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

NCT ID: NCT05202717

Last Updated: 2022-01-21

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 202 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-01-31
• Study Completion Date: 2022-12-31

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.

Conditions

Urinary Incontinence

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

PHENIX U4+

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

Group Type: EXPERIMENTAL

PHENIX U4+

Intervention Type: DEVICE

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.

Traditional pelvic floor electrical stimulation therapy instrument

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

Group Type: ACTIVE_COMPARATOR

Traditional pelvic floor treatment instrument

Intervention Type: DEVICE

Traditional pelvic floor treatment instrument commonly used in clinical practice

Interventions

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.

Intervention Type: DEVICE

Traditional pelvic floor treatment instrument

Traditional pelvic floor treatment instrument commonly used in clinical practice

Intervention Type: DEVICE

Eligibility Criteria

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).

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Peking University People's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Sun Xiuli

Chief Gynecology Physician

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Peking University People's Hospital

Beijing, Beijing Municipality, China

Countries

China

Central Contacts

xiuli P Sun, professor

Role: CONTACT

sunxiuli03351@126.com

18611661856

Other Identifiers

PkuH5

Identifier Type: -

Identifier Source: org_study_id