The aim of this study is to determine the effectiveness of PFMT added to EA vs PFMT added sham EA for SUI in women.
We will perform a multicenter, randomized, double-blind, sham-controlled, parallel-group clinical trial in four hospitals in China to compare the effectiveness of EA added to PFMT vs sham EA added to PFMT for women with SUI. The participated women with SUI will be recruited from four participating hospitals or through community clinics by advertising. Participated hospitals include: Yueyang Hospital of Integrated Traditional Chinese and Western Medicine Affiliated to Shanghai University of Traditional Chinese Medicine (Shanghai, China); Shaanxi Hospital of Traditional Chinese Medicine (Xi'an, China); First Teaching Hospital of Tianjin University of Traditional Chinese Medicine (Tianjin, China); and Nanjing Hospital of Chinese Medicine Affiliated to Nanjing University of Chinese Medicine (Nanjing, China). Patients will be screened for eligibility. Chief complaint, medical history, and general characteristics (such as age, race, education level, body mass index, manner of child delivery, menopause) will be obtained. Those who met inclusion criteria and are interested in participating in the study will sign an informed consent form and then make another appointment to complete the baseline data collection, including the 72-hr bladder diary, 1-h pad test, International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF) score, the weekly mean number of urine pads used). Participants will then be assigned randomly to either a PFMT (3 sets/day for 8 weeks) + EA (3 times per week for 8 weeks) group or a PFMT + sham EA group. The primary and secondary outcome will be measured from week 2 to 32. The participant-reported severity of UI and subjective self-evaluation of therapeutic effects will be recorded. Written informed consent will be obtained from all participants before they are included in the study. All clinical investigations will be conducted according to the principles of the Declaration of Helsinki.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
358
Department of Acupuncture and Moxibustion, Nanjing Hospital of Chinese Medicine, Nanjing University of Chinese Medicine
Nanjing, Jiangsu, China
Department of Acupuncture and Moxibustion, Shaanxi Hospital of Traditional Chinese Medicine
Xi'an, Shaanxi, China
Department of Acupuncture and Moxibustion, Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine
Shanghai, Shanghai Municipality, China
The change of urine loss
The change of urine loss is measured by the 1-hour urine pad test. The 1-hour pad test will be performed as follows: 1) Empty the bladder and wear a preweighted pad. 2) Drink 500 ml of sodium-free liquid in 15 minutes; 3) walk for half hours, including going up and down stairs; 4) perform the following activity in the remaining 30 minutes: squat and stand up 10 times; cough hard 10 times; run in place for 1 minute; bend down to pick up a small object on the ground 5 times; wash hands for 1 minute with running water. 5) Weigh the pad again to calculate the urine leakage (1 gram equivalent to 1 ml of urine).
Time frame: The evaluation will be performed when the participants are first distributed into the groups as a baseline, and then at weeks 2, 4, 6 and 8 of treatment.
The average 24-hour urinary incontinence episodes and reduction of more than 50%
The average 24-hour urinary incontinence episodes and reduction of more than 50% measured by a urinary diary. Reduction more than 50% in urine leakage at week 8 from baseline measured by the 1-hour pad test.
Time frame: The average 24-hour urinary incontinence episodes and reduction of more than 50% at weeks 2, 4, 6, and 8 of treatment measured by a urinary diary. Reduction more than 50% in urine leakage at week 8 from baseline measured by the 1-hour pad test.
The International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF) scores
The International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF) scores (range, 0 \[best\]-21\[worst\]), which is recommended by the International Consultation on Urological Diseases (ICUD) to evaluate the frequency and volume of urinary incontinence and its impact on quality of life
Time frame: The evaluation will be performed at baseline, weeks 4, 6, 8 of treatment, and weeks 20 and 32 of follow-up.
Participants using urine pads
The numbers of participants using urine pads and weekly mean pads usage measured by a urinary diary.
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Department of Acupuncture and Moxibustion, First Teaching Hospital of Tianjin University of Traditional Chinese Medicine
Tianjin, Tianjin Municipality, China
Time frame: week 2-8, week 17-20, week 29-32
severity of urinary incontinence
The participant-reported severity of urinary incontinence at weeks 2, 4, 6, and 8 of treatment (mild leaking, several drops; moderate leaking,wet through underwear; severe leaking, wet through trousers)
Time frame: weeks 2, 4, 6, and 8
Subjective self-evaluation of therapeutic effects
3 point scoring: totally unhelpful=0, minimally helpful=1, moderately helpful=2, very helpful=3
Time frame: week 2, week 4, week 6, week 8, week 20, week 32
Incidence of adverse events
subcutaneous edema, fatigue, severe pain, palpitations, etc.
Time frame: the 1-8 weeks