Trial Comparing Outpatient Flexible to Rigid Cystoscopy in Females

Randomized Trial Comparing Outpatient Flexible to Rigid Cystoscopy in Females

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.

Study Overview

• Status: Completed
• Conditions: Pain
• Intervention / Treatment: Device: 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.

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73104
      • University of Oklahoma Health Sciences Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Flexible cystoscopy; 16F flexible cysto urethroscope (Storz, Culver city, CA)	Device: 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)
Experimental: Rigid cystoscopy; 17F, 70° scope (Storz, Culver city, CA)	Device: 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Post Procedural Complications, Including Frequency, Urgency, Infection and Time to Resolution of These Symptoms Between the Two Procedures.	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"	1 week after procedure
Duration of Post-procedure Complications	Duration of post-procedure complications, surveyed 1 week post procedure	1 week after procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual Analog Pain Scale	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.	Immediately after procedure

Collaborators and Investigators

• Sponsor: University of Oklahoma
• Investigators: Principal Investigator: Lieschen H Quiroz, MD, University of Oklahoma

Study record dates

Study Major Dates

• Study Start: July 1, 2009
• Primary Completion (Actual): November 1, 2011
• Study Completion (Actual): November 1, 2011

Study Registration Dates

• First Submitted: July 22, 2009
• First Submitted That Met QC Criteria: July 23, 2009
• First Posted (Estimate): July 24, 2009

Study Record Updates

• Last Update Posted (Actual): June 6, 2019
• Last Update Submitted That Met QC Criteria: June 5, 2019
• Last Verified: June 1, 2019

More Information

Terms related to this study

• Keywords: bladder; pain measurement; outcome assessment; rigid cystoscopy; flexible cystoscopy
• Other Study ID Numbers: Cystoscopy