The Efficacy of Transcutaneous Electrical Nerve Stimulati... | NCT03634722

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

NCT03634722

Sponsor

Peking University People's Hospital

Status

Unknown status

Last Update Posted

Dec 27, 2018Actual

Enrollment

126Estimated

Phase

Not Applicable

Conditions

Pelvic Organ Prolapse

Interventions

PHENIX4-8-8 PLUS

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2018

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2019Estimated

Primary Completion Date

Jan 7, 2019Estimated

Completion Date

Dec 11, 2020Estimated

First Submitted Date

Jul 23, 2018

First Submission Date that Met QC Criteria

Aug 15, 2018

First Posted Date

Aug 16, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 25, 2018

Last Update Posted Date

Dec 27, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

126Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
PHENIX4-8-8 PLUS	Device	transcutaneous electrical nerve stimulation by PHENIX4-8-8 PLUS	The intervention group

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Xiuli Sun, professor	Contact	010-88324354		sunxiuli918@126.com

Overall Officials

Name	Affiliation	Role
Xiuli Sun	Beijing Key Laboratory of Female Pelvic Floor Disorders	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
The Peking University People's Hospital		Beijing	Beijing Municipality	100044	China

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

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

Types

Study Protocol
Clinical Study Report (CSR)

Time Frame

two years

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D056887	Pelvic Organ Prolapse

Ancestor Terms

ID	Term
D011391	Prolapse
D020763	Pathological Conditions, Anatomical
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided