NCT05202717

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

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 202 (estimated)
• Sponsor: Peking University People's Hospital · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
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.
DEVICE	Traditional pelvic floor treatment instrument	Traditional pelvic floor treatment instrument commonly used in clinical practice

Timeline

• Start date: 2022-01-01
• Primary completion: 2022-04-01
• Completion: 2022-12-01
• First posted: 2022-01-21
• Last updated: 2022-01-21

Locations

1 site across 1 country: China