NCT03634722

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
126

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 23, 2018

Completed
24 days until next milestone

First Posted

Study publicly available on registry

August 16, 2018

Completed
5 months until next milestone

Study Start

First participant enrolled

January 1, 2019

Completed
6 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 7, 2019

Completed
1.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 11, 2020

Completed
Last Updated

December 27, 2018

Status Verified

December 1, 2018

Enrollment Period

6 days

First QC Date

July 23, 2018

Last Update Submit

December 25, 2018

Conditions

Pelvic Organ Prolapse

Keywords

transcutaneous electrical nerve stimulation;

Outcome Measures

Primary Outcomes (1)

  • the rate of urinary retention

    urinary residual volume

    three days after surgery

Secondary Outcomes (1)

  • the rate of urinary incontinence

    three days; seven days; one month; three months; six months after surgery

Study Arms (2)

The intervention group

EXPERIMENTAL

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

Device: PHENIX4-8-8 PLUS

The observational group

NO INTERVENTION

routine nursing

Interventions

PHENIX4-8-8 PLUSDEVICE

transcutaneous electrical nerve stimulation by PHENIX4-8-8 PLUS

The intervention group

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • severe pelvic organ prolapse(POP-Q:3/4 stage)
  • accept pelvic reconstructive surgery

You may not qualify if:

  • Dominant stress urinary incontinence
  • Serious medical problems
  • mental disease
  • infectious disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Peking University People's Hospital

Beijing, Beijing Municipality, 100044, China

Location

MeSH Terms

Conditions

Pelvic Organ Prolapse

Condition Hierarchy (Ancestors)

ProlapsePathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Officials

  • Xiuli Sun

    Beijing Key Laboratory of Female Pelvic Floor Disorders

    STUDY CHAIR

Central Study Contacts

Xiuli Sun, professor

CONTACT

010-88324354sunxiuli918@126.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: the transcutaneous electrical nerve stimulation by PHENIX4-8-8 PLUS
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 23, 2018

First Posted

August 16, 2018

Study Start

January 1, 2019

Primary Completion

January 7, 2019

Study Completion

December 11, 2020

Last Updated

December 27, 2018

Record last verified: 2018-12

Data Sharing

IPD Sharing
Will share

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

Shared Documents
STUDY PROTOCOL, CSR
Time Frame
two years

Locations

CN(1)