Optimized Acupuncture Treatment for Female Stress Urinary Incontinence
ConditionStress Urinary Incontinence
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age40-75
SponsorYin Ping
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients with mild to moderate SUI mentioned in the diagnostic criteria above;
Aged 40～75 years;
Sign the informed consent.
Disqualifiers
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;
Trial design
Design model
Parallel
Treatments tested in this trial
Sacral acupoints acupuncture
DeviceBefore 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
DeviceBefore 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
DeviceBefore 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.
Treatment groups
360 Participants
are divided into 3 treatment groupsGroup A: Sacral acupoints group (Sacral group)Experimental treatment 1 intervention
Group B: Abdominal acupoints group (Abdominal group)Experimental treatment 1 intervention
Group C: Alternating acupoints group (Alternating group)Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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).
Time frame
Week 6Secondary outcomes
1
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).
Time frame
Week 4, 6, 18, 30, 42 and 542
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).
Time frame
Week 4, 6, 18, 30, 42 and 543
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.
Time frame
Week 4, 6, 18, 30, 42 and 544
Participant Self-evaluation of Therapeutic Effects
No help=0; Small help=1; Medium help=2; Great help=3
Time frame
Week 4, 6, 18, 30, 42 and 54Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Yin Ping
Lead sponsor
Shanghai University of Traditional Chinese Medicine
Sponsor institution
Longhua Hospital
Collaborator
Source ClinicalTrials.gov