Pain Outcomes During Rigid Cystoscopy in Females With and Without Cystoscopic Sheath Obturator
Primary Purpose
Dysuria
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cystoscopy - with use of obturator sheath
Cystoscopy - without use of obturator sheath
Sponsored by
About this trial
This is an interventional treatment trial for Dysuria focused on measuring Rigid Cystoscopy, Obturator Sheath, Urogynecology
Eligibility Criteria
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)
Sites / Locations
- Michigan State University
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Active Comparator
Arm Label
Cystoscopy with use of obturator sheath
Cystoscopy without use of obturator sheath
Arm Description
This intervention arm will include the use of the obturator sheath upon entry into the urethra during rigid cystoscopy.
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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
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?"
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?"
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?"
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?"
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.
Full Information
NCT ID
NCT05152199
First Posted
November 23, 2021
Last Updated
March 29, 2022
Sponsor
Todd Moyerbrailean DO FACOG
1. Study Identification
Unique Protocol Identification Number
NCT05152199
Brief Title
Pain Outcomes During Rigid Cystoscopy in Females With and Without Cystoscopic Sheath Obturator
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
Study Type
Interventional
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Terminated
Why Stopped
PI employment status change inhibiting continued recruitment
Study Start Date
December 22, 2021 (Actual)
Primary Completion Date
March 29, 2022 (Actual)
Study Completion Date
March 29, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Todd Moyerbrailean DO FACOG
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dysuria
Keywords
Rigid Cystoscopy, Obturator Sheath, Urogynecology
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
68 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Cystoscopy with use of obturator sheath
Arm Type
Other
Arm Description
This intervention arm will include the use of the obturator sheath upon entry into the urethra during rigid cystoscopy.
Arm Title
Cystoscopy without use of obturator sheath
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Cystoscopy - with use of obturator sheath
Intervention Description
The intervention arm will include the use of the obturator sheath upon entry into the urethra during rigid cystoscopy.
Intervention Type
Procedure
Intervention Name(s)
Cystoscopy - without use of obturator sheath
Intervention Description
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.
Primary Outcome Measure Information:
Title
Post-Procedure Dysuria
Description
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.
Time Frame
Post intervention pain scale assessment within 10 minutes following first void after the procedure.
Secondary Outcome Measure Information:
Title
Strength of stream
Description
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
Time Frame
Within 10 minutes following the first post-procedure void.
Title
Bladder pain
Description
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?"
Time Frame
Within 10 minutes following the first post-procedure void.
Title
Hesitancy
Description
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?"
Time Frame
Within 10 minutes following the first post-procedure void.
Title
Straining
Description
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?"
Time Frame
Within 10 minutes following the first post-procedure void.
Title
Incomplete Emptying
Description
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?"
Time Frame
Within 10 minutes following the first post-procedure void.
Title
Post-procedure pain
Description
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.
Time Frame
Within 10 minutes following completion of the procedure
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Todd Moyerbrailean, DO, FACOG
Organizational Affiliation
Michigan State University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Michigan State University
City
East Lansing
State/Province
Michigan
ZIP/Postal Code
48824
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
Individual participant data will be shared with members of the investigation team.
Citations:
PubMed Identifier
12861140
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. doi: 10.1067/mob.2003.377.
Results Reference
background
PubMed Identifier
18455622
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.
Results Reference
background
PubMed Identifier
22569690
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.
Results Reference
background
PubMed Identifier
24300559
Citation
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.
Results Reference
background
PubMed Identifier
25251958
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.
Results Reference
background
PubMed Identifier
25817101
Citation
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.
Results Reference
background
PubMed Identifier
28097268
Citation
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.
Results Reference
background
PubMed Identifier
30807424
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.
Results Reference
background
PubMed Identifier
32920032
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.
Results Reference
background
Learn more about this trial
Pain Outcomes During Rigid Cystoscopy in Females With and Without Cystoscopic Sheath Obturator
We'll reach out to this number within 24 hrs