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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lidocaine | Drug | Pad soaked with lidocaine gel (Esracaine) left on the introitus for 5 minutes |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pain before procedure | Pain measurement using a 0-10 visual analogue scale (VAS) and comparison of average pain score between the four study groups. | 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. | 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. | 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. | 15 minutes after end of procedure |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Assaf Harofe Medical Center | Be’er Ya‘aqov | 70300 | Israel |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19239453 | Result | 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. | |
| 18206920 | Result | Patel 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. |
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IPD data includes age, BMI, previous medical, urological information. Pain levels during different stages of cystoscopy will be recorded.
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| ID | Term |
|---|---|
| D006417 | Hematuria |
| D053159 | Dysuria |
| D014552 | Urinary Tract Infections |
| ID | Term |
|---|---|
| D014555 | Urination Disorders |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| ID | Term |
|---|---|
| D008012 | Lidocaine |
| D014867 | Water |
| ID | Term |
|---|---|
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 |
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Pain assessment 4 randomly assigned groups of women divided by type of cystoscope and type of local anesthesia.
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| Water | Drug | Water based non-anesthetic lubricant gel left on the introitus for 5 minutes. |
|
| 25817101 | Result | Seklehner 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. |
| 25818032 | Result | Stav 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. |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D059411 | Lower Urinary Tract Symptoms |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D007239 | Infections |
| Aniline Compounds |
| D000588 | Amines |
| D006878 | Hydroxides |
| D000468 | Alkalies |
| D007287 | Inorganic Chemicals |
| D000838 | Anions |
| D007477 | Ions |
| D004573 | Electrolytes |
| D010087 | Oxides |
| D017601 | Oxygen Compounds |