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

Study Overview
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Brief Summary
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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.

Detailed Description
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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 (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.

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

Conditions
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Dysuria

Intervention / Treatment
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* Procedure: Cystoscopy - with use of obturator sheath
* Procedure: Cystoscopy - without use of obturator sheath


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Cystoscopy with use of obturator sheath<br>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<br>* The intervention arm will include the use of the obturator sheath upon entry into the urethra during rigid cystoscopy.<br>|
| Active Comparator: Cystoscopy without use of obturator sheath<br>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<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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. | 

Secondary Outcome Measures

| Outcome Measure | 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. | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Rigid Cystoscopy, Obturator Sheath, Urogynecology