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

N/AUnknownNCT05202717

Peking University People's Hospital202 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

202

Conditions

Urinary Incontinence

Interventions

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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).