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

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

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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