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

Not Applicable

• Conditions: Urinary Incontinence
• Interventions: Device: Traditional pelvic floor treatment instrument; Device: PHENIX U4+

• Registration Number: NCT05202717
• Lead Sponsor: 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.

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 Timeline

• Status Verified: 2021-10
• Study First Submitted: 2021-11-23
• Study Start: 2022-01
• Study First Submitted QC: 2022-01-08
• Last Update Submitted: 2022-01-08
• Study First Posted: 2022-01-21
• Last Update Posted: 2022-01-21
• Primary Completion: 2022-04
• Study Completion: 2022-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 202

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Traditional pelvic floor electrical stimulation therapy instrument	Traditional pelvic floor treatment instrument	Electrical stimulation treatment for patients with urinary incontinence using traditional pelvic floor therapy instrument
PHENIX U4+	PHENIX U4+	Electrical stimulation treatment for patients with urinary incontinence using a new type of pelvic floor therapy instrument

Primary Outcome Measures

Name	Time	Method
The difference in the effective rate of urinary incontinence treatment between the two groups	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

Name	Time	Method
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 pelvic floor electromyography between the two groups	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	Questionnaires reflecting pelvic floor function, lower urinary tract symptoms, and quality of life
Differences in pelvic floor pressure test between the two groups	Before treatment, immediately after treatment, three months after treatment, and six months after treatment
Differences in pelvic floor tension test 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	reflect urination of 72 hours
Differences in questionnaire score： ICI-Q-SF	Before treatment, immediately after treatment, three months after treatment, and six months after treatment	Questionnaires reflecting lower urinary tract symptoms
Differences in questionnaire score： OABSS	Before treatment, immediately after treatment, three months after treatment, and six months after treatment	Questionnaires reflecting lower urinary tract symptoms
Differences in questionnaire score： UDI-6	Before treatment, immediately after treatment, three months after treatment, and six months after treatment	Questionnaires reflecting lower urinary tract symptoms, and quality of life

Trial Locations

Locations (1)

Peking University People's Hospital; 🇨🇳 Beijing, Beijing, China