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

Peking University

Status: Unknown

Conditions: Urinary Incontinence

Treatments: Device: Traditional pelvic floor treatment instrument; Device: PHENIX U4+

Study type: Interventional

Funder types: Other

Identifiers

NCT05202717

PkuH5

Details and patient eligibility

About

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.

Full 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.

Enrollment: 202 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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202 participants in 2 patient groups

PHENIX U4+

Experimental group

Description:

Electrical stimulation treatment for patients with urinary incontinence using a new type of pelvic floor therapy instrument

Treatment:

Device: PHENIX U4+

Traditional pelvic floor electrical stimulation therapy instrument

Active Comparator group

Description:

Electrical stimulation treatment for patients with urinary incontinence using traditional pelvic floor therapy instrument

Treatment:

Device: Traditional pelvic floor treatment instrument