Optimized Acupuncture Treatment for Female Stress Urinary Incontinence

NCT05635669 | Recruiting DMC

• 1 other identifier: 22Y21920100
• Study Type: interventional
• Target: 360
• Locations: 1 country
• Sites: 1

Brief Summary

This multicenter randomized controlled trial is designed to explore a relatively suitable application of acupoint combinations and to provide certain clinical evidence for the optimization of acupuncture treatment of female SUI.

Conditions

Stress Urinary Incontinence

Outcome Measures

Primary Outcomes (1)

• The change of urine leakage measured by the 1-hour pad test

  Quantity of fluid loss will be measured by 1-hour pad test, compared with the baseline (week 0).

  Week 6

Secondary Outcomes (17)

• The change of mean episodes of urinary incontinence in 72 hours

  Week 4, 6, 18, 30, 42 and 54

• The change of International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF)

  Week 4, 6, 18, 30, 42 and 54

• Severity of SUI according to '72 hours bladder diary'

  Week 4, 6, 18, 30, 42 and 54

• Participant Self-evaluation of Therapeutic Effects

  Week 4, 6, 18, 30, 42 and 54

• The number of patients who used other treatment for SUI

  Week 18, 30, 42 and 54

Study Arms (3)

Sacral acupoints group (Sacral group)

EXPERIMENTAL

Participants will receive sacral acupoints combination treatment at bilaterally Huiyang(BL35) and Zhongliao(BL33) with prone position during the whole treatment course.

Device: Sacral acupoints acupuncture

Abdominal acupoints group (Abdominal group)

EXPERIMENTAL

Participants will receive abdominal acupoints combination treatment at unilateral Zhongji(RN3), Guanyuan(RN4) and bilaterally Dahe(KI12) with dorsal position during the whole treatment course.

Device: Abdominal acupoints acupuncture

Alternating acupoints group (Alternating group)

EXPERIMENTAL

Participants will receive treatment of sacral acupoints combination and abdominal acupoints combination alternately. (For example, A for the first time, B for the second time, A for the third time, and so on. )

Device: Alternating acupoints acupuncture

Interventions

Sacral acupoints acupuncture DEVICE

Before treatment, the participants will be asked to go to the toilet. All treatments will be performed after skin disinfection. As acupuncture needles are inserted, all points will be lifted, twisted, and stabbed to activate the sensation of de qi. The electroacupuncture stimulation lasted for 30 minutes with a continuous wave of 50 Hz and a current intensity of 1 to 5 mA (preferably with the skin around the acupoints shivering mildly without pain). Participants will receive three treatments per week (every other day), each lasting 30 minutes, for a total of 18 sessions over the course of 6 weeks. The follow-up sessions are on week 18, 30, 42 and 54. In this group, paired electrodes from the electroacupuncture apparatus were attached transversely to the needle handles at bilateral Huiyang(BL35) and Zhongliao(BL33) .

Sacral acupoints group (Sacral group)

Abdominal acupoints acupuncture DEVICE

Before treatment, the participants will be asked to go to the toilet. All treatments will be performed after skin disinfection. As acupuncture needles are inserted, all points will be lifted, twisted, and stabbed to activate the sensation of de qi. The electroacupuncture stimulation lasted for 30 minutes with a continuous wave of 50 Hz and a current intensity of 1 to 5 mA (preferably with the skin around the acupoints shivering mildly without pain). Participants will receive three treatments per week (every other day), each lasting 30 minutes, for a total of 18 sessions over the course of 6 weeks. The follow-up sessions are on week 18, 30, 42 and 54. In this group, paired electrodes from the electroacupuncture apparatus were attached to the needle handles respectively at Zhongji(RN3) and one side of Dahe(KI12), as well as Guanyuan(RN4) and another side of Dahe(KI12).

Abdominal acupoints group (Abdominal group)

Alternating acupoints acupuncture DEVICE

Before treatment, the participants will be asked to go to the toilet. All treatments will be performed after skin disinfection. As acupuncture needles are inserted, all points will be lifted, twisted, and stabbed to activate the sensation of de qi. The electroacupuncture stimulation lasted for 30 minutes with a continuous wave of 50 Hz and a current intensity of 1 to 5 mA (preferably with the skin around the acupoints shivering mildly without pain). Participants will receive three treatments per week (every other day), each lasting 30 minutes, for a total of 18 sessions over the course of 6 weeks. The follow-up sessions are on week 18, 30, 42 and 54. The application of electroacupuncture is the same as Sacral group and Abdominal group.

Alternating acupoints group (Alternating group)

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with mild to moderate SUI mentioned in the diagnostic criteria above;
• Aged 40～75 years;
• Sign the informed consent.

You may not qualify if:

• Other types of urinary incontinence (urgent, overflow or mixed).
• History of urinary incontinence surgery or pelvic floor surgery;
• Pelvic organ prolapse ≥ stage II;
• Symptomatic urinary tract infection;
• Residual urine volume \> 30 mL;
• Maximum urinary flow rate \< 20ml/s.
• Limitation of movement (walk and/or run and/or climb stairs);
• Patients who have been using drugs that may affect bladder function or receiving SUI specialized treatment;
• Severe cardiovascular, cerebral, liver, kidney and hematopoietic system disease, mental disorders, diabetes, multiple system atrophy, cauda equina neuropathy and spinal cord disease;
• Pregnancy or lactation period.
• With cardiac pacemaker, acupuncture phobia or metal allergies;

Sponsors & Collaborators

• Yin Ping: lead
• Longhua Hospital: collaborator

Study Sites (1)

Longhua Hospital Shanghai University of Traditional Chinese Medicine

Shanghai, China

RECRUITING

Related Publications (5)

• Yang N, Ge X, Ye J, Liu Q, Wu Y, Yan H, Han X. Efficacy of acupuncture for urinary incontinence in middle-aged and elderly women: A systematic review and meta-analysis of randomized controlled trials. Eur J Obstet Gynecol Reprod Biol. 2021 Feb;257:138-143. doi: 10.1016/j.ejogrb.2020.11.001. Epub 2020 Nov 4.

  PMID: 33419589 BACKGROUND

• 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.

  PMID: 28655016 BACKGROUND

• Nambiar AK, Arlandis S, Bo K, Cobussen-Boekhorst H, Costantini E, de Heide M, Farag F, Groen J, Karavitakis M, Lapitan MC, Manso M, Arteaga SM, Riogh ANA, O'Connor E, Omar MI, Peyronnet B, Phe V, Sakalis VI, Sihra N, Tzelves L, van Poelgeest-Pomfret ML, van den Bos TWL, van der Vaart H, Harding CK. European Association of Urology Guidelines on the Diagnosis and Management of Female Non-neurogenic Lower Urinary Tract Symptoms. Part 1: Diagnostics, Overactive Bladder, Stress Urinary Incontinence, and Mixed Urinary Incontinence. Eur Urol. 2022 Jul;82(1):49-59. doi: 10.1016/j.eururo.2022.01.045. Epub 2022 Feb 23.

  PMID: 35216856 BACKGROUND

• Guan LX, Song XL, Wang X, Zhang X, Liu LM, Chen BL, Chen YL. Immediate effects of Zhongji point acupuncture on pelvic floor structure in female patients with stress urinary incontinence: a randomized, single-blind, and sham-controlled clinical trial protocol. Ann Palliat Med. 2021 Jul;10(7):8292-8299. doi: 10.21037/apm-21-662. Epub 2021 Jul 2.

  PMID: 34263647 BACKGROUND

• Liu L, Chen B, Si X, Hou W, Fan Q, Li X, Li J, Ming S, Yin P, Chen Y. Optimized electroacupuncture treatment for female stress urinary incontinence: study protocol for a multi-center randomized controlled trial. Front Psychiatry. 2023 Aug 17;14:1228131. doi: 10.3389/fpsyt.2023.1228131. eCollection 2023.

  PMID: 37663593 DERIVED

MeSH Terms

Conditions

Urinary Incontinence, Stress

Condition Hierarchy (Ancestors)

Urinary Incontinence; Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• YUELAI CHEN

  Shanghai University of Traditional Chinese Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

PING YIN

CONTACT

086-18917561621; bingxue616@163.com

YUELAI CHEN

CONTACT

0086-13020193726; chenyuelai@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Shanghai University of Traditional Chinese Medicine

Study Record Dates

• First Submitted: November 12, 2022
• First Posted: December 2, 2022
• Study Start: January 4, 2023
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: May 22, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)