Trial Comparing Outpatient Flexible to Rigid Cystoscopy in Females

Study Overview
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Brief Summary
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The primary purpose of this study to assess patient pain scores comparing rigid to flexible cystoscopy in females; to assess post procedural complications, including frequency, urgency, infection and time to resolution of these symptoms between the two procedures; to assess physician perception of patient pain or discomfort with flexible or rigid cystoscopy.

Detailed Description
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This will be a prospective randomized trial study in order to determine to compare rigid and flexible cystoscopy in female patients. Patients will be recruited from OU Physicians Pelvic and Bladder Health clinic. Patients receive an information leaflet describing the procedure prior to their appointment. All procedures are performed by the attending physician. Procedures performed by residents and/or fellows are excluded from this study. The vulva is cleaned with antiseptic solution and 10 ml of Xylocaine 2% is be instilled into the urethra before the endoscope was introduced. A 16 F flexible cysto urethroscope (Storz, Culver city, CA) is used for flexible cystoscopy. When rigid cystoscopy is performed, a 17F, 70° scope (Storz, Culver city, CA) is used to enable optimal visualization of the lateral bladder wall in those with previous continence surgeries. The investigator may choose to use a 30° scope when appropriate. Cystoscopy is commenced by recording a postvoid residual ensuring appropriate bladder emptying prior to filling. Filling is performed with continuous saline infusion until the maximum tolerated capacity or 300 ml. (whichever was reached first). A standard systematic approach was adopted to ensure global assessment of the vesical surface. This included the bladder dome, the bladder neck, bladder trigone, sidewalls and ureteral orifices. The urethroscopy portion of the procedure is performed last. When performing rigid cystoscopy, a 0° degree lens is used for this portion of the procedure.

Official Title
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Randomized Trial Comparing Outpatient Flexible to Rigid Cystoscopy in Females

Conditions
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Pain

Intervention / Treatment
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* Device: Cystoscopy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with the following indications for outpatient cystourethroscopy: Microscopic hematuria or Voiding dysfunction, or recurrence of urinary incontinence, or History of recurrent bacterial cystitis Age >18 Patient willingness to enroll Patient able to read and understand an English language self- administered questionnaire. Exclusion Criteria: Severe detrussor overactivity Interstitial cystitis or chronic urethral or bladder pain Acute urinary tract infection Urinary retention defined as a post void residual >120cc Pregnancy or planning pregnancy within the next 3 months Prior urethral surgery Dementia or inability to complete questionnaires

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 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: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Flexible cystoscopy<br>16F flexible cysto urethroscope (Storz, Culver city, CA) | Device: Cystoscopy<br>* A 16 F flexible cysto urethroscope (Storz, Culver city, CA) is used for flexible cystoscopy. When rigid cystoscopy is performed, a 17F, 70° scope (Storz, Culver city, CA)<br>|
| Experimental: Rigid cystoscopy<br>17F, 70° scope (Storz, Culver city, CA) | Device: Cystoscopy<br>* A 16 F flexible cysto urethroscope (Storz, Culver city, CA) is used for flexible cystoscopy. When rigid cystoscopy is performed, a 17F, 70° scope (Storz, Culver city, CA)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post Procedural Complications, Including Frequency, Urgency, Infection and Time to Resolution of These Symptoms Between the Two Procedures. | Post procedural complications, including frequency, urgency, infection and time to resolution of these symptoms between the two procedures. Patients were asked to report frequency or urgency as a yes or no | 1 week after procedure | 
| Duration of Post-procedure Complications | Duration of post-procedure complications, surveyed 1 week post procedure | 1 week after procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual Analog Pain Scale | The Visual analog pain scale measures patient-reported pain levels from 0-10, with 0 being no pain reported and 10 being the highest level of pain reported. In this study, researchers compared pain levels between females who had rigid and flexible cystoscopies. | Immediately after procedure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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flexible cystoscopy, rigid cystoscopy, bladder, outcome assessment, pain measurement