Clinical trial NCT05635669: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Stress Urinary Incontinence
Lead sponsor: Shanghai University of Traditional Chinese Medicine
Sponsor class: OTHER
Collaborators: name: Longhua Hospital
First posted: 2022-12-02
Enrollment: 360
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

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;

Primary outcomes:
measure: The change of urine leakage measured by the 1-hour pad test
timeFrame: Week 6
Secondary outcomes:
measure: The change of mean episodes of urinary incontinence in 72 hours
timeFrame: Week 4, 6, 18, 30, 42 and 54
measure: The change of International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF)
timeFrame: Week 4, 6, 18, 30, 42 and 54
measure: Severity of SUI according to '72 hours bladder diary'
timeFrame: Week 4, 6, 18, 30, 42 and 54
measure: Participant Self-evaluation of Therapeutic Effects
timeFrame: Week 4, 6, 18, 30, 42 and 54
measure: The number of patients who used other treatment for SUI
timeFrame: Week 18, 30, 42 and 54
measure: Bladder neck mobility by pelvic floor ultrasonography
timeFrame: Week 6
measure: Urethral rotation angle by pelvic floor ultrasonography
timeFrame: Week 6
measure: Retrovesical angle by pelvic floor ultrasonography
timeFrame: Week 6
measure: Lowest point of bladder by pelvic floor ultrasonography
timeFrame: Week 6
measure: Urethral funnel formation by pelvic floor ultrasonography
timeFrame: Week 6
measure: The type of bladder bulging by pelvic floor ultrasonography
timeFrame: Week 6
measure: Subgroup analysis: correlation between 1-hour pad test and severity of SUI
timeFrame: Week 6
measure: Subgroup analysis: correlation between episodes of urinary incontinence in 72 hours and severity of SUI
timeFrame: Week18, 30, 42 and 54
measure: Number of urine pads used weekly
timeFrame: Week 4, 6, 18, 30, 42 and 54
measure: Incidence of adverse events
timeFrame: Week 1-6
measure: Evaluation of discomfort during treatment
timeFrame: Within 5 minutes after the first and ninth acupuncture treatment
measure: Patient acceptability evaluation
timeFrame: Within 5 minutes after the first and ninth acupuncture treatment
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Longhua Hospital Shanghai University of Traditional Chinese Medicine
Study officials:
affiliation: Shanghai University of Traditional Chinese Medicine
name: YUELAI CHEN
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.