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

Not Applicable

Terminated

• Conditions: Dysuria
• Interventions: Procedure: Cystoscopy - without use of obturator sheath; Procedure: Cystoscopy - with use of obturator sheath

• Registration Number: NCT05152199
• Lead Sponsor: Todd Moyerbrailean DO FACOG

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.

Study Timeline

• Study First Submitted: 2021-11-23
• Study First Submitted QC: 2021-12-07
• Study First Posted: 2021-12-09
• Study Start: 2021-12-22
• Status Verified: 2022-03
• Primary Completion: 2022-03-29
• Study Completion: 2022-03-29
• Last Update Submitted: 2022-03-29
• Last Update Posted: 2022-04-07

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 68

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cystoscopy without use of obturator sheath	Cystoscopy - without use of obturator sheath	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.
Cystoscopy with use of obturator sheath	Cystoscopy - with use of obturator sheath	This intervention arm will include the use of the obturator sheath upon entry into the urethra during rigid cystoscopy.

Primary Outcome Measures

Name	Time	Method
Post-Procedure Dysuria	Post intervention pain scale assessment within 10 minutes following first void after the procedure.	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

Name	Time	Method
Incomplete Emptying	Within 10 minutes following the first post-procedure void.	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?"
Hesitancy	Within 10 minutes following the first post-procedure void.	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	Within 10 minutes following the first post-procedure void.	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?"
Post-procedure pain	Within 10 minutes following completion of the procedure	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.
Strength of stream	Within 10 minutes following the first post-procedure void.	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	Within 10 minutes following the first post-procedure void.	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?"

Trial Locations

Locations (1)

Michigan State University; 🇺🇸 East Lansing, Michigan, United States