Trial Comparing Outpatient Flexible to Rigid Cystoscopy in Females
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Flexible cystoscopy 16F flexible cysto urethroscope (Storz, Culver city, CA) |
Device: 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)
|
| Experimental: Rigid cystoscopy 17F, 70° scope (Storz, Culver city, CA) |
Device: 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)
|
Outcome Measures
Primary Outcome Measures
- 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"
- Duration of Post-procedure Complications [1 week after procedure]
Duration of post-procedure complications, surveyed 1 week post procedure
Secondary Outcome Measures
- 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.
Eligibility Criteria
Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University of Oklahoma Health Sciences Center | Oklahoma City | Oklahoma | United States | 73104 |
Sponsors and Collaborators
- University of Oklahoma
Investigators
- Principal Investigator: Lieschen H Quiroz, MD, University of Oklahoma
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- Cystoscopy
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Flexible Cystoscopy | Rigid Cystoscopy |
|---|---|---|
| Arm/Group Description | 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) | 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) |
| Period Title: Overall Study | ||
| STARTED | 50 | 50 |
| COMPLETED | 50 | 50 |
| NOT COMPLETED | 0 | 0 |
Baseline Characteristics
| Arm/Group Title | Flexible Cystoscopy | Rigid Cystoscopy | Total |
|---|---|---|---|
| Arm/Group Description | 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) | 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) | Total of all reporting groups |
| Overall Participants | 50 | 50 | 100 |
| Age (Years) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [Years] |
57.6
(13.9)
|
61.9
(14.8)
|
59.7
(14.6)
|
| Sex: Female, Male (Count of Participants) | |||
| Female |
50
100%
|
50
100%
|
100
100%
|
| Male |
0
0%
|
0
0%
|
0
0%
|
| Race (Count of Participants) | |||
| Caucasian |
47
94%
|
44
88%
|
91
91%
|
| Other |
3
6%
|
6
12%
|
9
9%
|
Outcome Measures
| Title | Post Procedural Complications, Including Frequency, Urgency, Infection and Time to Resolution of These Symptoms Between the Two Procedures. |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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/Group Title | Rigid Cystoscopy | Flexible Cystoscopy |
|---|---|---|
| Arm/Group Description | 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) | 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) |
| Measure Participants | 42 | 43 |
| No new symptoms |
17
34%
|
15
30%
|
| Frequency |
5
10%
|
15
30%
|
| Urgency |
6
12%
|
11
22%
|
| Blood in urine |
1
2%
|
0
0%
|
| Burning with urination |
13
26%
|
14
28%
|
| Urinary infection |
0
0%
|
0
0%
|
| Other |
3
6%
|
2
4%
|
| Title | Duration of Post-procedure Complications |
|---|---|
| Description | Duration of post-procedure complications, surveyed 1 week post procedure |
| Time Frame | 1 week after procedure |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Rigid Cystoscopy | Flexible Cystoscopy |
|---|---|---|
| Arm/Group Description | 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) | 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) |
| Measure Participants | 50 | 50 |
| Mean (Standard Deviation) [minutes] |
5.7
(3.4)
|
4.6
(1.8)
|
| Title | Visual Analog Pain Scale |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Flexible Cystoscopy | Rigid Cystoscopy |
|---|---|---|
| Arm/Group Description | 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) | 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) |
| Measure Participants | 50 | 50 |
| Median (Full Range) [units on a scale] |
0.9
|
0.5
|
Adverse Events
| Time Frame | 2 weeks | |||
|---|---|---|---|---|
| Adverse Event Reporting Description | ||||
| Arm/Group Title | Flexible Cystoscopy | Rigid Cystoscopy | ||
| Arm/Group Description | 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) | 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) | ||
All Cause Mortality |
||||
| Flexible Cystoscopy | Rigid Cystoscopy | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/50 (0%) | 0/50 (0%) | ||
Serious Adverse Events |
||||
| Flexible Cystoscopy | Rigid Cystoscopy | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/50 (0%) | 0/50 (0%) | ||
Other (Not Including Serious) Adverse Events |
||||
| Flexible Cystoscopy | Rigid Cystoscopy | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/50 (0%) | 0/50 (0%) | ||
Limitations/Caveats
More Information
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
| Name/Title | Lieschen Quiroz, MD |
|---|---|
| Organization | University of Oklahoma Health Sciences Center |
| Phone | 405-271-8787 |
| lieschen-quiroz@ouhsc.edu |
- Cystoscopy