Hematuria, Urination Disorders, Voiding Dysfunction, Recurrent Urinary Tract Infection
Conditions
Keywords
Bladder cancer surveillance, Voiding dysfunction, Cystoscopy
Brief summary
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.
Interventions
DEVICEFlexible Cystoscopy
DEVICERigid Cystoscopy
Sponsors
University of Wisconsin, Madison
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Female
Exclusion criteria
* Minors * Incarcerated individuals
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Visual Analog Scale for Pain | During procedure and 1 week post-procedure | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Flexible Cystoscopy Use of Flexible Cystoscope during clinically indicated cystoscopy | 18 |
| Rigid Cystoscopy Use of Rigid Cystoscope during clinically indicated cystoscopy | 18 |
| Total | 36 |
Baseline characteristics
| Characteristic | Flexible Cystoscopy | Rigid Cystoscopy | Total |
|---|---|---|---|
| Age, Customized Adults, >=18 yrs | 18 participants | 18 participants | 36 participants |
| Age, Customized Minors, <18 yrs | 0 participants | 0 participants | 0 participants |
| Region of Enrollment United States | 18 participants | 18 participants | 36 participants |
| Sex: Female, Male Female | 18 Participants | 18 Participants | 36 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 18 | 0 / 18 |
| serious Total, serious adverse events | 0 / 18 | 0 / 18 |
Outcome results
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.
Time frame: During procedure and 1 week post-procedure
Population: Per protocol.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Rigid | Visual Analog Scale for Pain | 1.8 Units on a Scale | Standard Deviation 0.2 |
| Flexible | Visual Analog Scale for Pain | 1.4 Units on a Scale | Standard Deviation 0.3 |
p-value: 0.39Wilcoxon (Mann-Whitney)
p-value: 0.37Wilcoxon (Mann-Whitney)