The Efficacy of Transcutaneous Electrical Nerve Stimulation on LUTS: One Prospective Study.

Not Applicable

• Conditions: Pelvic Organ Prolapse

• 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.

Study Timeline

• Study First Submitted: 2018-07-23
• Study First Submitted QC: 2018-08-15
• Study First Posted: 2018-08-16
• Status Verified: 2018-12
• Last Update Submitted: 2018-12-25
• Last Update Posted: 2018-12-27
• Study Start: 2019-01-01
• Primary Completion: 2019-01-07
• Study Completion: 2020-12-11

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

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