HematuriaNCT03210038
Cystoscopy in Females: Is There a Difference Between Rigid and Flex Cystoscopy, and Does it Require Local Anasthesia?
A study testing Lidocaine and Water in people with Hematuria and Dysuria, run by Assaf-Harofeh Medical Center at 1 site in Israel.
Trial summary
Women arriving to the Urology department outpatient clinic at Assaf-Harofeh Medical Center in order to undergo a cystoscopy examination will be recruited. Patients will be randomly assigned to one of four groups by method of cystoscopy (flexible and rigid) and by use of anesthesia to the introitus. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Hematuria, Dysuria, Recurrent Uti
- What is being tested?
- Lidocaine and Water
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteIsrael
- Study dates
- 1 Mar 2017to 1 Dec 2019
- 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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All women referred to elective outpatient cystoscopy.
Who cannot join
- Known urethral stricture.
- Known allergy to lubricant/anesthesia gel.
- Patients under the age of 18 (minors).
- Patients with current Urinary Tract Infections.
- Chronic pelvic pain (e.g Interstitial Cystitis/Bladder Pain Syndrome.
- Known neurlogical or other chronic pain syndrome requiring chronic analgesia medication.
- Mentally incapable for consensual agreement of participation.
Trial locations and contacts
1 site in 1 country.
About this study
Women arriving to the Urology department outpatient clinic at Assaf-Harofeh Medical Center in order to undergo a cystoscopy examination will be recruited.
Patients will be randomly assigned to one of four groups by method of cystoscopy (flexible and rigid) and by use of anesthesia to the introitus.
Pain levels will be recorded prior to the examination, during entrance of the cystoscope in the urethral meatus, immediately after the examination and 15 minutes after conclusion.
- Conditions
- Hematuria, Dysuria, Recurrent Uti
- Keywords
- Cystoscopy
- Medical subject headings
- Hematuria, Dysuria, Urinary Tract Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LidocaineDrug
Pad soaked with lidocaine gel (Esracaine) left on the introitus for 5 minutes
WaterDrug
Water based non-anesthetic lubricant gel left on the introitus for 5 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Rigid cystoscopy, water based gel on introitus | Active comparator | Rigid cystoscopy, Wolf 17FR. Pad soaked with water based gel put on introitus for 5 minutes prior to procedure. Receives: Drug: Water |
| Rigid cystoscopy, esracain gel based on introitus | Active comparator | Rigid Cystoscopy, Wolf 17FR. Pad soaked with Esracain (Lidocaine) put on the introitus for 5 minutes prior to procedure. Receives: Drug: Lidocaine |
| Flexible cystoscopy, water based gel on introitus | Active comparator | Flexible cystoscopy, Olympus 16FR. Pad soaked with water based gel put on introitus for 5 minutes prior to procedure. Receives: Drug: Water |
| Flexible cystoscopy, Esracain gel based on introitus | Active comparator | Flexible cystoscopy, Olympus 16FR. Pad soaked with Esracain (Lidocaine) put on the introitus for 5 minutes prior to procedure. Receives: Drug: Lidocaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain before procedure
Pain measurement using a 0-10 visual analogue scale (VAS) and comparison of average pain score between the four study groups.
Measured: Before cystoscopy
Pain during meatus insertion of cystoscope
Pain measurement using a 0-10 visual analogue scale (VAS) and comparison of average pain score between the four study groups.
Measured: During the procedure, at the moment of cystoscopy insertion through the urethra
Pain immediately after procedure
Pain measurement using a 0-10 visual analogue scale (VAS) and comparison of average pain score between the four study groups.
Measured: Immediately after withdrawal of the cystoscope from the urethra
Pain 15 minutes after procedure
Pain measurement using a 0-10 visual analogue scale (VAS) and comparison of average pain score between the four study groups.
Measured: 15 minutes after end of procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2017
- Study start1 Mar 2017
- Primary completion1 Dec 2019
- Study completion1 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for HematuriaStudies 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Pain assessment 4 randomly assigned groups of women divided by type of cystoscope and type of local anesthesia.
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assaf-Harofeh Medical Center
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Prof. Kobi Stav, Assaf-Harofeh Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03210038
- Sponsor's protocol ID
- 0290-16-ASF
- Status last verified
- Dec 2019
- First submitted
- 21 May 2017
- Last updated
- 4 Dec 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: IPD data includes age, BMI, previous medical, urological information. Pain levels during different stages of cystoscopy will be recorded.
Publications
Aaronson DS, Walsh TJ, Smith JF, Davies BJ, Hsieh MH, Konety BR. Meta-analysis: does lidocaine gel before flexible cystoscopy provide pain relief? BJU Int. 2009 Aug;104(4):506-9; discussion 509-10. doi: 10.1111/j.1464-410X.2009.08417.x. Epub 2009 Feb 23.
PubMed 19239453Patel AR, Jones JS, Babineau D. Lidocaine 2% gel versus plain lubricating gel for pain reduction during flexible cystoscopy: a meta-analysis of prospective, randomized, controlled trials. J Urol. 2008 Mar;179(3):986-90. doi: 10.1016/j.juro.2007.10.065. Epub 2008 Jan 18.
PubMed 18206920Seklehner S, Remzi M, Fajkovic H, Saratlija-Novakovic Z, Skopek M, Resch I, Duvnjak M, Hruby S, Librenjak D, Hubner W, Breinl E, Riedl C, Engelhardt PF. Prospective multi-institutional study analyzing pain perception of flexible and rigid cystoscopy in men. Urology. 2015 Apr;85(4):737-41. doi: 10.1016/j.urology.2015.01.007.
PubMed 25817101Stav K, Ohlgisser R, Siegel YI, Beberashvili I, Padoa A, Zisman A. Pain during Female Urethral Catheterization: Intraurethral Lubricant Injection versus Catheter Tip Lubrication--A Prospective Randomized Trial. J Urol. 2015 Oct;194(4):1018-21. doi: 10.1016/j.juro.2015.03.097. Epub 2015 Mar 25.
PubMed 25818032
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cystoscopy in Females: Is There a Difference Between Rigid and Flex Cystoscopy, and Does it Require Local Anasthesia?
- ClinicalTrials.gov ID
- NCT03210038
- Acronym / sponsor ID
- 0290-16-ASF
- Conditions
- Hematuria, Dysuria, Recurrent Uti
- Keywords
- Cystoscopy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Assaf-Harofeh Medical CenterOther government
- Study start
- 1 Mar 2017 (actual)
- Primary completion
- 1 Dec 2019 (actual)
- Study completion
- 1 Dec 2019 (actual)
- First posted
- 6 Jul 2017 (actual)
- 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.
Women arriving to the Urology department outpatient clinic at Assaf-Harofeh Medical Center in order to undergo a cystoscopy examination will be recruited.
Patients will be randomly assigned to one of four groups by method of cystoscopy (flexible and rigid) and by use of anesthesia to the introitus.
Pain levels will be recorded prior to the examination, during entrance of the cystoscope in the urethral meatus, immediately after the examination and 15 minutes after conclusion.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- Pain assessment 4 randomly assigned groups of women divided by type of cystoscope and type of local anesthesia.
| Arm | Type | Receives |
|---|---|---|
| Rigid cystoscopy, water based gel on introitus | Active comparator | Drug: WaterRigid cystoscopy, Wolf 17FR. Pad soaked with water based gel put on introitus for 5 minutes prior to procedure. |
| Rigid cystoscopy, esracain gel based on introitus | Active comparator | Drug: LidocaineRigid Cystoscopy, Wolf 17FR. Pad soaked with Esracain (Lidocaine) put on the introitus for 5 minutes prior to procedure. |
| Flexible cystoscopy, water based gel on introitus | Active comparator | Drug: WaterFlexible cystoscopy, Olympus 16FR. Pad soaked with water based gel put on introitus for 5 minutes prior to procedure. |
| Flexible cystoscopy, Esracain gel based on introitus | Active comparator | Drug: LidocaineFlexible cystoscopy, Olympus 16FR. Pad soaked with Esracain (Lidocaine) put on the introitus for 5 minutes prior to procedure. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All women referred to elective outpatient cystoscopy.
Key exclusion criteria (7 listed)
- Known urethral stricture.
- Known allergy to lubricant/anesthesia gel.
- Patients under the age of 18 (minors).
- Patients with current Urinary Tract Infections.
- Chronic pelvic pain (e.g Interstitial Cystitis/Bladder Pain Syndrome.
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 |
|---|---|---|
| LidocainePad soaked with lidocaine gel (Esracaine) left on the introitus for 5 minutes | Drug | Flexible cystoscopy, Esracain gel based on introitus, Rigid cystoscopy, esracain gel based on introitus |
| WaterWater based non-anesthetic lubricant gel left on the introitus for 5 minutes. | Drug | Flexible cystoscopy, water based gel on introitus, Rigid cystoscopy, water based gel on introitus |
Primary outcome
Pain before procedure
Time frame: Before cystoscopy
Pain measurement using a 0-10 visual analogue scale (VAS) and comparison of average pain score between the four study groups.
Pain during meatus insertion of cystoscope
Time frame: During the procedure, at the moment of cystoscopy insertion through the urethra
Pain measurement using a 0-10 visual analogue scale (VAS) and comparison of average pain score between the four study groups.
Pain immediately after procedure
Time frame: Immediately after withdrawal of the cystoscope from the urethra
Pain measurement using a 0-10 visual analogue scale (VAS) and comparison of average pain score between the four study groups.
Pain 15 minutes after procedure
Time frame: 15 minutes after end of procedure
Pain measurement using a 0-10 visual analogue scale (VAS) and comparison of average pain score between the four study groups.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2019.
- Results publication: PubMed 19239453Aaronson DS, Walsh TJ, Smith JF, Davies BJ, Hsieh MH, Konety BR. Meta-analysis: does lidocaine gel before flexible cystoscopy provide pain relief? BJU Int. 2009 Aug;104(4):506-9; discussion 509-10. doi: 10.1111/j.1464-410X.2009.08417.x. Epub 2009 Feb 23.
- Results publication: PubMed 18206920Patel AR, Jones JS, Babineau D. Lidocaine 2% gel versus plain lubricating gel for pain reduction during flexible cystoscopy: a meta-analysis of prospective, randomized, controlled trials. J Urol. 2008 Mar;179(3):986-90. doi: 10.1016/j.juro.2007.10.065. Epub 2008 Jan 18.
- Results publication: PubMed 25817101Seklehner S, Remzi M, Fajkovic H, Saratlija-Novakovic Z, Skopek M, Resch I, Duvnjak M, Hruby S, Librenjak D, Hubner W, Breinl E, Riedl C, Engelhardt PF. Prospective multi-institutional study analyzing pain perception of flexible and rigid cystoscopy in men. Urology. 2015 Apr;85(4):737-41. doi: 10.1016/j.urology.2015.01.007.
- Results publication: PubMed 25818032Stav K, Ohlgisser R, Siegel YI, Beberashvili I, Padoa A, Zisman A. Pain during Female Urethral Catheterization: Intraurethral Lubricant Injection versus Catheter Tip Lubrication--A Prospective Randomized Trial. J Urol. 2015 Oct;194(4):1018-21. doi: 10.1016/j.juro.2015.03.097. Epub 2015 Mar 25.
- Individual participant dataSharing planned: Yes. IPD data includes age, BMI, previous medical, urological information. Pain levels during different stages of cystoscopy will be recorded.
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Hematuria - Cause Not Known
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lidocaine and Water in people with Hematuria and Dysuria, run by Assaf-Harofeh Medical Center at 1 site in Israel.
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 1 inclusion and 7 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: finished, as of the sponsor's last update on 4 Dec 2019. 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 Israel. 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. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Pain before procedure (time frame: Before cystoscopy). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03210038, which also lists 4 linked publications.
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 4 Dec 2019.