Prostate BiopsyNCT02819713
Difference in Pain Perception by Patients With Prostate Biopsy Using Instillagel Compared With Guided Ultrasound Gel
A study testing ultrasound gel and Instillagel in people with Prostate Biopsy, run by Rijnstate Hospital at 1 site in Netherlands.
Trial 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). Read more about this study
- Who is it for?
- Ages 40 to 85 years, men only
- Conditions the study is for
- Prostate Biopsy
- What is being tested?
- ultrasound gel and Instillagel
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteNetherlands
- Study dates
- Start not givento not given
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 85 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- outpatient ultrasound guide prostate biopsy
- > 40 years old.
- Good knowledge of dutch language
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: Difference in Pain Perception by Patients With Prostate Biopsy Using Instillagel Compared Guided Ultrasound Gel, a Randomized Controlled Trial
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.
Read the 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.
- Conditions
- Prostate Biopsy
- Being tested
- ultrasound gel, Instillagel
- Keywords
- Prostate Biopsy, NRS-score, instillagel, ultrasound conductive gel
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ultrasound gelOther
InstillagelOther
| Study group | Role | What they receive |
|---|---|---|
| ultrasound gel | Placebo comparator | Not described Receives: Other: ultrasound gel |
| Instillagel | Active comparator | Not described Receives: Other: Instillagel |
What is being measured
The primary outcome is the main question the study is designed to answer.
NRS score
Measured: Three measurements before, just after and 5 -30 minutes after procedure
Secondary outcomes (4)
age of patient
Measured: Two weeks after the prostate biopsy.
Previous prostate biopsy
Measured: Two weeks after the prostate biopsy.
The number of biopsies taken
Measured: two weeks after prostate biopsy
Other complications as after prostate biopsy
Measured: two weeks after prostate biopsy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate BiopsyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rijnstate Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marita van den Berg, Principal investigator, Rijnstate Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02819713
- Sponsor's protocol ID
- LTC-744-040111-Roelofs
- Other IDs
- NL35454.091.11
- Status last verified
- Jun 2016
- First submitted
- 8 Aug 2011
- Last updated
- 1 Jul 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Difference in Pain Perception by Patients With Prostate Biopsy Using Instillagel Compared Guided Ultrasound Gel, a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02819713
- Acronym / sponsor ID
- LTC-744-040111-Roelofs
- Conditions
- Prostate Biopsy
- Keywords
- Prostate Biopsy, NRS-score, instillagel, ultrasound conductive gel
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Rijnstate HospitalUniversity, hospital or other
- First posted
- 30 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ultrasound gel | Placebo comparator | Other: ultrasound gel |
| Instillagel | Active comparator | Other: Instillagel |
Who may qualify
- Ages
- 40 to 85 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- outpatient ultrasound guide prostate biopsy
- > 40 years old.
- Good knowledge of dutch language
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ultrasound gel | Other | ultrasound gel |
| Instillagel | Other | Instillagel |
Primary outcome
NRS score
Time frame: Three measurements before, just after and 5 -30 minutes after procedure
4 secondary outcomes
age of patient
Time frame: Two weeks after the prostate biopsy.
Previous prostate biopsy
Time frame: Two weeks after the prostate biopsy.
The number of biopsies taken
Time frame: two weeks after prostate biopsy
Other complications as after prostate biopsy
Time frame: two weeks after prostate biopsy
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marita van den Berg principal investigator
Rijnstate Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ultrasound gel and Instillagel in people with Prostate Biopsy, run by Rijnstate Hospital at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 1 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
NRS score (time frame: Three measurements before, just after and 5 -30 minutes after procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2016.