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Voiding DisordersNCT03631160

Effect of Transcutaneous Acupoint Electrical Stimulation on Postoperative Spontaneous Voiding for Laparoscopic Patients

A study testing TAES treatmen in people with Voiding Disorders, run by Tianjin Nankai Hospital at 1 site 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

1. Title: Effect of Transcutaneous Acupoint Electrical Stimulation on postoperative spontaneous voiding for Laparoscopic Cholecystectomy patients：A Randomized Clinical Trial 2. Research center: Multicenter 3. Design of the research: A randomized, double-blind and parallel controlled study 4. Read more about this study

Who is it for?
Ages 40 to 75 years
Conditions the study is for
Voiding Disorders
What is being tested?
TAES treatmen
Type of treatment
Medical device
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
1,948 participants
Where
1 siteChina
Study dates
20 Aug 2018to 24 Aug 2020
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
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age ≥ 40 years old and < 75 years old, gender and nationality are not limited;
  • Patients undergoing elective laparoscopic cholecystectomy under general anesthesia
  • agree to participate in this study and sign the informed consent;

Who cannot join

  • Refused to participate in this study;
  • laparotomy or preventive indwelling catheter;
  • There are obvious symptoms of urinary difficulty caused by various causes recently;
  • Patients who are have treatment taboo with skin injury or insensitivity to acupoint stimulation.
  • Critical condition (preoperative ASA grade ≥ IV grade); severe renal impairment (need to undergo renal replacement therapy); severe liver and kidney dysfunction (Child-Pugh grade C);
  • There are other circumstances where it is not appropriate to participate in this study

Trial locations and contacts

1 site in 1 country.

China1 site

  • Tianjin Nankai Hospital

    Tianjin, Tianjin Municipality, 300000

Other trials in China

About this study

Official title: Effect of Transcutaneous Acupoint Electrical Stimulation on Postoperative Spontaneous Voiding for Laparoscopic Cholecystectomy Patients：A Randomized Clinical Trial

  1. Title: Effect of Transcutaneous Acupoint Electrical Stimulation on postoperative spontaneous voiding for Laparoscopic Cholecystectomy patients：A Randomized Clinical Trial
  2. Research center: Multicenter
  3. Design of the research: A randomized, double-blind and parallel controlled study
  4. Object of the research: Patients （40≤age<75 years）planing to elective laparoscopic cholecystectomy under general anesthesia without preoperative placement of catheter.
  5. Sample size of the research: A total of 1,200 patients,600 cases in each group
  6. Interventions: The acupuncture points for Transcutaneous Acupoint Electrical Stimulation(TAES) are Zhongji ( CV3),Guanyuan ( CV4),Sanyinjiao ( SP6) and Ciliao ( BL32) points . In treatment group patients are treated with low-frequency pulse electroacupuncture stimulation apparatus (HANS G6805-2, Huayi Co, Shanghai, China) at bilateral of SP6 and BL 32 points during the operation,and treated with a similar method at CV6 and CV4 acupoints for 45 minutes in postanesthesia Care Unit. Each devic is connected and maintained after "Deqi". Participants in the control group received nonacupoints (located 1 inch beside acupoints) and avoided manual stimulation and no "Deqi" without actual current output.
  7. Aim of the research: Evaluate the effect of TAES on the postoperative spontaneous voiding in patients for Laparoscopic Cholecystectomy (LC ).
  8. Outcome：Primary outcomes: The time of the first spontaneous voiding after surgery . Secondary outcomes: symptoms of postoperative voiding, the incidence of Postoperative dysuria,postoperative catheterization rate, catheterization time, incidence of related complications,as well as the effects on postoperative NRS pain and sleep quality scores etc.
  9. The estimated duration of the study：2 years.
Read the detailed description

This study is a large sample, randomized, double-blinded, placebo-controlled and long-term follow-up design. In this study, bilateralZhongji ( CV3),Guanyuan ( CV4),Sanyinjiao ( SP6) and Ciliao ( BL32) points were selected for perioperative TAES treatment, accompanied with evaluating the postoperative spontaneous voiding, the incidence of Postoperative dysuria,postoperative catheterization rate, as well as the effects on postoperative NRS pain and sleep quality scores . To clarify the effect of TAES on the postoperative spontaneous voiding in patients for laparoscopic surgery is of great significance to the clinical applications and popularization of traditional acupuncture treatment perioperatively across the world.

Being tested
TAES treatmen, Sham TAES treatmen
Keywords
Laparoscopic Cholecystectomy, Transcutaneous Acupoint Electrical Stimulation, Postoperative spontaneous voiding, Postoperative Dysuria

What participants receive

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

  • TAES treatmenDevice

    In the acupoints group patients are treated with low-frequency pulse electroacupuncture stimulation apparatus (HANS G6805-2, Huayi Co, Shanghai, China) at SP6 and BL 32 points during the operation in the operating room ,and at CV3 and CV4 acupoints for 45 minutes in postanesthesia Care Unit. After "Deqi", electroacupuncture stimulation apparatus is connected with the density wave (2/100 Hz), width 0.25 ms, intensity of 1 ~ 30 milliamp (mA) (gradually increase to the patient's maximum tolerance) and maintained until the end of treatment.

  • Sham TAES treatmenDevice

    Participants in the acupoints group receive shallow acupointing at SP6, BL 32 ,CV3 and CV4 (nonacupoints located 1 inch beside acupoints, about 20mm).Specifically, the acupoint is shamed without manual stimulation and "Deqi" and the stimulation apparatus is inefficiency without actual current output .

Study groups in NCT03631160
Study groupRoleWhat they receive
TAES treatmentExperimentalPatients in the treatment group receive Transcutaneous Acupoint Electrical Stimulation (TAES) at Zhongji ( CV3),Guanyuan ( CV4), bilaterally Sanyinjiao ( SP6) and bilaterally Ciliao ( BL32) points by electroacupuncture stimulation apparatus (HANS G6805-2, Huayi Co, Shanghai, China).After "Deqi", electroacupuncture stimulation apparatus (HANS G6805-2, Huayi Co, Shanghai, China) is connected and maintained until the end of treatment.
Receives: Device: TAES treatmen
Sham TAES treatmentSham comparatorParticipants in the control group receive shallow TAES at SP6, BL32 ,CV3 and CV4 (nonacupoints located 1 inch beside acupoints, about 20mm). Specifically, the acuponit is shamed without manual stimulation and "Deqi" and the stimulation apparatus is inefficiency without actual current output.
Receives: Device: Sham TAES treatmen

What is being measured

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

  1. The first spontaneous voiding after surgery

    Record the time from the end of the procedure to the patient's first spontaneous postoperatively, and record the amount of urine and discomfort

    Measured: an average of 1 year

Secondary outcomes (7)

  1. symptoms of postoperative voiding

    The number of urination, total urine output and possible urinary discomfort symptoms during the perioperative period

    Measured: an average of 1 year

  2. postoperative catheterization rate

    The incidence of catheterization in patients who were unable to urinate for a long time after surgery

    Measured: 12 months

  3. Incidence Urinary tract complications after surgery (including re-hospitalization)

    Urinary retention, urinary incontinence, hematuria, urinary tract infection, etc.

    Measured: an average of 1 year

  4. NRS pain scores

    NRS method is used to evaluate the pain scores of patients (0 points to complete Painless, 10 points to the maximum pain that can be tolerated) The NRS method was used to evaluate the pain scores of patients at resting state and activity (cough) 6-8 hours after operation.

    Measured: 12 months

  5. Anxiety and depression assessment

    Using Hospital Anxiety and Depression Scale (HADS) to evaluate perioperative anxiety and depression of patients.HADS includes two scales of anxiety and depression, of which 0-7 is negative, 8-10 is mild, 11-14 is moderate, and 15-21 is severe.

    Measured: an average of 1 year

  6. The effects on postoperative sleep quality scores

    Using the NRS method (0 for the best quality of sleep and 10 for the worst quality of sleep)

    Measured: 12 months

  7. Length of stay in hospital after surgery

    The hospitalization time from the patient's surgery to the time of discharge (excluding re-hospitalization)

    Measured: an average of 1 year

Timeline

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

  1. First posted15 Aug 2018
  2. Study start20 Aug 2018
  3. Primary completion21 Jun 2020
  4. Study completion24 Aug 2020

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
Model description
patients undergoing elective laparoscopy cholecystectomy surgery were recruited and allocated into TEAS（transcutaneous electrical acupoint stimulation）group or control group
Masking
Triple blind
Who is masked
Participant, Care provider, Outcomes assessor
Enrolment
1,948 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03631160
Sponsor's protocol ID
TianjinNH Clinic
Status last verified
May 2021
First submitted
2 Jul 2018
Last updated
25 May 2021
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: All of the individual participant data collected during the trial,after deidentification will be shared.And anyone who wishes to acess the date will be available for any purpose.

Publications

  • Liu Z, Liu Y, Xu H, He L, Chen Y, Fu L, Li N, Lu Y, Su T, Sun J, Wang J, Yue Z, Zhang W, Zhao J, Zhou Z, Wu J, Zhou K, Ai Y, Zhou J, Pang R, Wang Y, Qin Z, Yan S, Li H, Luo L, Liu B. Effect of Electroacupuncture on Urinary Leakage Among Women With Stress Urinary Incontinence: A Randomized Clinical Trial. JAMA. 2017 Jun 27;317(24):2493-2501. doi: 10.1001/jama.2017.7220.

    PubMed 28655016

  • Arvidsdotter T, Marklund B, Taft C. Six-month effects of integrative treatment, therapeutic acupuncture and conventional treatment in alleviating psychological distress in primary care patients--follow up from an open, pragmatic randomized controlled trial. BMC Complement Altern Med. 2014 Jun 30;14:210. doi: 10.1186/1472-6882-14-210.

    PubMed 24980440

  • Chao AS, Chao A, Wang TH, Chang YC, Peng HH, Chang SD, Chao A, Chang CJ, Lai CH, Wong AMK. Pain relief by applying transcutaneous electrical nerve stimulation (TENS) on acupuncture points during the first stage of labor: a randomized double-blind placebo-controlled trial. Pain. 2007 Feb;127(3):214-220. doi: 10.1016/j.pain.2006.08.016. Epub 2006 Oct 6.

    PubMed 17030438

  • Zigmond AS, Snaith RP. The hospital anxiety and depression scale. Acta Psychiatr Scand. 1983 Jun;67(6):361-70. doi: 10.1111/j.1600-0447.1983.tb09716.x.

    PubMed 6880820

  • Lee SJ, Hyung WJ, Koo BN, Lee JY, Jun NH, Kim SC, Kim JW, Liu J, Kim KJ. Laparoscopy-assisted subtotal gastrectomy under thoracic epidural-general anesthesia leading to the effects on postoperative micturition. Surg Endosc. 2008 Mar;22(3):724-30. doi: 10.1007/s00464-007-9475-6.

    PubMed 17661136

  • Partelli S, Barugola G, Sartori A, Crippa S, Falconi M, Ruffo G. Single-incision laparoscopic cholecystectomy versus traditional laparoscopic cholecystectomy performed by a single surgeon: findings of a randomized trial. Surg Today. 2016 Mar;46(3):313-8. doi: 10.1007/s00595-015-1182-7. Epub 2015 Jun 3.

    PubMed 26036221

  • Hata T, Noda T, Shimizu J, Hatano H, Dono K. Omitting perioperative urinary catheterization in laparoscopic cholecystectomy: a single-institution experience. Surg Today. 2017 Aug;47(8):928-933. doi: 10.1007/s00595-016-1454-x. Epub 2016 Dec 9.

    PubMed 27943036

  • Hawkes N. Cochrane reviews evidence on surgery for stress incontinence after controversy in Scotland. BMJ. 2015 Jul 2;351:h3578. doi: 10.1136/bmj.h3578. No abstract available.

    PubMed 26139091

  • Zhang YF, Li XY, Liu XY, Zhang Y, Gong LR, Shi J, Du SH, He SM, Li C, Li YT, Li N, Liu SS, Wu Y, Xie ZL, Pei ZC, Yu JB. Transcutaneous Electrical Acupoints Stimulation Improves Spontaneous Voiding Recovery After Laparoscopic Cholecystectomy: A Randomized Clinical Trial. World J Surg. 2023 May;47(5):1153-1162. doi: 10.1007/s00268-023-06924-7. Epub 2023 Feb 6.

    PubMed 36745198

Questions about this trial

What is this clinical trial studying?

A study testing TAES treatmen in people with Voiding Disorders, run by Tianjin Nankai Hospital at 1 site 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 3 inclusion and 6 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 25 May 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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. Some participants in this study may receive a placebo. 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 first spontaneous voiding after surgery (time frame: an average of 1 year). 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 NCT03631160, which also lists 9 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 25 May 2021.

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