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PI employment status change inhibiting continued recruitment
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Rigid cystoscopy is a common procedure to evaluate lower urinary tract symptoms in females. This procedure can be done with or without an instrument called a sheath obturator. Both techniques are used by surgeons and are considered safe, but have never been studied to see if one technique leads to less discomfort with the patient's first void after the procedure. The obturator's use may potentially reduce urethral irritation and bothersome postprocedural symptoms, primarily dysuria. The investigators aim to determine whether there is a difference in dysuria outcomes postoperatively when cystoscopy is performed with or without an obturator.
Rigid cystoscopy is a common procedure to evaluate lower urinary tract symptoms in females. This procedure can be done with or without an instrument called a sheath obturator (or obturator for short). There are two acceptable insertion techniques for performing cystoscopy in women. Surgeons can perform cystoscope without the use of the obturator by using a "visual" technique where a telescope with a sheath is inserted for entry into the bladder (referred to as cystoscopy without the obturator). Surgeons can also perform cystoscopy by using an obturator with a sheath allowing for smooth entry without needing the telescope (referred to as cystoscopy with the obturator). Both techniques are used by surgeons and are considered safe, but have never been studied to see if one technique leads to less discomfort with the patient's first void after the procedure. The obturator's use may potentially reduce urethral irritation and bothersome postprocedural symptoms, primarily dysuria. The investigators aim to determine whether there is a difference in dysuria outcomes postoperatively when cystoscopy is performed with or without an obturator.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cystoscopy with use of obturator sheath | Other | This intervention arm will include the use of the obturator sheath upon entry into the urethra during rigid cystoscopy. |
|
| Cystoscopy without use of obturator sheath | Active Comparator | This intervention arm will not include the use of the obturator sheath upon entry into the urethra during rigid cystoscopy, but will consist of using the telescope under direct visualization. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cystoscopy - with use of obturator sheath | Procedure | The intervention arm will include the use of the obturator sheath upon entry into the urethra during rigid cystoscopy. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Post-Procedure Dysuria | The participant will be asked to void within 10 minutes of the completed procedure. The participant will then complete a Visual Analog Numeric Pain Scale, where 1 = no pain and 10 = worst possible pain, within 10 minutes of voiding. | Post intervention pain scale assessment within 10 minutes following first void after the procedure. |
| Measure | Description | Time Frame |
|---|---|---|
| Strength of stream | A 6 item questionnaire will be completed within 10 minutes following the first post-procedure void and include a multiple choice question assessing the participants strength of stream as: 1 - not reduced, 2 - reduced a little, 3 - quite reduced, 4 - reduced a great deal, 5 - I had no stream | Within 10 minutes following the first post-procedure void. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Todd Moyerbrailean, DO, FACOG | Michigan State University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Michigan State University | East Lansing | Michigan | 48824 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 12861140 | Background | Ellerkmann RM, Dunn JS, McBride AW, Kummer LG, Melick CF, Bent AE, Blomquist JL. A comparison of anticipated pain before and pain rating after the procedure in patients who undergo cystourethroscopy. Am J Obstet Gynecol. 2003 Jul;189(1):66-9. doi: 10.1067/mob.2003.377. | |
| 18455622 | Background | Nguyen CT, Babineau DC, Jones JS. Impact of urologic resident training on patient pain and morbidity associated with office-based cystoscopy. Urology. 2008 May;71(5):782-6. doi: 10.1016/j.urology.2007.12.032. |
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Individual participant data will be shared with members of the investigation team.
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| ID | Term |
|---|---|
| D053159 | Dysuria |
| ID | Term |
|---|---|
| D059411 | Lower Urinary Tract Symptoms |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D003558 | Cystoscopy |
| ID | Term |
|---|---|
| D004724 | Endoscopy |
| D003949 | Diagnostic Techniques, Surgical |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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| Cystoscopy - without use of obturator sheath | Procedure | The intervention arm will not include the use of the obturator sheath upon entry into the urethra during rigid cystoscopy, but will consist of using the telescope under direct visualization. |
|
| Bladder pain | A 6 item questionnaire will be completed within 10 minutes following the first post-procedure void and include a yes/no question "Do you have pain in your bladder?" | Within 10 minutes following the first post-procedure void. |
| Hesitancy | A 6 item questionnaire will be completed within 10 minutes following the first post-procedure void and include a yes/no question "Was there a delay before you started to urinate?" | Within 10 minutes following the first post-procedure void. |
| Straining | A 6 item questionnaire will be completed within 10 minutes following the first post-procedure void and include a yes/no question "Did you have to strain to start urinating?" | Within 10 minutes following the first post-procedure void. |
| Incomplete Emptying | A 6 item questionnaire will be completed within 10 minutes following the first post-procedure void and include a yes/no question "Did you feel that your bladder was empty after urinating?" | Within 10 minutes following the first post-procedure void. |
| Post-procedure pain | The participant will be asked to complete a Visual Analog Numeric Pain Scale, where 1 = no pain and 10 = worst possible pain, within 10 minutes of procedure completion. | Within 10 minutes following completion of the procedure |
| 22569690 | Background | Quiroz LH, Shobeiri SA, Nihira MA, Brady J, Wild RA. Randomized trial comparing office flexible to rigid cystoscopy in women. Int Urogynecol J. 2012 Nov;23(11):1625-30. doi: 10.1007/s00192-012-1777-0. Epub 2012 May 9. |
| 24300559 | Background | Yerlikaya G, Laml T, Elenskaia K, Hanzal E, Kolbl H, Umek W. Pain perception during outpatient cystoscopy: a prospective controlled study. Eur J Obstet Gynecol Reprod Biol. 2014 Feb;173:101-5. doi: 10.1016/j.ejogrb.2013.11.007. Epub 2013 Nov 14. |
| 25251958 | Background | Greenstein A, Greenstein I, Senderovich S, Mabjeesh NJ. Is diagnostic cystoscopy painful? Analysis of 1,320 consecutive procedures. Int Braz J Urol. 2014 Jul-Aug;40(4):533-8. doi: 10.1590/S1677-5538.IBJU.2014.04.13. |
| 25817101 | Background | 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. |
| 28097268 | Background | Casteleijn NF, Vriesema JL, Stomps SP, van Balen OL, Cornel EB. The effect of office based flexible and rigid cystoscopy on pain experience in female patients. Investig Clin Urol. 2017 Jan;58(1):48-53. doi: 10.4111/icu.2017.58.1.48. Epub 2017 Jan 4. |
| 30807424 | Background | Dougher E, Zoorob D, Thomas D, Hagan J, Peacock L. The Effect of Lidocaine Gel on Pain Perception During Diagnostic Flexible Cystoscopy in Women: A Randomized Control Trial. Female Pelvic Med Reconstr Surg. 2019 Mar/Apr;25(2):178-184. doi: 10.1097/SPV.0000000000000680. |
| 32920032 | Background | Rappaport YH, Beberashvili I, Zisman A, Stav K. Is Meatal Analgesia Necessary for Pain Reduction During Cystoscopy in Females? A Prospective Randomized Study. Urology. 2020 Dec;146:79-82. doi: 10.1016/j.urology.2020.08.052. Epub 2020 Sep 11. |
| D003950 | Diagnostic Techniques, Urological |
| D019060 | Minimally Invasive Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D013520 | Urologic Surgical Procedures |
| D013519 | Urogenital Surgical Procedures |