Difference in Pain Perception by Patients With Prostate B... | NCT02819713

Studies
Difference in Pain Perception by Patients With Prostate Biopsy Using Instillagel Compared With Guided Ultrasound Gel

NCT02819713

Sponsor

Rijnstate Hospital

Status

Withdrawn

Last Update Posted

Jul 1, 2016Estimated

Enrollment

0Actual

Phase

Not Applicable

Conditions

Prostate Biopsy

Interventions

ultrasound gel
Instillagel

Countries

Netherlands

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

ID	Type	Description	Link
NL35454.091.11	Other Identifier	CMO regio Arnhem-Nijmegen

Status Module

Record Verification Date

Jun 2016

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Not provided

Primary Completion Date

Not provided

Completion Date

Not provided

First Submitted Date

Aug 8, 2011

First Submission Date that Met QC Criteria

Jun 27, 2016

First Posted Date

Jun 30, 2016Estimated

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

Jun 30, 2016

Last Update Posted Date

Jul 1, 2016Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This is a randomized controlled trial. One group (intervention group) will get in advance to the prostate biopsy rectal approximately 5 cc Instillagel. And one group (control group) will get in advance to the ultrasound -guided prostate biopsy rectal gel. Pain is measured using the Numerical Rating Scale (NRS). The NRS is an imaginary line from 0 until 10. The 0 is no pain and 10 is most worst imaginable pain.

Detailed Description

Urologist within Rijnstate use both Instillagel and ultrasound gel during prostate biopsy. According to the protocol, the ultrasound-guided prostate biopsy must be performed using ultrasound gel. Some urologists departed from the protocols because they think that Instillagel will give a pain reduction. With this research we investigate whether Instillagel will have an effect on the pain perception bij the patients.

There will be three moments of pain measurements; Prior to het prostate biopsy. Immediately after the prostate biopsy. And five to thirty minutes after the prostate biopsy, when the patient is dressed and before the patient goes home.

Primary endpoint Pain measured by the Numeric Rating Scale

Secondary endpoints

Age of patient
Previous prostate biopsy
The number of biopsies taken
Presence of prostate cancer
Other complications as after prostate biopsy

The prostate biopsy will be performed by a urologist working at the outpatient clinic of Rijnstate. The ultrasound equipment that will be used during prostate biopsy is Aloka ProSound SSD-3500 or Aloka ProSound SSD or SV-3500 SX.

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

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
ultrasound gel	Placebo Comparator		Other: ultrasound gel
Instillagel	Active Comparator		Other: Instillagel

Interventions

Name	Type	Description	Arm Group Labels	Other Names
ultrasound gel	Other		ultrasound gel
Instillagel

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
NRS score		Three measurements before, just after and 5 -30 minutes after procedure

Secondary Outcomes

Measure	Description	Time Frame
age of patient		Two weeks after the prostate biopsy.
Previous prostate biopsy		Two weeks after the prostate biopsy.
The number of biopsies taken

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

outpatient ultrasound guide prostate biopsy
> 40 years old.
Good knowledge of dutch language

Exclusion Criteria:

coagulation disorders
disorders of the rectum like hemorrhoids, anal fistula, proctitis, rectal polyps and rectal cancer.
treated for active urinary tract infection
known of allergy to lidocaine
taking antidepressants
using anaesthetic agents
neurological disorders such as Parkinsons disease, hernias and spinal cord injury
treated with radiotherapy for prostate cancer

Accepts Healthy Volunteers

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

40 Years

Maximum Age

85 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Marita van den Berg	Rijnstate Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Rijnstate location Arnhem		Arnhem	Gelderland	6815 AD	Netherlands

Intervention Browse Module

MeSH Terms

ID	Term
C008129	chlorhexidine gluconate, lidocaine drug combination

Ancestor Terms

Not provided

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Browse Branches

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