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

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

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.

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.

Study Design

• 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

Arms and Interventions

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

Outcome Measures

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 ]

Eligibility Criteria

• 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).

Contacts and Locations

Contacts

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

Locations

China, Beijing

Peking University People's Hospital

Beijing, Beijing, China, 100044

Sponsors and Collaborators

Peking University People's Hospital

More Information

• 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
• 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

• 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:

Urinary Incontinence; Enuresis; Urination Disorders; Urologic Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Behavioral Symptoms; Elimination Disorders; Mental Disorders