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the Effect of a New Type of Pelvic Floor Rehabilitation Device PHENIX U4+ on the Treatment of Urinary Incontinence

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ClinicalTrials.gov Identifier: NCT05202717
Recruitment Status : Not yet recruiting
First Posted : January 21, 2022
Last Update Posted : January 21, 2022
Sponsor:
Information provided by (Responsible Party):
Sun Xiuli, Peking University People's Hospital

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.

Condition or disease Intervention/treatment Phase
Urinary Incontinence Device: PHENIX U4+ Device: Traditional pelvic floor treatment instrument Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 202 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Estimated Study Start Date : January 2022
Estimated Primary Completion Date : April 2022
Estimated Study Completion Date : December 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: PHENIX U4+
Electrical stimulation treatment for patients with urinary incontinence using a new type of pelvic floor therapy instrument
Device: PHENIX U4+
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.

Active Comparator: Traditional pelvic floor electrical stimulation therapy instrument
Electrical stimulation treatment for patients with urinary incontinence using traditional pelvic floor therapy instrument
Device: Traditional pelvic floor treatment instrument
Traditional pelvic floor treatment instrument commonly used in clinical practice




Primary Outcome Measures :
  1. The difference in the effective rate of urinary incontinence treatment between the two groups [ Time Frame: Before treatment, immediately after treatment, three months after treatment, and six months after treatment ]
    The effective rate of urinary incontinence treatment is judged by whether it leaks urine or not


Secondary Outcome Measures :
  1. 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 ]
  2. Differences in 72-hour urination diary [ Time Frame: Before treatment, immediately after treatment, three months after treatment, and six months after treatment ]
    reflect urination of 72 hours

  3. 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 ]
  4. Differences in questionnaire score: PFDI-20 [ Time Frame: Before treatment, immediately after treatment, three months after treatment, and six months after treatment ]
    Questionnaires reflecting pelvic floor function, lower urinary tract symptoms, and quality of life

  5. Differences in questionnaire score: ICI-Q-SF [ Time Frame: Before treatment, immediately after treatment, three months after treatment, and six months after treatment ]
    Questionnaires reflecting lower urinary tract symptoms

  6. Differences in questionnaire score: OABSS [ Time Frame: Before treatment, immediately after treatment, three months after treatment, and six months after treatment ]
    Questionnaires reflecting lower urinary tract symptoms

  7. Differences in questionnaire score: UDI-6 [ Time Frame: Before treatment, immediately after treatment, three months after treatment, and six months after treatment ]
    Questionnaires reflecting lower urinary tract symptoms, and quality of life

  8. 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 ]
  9. 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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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:

  1. Combined pelvic organ prolapse (with extrahymen bulging);
  2. Obesity (BMI>28kg/m2, BMI=weight (kg)/height square (m2));
  3. Uncontrolled asthma and chronic obstructive pulmonary disease (COPD);
  4. Combined connective tissue disease;
  5. Women with unclean lochia during pregnancy, within 6 weeks of postpartum and postpartum
  6. Malignant tumors;
  7. Combined neurological diseases (patients with epilepsy and dementia);
  8. Those with a synchronized pacemaker on their chest (biofeedback can be done).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05202717


Contacts
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Contact: xiuli P Sun, professor 18611661856 sunxiuli03351@126.com

Locations
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China, Beijing
Peking University People's Hospital
Beijing, Beijing, China, 100044
Sponsors and Collaborators
Peking University People's Hospital
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Responsible Party: Sun Xiuli, Chief Gynecology Physician, Peking University People's Hospital
ClinicalTrials.gov Identifier: NCT05202717    
Other Study ID Numbers: PkuH5
First Posted: January 21, 2022    Key Record Dates
Last Update Posted: January 21, 2022
Last Verified: October 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Supporting Materials: Study Protocol
Clinical Study Report (CSR)
Time Frame: 1 year

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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
Keywords provided by Sun Xiuli, Peking University People's Hospital:
new type of pelvic floor rehabilitation device PHENIX U4+
Traditional pelvic floor electrical stimulation therapy instrument
Additional relevant MeSH terms:
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Urinary Incontinence
Enuresis
Urination Disorders
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Behavioral Symptoms
Elimination Disorders
Mental Disorders