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

December 25, 2018 updated by: Peking University People's Hospital

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

126

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100044
        • The Peking University People's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: The intervention group
the transcutaneous electrical nerve stimulation by PHENIX4-8-8 PLUS
Device: PHENIX4-8-8 PLUS
transcutaneous electrical nerve stimulation by PHENIX4-8-8 PLUS
NO_INTERVENTION: The observational group
routine nursing

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
the rate of urinary retention
Time Frame: three days after surgery
urinary residual volume
three days after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
the rate of urinary incontinence
Time Frame: three days; seven days; one month; three months; six months after surgery
according to the 1-h pad test
three days; seven days; one month; three months; six months after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peking University People's Hospital

Investigators

  • Study Chair: Xiuli Sun, Beijing Key Laboratory of Female Pelvic Floor Disorders

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

January 1, 2019

Primary Completion (ANTICIPATED)

January 7, 2019

Study Completion (ANTICIPATED)

December 11, 2020

Study Registration Dates

First Submitted

July 23, 2018

First Submitted That Met QC Criteria

August 15, 2018

First Posted (ACTUAL)

August 16, 2018

Study Record Updates

Last Update Posted (ACTUAL)

December 27, 2018

Last Update Submitted That Met QC Criteria

December 25, 2018

Last Verified

December 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PKUPH2

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The Transcutaneous Electrical Nerve Stimulation can decrease the rate of Lower Urinary Tract Symptoms after Pelvic Reconstructive Surgery

IPD Sharing Time Frame

two years

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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