Back to resultsthe Effect of a New Type of Pelvic Floor Rehabilitation Device PHENIX U4+ on the Treatment of Urinary Incontinence
Primary Purpose
Urinary Incontinence
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
PHENIX U4+
Traditional pelvic floor treatment instrument
Sponsored by
About this trial
This is an interventional treatment trial for Urinary Incontinence focused on measuring new type of pelvic floor rehabilitation device PHENIX U4+, Traditional pelvic floor electrical stimulation therapy instrument
Eligibility Criteria
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:
- Combined pelvic organ prolapse (with extrahymen bulging);
- Obesity (BMI>28kg/m2, BMI=weight (kg)/height square (m2));
- Uncontrolled asthma and chronic obstructive pulmonary disease (COPD);
- Combined connective tissue disease;
- Women with unclean lochia during pregnancy, within 6 weeks of postpartum and postpartum
- Malignant tumors;
- Combined neurological diseases (patients with epilepsy and dementia);
- Those with a synchronized pacemaker on their chest (biofeedback can be done).
Sites / Locations
- Peking University People's Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
PHENIX U4+
Traditional pelvic floor electrical stimulation therapy instrument
Arm Description
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
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Differences in pelvic floor electromyography between the two groups
Differences in 72-hour urination diary
reflect urination of 72 hours
Person coefficient of correlation between results of gynecological examination and new equipment examination
Differences in questionnaire score： PFDI-20
Questionnaires reflecting pelvic floor function, lower urinary tract symptoms, and quality of life
Differences in questionnaire score： ICI-Q-SF
Questionnaires reflecting lower urinary tract symptoms
Differences in questionnaire score： OABSS
Questionnaires reflecting lower urinary tract symptoms
Differences in questionnaire score： UDI-6
Questionnaires reflecting lower urinary tract symptoms, and quality of life
Differences in pelvic floor pressure test between the two groups
Differences in pelvic floor tension test between the two groups
Full Information
NCT ID
NCT05202717
First Posted
November 23, 2021
Last Updated
January 8, 2022
Sponsor
Peking University People's Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05202717
Brief Title
the Effect of a New Type of Pelvic Floor Rehabilitation Device PHENIX U4+ on the Treatment of Urinary Incontinence
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
October 2021
Overall Recruitment Status
Unknown status
Study Start Date
January 2022 (Anticipated)
Primary Completion Date
April 2022 (Anticipated)
Study Completion Date
December 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Peking University People's Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
Detailed Description
Use two pelvic floor treatment devices to treat urinary incontinence, collect relevant questionnaires and pelvic floor muscle strength, and compare the two treatment devices.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urinary Incontinence
Keywords
new type of pelvic floor rehabilitation device PHENIX U4+, Traditional pelvic floor electrical stimulation therapy instrument
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
202 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
PHENIX U4+
Arm Type
Experimental
Arm Description
Electrical stimulation treatment for patients with urinary incontinence using a new type of pelvic floor therapy instrument
Arm Title
Traditional pelvic floor electrical stimulation therapy instrument
Arm Type
Active Comparator
Arm Description
Electrical stimulation treatment for patients with urinary incontinence using traditional pelvic floor therapy instrument
Intervention Type
Device
Intervention Name(s)
PHENIX U4+
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Traditional pelvic floor treatment instrument
Intervention Description
Traditional pelvic floor treatment instrument commonly used in clinical practice
Primary Outcome Measure Information:
Title
The difference in the effective rate of urinary incontinence treatment between the two groups
Description
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
Secondary Outcome Measure Information:
Title
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
Title
Differences in 72-hour urination diary
Description
reflect urination of 72 hours
Time Frame
Before treatment, immediately after treatment, three months after treatment, and six months after treatment
Title
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
Title
Differences in questionnaire score： PFDI-20
Description
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
Title
Differences in questionnaire score： ICI-Q-SF
Description
Questionnaires reflecting lower urinary tract symptoms
Time Frame
Before treatment, immediately after treatment, three months after treatment, and six months after treatment
Title
Differences in questionnaire score： OABSS
Description
Questionnaires reflecting lower urinary tract symptoms
Time Frame
Before treatment, immediately after treatment, three months after treatment, and six months after treatment
Title
Differences in questionnaire score： UDI-6
Description
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
Title
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
Title
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
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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:
Combined pelvic organ prolapse (with extrahymen bulging);
Obesity (BMI>28kg/m2, BMI=weight (kg)/height square (m2));
Uncontrolled asthma and chronic obstructive pulmonary disease (COPD);
Combined connective tissue disease;
Women with unclean lochia during pregnancy, within 6 weeks of postpartum and postpartum
Malignant tumors;
Combined neurological diseases (patients with epilepsy and dementia);
Those with a synchronized pacemaker on their chest (biofeedback can be done).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
xiuli P Sun, professor
Phone
18611661856
Email
sunxiuli03351@126.com
Facility Information:
Facility Name
Peking University People's Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100044
Country
China
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Time Frame
1 year
Learn more about this trial
the Effect of a New Type of Pelvic Floor Rehabilitation Device PHENIX U4+ on the Treatment of Urinary Incontinence
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