N/A
N=100
Trial Comparing Outpatient Flexible to Rigid Cystoscopy in Females
Pain
Bottom Line
View on ClinicalTrials.gov: NCT00945594 ↗Enrolled (actual)
100
Serious AEs
0.0%
Results posted
Jun 2019
Primary outcome: Primary: Post Procedural Complications, Including Frequency, Urgency, Infection and Time to Resolution of These Symptoms Between the Two Procedures. — 17; 15; 5; 15 participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Cystoscopy (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- University of Oklahoma
- Primary completion
- Nov 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Post Procedural Complications, Including Frequency, Urgency, Infection and Time to Resolution of These Symptoms Between the Two Procedures. |
17; 15; 5; 15; 6; 11 | — |
| PRIMARY Duration of Post-procedure Complications |
5.7; 4.6 | — |
| SECONDARY Visual Analog Pain Scale |
0.9; 0.5 | — |
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.
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT00945594). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.