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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Prostate Biopsy

Intervention / Treatment
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* Other: ultrasound gel
* Other: Instillagel


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: ultrasound gel<br> | Other: ultrasound gel<br> <br> |
| Active Comparator: Instillagel<br> | Other: Instillagel<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| NRS score |  | Three measurements before, just after and 5 -30 minutes after procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| age of patient |  | Two weeks after the prostate biopsy. | 
| Previous prostate biopsy |  | Two weeks after the prostate biopsy. | 
| The number of biopsies taken |  | two weeks after prostate biopsy | 
| Other complications as after prostate biopsy |  | two weeks after prostate biopsy | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Prostate Biopsy, NRS-score, instillagel, ultrasound conductive gel