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

NCT ID: NCT03634722

Last Updated: 2018-12-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

126 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-01-01

Study Completion Date

2020-12-11

Brief Summary

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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

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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.

Conditions

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Pelvic Organ Prolapse

Keywords

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transcutaneous electrical nerve stimulation;

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

the transcutaneous electrical nerve stimulation by PHENIX4-8-8 PLUS
Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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The intervention group

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

Group Type EXPERIMENTAL

PHENIX4-8-8 PLUS

Intervention Type DEVICE

transcutaneous electrical nerve stimulation by PHENIX4-8-8 PLUS

The observational group

routine nursing

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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PHENIX4-8-8 PLUS

transcutaneous electrical nerve stimulation by PHENIX4-8-8 PLUS

Intervention Type DEVICE

Eligibility Criteria

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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
Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Peking University People's Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Xiuli Sun

Role: STUDY_CHAIR

Beijing Key Laboratory of Female Pelvic Floor Disorders

Locations

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The Peking University People's Hospital

Beijing, Beijing Municipality, China

Site Status

Countries

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China

Central Contacts

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Xiuli Sun, professor

Role: CONTACT

Phone: 010-88324354

Email: [email protected]

Facility Contacts

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Xiuli Sun, professor

Role: primary

Tingting Cao, doctor

Role: backup

Other Identifiers

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PKUPH2

Identifier Type: -

Identifier Source: org_study_id