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

2016-06-30 21:08:26 | BioPortfolio


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.


Urologist within Rijnsate 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 give a pain reduction. With this research we wil find out if instillagel wil give a related to pain perception bij the patients. And we want make an opinion to the use of any of those gels during ultrasound-guided prostate biopsy.

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Supportive Care


Prostate Biopsy




Rijnstate location Arnhem
6815 AD




Rijnstate Hospital

Results (where available)

View Results


Published on BioPortfolio: 2016-06-30T21:08:26-0400

Clinical Trials [2249 Associated Clinical Trials listed on BioPortfolio]

Prostate Biopsy Antisepsis

During a prostate biopsy, a needle is guided through the rectum into the prostate. Although patients are given antibiotics before the biopsy, there is still a risk of bacteria getting from...

MR-targeted vs. Random TRUS-guided Prostate Biopsy

To compare prostate cancer (PCa) detection rate of magnetic resonance (MR)-targeted biopsy and transrectal ultrasound (TRUS)-guided biopsy in patients with high PSA values and at least one...

Transperineal, MRI-guided, Prostate Biopsy

Primary purpose: Complications and rehospitalizations after transperineal prostate biopsy MRI-guided are reduced than transrectal prostate biopsies. Secondary purposes: - ...

Comparison of 20-core Versus 12-core Prostate Biopsy Diagnostic Performance in the Detection of Prostate Cancer

The optimal number of prostate cores extracted during a prostate biopsy performed because of a suspected prostate cancer is still debated. The present consensus is to sample 12 cores. Howe...

Randomized Study Comparing MR-guided in Bore Versus MRI/US Fusion-guided Prostate Biopsy

The hypothesis of the study is that targeted MRI/US fusion-guided prostate biopsy with additional systematic transrectal ultrasound (TRUS)-guided biopsy significantly detects more prostate...

PubMed Articles [2338 Associated PubMed Articles listed on BioPortfolio]

The Association of Previous Prostate Biopsy-Related Complications and the Type of Complication with Patient Compliance with Re-Biopsy Scheme.

Prostate biopsy complications have important consequences that may affect patient compliance with re-biopsy schemes; however, this has not been studied in earnest. Thus, we evaluated whether previous ...

How Would MRI-Targeted Prostate Biopsy Alter Radiation Therapy Approaches in Treating Prostate Cancer?

To determine if MRI/ultrasound fusion-targeted prostate biopsy (TB) would lead to increased recommendations of aggressive radiotherapy treatments for higher risk prostate cancer compared to systematic...

Fusion prostate biopsy outperforms 12-core systematic prostate biopsy in patients with prior negative systematic biopsy: A multi-institutional analysis.

Patients with persistently elevated prostate specific antigen (PSA) and prior negative 12-core TRUS prostate biopsy (or biopsies) (systematic biopsy-SBx) are a diagnostic challenge. Repeat SBx or satu...

Clinical Importance of Antibiotic Regimen in Transrectal Ultrasound-Guided Prostate Biopsy: A Single Center Analysis of Nine Thousand Four Hundred Eighty-Seven Cases.

To evaluate the effectiveness of an antibiotic regimen for prostate biopsy by analyzing patients who were hospitalized because of complications after transrectal ultrasound-guided prostate biopsy.

Incorporating biomarkers into the primary prostate biopsy setting: a cost-effectiveness analysis.

To perform a cost-effectiveness analysis of using Prostate Health Index (PHI), 4Kscore, SelectMDx and ExoDx Prostate IntelliScore (EPI) in men with an elevated PSA value to determine the need for biop...

Medical and Biotech [MESH] Definitions

Proteins secreted by the prostate gland. The major secretory proteins from the human prostate gland include PROSTATE-SPECIFIC ANTIGEN, prostate-specific acid phosphatase, prostate-specific membrane antigen, and prostate-specific protein-94.

A glycoprotein that is a kallikrein-like serine proteinase and an esterase, produced by epithelial cells of both normal and malignant prostate tissue. It is an important marker for the diagnosis of prostate cancer.

Conducting a biopsy procedure with the aid of a MEDICAL IMAGING modality.

Removal of all or part of the PROSTATE, often using a cystoscope and/or resectoscope passed through the URETHRA.

A subtype of MICROSCOPIC COLITIS, characterized by chronic watery DIARRHEA of unknown origin, a normal COLONOSCOPY but abnormal histopathology on BIOPSY. Microscopic examination of biopsy samples taken from the COLON show larger-than-normal band of subepithelial COLLAGEN.

More From BioPortfolio on "Difference in Pain Perception by Patients With Prostate Biopsy Using Instillagel Compared With Guided Ultrasound Gel"

Quick Search


Relevant Topics

Radiology is the branch of medicine that studies imaging of the body; X-ray (basic, angiography, barium swallows), ultrasound, MRI, CT and PET. These imaging techniques can be used to diagnose, but also to treat a range of conditions, by allowing visuali...

Prostate Cancer
Prostate cancer (cancer de prostata) Prostate cancer (cancer de prostata) is a form of cancer that develops in the prostate, a gland in the male reproductive system. Most prostate cancers are slow growing; however, there are cases of aggressive prostat...

Searches Linking to this Trial