Trial Outcomes & Findings for Trial Comparing Outpatient Flexible to Rigid Cystoscopy in Females (NCT NCT00945594)
NCT ID: NCT00945594
Last Updated: 2019-06-06
Results Overview
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"
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
100 participants
Primary outcome timeframe
1 week after procedure
Results posted on
2019-06-06
Participant Flow
Participant milestones
| Measure |
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)
|
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)
|
|---|---|---|
|
Overall Study
STARTED
|
50
|
50
|
|
Overall Study
COMPLETED
|
50
|
50
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Trial Comparing Outpatient Flexible to Rigid Cystoscopy in Females
Baseline characteristics by cohort
| Measure |
Flexible Cystoscopy
n=50 Participants
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)
|
Rigid Cystoscopy
n=50 Participants
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
n=100 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
57.6 Years
STANDARD_DEVIATION 13.9 • n=5 Participants
|
61.9 Years
STANDARD_DEVIATION 14.8 • n=7 Participants
|
59.7 Years
STANDARD_DEVIATION 14.6 • n=5 Participants
|
|
Sex: Female, Male
Female
|
50 Participants
n=5 Participants
|
50 Participants
n=7 Participants
|
100 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race
Caucasian
|
47 Participants
n=5 Participants
|
44 Participants
n=7 Participants
|
91 Participants
n=5 Participants
|
|
Race
Other
|
3 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 1 week after procedurePopulation: 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.
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"
Outcome measures
| Measure |
Rigid Cystoscopy
n=42 Participants
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)
|
Flexible Cystoscopy
n=43 Participants
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)
|
|---|---|---|
|
Post Procedural Complications, Including Frequency, Urgency, Infection and Time to Resolution of These Symptoms Between the Two Procedures.
Burning with urination
|
13 participants
|
14 participants
|
|
Post Procedural Complications, Including Frequency, Urgency, Infection and Time to Resolution of These Symptoms Between the Two Procedures.
Urinary infection
|
0 participants
|
0 participants
|
|
Post Procedural Complications, Including Frequency, Urgency, Infection and Time to Resolution of These Symptoms Between the Two Procedures.
No new symptoms
|
17 participants
|
15 participants
|
|
Post Procedural Complications, Including Frequency, Urgency, Infection and Time to Resolution of These Symptoms Between the Two Procedures.
Frequency
|
5 participants
|
15 participants
|
|
Post Procedural Complications, Including Frequency, Urgency, Infection and Time to Resolution of These Symptoms Between the Two Procedures.
Urgency
|
6 participants
|
11 participants
|
|
Post Procedural Complications, Including Frequency, Urgency, Infection and Time to Resolution of These Symptoms Between the Two Procedures.
Blood in urine
|
1 participants
|
0 participants
|
|
Post Procedural Complications, Including Frequency, Urgency, Infection and Time to Resolution of These Symptoms Between the Two Procedures.
Other
|
3 participants
|
2 participants
|
PRIMARY outcome
Timeframe: 1 week after procedureDuration of post-procedure complications, surveyed 1 week post procedure
Outcome measures
| Measure |
Rigid Cystoscopy
n=50 Participants
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)
|
Flexible Cystoscopy
n=50 Participants
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)
|
|---|---|---|
|
Duration of Post-procedure Complications
|
5.7 minutes
Standard Deviation 3.4
|
4.6 minutes
Standard Deviation 1.8
|
SECONDARY outcome
Timeframe: Immediately after procedureThe 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.
Outcome measures
| Measure |
Rigid Cystoscopy
n=50 Participants
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)
|
Flexible Cystoscopy
n=50 Participants
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)
|
|---|---|---|
|
Visual Analog Pain Scale
|
0.9 units on a scale
Interval 0.1 to 2.72
|
0.5 units on a scale
Interval 0.0 to 2.4
|
Adverse Events
Flexible Cystoscopy
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Rigid Cystoscopy
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Lieschen Quiroz, MD
University of Oklahoma Health Sciences Center
Phone: 405-271-8787
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place