Evaluation of Integrated Optimization Schemes for Female Stress Incontinence

Stress Urinary Incontinence in Women Clinical Trial

— EIOSFSI  

Official title:

Evaluation of Integrated Optimization Schemes for Female Stress Incontinence

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05053373
• Other study ID #: ChiCTR-IPR-15006711
• Secondary ID: 2012BAI24B01
• Status: Completed
• Phase: N/A
• Start date: May 20, 2014
• Est. completion date: November 21, 2017

Study information

• Verified date: September 2021
• Source: Shanghai Yueyang Integrated Medicine Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim of this study is to determine the effectiveness of PFMT added to EA vs PFMT added sham EA for SUI in women.

Description:

We will perform a multicenter, randomized, double-blind, sham-controlled, parallel-group clinical trial in four hospitals in China to compare the effectiveness of EA added to PFMT vs sham EA added to PFMT for women with SUI.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 358
• Est. completion date: November 21, 2017
• Est. primary completion date: June 9, 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 40 Years to 75 Years

Eligibility

Inclusion Criteria:

• Women who are 40-75 years of age

• 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:

• Subject has urgency and mixed urinary

• 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.

Related Conditions & MeSH terms

• Enuresis
• Stress Urinary Incontinence in Women
• Urinary Incontinence
• Urinary Incontinence, Stress

Intervention

Device:
• Electroacupuncture group

• Sham electroacupuncture group

Behavioral:
• Pelvic floor muscle training

Locations

Country	Name	City	State
China	Department of Acupuncture and Moxibustion, Nanjing Hospital of Chinese Medicine, Nanjing University of Chinese Medicine	Nanjing	Jiangsu
China	Department of Acupuncture and Moxibustion, Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine	Shanghai	Shanghai
China	Department of Acupuncture and Moxibustion, First Teaching Hospital of Tianjin University of Traditional Chinese Medicine	Tianjin	Tianjin
China	Department of Acupuncture and Moxibustion, Shaanxi Hospital of Traditional Chinese Medicine	Xi'an	Shaanxi

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Yueyang Integrated Medicine Hospital

Country where clinical trial is conducted

China, 

References & Publications (24)

Abrams P, Khoury S, Cardozo L, Wein A. Incontinence : 5th International Consultation on Incontinence, Paris, February 2012. 2013.

Antonov NM, Lachinova IN. [Ambulatory acupuncture treatment of patients with nocturnal urinary incontinence]. Urol Nefrol (Mosk). 1974;39(4):44-6. Russian. — View Citation

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. Review. Erratum in: Nat Rev Dis Primers. 2017 Nov 16;3:17097. — View Citation

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. — View Citation

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:CD005654. doi: 10.1002/14651858.CD005654.pub4. — View Citation

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. Review. — View Citation

KEGEL AH. Progressive resistance exercise in the functional restoration of the perineal muscles. Am J Obstet Gynecol. 1948 Aug;56(2):238-48. — View Citation

Kim JH, Nam D, Park MK, Lee ES, Kim SH. Randomized control trial of hand acupuncture for female stress urinary incontinence. Acupunct Electrother Res. 2008;33(3-4):179-92. — View Citation

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. — View Citation

Kost'ál M, Hrubecký I. [Acupuncture in the treatment of female incontinence]. Cesk Gynekol. 1985 Aug;50(7):488-90. Czech. — View Citation

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. — View Citation

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. Review. — View Citation

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. Review. — View Citation

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. — View Citation

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. Review. — View Citation

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. — View Citation

Nambiar AK, Bosch R, Cruz F, Lemack GE, Thiruchelvam N, Tubaro A, Bedretdinova DA, Ambühl 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. — View Citation

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. — View Citation

Philp T, Shah PJ, Worth PH. Acupuncture in the treatment of bladder instability. Br J Urol. 1988 Jun;61(6):490-3. — View Citation

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. Erratum in: Ann Intern Med. 2014 Nov 18;161(10):764. — View Citation

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. Epub 2006 Nov 28. — View Citation

Wang Y, Zhishun L, Peng W, Zhao J, Liu B. Acupuncture for stress urinary incontinence in adults. Cochrane Database Syst Rev. 2013 Jul 1;(7):CD009408. doi: 10.1002/14651858.CD009408.pub2. Review. — View Citation

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. Chinese. — View Citation

Yang XY, Shi GX, Li QQ, Zhang ZH, Xu Q, Liu CZ. Characterization of deqi sensation and acupuncture effect. Evid Based Complement Alternat Med. 2013;2013:319734. doi: 10.1155/2013/319734. Epub 2013 Jun 20. — View Citation

* Note: There are 24 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The change of urine loss	The change of urine loss is measured by the 1-hour urine pad test. The 1-hour pad test will be performed as follows: 1) Empty the bladder and wear a preweighted pad. 2) Drink 500 ml of sodium-free liquid in 15 minutes; 3) walk for half hours, including going up and down stairs; 4) perform the following activity in the remaining 30 minutes: squat and stand up 10 times; cough hard 10 times; run in place for 1 minute; bend down to pick up a small object on the ground 5 times; wash hands for 1 minute with running water. 5) Weigh the pad again to calculate the urine leakage (1 gram equivalent to 1 ml of urine).	The evaluation will be performed when the participants are first distributed into the groups as a baseline, and then at weeks 2, 4, 6 and 8 of treatment.
Secondary	The average 24-hour urinary incontinence episodes and reduction of more than 50%	The average 24-hour urinary incontinence episodes and reduction of more than 50% measured by a urinary diary. Reduction more than 50% in urine leakage at week 8 from baseline measured by the 1-hour pad test.	The average 24-hour urinary incontinence episodes and reduction of more than 50% at weeks 2, 4, 6, and 8 of treatment measured by a urinary diary. Reduction more than 50% in urine leakage at week 8 from baseline measured by the 1-hour pad test.
Secondary	The International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF) scores	The International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF) scores (range, 0 [best]-21[worst]), which is recommended by the International Consultation on Urological Diseases (ICUD) to evaluate the frequency and volume of urinary incontinence and its impact on quality of life	The evaluation will be performed at baseline, weeks 4, 6, 8 of treatment, and weeks 20 and 32 of follow-up.
Secondary	Participants using urine pads	The numbers of participants using urine pads and weekly mean pads usage measured by a urinary diary.	week 2-8, week 17-20, week 29-32
Secondary	severity of urinary incontinence	The participant-reported severity of urinary incontinence at weeks 2, 4, 6, and 8 of treatment (mild leaking, several drops; moderate leaking,wet through underwear; severe leaking, wet through trousers)	weeks 2, 4, 6, and 8
Secondary	Subjective self-evaluation of therapeutic effects	3 point scoring: totally unhelpful=0, minimally helpful=1, moderately helpful=2, very helpful=3	week 2, week 4, week 6, week 8, week 20, week 32
Secondary	Incidence of adverse events	subcutaneous edema, fatigue, severe pain, palpitations, etc.	the 1-8 weeks