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

Urinary Incontinence Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05202717
• Other study ID #: PkuH5
• Status: Not yet recruiting
• Phase: N/A
• Start date: January 2022
• Est. completion date: December 2022

Study information

• Verified date: October 2021
• Source: Peking University People's Hospital
• Contact: xiuli P Sun, professor
• Phone: 18611661856
• Email: sunxiuli03351[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 202
• Est. completion date: December 2022
• Est. primary completion date: April 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Enuresis
• Urinary Incontinence

Intervention

Device:
• 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.
• Traditional pelvic floor treatment instrument
Traditional pelvic floor treatment instrument commonly used in clinical practice

Locations

Country	Name	City	State
China	Peking University People's Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking University People's Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Differences in pelvic floor electromyography between the two groups		Before treatment, immediately after treatment, three months after treatment, and six months after treatment
Secondary	Differences in 72-hour urination diary	reflect urination of 72 hours	Before treatment, immediately after treatment, three months after treatment, and six months after treatment
Secondary	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
Secondary	Differences in questionnaire score: PFDI-20	Questionnaires reflecting pelvic floor function, lower urinary tract symptoms, and quality of life	Before treatment, immediately after treatment, three months after treatment, and six months after treatment
Secondary	Differences in questionnaire score: ICI-Q-SF	Questionnaires reflecting lower urinary tract symptoms	Before treatment, immediately after treatment, three months after treatment, and six months after treatment
Secondary	Differences in questionnaire score: OABSS	Questionnaires reflecting lower urinary tract symptoms	Before treatment, immediately after treatment, three months after treatment, and six months after treatment
Secondary	Differences in questionnaire score: UDI-6	Questionnaires reflecting lower urinary tract symptoms, and quality of life	Before treatment, immediately after treatment, three months after treatment, and six months after treatment
Secondary	Differences in pelvic floor pressure test between the two groups		Before treatment, immediately after treatment, three months after treatment, and six months after treatment
Secondary	Differences in pelvic floor tension test between the two groups		Before treatment, immediately after treatment, three months after treatment, and six months after treatment