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

2016-06-30 21:08:26 | BioPortfolio

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.

Description

Urologist within Rijnsate 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 give a pain reduction. With this research we wil find out if instillagel wil give a related to pain perception bij the patients. And we want make an opinion to the use of any of those gels during ultrasound-guided prostate biopsy.

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Supportive Care

Conditions

Prostate Biopsy

Intervention

Instillagel

Location

Rijnstate location Arnhem
Arnhem
Gelderland
Netherlands
6815 AD

Status

Withdrawn

Source

Rijnstate Hospital

Results (where available)

View Results

Links

Published on BioPortfolio: 2016-06-30T21:08:26-0400

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