Trial Comparing Outpatient Flexible to Rigid Cystoscopy in Females

Pain Clinical Trial

Official title:

Randomized Trial Comparing Outpatient Flexible to Rigid Cystoscopy in Females

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00945594
• Other study ID #: Cystoscopy
• Status: Completed
• Phase: N/A
• Start date: July 2009
• Est. completion date: November 2011

Study information

• Verified date: June 2019
• Source: University of Oklahoma
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: November 2011
• Est. primary completion date: November 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Pain

Intervention

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)

Locations

Country	Name	City	State
United States	University of Oklahoma Health Sciences Center	Oklahoma City	Oklahoma

Sponsors (1)

Lead Sponsor	Collaborator
University of Oklahoma

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Duration of Post-procedure Complications	Duration of post-procedure complications, surveyed 1 week post procedure	1 week after procedure
Secondary	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