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

Rijnstate Hospital

Status: Withdrawn

Conditions: Prostate Biopsy

Treatments: Other: Instillagel; Other: ultrasound gel

Study type: Interventional

Funder types: Other

Identifiers

NCT02819713

LTC-744-040111-Roelofs

NL35454.091.11 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Sex: Male

Ages: 40 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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0 participants in 2 patient groups, including a placebo group

ultrasound gel

Placebo Comparator group

Treatment:

Other: ultrasound gel

Instillagel

Active Comparator group

Treatment:

Other: Instillagel