Pain
Conditions
Keywords
flexible cystoscopy, rigid cystoscopy, bladder, outcome assessment, pain measurement
Brief summary
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
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.
Interventions
DEVICECystoscopy
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)
Sponsors
University of Oklahoma
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 99 Years
Healthy volunteers
Yes
Inclusion criteria
* Patients with the following indications for outpatient cystourethroscopy: 1. Microscopic hematuria or 2. Voiding dysfunction, or recurrence of urinary incontinence, or 3. 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Duration of Post-procedure Complications | 1 week after procedure | Duration of post-procedure complications, surveyed 1 week post procedure |
| Post Procedural Complications, Including Frequency, Urgency, Infection and Time to Resolution of These Symptoms Between the Two Procedures. | 1 week after procedure | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Visual Analog Pain Scale | Immediately after procedure | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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) | 50 |
| 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) | 50 |
| Total | 100 |
Baseline characteristics
| Characteristic | Rigid Cystoscopy | Total | Flexible Cystoscopy |
|---|---|---|---|
| Age, Continuous | 61.9 Years STANDARD_DEVIATION 14.8 | 59.7 Years STANDARD_DEVIATION 14.6 | 57.6 Years STANDARD_DEVIATION 13.9 |
| Race Caucasian | 44 Participants | 91 Participants | 47 Participants |
| Race Other | 6 Participants | 9 Participants | 3 Participants |
| Sex: Female, Male Female | 50 Participants | 100 Participants | 50 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 | 0 / 50 | 0 / 50 |
| other Total, other adverse events | 0 / 50 | 0 / 50 |
| serious Total, serious adverse events | 0 / 50 | 0 / 50 |
Outcome results
Primary
Duration of Post-procedure Complications
Duration of post-procedure complications, surveyed 1 week post procedure
Time frame: 1 week after procedure
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Rigid Cystoscopy | Duration of Post-procedure Complications | 5.7 minutes | Standard Deviation 3.4 |
| Flexible Cystoscopy | Duration of Post-procedure Complications | 4.6 minutes | Standard Deviation 1.8 |
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
Time frame: 1 week after procedure
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Rigid Cystoscopy | Post Procedural Complications, Including Frequency, Urgency, Infection and Time to Resolution of These Symptoms Between the Two Procedures. | Urgency | 6 participants |
| Rigid Cystoscopy | Post Procedural Complications, Including Frequency, Urgency, Infection and Time to Resolution of These Symptoms Between the Two Procedures. | Burning with urination | 13 participants |
| Rigid Cystoscopy | Post Procedural Complications, Including Frequency, Urgency, Infection and Time to Resolution of These Symptoms Between the Two Procedures. | Frequency | 5 participants |
| Rigid Cystoscopy | Post Procedural Complications, Including Frequency, Urgency, Infection and Time to Resolution of These Symptoms Between the Two Procedures. | Urinary infection | 0 participants |
| Rigid Cystoscopy | Post Procedural Complications, Including Frequency, Urgency, Infection and Time to Resolution of These Symptoms Between the Two Procedures. | Blood in urine | 1 participants |
| Rigid Cystoscopy | Post Procedural Complications, Including Frequency, Urgency, Infection and Time to Resolution of These Symptoms Between the Two Procedures. | Other | 3 participants |
| Rigid Cystoscopy | Post Procedural Complications, Including Frequency, Urgency, Infection and Time to Resolution of These Symptoms Between the Two Procedures. | No new symptoms | 17 participants |
| Flexible Cystoscopy | Post Procedural Complications, Including Frequency, Urgency, Infection and Time to Resolution of These Symptoms Between the Two Procedures. | Other | 2 participants |
| Flexible Cystoscopy | Post Procedural Complications, Including Frequency, Urgency, Infection and Time to Resolution of These Symptoms Between the Two Procedures. | No new symptoms | 15 participants |
| Flexible Cystoscopy | Post Procedural Complications, Including Frequency, Urgency, Infection and Time to Resolution of These Symptoms Between the Two Procedures. | Frequency | 15 participants |
| Flexible Cystoscopy | Post Procedural Complications, Including Frequency, Urgency, Infection and Time to Resolution of These Symptoms Between the Two Procedures. | Urgency | 11 participants |
| Flexible Cystoscopy | Post Procedural Complications, Including Frequency, Urgency, Infection and Time to Resolution of These Symptoms Between the Two Procedures. | Blood in urine | 0 participants |
| Flexible Cystoscopy | Post Procedural Complications, Including Frequency, Urgency, Infection and Time to Resolution of These Symptoms Between the Two Procedures. | Burning with urination | 14 participants |
| Flexible Cystoscopy | Post Procedural Complications, Including Frequency, Urgency, Infection and Time to Resolution of These Symptoms Between the Two Procedures. | Urinary infection | 0 participants |
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.
Time frame: Immediately after procedure
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Rigid Cystoscopy | Visual Analog Pain Scale | 0.9 units on a scale |
| Flexible Cystoscopy | Visual Analog Pain Scale | 0.5 units on a scale |