Optimized Acupuncture Treatment for Female Stress Urinary Incontinence

Official title

Optimized Acupuncture Treatment for Female Stress Urinary Incontinence: a Study Protocol for a Multicenter Randomized Controlled Trial

Overview

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.

Detailed description

Stress urinary incontinence (SUI) mainly refers to the involuntary leakage of urine when abdominal pressure increases, such as sneezing, coughing, laughing or exercise. According to epidemiological studies, the global median prevalence of female urinary incontinence is 27.6% (4.8%-58.4%), of which SUI accounts for more than 50%. Previous study have demonstrated that acupuncture intervention can reduce the urine leakage in pad test, decrease the ICIQ-SF score, so as to help the patients alleviate the symptoms and improve their quality of life. This multicenter randomized controlled trial set 3 groups. Patients will receive 3 different applications of acupoint combinations so that the optimization of acupuncture treatment of female SUI will be find.

Interventions

• Device Sacral acupoints acupuncture
  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
• Device Abdominal acupoints acupuncture
  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
• Device Alternating acupoints acupuncture
  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

Primary outcome measures

• The change of urine leakage measured by the 1-hour pad test [Time frame: Week 6]

Secondary outcome measures (12)

• The change of mean episodes of urinary incontinence in 72 hours [Time frame: Week 4, 6, 18, 30, 42 and 54]
• The change of International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF) [Time frame: Week 4, 6, 18, 30, 42 and 54]
• Severity of SUI according to '72 hours bladder diary' [Time frame: Week 4, 6, 18, 30, 42 and 54]
• Participant Self-evaluation of Therapeutic Effects [Time frame: Week 4, 6, 18, 30, 42 and 54]
• The number of patients who used other treatment for SUI [Time frame: Week 18, 30, 42 and 54]
• Bladder neck mobility by pelvic floor ultrasonography [Time frame: Week 6]
• Urethral rotation angle by pelvic floor ultrasonography [Time frame: Week 6]
• Retrovesical angle by pelvic floor ultrasonography [Time frame: Week 6]
• Lowest point of bladder by pelvic floor ultrasonography [Time frame: Week 6]
• Urethral funnel formation by pelvic floor ultrasonography [Time frame: Week 6]
• The type of bladder bulging by pelvic floor ultrasonography [Time frame: Week 6]
• Subgroup analysis: correlation between 1-hour pad test and severity of SUI [Time frame: Week 6]

Eligibility criteria

Inclusion criteria

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

Exclusion criteria

• 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;

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Double blind

Primary purpose

Treatment

Study locations

China · 1 center

• Longhua Hospital Shanghai University of Traditional Chinese Medicine — Shanghai

Publications

• 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
• 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
• 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 PMID 35216856
• 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
• 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

Identifiers

NCT: NCT05635669 · 22Y21920100

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗