NCT02819713

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.

Trial Health

35
At Risk

Trial Health Score

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

Geographic Reach
1 country

1 active site

Status
withdrawn

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

August 8, 2011

Completed
4.9 years until next milestone

First Posted

Study publicly available on registry

June 30, 2016

Completed
Last Updated

July 1, 2016

Status Verified

June 1, 2016

First QC Date

August 8, 2011

Last Update Submit

June 30, 2016

Conditions

Prostate Biopsy

Keywords

Prostate BiopsyNRS-scoreinstillagelultrasound conductive gel

Outcome Measures

Primary Outcomes (1)

  • NRS score

    Three measurements before, just after and 5 -30 minutes after procedure

Secondary Outcomes (4)

  • age of patient

    Two weeks after the prostate biopsy.

  • Previous prostate biopsy

    Two weeks after the prostate biopsy.

  • The number of biopsies taken

    two weeks after prostate biopsy

  • Other complications as after prostate biopsy

    two weeks after prostate biopsy

Study Arms (2)

ultrasound gel

PLACEBO COMPARATOR
Other: ultrasound gel

Instillagel

ACTIVE COMPARATOR
Other: Instillagel

Interventions

ultrasound gelOTHER
ultrasound gel
InstillagelOTHER
Instillagel

Eligibility Criteria

Age40 Years - 85 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rijnstate location Arnhem

Arnhem, Gelderland, 6815 AD, Netherlands

Location

MeSH Terms

Interventions

chlorhexidine gluconate, lidocaine drug combination

Study Officials

  • Marita van den Berg

    Rijnstate Hospital

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 8, 2011

First Posted

June 30, 2016

Last Updated

July 1, 2016

Record last verified: 2016-06

Locations

NL(1)