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

P

Peking University

Status

Unknown

Conditions

Pelvic Organ Prolapse

Treatments

Device: PHENIX4-8-8 PLUS

Study type

Interventional

Funder types

Other

Identifiers

NCT03634722
PKUPH2

Details and patient eligibility

About

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.

Full 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.

Enrollment

126 estimated patients

Sex

Female

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

126 participants in 2 patient groups

The intervention group
Experimental group
Description:
the transcutaneous electrical nerve stimulation by PHENIX4-8-8 PLUS
Treatment:
Device: PHENIX4-8-8 PLUS
The observational group
No Intervention group
Description:
routine nursing

Trial contacts and locations

1

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Central trial contact

Xiuli Sun, professor

Data sourced from clinicaltrials.gov

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