The Efficacy of Transcutaneous Electrical Nerve Stimulation on LUTS: One Prospective Study.
Not Applicable
- Conditions
- Pelvic Organ Prolapse
- Interventions
- Device: PHENIX4-8-8 PLUS
- Registration Number
- NCT03634722
- Lead Sponsor
- Peking University People's Hospital
- Brief Summary
The study is a prospective study at a single institution. Investigators create strict inclusion and exclusion criteria, selecting 126 patients who undergo the pelvic reconstructive surgery. 63 patients in the intervention group accept 10 times of the transcutaneous electrical nerve stimulation.
- Detailed Description
All the patients have severe pelvic organ prolapse and undergo the pelvic reconstructive surgery. Investigators evaluate all patients' lower urinary tract symptoms, quality of life score, overactive bladder questionnaire, maximal rate and residual urine volume, at 1, 3, 6 and 12 months after the surgery.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- Female
- Target Recruitment
- 126
Inclusion Criteria
- severe pelvic organ prolapse(POP-Q:3/4 stage)
- accept pelvic reconstructive surgery
Exclusion Criteria
- Dominant stress urinary incontinence
- Serious medical problems
- mental disease
- infectious disease
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description The intervention group PHENIX4-8-8 PLUS the transcutaneous electrical nerve stimulation by PHENIX4-8-8 PLUS
- Primary Outcome Measures
Name Time Method the rate of urinary retention three days after surgery urinary residual volume
- Secondary Outcome Measures
Name Time Method the rate of urinary incontinence three days; seven days; one month; three months; six months after surgery according to the 1-h pad test
Trial Locations
- Locations (1)
The Peking University People's Hospital
🇨🇳Beijing, Beijing, China