Clinical Trial of Sacral Neuromodulation for Treatment of... | NCT02619721

Studies
Clinical Trial of Sacral Neuromodulation for Treatment of Refractory Overactive Bladder (OAB)

NCT02619721

Sponsor

Beijing Pins Medical Co., Ltd

Status

Unknown status

Last Update Posted

Oct 11, 2016Estimated

Enrollment

7Estimated

Phase

Early Phase 1

Conditions

Refractory Overactive Bladder

Interventions

PINS SNS

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

Mar 2016

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2015

Primary Completion Date

Nov 2017Estimated

Completion Date

Feb 2018Estimated

First Submitted Date

Nov 30, 2015

First Submission Date that Met QC Criteria

Nov 30, 2015

First Posted Date

Dec 2, 2015Estimated

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

Oct 8, 2016

Last Update Posted Date

Oct 11, 2016Estimated

Name	Class
Beijing Hospital	OTHER_GOV

Description Module

Brief Summary

Evaluate the long-term clinical effectiveness and safety of the PINS Sacral Neuromodulation to patients with refractory Overactive Bladder.

Detailed Description

Not provided

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

Early Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

7Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Sacral Neuromodulation is on	Experimental	Sacral Neuromodulation is on as soon as implantation	Device: PINS SNS
Sacral Neuromodulation is off	Placebo Comparator	Sacral Neuromodulation is off after implantation	Device: PINS SNS

Interventions

Name	Type	Description	Arm Group Labels	Other Names
PINS SNS	Device		Sacral Neuromodulation is off Sacral Neuromodulation is on

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Changes in voiding frequency from baseline to the voiding frequency evaluvation period 6 month		6 month of stimulation

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age greater than 16 years OAB and/or OAB symptoms Refractory to standard medical therapy 100ml bladder capacity with normal upper urinary tract Good surgical candidate Able to complete study documentation and return for followup evaluation

Exclusion Criteria:

Neurological conditions Stress urinary incontinence OAB symptoms caused by urinary tract infections

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

16 Years

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Beijing Hospital		Beijing	Beijing Municipality	100050	China

Condition Browse Module

MeSH Terms

ID	Term
D053201	Urinary Bladder, Overactive

Ancestor Terms

ID	Term
D001745	Urinary Bladder Diseases
D014570	Urologic Diseases
D052776	Female Urogenital Diseases
D005261	Female Urogenital Diseases and Pregnancy Complications

Browse Leaves

Not provided

Browse Branches

Not provided