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Stress Urinary Incontinence in WomenEIOSFSINCT05053373

Evaluation of Integrated Optimization Schemes for Female Stress Incontinence

A study testing Electroacupuncture group and Pelvic floor muscle training in people with Stress Urinary Incontinence in Women, run by Shanghai Yueyang Integrated Medicine Hospital at 4 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 40 to 75 years, women only
Conditions the study is for
Stress Urinary Incontinence in Women
What is being tested?
Electroacupuncture group and Pelvic floor muscle training
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
358 participants
Where
4 sitesChina
Study dates
20 May 2014to 21 Nov 2017
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 40 to 75 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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.

Trial locations and contacts

4 sites in 1 country.

China4 sites

  • Department of Acupuncture and Moxibustion, Nanjing Hospital of Chinese Medicine, Nanjing University of Chinese Medicine

    Nanjing, Jiangsu, 210006

  • Department of Acupuncture and Moxibustion, Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine

    Shanghai, Shanghai Municipality, 200437

  • Department of Acupuncture and Moxibustion, First Teaching Hospital of Tianjin University of Traditional Chinese Medicine

    Tianjin, Tianjin Municipality, 300193

  • Department of Acupuncture and Moxibustion, Shaanxi Hospital of Traditional Chinese Medicine

    Xi'an, Shaanxi, 710003

Other trials in China

About this study

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

Read the detailed 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.

Being tested
Electroacupuncture group, Sham electroacupuncture group, Pelvic floor muscle training
Keywords
Stress Urinary Incontinence; Acupuncture
Medical subject headings
Urinary Incontinence, Stress

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Electroacupuncture groupDevice

    Also called SDA-V electroacupuncture apparatus(Huatuo,made in China)

  • Sham electroacupuncture groupDevice

    Also called Sham SDZ-V electroacupuncture apparatus(Huatuo,China)

  • Pelvic floor muscle trainingBehavioural

Study groups in NCT05053373
Study groupRoleWhat they receive
Electroacupuncture Added to Pelvic Floor Muscle TrainingExperimentalPatients 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).
Receives: Device: Electroacupuncture group; Behavioral: Pelvic floor muscle training
Sham Electroacupuncture Added to Pelvic Floor Muscle TrainingExperimentalThe 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),
Receives: Device: Sham electroacupuncture group; Behavioral: Pelvic floor muscle training

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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).

    Measured: 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 outcomes (6)

  1. 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.

    Measured: 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.

  2. 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

    Measured: The evaluation will be performed at baseline, weeks 4, 6, 8 of treatment, and weeks 20 and 32 of follow-up.

  3. Participants using urine pads

    The numbers of participants using urine pads and weekly mean pads usage measured by a urinary diary.

    Measured: week 2-8, week 17-20, week 29-32

  4. 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)

    Measured: weeks 2, 4, 6, and 8

  5. Subjective self-evaluation of therapeutic effects

    3 point scoring: totally unhelpful=0, minimally helpful=1, moderately helpful=2, very helpful=3

    Measured: week 2, week 4, week 6, week 8, week 20, week 32

  6. Incidence of adverse events

    subcutaneous edema, fatigue, severe pain, palpitations, etc.

    Measured: the 1-8 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Sep 2021
  2. Study start20 May 2014
  3. Primary completion9 Jun 2017
  4. Study completion21 Nov 2017

Resources

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
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
358 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05053373
Sponsor's protocol ID
ChiCTR-IPR-15006711
Other IDs
2012BAI24B01
Acronym
EIOSFSI
Status last verified
Sep 2021
First submitted
21 Sep 2021
Last updated
22 Sep 2021
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Data are available for the editorial office and other investigators following reasonable requests. A data use agreement needs to be signed. There may be handling and processing costs, depending on the complexity and scope of the request.

Publications

  • 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.

    PubMed 19941278

  • 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.

    PubMed 28321473

  • 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.

    PubMed 29067433

  • 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.

    PubMed 18238969

  • 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.

    PubMed 28681849

  • 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.

    PubMed 28977091

  • 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.

    PubMed 21684555

  • 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.

    PubMed 19281467

  • 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.

    PubMed 17132698

  • 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.

    PubMed 26670573

  • 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.

    PubMed 29398262

  • 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.

    PubMed 18877152

  • 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.

    PubMed 25222388

  • 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.

    PubMed 30288727

  • Antonov NM, Lachinova IN. [Ambulatory acupuncture treatment of patients with nocturnal urinary incontinence]. Urol Nefrol (Mosk). 1974;39(4):44-6. No abstract available. Russian.

    PubMed 4408536

Questions about this trial

What is this clinical trial studying?

A study testing Electroacupuncture group and Pelvic floor muscle training in people with Stress Urinary Incontinence in Women, run by Shanghai Yueyang Integrated Medicine Hospital at 4 sites in China.

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 4 inclusion and 2 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 22 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in China. 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?

The change of urine loss (time frame: 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.). 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 NCT05053373, which also lists 24 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 22 Sep 2021.

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