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

June 30, 2016 updated by: Rijnstate Hospital

Difference in Pain Perception by Patients With Prostate Biopsy Using Instillagel Compared Guided Ultrasound Gel, a Randomized Controlled Trial

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
    • Gelderland
      • Arnhem, Gelderland, Netherlands, 6815 AD
        • Rijnstate location Arnhem

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: ultrasound gel
Other: ultrasound gel
Active Comparator: Instillagel
Other: Instillagel

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
age of patient
Time Frame: Two weeks after the prostate biopsy.
Two weeks after the prostate biopsy.
Previous prostate biopsy
Time Frame: Two weeks after the prostate biopsy.
Two weeks after the prostate biopsy.
The number of biopsies taken
Time Frame: two weeks after prostate biopsy
two weeks after prostate biopsy
Other complications as after prostate biopsy
Time Frame: two weeks after prostate biopsy
two weeks after prostate biopsy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rijnstate Hospital

Investigators

  • Principal Investigator: Marita van den Berg, Rijnstate Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted

August 8, 2011

First Submitted That Met QC Criteria

June 27, 2016

First Posted (Estimate)

June 30, 2016

Study Record Updates

Last Update Posted (Estimate)

July 1, 2016

Last Update Submitted That Met QC Criteria

June 30, 2016

Last Verified

June 1, 2016

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • LTC-744-040111-Roelofs
  • NL35454.091.11 (Other Identifier: CMO regio Arnhem-Nijmegen)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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