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

NCT05152199 | Terminated

• 1 other identifier: STUDY00005662
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Dysuria

Keywords

Rigid Cystoscopy; Obturator Sheath; Urogynecology

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Strength of stream

  Within 10 minutes following the first post-procedure void.

• Bladder pain

  Within 10 minutes following the first post-procedure void.

• Hesitancy

  Within 10 minutes following the first post-procedure void.

• Straining

  Within 10 minutes following the first post-procedure void.

• Incomplete Emptying

  Within 10 minutes following the first post-procedure void.

Study Arms (2)

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.

Procedure: Cystoscopy - with use of obturator sheath

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.

Procedure: Cystoscopy - without use of obturator sheath

Interventions

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.

Cystoscopy with use of obturator sheath

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.

Cystoscopy without use of obturator sheath

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Female patients scheduled for gynecological procedures where cystoscopy is indicated
• Ability to comprehend and participate in the study

You may not qualify if:

• \< 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)

Sponsors & Collaborators

• Todd Moyerbrailean DO FACOG: lead

Study Sites (1)

Michigan State University

East Lansing, Michigan, 48824, United States

Location

Related Publications (9)

• 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.

  PMID: 12861140 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.

  PMID: 18455622 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.

  PMID: 22569690 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.

  PMID: 24300559 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.

  PMID: 25251958 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.

  PMID: 25817101 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.

  PMID: 28097268 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.

  PMID: 30807424 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.

  PMID: 32920032 BACKGROUND

MeSH Terms

Conditions

Dysuria

Interventions

Cystoscopy

Condition Hierarchy (Ancestors)

Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Endoscopy; Diagnostic Techniques, Surgical; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Urological; Minimally Invasive Surgical Procedures; Surgical Procedures, Operative; Urologic Surgical Procedures; Urogenital Surgical Procedures

Study Officials

• Todd Moyerbrailean, DO, FACOG

  Michigan State University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: November 23, 2021
• First Posted: December 9, 2021
• Study Start: December 22, 2021
• Primary Completion: March 29, 2022
• Study Completion: March 29, 2022
• Last Updated: April 7, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)