Clinical trial NCT02819713: Difference in Pain Perception by Patients With Prostate Biopsy Using Instillagel Compared With Guided Ultrasound Gel
Official title: Difference in Pain Perception by Patients With Prostate Biopsy Using Instillagel Compared Guided Ultrasound Gel, a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Prostate Biopsy
Keywords: Prostate Biopsy
NRS-score
instillagel
ultrasound conductive gel
Lead sponsor: Rijnstate Hospital
Sponsor class: OTHER
First posted: 2016-06-30
Enrollment: 0
Sex: MALE
Minimum age (years): 40
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: NRS score
timeFrame: Three measurements before, just after and 5 -30 minutes after procedure
Secondary outcomes:
measure: age of patient
timeFrame: Two weeks after the prostate biopsy.
measure: Previous prostate biopsy
timeFrame: Two weeks after the prostate biopsy.
measure: The number of biopsies taken
timeFrame: two weeks after prostate biopsy
measure: Other complications as after prostate biopsy
timeFrame: two weeks after prostate biopsy
Other outcomes:
Locations:
city: Arnhem
country: Netherlands
facility: Rijnstate location Arnhem
state: Gelderland
Study officials:
affiliation: Rijnstate Hospital
name: Marita van den Berg
role: PRINCIPAL_INVESTIGATOR
References: