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

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

Status
Withdrawn
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02819713
Enrollment
0
Registered
2016-06-30
Start date
Unknown
Completion date
Unknown
Last updated
2016-07-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prostate Biopsy

Keywords

Prostate Biopsy, NRS-score, instillagel, ultrasound conductive gel

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.

Interventions

Sponsors

Rijnstate Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
MALE
Age
40 Years to 85 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
NRS scoreThree measurements before, just after and 5 -30 minutes after procedure

Secondary

MeasureTime frame
age of patientTwo weeks after the prostate biopsy.
Previous prostate biopsyTwo weeks after the prostate biopsy.
The number of biopsies takentwo weeks after prostate biopsy
Other complications as after prostate biopsytwo weeks after prostate biopsy

Countries

Netherlands

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026