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

NCT05202717 | Unknown

• 1 other identifier: PkuH5
• Study Type: interventional
• Target: 202
• Locations: 1 country
• Sites: 1

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.

Conditions

Urinary Incontinence

Keywords

new type of pelvic floor rehabilitation device PHENIX U4+; Traditional pelvic floor electrical stimulation therapy instrument

Outcome Measures

Primary Outcomes (1)

• The difference in the effective rate of urinary incontinence treatment between the two groups

  The effective rate of urinary incontinence treatment is judged by whether it leaks urine or not

  Before treatment, immediately after treatment, three months after treatment, and six months after treatment

Secondary Outcomes (9)

• 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 72-hour urination diary

  Before treatment, immediately after treatment, three months after treatment, and six months after treatment

• 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 questionnaire score： PFDI-20

  Before treatment, immediately after treatment, three months after treatment, and six months after treatment

• Differences in questionnaire score： ICI-Q-SF

  Before treatment, immediately after treatment, three months after treatment, and six months after treatment

Study Arms (2)

PHENIX U4+

EXPERIMENTAL

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

Device: PHENIX U4+

Traditional pelvic floor electrical stimulation therapy instrument

ACTIVE COMPARATOR

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

Device: Traditional pelvic floor treatment instrument

Interventions

PHENIX U4+ 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.

PHENIX U4+

Traditional pelvic floor treatment instrument DEVICE

Traditional pelvic floor treatment instrument commonly used in clinical practice

Traditional pelvic floor electrical stimulation therapy instrument

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• Combined pelvic organ prolapse (with extrahymen bulging);
• Obesity (BMI\>28kg/m2, BMI=weight (kg)/height square (m2));
• Uncontrolled asthma and chronic obstructive pulmonary disease (COPD);
• Combined connective tissue disease;
• Women with unclean lochia during pregnancy, within 6 weeks of postpartum and postpartum
• Malignant tumors;
• Combined neurological diseases (patients with epilepsy and dementia);
• Those with a synchronized pacemaker on their chest (biofeedback can be done).

Sponsors & Collaborators

• Peking University People's Hospital: lead

Study Sites (1)

Peking University People's Hospital

Beijing, Beijing Municipality, 100044, China

Location

MeSH Terms

Conditions

Urinary Incontinence

Condition Hierarchy (Ancestors)

Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

xiuli P Sun, professor

CONTACT

18611661856; sunxiuli03351@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Gynecology Physician

Study Record Dates

• First Submitted: November 23, 2021
• First Posted: January 21, 2022
• Study Start: January 1, 2022
• Primary Completion: April 1, 2022
• Study Completion: December 1, 2022
• Last Updated: January 21, 2022

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR
• Time Frame: 1 year

Locations

CN (1)