Pain Outcomes During Rigid Cystoscopy in Females With and Without Cystoscopic Sheath Obturator

Dysuria Clinical Trial

Official title:

The Assessment of Pain Outcomes During Rigid Cystoscopy in Females With and Without the Use of the Rigid Cystoscope Obturator: A Randomized Control Trial

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT05152199
• Other study ID #: STUDY00005662
• Status: Terminated
• Phase: N/A
• Start date: December 22, 2021
• Est. completion date: March 29, 2022

Study information

• Verified date: March 2022
• Source: Michigan State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 68
• Est. completion date: March 29, 2022
• Est. primary completion date: March 29, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 100 Years

Eligibility

Inclusion Criteria:

• Female patients scheduled for gynecological procedures where cystoscopy is indicated

• Ability to comprehend and participate in the study

Exclusion Criteria:

• < 18 years

• Pregnancy

• Current pelvic mesh erosion

• Exposure or pain complications from mesh

• Genitourinary malignancy;

• History of recurrent urinary tract infection (e.g., 2 in 6 months)

Related Conditions & MeSH terms

• Dysuria

Intervention

Procedure:
• Cystoscopy - with use of obturator sheath
The intervention arm will include the use of the obturator sheath upon entry into the urethra during rigid cystoscopy.
• Cystoscopy - without use of obturator sheath
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.

Locations

Country	Name	City	State
United States	Michigan State University	East Lansing	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
Todd Moyerbrailean DO FACOG

Country where clinical trial is conducted

United States, 

References & Publications (9)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Seklehner S, Remzi M, Fajkovic H, Saratlija-Novakovic Z, Skopek M, Resch I, Duvnjak M, Hruby S, Librenjak D, Hübner 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. — View Citation

Yerlikaya G, Laml T, Elenskaia K, Hanzal E, Kölbl 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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