Back to resultsOptimized Acupuncture Treatment for Female Stress Urinary Incontinence
Primary Purpose
Stress Urinary Incontinence
Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Sacral acupoints acupuncture
Abdominal acupoints acupuncture
Alternating acupoints acupuncture
Sponsored by
About this trial
This is an interventional treatment trial for Stress Urinary Incontinence
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;
Sites / Locations
- Longhua Hospital Shanghai University of Traditional Chinese MedicineRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
Sacral acupoints group (Sacral group)
Abdominal acupoints group (Abdominal group)
Alternating acupoints group (Alternating group)
Arm Description
Participants will receive sacral acupoints combination treatment at bilaterally Huiyang(BL35) and Zhongliao(BL33) with prone position during the whole treatment course.
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.
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. )
Outcomes
Primary Outcome Measures
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).
Secondary Outcome Measures
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).
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).
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.
Participant Self-evaluation of Therapeutic Effects
No help=0; Small help=1; Medium help=2; Great help=3
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.
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.
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.
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.
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.
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.
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.
Subgroup analysis: correlation between 1-hour pad test and severity of SUI
Analyze the correlation between 1-hour pad test and severity of SUI.
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.
Number of urine pads used weekly
The weekly consumption of urine pads was assessed in participants.
Incidence of adverse events
Observe the incidence of adverse events during the treatment.
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.
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.
Full Information
NCT ID
NCT05635669
First Posted
November 12, 2022
Last Updated
March 10, 2023
Sponsor
Shanghai University of Traditional Chinese Medicine
Collaborators
Longhua Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05635669
Brief Title
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
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
January 4, 2023 (Actual)
Primary Completion Date
March 2024 (Anticipated)
Study Completion Date
March 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shanghai University of Traditional Chinese Medicine
Collaborators
Longhua Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stress Urinary Incontinence
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
360 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Sacral acupoints group (Sacral group)
Arm Type
Experimental
Arm Description
Participants will receive sacral acupoints combination treatment at bilaterally Huiyang(BL35) and Zhongliao(BL33) with prone position during the whole treatment course.
Arm Title
Abdominal acupoints group (Abdominal group)
Arm Type
Experimental
Arm Description
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.
Arm Title
Alternating acupoints group (Alternating group)
Arm Type
Experimental
Arm Description
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. )
Intervention Type
Device
Intervention Name(s)
Sacral acupoints acupuncture
Intervention Description
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) .
Intervention Type
Device
Intervention Name(s)
Abdominal acupoints acupuncture
Intervention Description
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).
Intervention Type
Device
Intervention Name(s)
Alternating acupoints acupuncture
Intervention Description
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.
Primary Outcome Measure Information:
Title
The change of urine leakage measured by the 1-hour pad test
Description
Quantity of fluid loss will be measured by 1-hour pad test, compared with the baseline (week 0).
Time Frame
Week 6
Secondary Outcome Measure Information:
Title
The change of mean episodes of urinary incontinence in 72 hours
Description
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).
Time Frame
Week 4, 6, 18, 30, 42 and 54
Title
The change of International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF)
Description
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).
Time Frame
Week 4, 6, 18, 30, 42 and 54
Title
Severity of SUI according to '72 hours bladder diary'
Description
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.
Time Frame
Week 4, 6, 18, 30, 42 and 54
Title
Participant Self-evaluation of Therapeutic Effects
Description
No help=0; Small help=1; Medium help=2; Great help=3
Time Frame
Week 4, 6, 18, 30, 42 and 54
Title
The number of patients who used other treatment for SUI
Description
Compare the number of patients who used other specialty therapy for SUI during the study between 3 groups.
Time Frame
Week 18, 30, 42 and 54
Title
Bladder neck mobility by pelvic floor ultrasonography
Description
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.
Time Frame
Week 6
Title
Urethral rotation angle by pelvic floor ultrasonography
Description
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.
Time Frame
Week 6
Title
Retrovesical angle by pelvic floor ultrasonography
Description
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.
Time Frame
Week 6
Title
Lowest point of bladder by pelvic floor ultrasonography
Description
Lowest point of bladder at rest and during a Valsalva maneuver by pelvic floor ultrasonography. The result can be observed from the ultrasonic image.
Time Frame
Week 6
Title
Urethral funnel formation by pelvic floor ultrasonography
Description
Urethral funnel formation at rest and during a Valsalva maneuver by pelvic floor ultrasonography. The result can be observed from the ultrasonic image.
Time Frame
Week 6
Title
The type of bladder bulging by pelvic floor ultrasonography
Description
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.
Time Frame
Week 6
Title
Subgroup analysis: correlation between 1-hour pad test and severity of SUI
Description
Analyze the correlation between 1-hour pad test and severity of SUI.
Time Frame
Week 6
Title
Subgroup analysis: correlation between episodes of urinary incontinence in 72 hours and severity of SUI
Description
Analyze the correlation between episodes of urinary incontinence in 72 hours and severity of SUI.
Time Frame
Week18, 30, 42 and 54
Title
Number of urine pads used weekly
Description
The weekly consumption of urine pads was assessed in participants.
Time Frame
Week 4, 6, 18, 30, 42 and 54
Title
Incidence of adverse events
Description
Observe the incidence of adverse events during the treatment.
Time Frame
Week 1-6
Title
Evaluation of discomfort during treatment
Description
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.
Time Frame
Within 5 minutes after the first and ninth acupuncture treatment
Title
Patient acceptability evaluation
Description
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.
Time Frame
Within 5 minutes after the first and ninth acupuncture treatment
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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;
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
PING YIN
Phone
086-18917561621
Email
bingxue616@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
YUELAI CHEN
Phone
0086-13020193726
Email
chenyuelai@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
YUELAI CHEN
Organizational Affiliation
Shanghai University of Traditional Chinese Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Longhua Hospital Shanghai University of Traditional Chinese Medicine
City
Shanghai
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yuelai Chen
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
33419589
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.
Results Reference
background
PubMed Identifier
28655016
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.
Results Reference
background
PubMed Identifier
35216856
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.
Results Reference
background
PubMed Identifier
34263647
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.
Results Reference
background
Learn more about this trial
Optimized Acupuncture Treatment for Female Stress Urinary Incontinence
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