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

NCT ID: NCT02819713

Last Updated: 2016-07-01

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL

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.

Conditions

Prostate Biopsy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

ultrasound gel

Group Type: PLACEBO_COMPARATOR

ultrasound gel

Intervention Type: OTHER

Instillagel

Group Type: ACTIVE_COMPARATOR

Instillagel

Intervention Type: OTHER

Interventions

ultrasound gel

Intervention Type: OTHER

Instillagel

Intervention Type: OTHER

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

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Rijnstate Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Marita van den Berg

Role: PRINCIPAL_INVESTIGATOR

Rijnstate Hospital

Locations

Rijnstate location Arnhem

Arnhem, Gelderland, Netherlands

Countries

Netherlands

Other Identifiers

NL35454.091.11

Identifier Type: OTHER

Identifier Source: secondary_id

LTC-744-040111-Roelofs

Identifier Type: -

Identifier Source: org_study_id