Clinical trial NCT05202717: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Urinary Incontinence
Keywords: new type of pelvic floor rehabilitation device PHENIX U4+
Traditional pelvic floor electrical stimulation therapy instrument
Lead sponsor: Peking University People's Hospital
Sponsor class: OTHER
First posted: 2022-01-21
Enrollment: 202
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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:

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).

Primary outcomes:
measure: The difference in the effective rate of urinary incontinence treatment between the two groups
timeFrame: Before treatment, immediately after treatment, three months after treatment, and six months after treatment
Secondary outcomes:
measure: Differences in pelvic floor electromyography between the two groups
timeFrame: Before treatment, immediately after treatment, three months after treatment, and six months after treatment
measure: Differences in 72-hour urination diary
timeFrame: Before treatment, immediately after treatment, three months after treatment, and six months after treatment
measure: Person coefficient of correlation between results of gynecological examination and new equipment examination
timeFrame: Before treatment, immediately after treatment, three months after treatment, and six months after treatment
measure: Differences in questionnaire score： PFDI-20
timeFrame: Before treatment, immediately after treatment, three months after treatment, and six months after treatment
measure: Differences in questionnaire score： ICI-Q-SF
timeFrame: Before treatment, immediately after treatment, three months after treatment, and six months after treatment
measure: Differences in questionnaire score： OABSS
timeFrame: Before treatment, immediately after treatment, three months after treatment, and six months after treatment
measure: Differences in questionnaire score： UDI-6
timeFrame: Before treatment, immediately after treatment, three months after treatment, and six months after treatment
measure: Differences in pelvic floor pressure test between the two groups
timeFrame: Before treatment, immediately after treatment, three months after treatment, and six months after treatment
measure: Differences in pelvic floor tension test between the two groups
timeFrame: Before treatment, immediately after treatment, three months after treatment, and six months after treatment
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University People's Hospital
state: Beijing
Study officials:
References: