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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02819713
• Other study ID #: LTC-744-040111-Roelofs
• Secondary ID: NL35454.091.11
• Status: Withdrawn
• Phase: N/A
• First received: August 8, 2011
• Last updated: June 30, 2016

Study information

• Verified date: June 2016
• Source: Rijnstate Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 40 Years to 85 Years

Eligibility

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 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

Intervention

Other:
• ultrasound gel

• Instillagel

Locations

Country	Name	City	State
Netherlands	Rijnstate location Arnhem	Arnhem	Gelderland

Sponsors (1)

Lead Sponsor	Collaborator
Rijnstate Hospital

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	NRS score		Three measurements before, just after and 5 -30 minutes after procedure	No
Secondary	age of patient		Two weeks after the prostate biopsy.	No
Secondary	Previous prostate biopsy		Two weeks after the prostate biopsy.	No
Secondary	The number of biopsies taken		two weeks after prostate biopsy	No
Secondary	Other complications as after prostate biopsy		two weeks after prostate biopsy	No