1001/jama.2017.12137.
Minassian VA, Stewart WF, Wood GC. Urinary incontinence in women: variation in prevalence estimates and risk factors. Obstet Gynecol. 2008 Feb;111(2 Pt 1):324-31. doi: 10.1097/01.AOG.0000267220.48987.17.
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.
Oliveira M, Ferreira M, Azevedo MJ, Firmino-Machado J, Santos PC. Pelvic floor muscle training protocol for stress urinary incontinence in women: A systematic review. Rev Assoc Med Bras (1992). 2017 Jul;63(7):642-650. doi: 10.1590/1806-9282.63.07.642.
Markland AD, Richter HE, Fwu CW, Eggers P, Kusek JW. Prevalence and trends of urinary incontinence in adults in the United States, 2001 to 2008. J Urol. 2011 Aug;186(2):589-93. doi: 10.1016/j.juro.2011.03.114.
Coyne KS, Sexton CC, Thompson CL, Milsom I, Irwin D, Kopp ZS, Chapple CR, Kaplan S, Tubaro A, Aiyer LP, Wein AJ. The prevalence of lower urinary tract symptoms (LUTS) in the USA, the UK and Sweden: results from the Epidemiology of LUTS (EpiLUTS) study. BJU Int. 2009 Aug;104(3):352-60. doi: 10.1111/j.1464-410X.2009.08427.x. Epub 2009 Mar 5.
Waetjen LE, Liao S, Johnson WO, Sampselle CM, Sternfield B, Harlow SD, Gold EB. Factors associated with prevalent and incident urinary incontinence in a cohort of midlife women: a longitudinal analysis of data: study of women's health across the nation. Am J Epidemiol. 2007 Feb 1;165(3):309-18. doi: 10.1093/aje/kwk018. Epub 2006 Nov 28.
Komesu YM, Schrader RM, Ketai LH, Rogers RG, Dunivan GC. Epidemiology of mixed, stress, and urgency urinary incontinence in middle-aged/older women: the importance of incontinence history. Int Urogynecol J. 2016 May;27(5):763-72. doi: 10.1007/s00192-015-2888-1. Epub 2015 Dec 15.
Nambiar AK, Bosch R, Cruz F, Lemack GE, Thiruchelvam N, Tubaro A, Bedretdinova DA, Ambuhl D, Farag F, Lombardo R, Schneider MP, Burkhard FC. EAU Guidelines on Assessment and Nonsurgical Management of Urinary Incontinence. Eur Urol. 2018 Apr;73(4):596-609. doi: 10.1016/j.eururo.2017.12.031. Epub 2018 Feb 3.
KEGEL AH. Progressive resistance exercise in the functional restoration of the perineal muscles. Am J Obstet Gynecol. 1948 Aug;56(2):238-48. doi: 10.1016/0002-9378(48)90266-x. No abstract available.
Qaseem A, Dallas P, Forciea MA, Starkey M, Denberg TD, Shekelle P; Clinical Guidelines Committee of the American College of Physicians. Nonsurgical management of urinary incontinence in women: a clinical practice guideline from the American College of Physicians. Ann Intern Med. 2014 Sep 16;161(6):429-40. doi: 10.7326/M13-2410.
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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Kubista E, Altmann P, Kucera H, Rudelstorfer B. Electro-acupuncture's influence on the closure mechanism of the female urethra in incontinence. Am J Chin Med (Gard City N Y). 1976 Summer;4(2):177-81. doi: 10.1142/s0192415x76000226.
Xie HZ. [Stress urinary incontinence in the female (analysis of 116 cases (author's transl)]. Zhonghua Fu Chan Ke Za Zhi. 1980;15(2):68-70. No abstract available. Chinese.
Philp T, Shah PJ, Worth PH. Acupuncture in the treatment of bladder instability. Br J Urol. 1988 Jun;61(6):490-3. doi: 10.1111/j.1464-410x.1988.tb05086.x.
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Wang Y, Zhishun L, Peng W, Zhao J, Liu B. Acupuncture for stress urinary incontinence in adults. Cochrane Database Syst Rev. 2013 Jul 1;2013(7):CD009408. doi: 10.1002/14651858.CD009408.pub2.
Langevin HM, Schnyer R, MacPherson H, Davis R, Harris RE, Napadow V, Wayne PM, Milley RJ, Lao L, Stener-Victorin E, Kong JT, Hammerschlag R; Executive Board of the Society for Acupuncture Research. Manual and electrical needle stimulation in acupuncture research: pitfalls and challenges of heterogeneity. J Altern Complement Med. 2015 Mar;21(3):113-28. doi: 10.1089/acm.2014.0186. Epub 2015 Feb 24.
Abrams P, Khoury S, Cardozo L, Wein A. Incontinence : 5th International Consultation on Incontinence, Paris, February 2012. 2013.
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Study Documents
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Document Type: Individual Participant Data Set
View DocumentOther Identifiers
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2012BAI24B01
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
ChiCTR-IPR-15006711
Identifier Type: -
Identifier Source: org_study_id
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