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NCT03634722 Clinical Trial

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

Pelvic Organ Prolapse Clinical Trial

Official title:
Beijing Key Laboratory of Female Pelvic Floor Disorders of Peking University People's Hospital

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT03634722
Other study ID # PKUPH2
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date January 1, 2019
Est. completion date December 11, 2020

Study information
Verified date December 2018
Source Peking University People's Hospital
Contact Xiuli Sun, professor
Phone 010-88324354
Email sunxiuli918@126.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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 information / eligibility
Status Not yet recruiting
Enrollment 126
Est. completion date December 11, 2020
Est. primary completion date January 7, 2019
Accepts healthy volunteers No
Gender Female
Age group N/A and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

Device:
• PHENIX4-8-8 PLUS
transcutaneous electrical nerve stimulation by PHENIX4-8-8 PLUS

Locations
Country Name City State
China The 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 rate of urinary retention urinary residual volume three days after surgery
Secondary the rate of urinary incontinence according to the 1-h pad test three days; seven days; one month; three months; six months after surgery
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