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The study will help define the best tolerated approach to cystoscopy in women by randomly comparing flexible to rigid cystoscopy. Previous randomized studies evaluated rigid cystoscopy under general anesthesia versus flexible cystoscopy under local anesthesia. As a result of these studies, flexible cystoscopy is performed in the clinic setting generally in males. However, many women have rigid cystoscopy performed in the clinic while the men have flexible cystoscopy. No studies to date have evaluated whether flexible cystoscopy is better tolerated in women compared to rigid cystoscopy in women in the clinic setting.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Flexible Cystoscopy | Active Comparator | Flexible Cystoscopy |
|
| Rigid Cystoscopy | Active Comparator | Rigid Cystoscopy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Flexible Cystoscopy | Device |
| ||
| Rigid Cystoscopy |
| Measure | Description | Time Frame |
|---|---|---|
| Visual Analog Scale for Pain | The Visual Analog Scale for pain ranges from 1 to 5, with higher scores indicating higher pain. Results report the average of two measures, taken during procedure and 1 week post-procedure. | During procedure and 1 week post-procedure |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Stephen Nakada, MD | University of Wisconsin, Madison | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Wisconsin | Madison | Wisconsin | 53792 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Flexible Cystoscopy | Use of Flexible Cystoscope during clinically indicated cystoscopy |
| FG001 | Rigid Cystoscopy | Use of Rigid Cystoscope during clinically indicated cystoscopy |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Flexible Cystoscopy | Use of Flexible Cystoscope during clinically indicated cystoscopy |
| BG001 | Rigid Cystoscopy | Use of Rigid Cystoscope during clinically indicated cystoscopy |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number |
| 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 | Visual Analog Scale for Pain | The Visual Analog Scale for pain ranges from 1 to 5, with higher scores indicating higher pain. Results report the average of two measures, taken during procedure and 1 week post-procedure. | Per protocol. | Posted | Mean | Standard Deviation | Units on a Scale | During procedure and 1 week post-procedure |
|
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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 | Use of Flexible Cystoscope during clinically indicated cystoscopy |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Stephen Nakada | University of Wisconsin School of Medicine and Public Health | (608)263-1359 | nakada@urology.wisc.edu |
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| ID | Term |
|---|---|
| D006417 | Hematuria |
| D014555 | Urination Disorders |
| D014552 | Urinary Tract Infections |
| ID | Term |
|---|---|
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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|
| BG002 | Total | Total of all reporting groups |
| participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
|
| 0 |
| 18 |
| 0 |
| 18 |
| EG001 | Rigid Cystoscopy | Use of Rigid Cystoscope during clinically indicated cystoscopy | 0 | 18 | 0 | 18 |
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| D052801 | Male Urogenital Diseases |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007239 | Infections |