Clinical trial NCT00945594: Trial Comparing Outpatient Flexible to Rigid Cystoscopy in Females
Official title: Randomized Trial Comparing Outpatient Flexible to Rigid Cystoscopy in Females
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain
Keywords: flexible cystoscopy
rigid cystoscopy
bladder
outcome assessment
pain measurement
Lead sponsor: University of Oklahoma
Sponsor class: OTHER
First posted: 2009-07-24
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

Eligibility criteria: 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

Primary outcomes:
measure: Post Procedural Complications, Including Frequency, Urgency, Infection and Time to Resolution of These Symptoms Between the Two Procedures.
timeFrame: 1 week after procedure
measure: Duration of Post-procedure Complications
timeFrame: 1 week after procedure
Secondary outcomes:
measure: Visual Analog Pain Scale
timeFrame: Immediately after procedure
Other outcomes:
Locations:
city: Oklahoma City
country: United States
facility: University of Oklahoma Health Sciences Center
state: Oklahoma
Study officials:
affiliation: University of Oklahoma
name: Lieschen H Quiroz, MD
role: PRINCIPAL_INVESTIGATOR
References: