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

Primary Purpose

Pelvic Organ Prolapse

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
PHENIX4-8-8 PLUS
Sponsored by
Peking University People's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Pelvic Organ Prolapse focused on measuring transcutaneous electrical nerve stimulation;

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)FemaleDoes not accept 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

Sites / Locations

  • The Peking University People's Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

The intervention group

The observational group

Arm Description

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

routine nursing

Outcomes

Primary Outcome Measures

the rate of urinary retention
urinary residual volume

Secondary Outcome Measures

the rate of urinary incontinence
according to the 1-h pad test

Full Information

First Posted
July 23, 2018
Last Updated
December 25, 2018
Sponsor
Peking University People's Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03634722
Brief Title
The Efficacy of Transcutaneous Electrical Nerve Stimulation on LUTS: One Prospective Study.
Official Title
Beijing Key Laboratory of Female Pelvic Floor Disorders of Peking University People's Hospital
Study Type
Interventional

2. Study Status

Record Verification Date
December 2018
Overall Recruitment Status
Unknown status
Study Start Date
January 1, 2019 (Anticipated)
Primary Completion Date
January 7, 2019 (Anticipated)
Study Completion Date
December 11, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Peking University People's Hospital

4. Oversight

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

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pelvic Organ Prolapse
Keywords
transcutaneous electrical nerve stimulation;

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
the transcutaneous electrical nerve stimulation by PHENIX4-8-8 PLUS
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
126 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
The intervention group
Arm Type
Experimental
Arm Description
the transcutaneous electrical nerve stimulation by PHENIX4-8-8 PLUS
Arm Title
The observational group
Arm Type
No Intervention
Arm Description
routine nursing
Intervention Type
Device
Intervention Name(s)
PHENIX4-8-8 PLUS
Intervention Description
transcutaneous electrical nerve stimulation by PHENIX4-8-8 PLUS
Primary Outcome Measure Information:
Title
the rate of urinary retention
Description
urinary residual volume
Time Frame
three days after surgery
Secondary Outcome Measure Information:
Title
the rate of urinary incontinence
Description
according to the 1-h pad test
Time Frame
three days; seven days; one month; three months; six months after surgery

10. Eligibility

Sex
Female
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xiuli Sun, professor
Phone
010-88324354
Email
sunxiuli918@126.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xiuli Sun
Organizational Affiliation
Beijing Key Laboratory of Female Pelvic Floor Disorders
Official's Role
Study Chair
Facility Information:
Facility Name
The Peking University People's Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100044
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiuli Sun, professor
Phone
010-88324354
Email
sunxiuli918@126.com
First Name & Middle Initial & Last Name & Degree
Tingting Cao, doctor
Phone
010-88324354
Email
zzucaotingting@163.com

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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

Learn more about this trial

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

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