Trial Comparing Outpatient Flexible to Rigid Cystoscopy in Females

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of Oklahoma
ClinicalTrials.gov Identifier:
NCT00945594
First received: July 22, 2009
Last updated: October 29, 2013
Last verified: October 2013
  Purpose

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.


Condition Intervention
Pain
Device: Cystoscopy

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: Randomized Trial Comparing Outpatient Flexible to Rigid Cystoscopy in Females

Further study details as provided by University of Oklahoma:

Primary Outcome Measures:
  • To assess patient pain scores comparing rigid to flexible cystoscopy in females. [ Time Frame: July 2011 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To assess post procedural complications, including frequency, urgency, infection and time to resolution of these symptoms between the two procedures. [ Time Frame: July 2011 ] [ Designated as safety issue: No ]
  • To assess physician perception of patient pain or discomfort with flexible or rigid cystoscopy. [ Time Frame: July 2011 ] [ Designated as safety issue: No ]

Enrollment: 100
Study Start Date: July 2009
Study Completion Date: November 2011
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00945594

Locations
United States, Oklahoma
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States, 73104
Sponsors and Collaborators
University of Oklahoma
  More Information

No publications provided

Responsible Party: University of Oklahoma
ClinicalTrials.gov Identifier: NCT00945594     History of Changes
Other Study ID Numbers: Cystoscopy
Study First Received: July 22, 2009
Last Updated: October 29, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Oklahoma:
flexible cystoscopy
rigid cystoscopy
bladder
outcome assessment
pain measurement

ClinicalTrials.gov processed this record on August 19, 2014