Clinical trial NCT05053373: Evaluation of Integrated Optimization Schemes for Female Stress Incontinence
Official title: Evaluation of Integrated Optimization Schemes for Female Stress Incontinence
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stress Urinary Incontinence in Women
Keywords: Stress Urinary Incontinence; Acupuncture
Lead sponsor: Shanghai Yueyang Integrated Medicine Hospital
Sponsor class: OTHER
First posted: 2021-09-22
Enrollment: 358
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is to determine the effectiveness of PFMT added to EA vs PFMT added sham EA for SUI in women.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Women who are 40-75 years of age
* Involuntary leakage of urine during increased intra-abdominal pressure in the absence of a bladder contraction, such as coughing, sneezing, or other physical activities
* a 1-hour pad test exceeds 1 g
* no other treatments are administered for urinary incontinence currently

Exclusion Criteria:

* Subject has urgency and mixed urinary
* Subjects with pelvic organ prolapse, pregnancy, a history of pelvic surgery, chronic respiratory diseases, urinary tract infection, cardiac pacemaker installation, metal allergy, severe needle fear, and currently taking medications for SUI or psychological disorders.

Primary outcomes:
measure: The change of urine loss
timeFrame: 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.
Secondary outcomes:
measure: The average 24-hour urinary incontinence episodes and reduction of more than 50%
timeFrame: 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.
measure: The International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF) scores
timeFrame: The evaluation will be performed at baseline, weeks 4, 6, 8 of treatment, and weeks 20 and 32 of follow-up.
measure: Participants using urine pads
timeFrame: week 2-8, week 17-20, week 29-32
measure: severity of urinary incontinence
timeFrame: weeks 2, 4, 6, and 8
measure: Subjective self-evaluation of therapeutic effects
timeFrame: week 2, week 4, week 6, week 8, week 20, week 32
measure: Incidence of adverse events
timeFrame: the 1-8 weeks
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Department of Acupuncture and Moxibustion, Nanjing Hospital of Chinese Medicine, Nanjing University of Chinese Medicine
state: Jiangsu
city: Xi'an
country: China
facility: Department of Acupuncture and Moxibustion, Shaanxi Hospital of Traditional Chinese Medicine
state: Shaanxi
city: Shanghai
country: China
facility: Department of Acupuncture and Moxibustion, Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine
state: Shanghai
city: Tianjin
country: China
facility: Department of Acupuncture and Moxibustion, First Teaching Hospital of Tianjin University of Traditional Chinese Medicine
state: Tianjin
Study officials:
affiliation: Yueyang Hospital of Integrated Traditional Chinese and Western Medicine
name: Yuelai Chen, Doctor
role: STUDY_CHAIR
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