An interventional study of PHENIX U4+ and Traditional pelvic floor treatment instrument in Urinary Incontinence, sponsored by Peking University People's Hospital. Status unknown at 1 site in China. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-01-21.
Sponsored by Peking University People's Hospital · Not applicable, Interventional, and Treatment
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.
Use two pelvic floor treatment devices to treat urinary incontinence, collect relevant questionnaires and pelvic floor muscle strength, and compare the two treatment devices.
1,363 studies on the registry are indexed under Urinary Incontinence; 228 are open to participants now.
This study's planned enrollment of 202 is above the median of 66 across 1,011 interventional studies indexed under Urinary Incontinence.
Browse Urinary Incontinence studies →Peking University People's Hospital is the lead sponsor of 584 studies on the registry; 233 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria:1) 18 years old and above; 2) Have a history of sexual life; 3) Plan to live locally for a long time; 4) Mild to moderate pressure, urgency or mixed urinary incontinence; 5) The patient agrees to conduct the study and signs an informed consent form.
Exclusion Criteria:
Electrical stimulation treatment for patients with urinary incontinence using a new type of pelvic floor therapy instrument
Device: PHENIX U4+
Electrical stimulation treatment for patients with urinary incontinence using traditional pelvic floor therapy instrument
Device: Traditional pelvic floor treatment 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
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
Time frame: Before treatment, immediately after treatment, three months after treatment, and six months after treatment
Differences in pelvic floor electromyography between the two groups
Time frame: Before treatment, immediately after treatment, three months after treatment, and six months after treatment
Differences in 72-hour urination diary
reflect urination of 72 hours
Time frame: 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
Time frame: Before treatment, immediately after treatment, three months after treatment, and six months after treatment
Differences in questionnaire score： PFDI-20
Questionnaires reflecting pelvic floor function, lower urinary tract symptoms, and quality of life
Time frame: Before treatment, immediately after treatment, three months after treatment, and six months after treatment
Differences in questionnaire score： ICI-Q-SF
Questionnaires reflecting lower urinary tract symptoms
Time frame: Before treatment, immediately after treatment, three months after treatment, and six months after treatment
Differences in questionnaire score： OABSS
Questionnaires reflecting lower urinary tract symptoms
Time frame: Before treatment, immediately after treatment, three months after treatment, and six months after treatment
Differences in questionnaire score： UDI-6
Questionnaires reflecting lower urinary tract symptoms, and quality of life
Time frame: Before treatment, immediately after treatment, three months after treatment, and six months after treatment
Differences in pelvic floor pressure test between the two groups
Time frame: Before treatment, immediately after treatment, three months after treatment, and six months after treatment
Differences in pelvic floor tension test between the two groups
Time frame: Before treatment, immediately after treatment, three months after treatment, and six months after treatment
Plan to share: Yes
Supporting information: Study protocol, Csr
No publications or documents are linked to this record.
This study is status unknown, as verified in Oct 2021. You cannot join it, but the record below documents what was studied.
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Peking University People's Hospital