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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03634722
Enrollment
126
Registered
2018-08-16
Start date
2019-01-01
Completion date
2020-12-11
Last updated
2018-12-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pelvic Organ Prolapse

Keywords

transcutaneous electrical nerve stimulation;

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.

Interventions

DEVICEPHENIX4-8-8 PLUS

transcutaneous electrical nerve stimulation by PHENIX4-8-8 PLUS

Sponsors

Peking University People's Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)

Intervention model description

the transcutaneous electrical nerve stimulation by PHENIX4-8-8 PLUS

Eligibility

Sex/Gender
FEMALE
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
the rate of urinary retentionthree days after surgeryurinary residual volume

Secondary

MeasureTime frameDescription
the rate of urinary incontinencethree days; seven days; one month; three months; six months after surgeryaccording to the 1-h pad test

Countries

China

Contacts

Primary ContactXiuli Sun, professor
sunxiuli918@126.com010-88324354

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026