Trial Comparing Outpatient Flexible to Rigid Cystoscopy in Females

NCT ID: NCT00945594

Last Updated: 2019-06-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-07-31
• Study Completion Date: 2011-11-30

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.

Conditions

Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Flexible cystoscopy

16F flexible cysto urethroscope (Storz, Culver city, CA)

Group Type: EXPERIMENTAL

Cystoscopy

Intervention Type: DEVICE

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)

Rigid cystoscopy

17F, 70° scope (Storz, Culver city, CA)

Group Type: EXPERIMENTAL

Cystoscopy

Intervention Type: DEVICE

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)

Interventions

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)

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

University of Oklahoma

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Lieschen H Quiroz, MD

Role: PRINCIPAL_INVESTIGATOR

University of Oklahoma

Locations

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, United States

Countries

United States

Other Identifiers

Cystoscopy

Identifier Type: -

Identifier Source: org_study_id