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

Prostate Biopsy Clinical Trial

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

Status Withdrawn

Clinical Trial 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.

Clinical Trial 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 Design

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

Related Conditions & MeSH terms

• Prostate Biopsy

• NCT number: NCT02819713
• Study type: Interventional
• Source: Rijnstate Hospital
• Status: Withdrawn
• Phase: N/A