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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Flexible cystoscopy | Experimental | 16F flexible cysto urethroscope (Storz, Culver city, CA) |
|
| Rigid cystoscopy | Experimental | 17F, 70° scope (Storz, Culver city, CA) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cystoscopy | Device | 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) |
| 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 |
| 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 |
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Inclusion Criteria:
Patients with the following indications for outpatient cystourethroscopy:
Age >18
Patient willingness to enroll
Patient able to read and understand an English language self- administered questionnaire.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lieschen H Quiroz, MD | University of Oklahoma | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Oklahoma Health Sciences Center | Oklahoma City | Oklahoma | 73104 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Flexible Cystoscopy | 16F flexible cysto urethroscope (Storz, Culver city, CA) Cystoscopy: 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) |
| FG001 | Rigid Cystoscopy | 17F, 70° scope (Storz, Culver city, CA) Cystoscopy: 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) |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Flexible Cystoscopy | 16F flexible cysto urethroscope (Storz, Culver city, CA) Cystoscopy: 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) |
| BG001 | Rigid Cystoscopy |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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" | A total of 42 participants and 43 participants were analyzed from each group, respectively. Some participants may have reported multiple symptoms, which is why the numbers below may exceed to total number of participants analyzed. | Posted | Number | participants | 1 week after procedure |
|
2 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Flexible Cystoscopy | 16F flexible cysto urethroscope (Storz, Culver city, CA) Cystoscopy: 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) |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Lieschen Quiroz, MD | University of Oklahoma Health Sciences Center | 405-271-8787 | lieschen-quiroz@ouhsc.edu |
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| ID | Term |
|---|---|
| D010146 | Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D003558 | Cystoscopy |
| ID | Term |
|---|---|
| D004724 | Endoscopy |
| D003949 | Diagnostic Techniques, Surgical |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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17F, 70° scope (Storz, Culver city, CA) Cystoscopy: 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) |
| BG002 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race | Count of Participants | Participants |
|
| OG001 | Flexible Cystoscopy | 16F flexible cysto urethroscope (Storz, Culver city, CA) Cystoscopy: 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) |
|
|
| Primary | Duration of Post-procedure Complications | Duration of post-procedure complications, surveyed 1 week post procedure | Posted | Mean | Standard Deviation | minutes | 1 week after procedure |
|
|
|
| Secondary | 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. | Posted | Median | Full Range | units on a scale | Immediately after procedure |
|
|
|
| 0 |
| 50 |
| 0 |
| 50 |
| 0 |
| 50 |
| EG001 | Rigid Cystoscopy | 17F, 70° scope (Storz, Culver city, CA) Cystoscopy: 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) | 0 | 50 | 0 | 50 | 0 | 50 |
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| D003950 | Diagnostic Techniques, Urological |
| D019060 | Minimally Invasive Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D013520 | Urologic Surgical Procedures |
| D013519 | Urogenital Surgical Procedures |