Trial Comparing Outpatient Flexible to Rigid Cystoscopy in Females

Not Applicable

Completed

Conditions: Pain

Interventions: Device: Cystoscopy

Registration Number: NCT00945594

Lead Sponsor: University of Oklahoma

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: Female

Target Recruitment: 100

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Flexible cystoscopy	Cystoscopy	16F flexible cysto urethroscope (Storz, Culver city, CA)
Rigid cystoscopy	Cystoscopy	17F, 70° scope (Storz, Culver city, CA)

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.