Construction of the Early Warning and Prevention System for Urinary Incontinence in the Elderly--the Effect of a New Type of Pelvic Floor Rehabilitation Device PHENIX U4+ on the Treatment of Urinary Incontinence--a Multi-center Randomized Controlled Clinical Study
Sponsor study identifier
interventional
202
1 country
1
Study Start
January 2022
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Primary Completion
April 2022
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Study Completion
December 2022
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Enrolled patients with urinary incontinence in Peking University People's Hospital, Wuhan People's Hospital, Zhongshan People's Hospital, and Jiangsu Maternity and Child Health Hospital in the Department of Gynecology, and collected baseline data. The random number table was used to divide the period into observation group and control group. The observation group was treated with a new type of pelvic floor rehabilitation therapy device PHENIX U4+, and the control group was treated with a traditional pelvic floor electrical stimulation therapy device. Follow-up observations during the treatment period and at the end of the treatment, 3 months and 6 months, the main follow-up content includes 1h pad test, 72-hour urination diary, modified Oxford muscle strength classification diagnosis, urinary incontinence-related questionnaires, new equipment inspections, etc. , Track and compare the treatment effect.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 2022
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
November 23, 2021
Actual (reported)January 2022
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January 21, 2022
Actual (reported)April 2022
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December 2022
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The difference in the effective rate of urinary incontinence treatment between the two groups
The effective rate of urinary incontinence treatment is judged by whether it leaks urine or not
Before treatment, immediately after treatment, three months after treatment, and six months after treatment
Differences in pelvic floor electromyography between the two groups
Before treatment, immediately after treatment, three months after treatment, and six months after treatment
Differences in 72-hour urination diary
Before treatment, immediately after treatment, three months after treatment, and six months after treatment
Person coefficient of correlation between results of gynecological examination and new equipment examination
Before treatment, immediately after treatment, three months after treatment, and six months after treatment
Differences in questionnaire score： PFDI-20
Before treatment, immediately after treatment, three months after treatment, and six months after treatment
Differences in questionnaire score： ICI-Q-SF
Before treatment, immediately after treatment, three months after treatment, and six months after treatment
Electrical stimulation treatment for patients with urinary incontinence using a new type of pelvic floor therapy instrument
Electrical stimulation treatment for patients with urinary incontinence using traditional pelvic floor therapy instrument
The newly developed domestic PHENIX U4+ is relatively small in size. In addition to the smooth muscle stimulation function of the traditional therapy device, its electrical stimulation waveform setting can also stimulate the striated muscle, and adds more than 10 A3 reflex treatment options, which can inhibit Urinary reflex, resulting in symptoms related to urinary incontinence in the patient.
Traditional pelvic floor treatment instrument commonly used in clinical practice
Peking University People's Hospital
Beijing, Beijing Municipality, 100044, China
First Submitted
November 23, 2021
First Posted
January 21, 2022
Study Start
January 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
April 2022
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Study Completion
December 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
January 21, 2022
Record last verified: 2021-10
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