Trial Outcomes & Findings for Rigid Versus Flexible Cystoscopy in Women (NCT NCT00214045)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

36 participants

Primary outcome timeframe

During procedure and 1 week post-procedure

Results posted on

2019-05-15

Participant Flow

Participant milestones

Participant milestones
Measure	Flexible Cystoscopy Use of Flexible Cystoscope during clinically indicated cystoscopy	Rigid Cystoscopy Use of Rigid Cystoscope during clinically indicated cystoscopy
Overall Study STARTED	18	18
Overall Study COMPLETED	18	18
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Rigid Versus Flexible Cystoscopy in Women

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Flexible Cystoscopy n=18 Participants Use of Flexible Cystoscope during clinically indicated cystoscopy	Rigid Cystoscopy n=18 Participants Use of Rigid Cystoscope during clinically indicated cystoscopy	Total n=36 Participants Total of all reporting groups
Age, Customized Minors, <18 yrs	0 participants n=5 Participants	0 participants n=7 Participants	0 participants n=5 Participants
Age, Customized Adults, >=18 yrs	18 participants n=5 Participants	18 participants n=7 Participants	36 participants n=5 Participants
Sex: Female, Male Female	18 Participants n=5 Participants	18 Participants n=7 Participants	36 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	18 participants n=5 Participants	18 participants n=7 Participants	36 participants n=5 Participants

PRIMARY outcome

Timeframe: During procedure and 1 week post-procedure

Population: Per protocol.

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.

Outcome measures

Outcome measures
Measure	Rigid n=18 Participants Rigid	Flexible n=18 Participants Flexible
Visual Analog Scale for Pain	1.8 Units on a Scale Standard Deviation 0.2	1.4 Units on a Scale Standard Deviation 0.3

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

Dr. Stephen Nakada

University of Wisconsin School of Medicine and Public Health

Phone: (608)263-1359

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place