Optimized Acupuncture Treatment for Female Stress Urinary Incontinence

Stress Urinary Incontinence Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05635669
• Other study ID #: 22Y21920100
• Status: Recruiting
• Phase: N/A
• Start date: January 4, 2023
• Est. completion date: November 2025

Study information

• Verified date: May 2024
• Source: Shanghai University of Traditional Chinese Medicine
• Contact: PING YIN
• Phone: 086-18917561621
• Email: bingxue616[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 360
• Est. completion date: November 2025
• Est. primary completion date: November 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 40 Years to 75 Years

Eligibility

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;

Related Conditions & MeSH terms

• Enuresis
• Stress Urinary Incontinence
• Urinary Incontinence
• Urinary Incontinence, Stress

Intervention

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 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) .
• 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 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).
• 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 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.

Locations

Country	Name	City	State
China	Longhua Hospital Shanghai University of Traditional Chinese Medicine	Shanghai

Sponsors (2)

Lead Sponsor	Collaborator
Shanghai University of Traditional Chinese Medicine	Longhua Hospital

Country where clinical trial is conducted

China, 

References & Publications (4)

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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	The change of mean episodes of urinary incontinence in 72 hours	The mean episodes of urinary incontinence in 72 hours based on '72 hours bladder diary', comparing the value at week 4, 6, 18, 30, 42 and 54 with the baseline(week 0).	Week 4, 6, 18, 30, 42 and 54
Secondary	The change of International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF)	ICIQ-SF is a brief instrument used to assess the frequency of incontinence, the volume of incontinence, as well as the impact of life quality). The value will be recorded at week 4, 6, 18, 30, 42 and 54, compared to that at baseline(week 0).	Week 4, 6, 18, 30, 42 and 54
Secondary	Severity of SUI according to '72 hours bladder diary'	The severity of SUI will be rated according to the amount of UI in usual conditions without extreme activities like severe cough, strenuous exercise or carrying heavy loads in the past 72 hours. Definition: mild(several drops of leakage);moderate(leak that soaked through underwear); severe(leak that soaked through outerwear). In case that participants worn urinal pads, the severity of SUI will be graded as follows. Mild(several drops of leakage); moderate(soaked urine pads in patches by several leakages); severe(soaked urine pads in patches by one leakage). The most severe degree of urine leakage in patient's 72 hours bladder diaries over the assessment period will be selected as the severity of SUI for analyses.	Week 4, 6, 18, 30, 42 and 54
Secondary	Participant Self-evaluation of Therapeutic Effects	No help=0; Small help=1; Medium help=2; Great help=3	Week 4, 6, 18, 30, 42 and 54
Secondary	The number of patients who used other treatment for SUI	Compare the number of patients who used other specialty therapy for SUI during the study between 3 groups.	Week 18, 30, 42 and 54
Secondary	Bladder neck mobility by pelvic floor ultrasonography	Bladder neck mobility will be observed both at rest and during a Valsalva maneuver by pelvic floor ultrasonography. The result can be measured from the ultrasonic image.	Week 6
Secondary	Urethral rotation angle by pelvic floor ultrasonography	Urethral rotation angle will be observed both at rest and during a Valsalva maneuver by pelvic floor ultrasonography. The result can be measured from the ultrasonic image.	Week 6
Secondary	Retrovesical angle by pelvic floor ultrasonography	Retrovesical angle will be observed both at rest and during a Valsalva maneuver by pelvic floor ultrasonography. The result can be measured from the ultrasonic image.	Week 6
Secondary	Lowest point of bladder by pelvic floor ultrasonography	Lowest point of bladder at rest and during a Valsalva maneuver by pelvic floor ultrasonography. The result can be observed from the ultrasonic image.	Week 6
Secondary	Urethral funnel formation by pelvic floor ultrasonography	Urethral funnel formation at rest and during a Valsalva maneuver by pelvic floor ultrasonography. The result can be observed from the ultrasonic image.	Week 6
Secondary	The type of bladder bulging by pelvic floor ultrasonography	The type of bladder bulging at rest and during a Valsalva maneuver by pelvic floor ultrasonography. The result can be observed from the ultrasonic image.	Week 6
Secondary	Subgroup analysis: correlation between 1-hour pad test and severity of SUI	Analyze the correlation between 1-hour pad test and severity of SUI.	Week 6
Secondary	Subgroup analysis: correlation between episodes of urinary incontinence in 72 hours and severity of SUI	Analyze the correlation between episodes of urinary incontinence in 72 hours and severity of SUI.	Week18, 30, 42 and 54
Secondary	Number of urine pads used weekly	The weekly consumption of urine pads was assessed in participants.	Week 4, 6, 18, 30, 42 and 54
Secondary	Incidence of adverse events	Observe the incidence of adverse events during the treatment.	Week 1-6
Secondary	Evaluation of discomfort during treatment	Visual analog scale (VAS) will be used to evaluate the degree of discomfort during treatment. The scale ranging from 0 to 10cm, with 0cm indicating no discomfort and 10cm indicating severe discomfort. Evaluation time: The average value of the first and ninth acupuncture treatments was taken within 5 minutes after the end of the two treatments. If the VAS value is missing in one of the cases, another is taken as the result.	Within 5 minutes after the first and ninth acupuncture treatment
Secondary	Patient acceptability evaluation	0=very difficult to accept, 1=slightly difficult to accept, 2=acceptable, 3=easy to accept, 4=very easy to accept. Evaluation time: The average value of the first and ninth acupuncture treatments was taken within 5 minutes after the end of the two treatments. If the VAS value is missing in one of the cases, another is taken as the result.	Within 5 minutes after the first and ninth acupuncture treatment