Optimized Acupuncture Treatment for Female Stress Urinary Incontinence
- Conditions
- Stress Urinary Incontinence
- Interventions
- Device: Abdominal acupoints acupunctureDevice: Sacral acupoints acupunctureDevice: Alternating acupoints acupuncture
- Registration Number
- NCT05635669
- Lead Sponsor
- Yin Ping
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Female
- Target Recruitment
- 360
- Patients with mild to moderate SUI mentioned in the diagnostic criteria above;
- Aged 40～75 years;
- Sign the informed consent.
- 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;
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Abdominal acupoints group (Abdominal group) Abdominal acupoints acupuncture 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. Sacral acupoints group (Sacral group) Sacral acupoints acupuncture Participants will receive sacral acupoints combination treatment at bilaterally Huiyang(BL35) and Zhongliao(BL33) with prone position during the whole treatment course. Alternating acupoints group (Alternating group) Alternating acupoints acupuncture 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. )
- Primary Outcome Measures
Name Time Method The change of urine leakage measured by the 1-hour pad test Week 6 Quantity of fluid loss will be measured by 1-hour pad test, compared with the baseline (week 0).
- Secondary Outcome Measures
Name Time Method Urethral funnel formation by pelvic floor ultrasonography Week 6 Urethral funnel formation at rest and during a Valsalva maneuver by pelvic floor ultrasonography. The result can be observed from the ultrasonic image.
Participant Self-evaluation of Therapeutic Effects Week 4, 6, 18, 30, 42 and 54 No help=0; Small help=1; Medium help=2; Great help=3
The number of patients who used other treatment for SUI Week 18, 30, 42 and 54 Compare the number of patients who used other specialty therapy for SUI during the study between 3 groups.
Incidence of adverse events Week 1-6 Observe the incidence of adverse events during the treatment.
Severity of SUI according to '72 hours bladder diary' Week 4, 6, 18, 30, 42 and 54 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.
Lowest point of bladder by pelvic floor ultrasonography Week 6 Lowest point of bladder 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 Week 6 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 Week 6 Analyze the correlation between 1-hour pad test and severity of SUI.
Number of urine pads used weekly Week 4, 6, 18, 30, 42 and 54 The weekly consumption of urine pads was assessed in participants.
Evaluation of discomfort during treatment Within 5 minutes after the first and ninth acupuncture 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.
The change of mean episodes of urinary incontinence in 72 hours Week 4, 6, 18, 30, 42 and 54 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).
Urethral rotation angle by pelvic floor ultrasonography Week 6 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 Week 6 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.
The change of International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF) Week 4, 6, 18, 30, 42 and 54 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).
Bladder neck mobility by pelvic floor ultrasonography Week 6 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.
Subgroup analysis: correlation between episodes of urinary incontinence in 72 hours and severity of SUI Week18, 30, 42 and 54 Analyze the correlation between episodes of urinary incontinence in 72 hours and severity of SUI.
Patient acceptability evaluation Within 5 minutes after the first and ninth acupuncture treatment 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.
Trial Locations
- Locations (1)
Longhua Hospital Shanghai University of Traditional Chinese Medicine
🇨🇳Shanghai, China