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Completed

NCT Number: NCT00945594

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.

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Key information

Age range

18 year–99 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, 73104, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients with the following indications for outpatient cystourethroscopy:
  • Microscopic hematuria or
  • Voiding dysfunction, or recurrence of urinary incontinence, or
  • 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

Treatment and study plan

cystoscopy

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)

Primary outcomes

  1. Post Procedural Complications, Including Frequency, Urgency, Infection and Time to Resolution of These Symptoms Between the Two Procedures.

    Time frame: 1 week after procedure

    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"

  2. Duration of Post-procedure Complications

    Time frame: 1 week after procedure

    Duration of post-procedure complications, surveyed 1 week post procedure

Secondary outcomes

  1. Visual Analog Pain Scale

    Time frame: Immediately after procedure

    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.

Sponsors and collaborators

Lead sponsor

University of Oklahoma

Other

Registry information

Official study title

Randomized Trial Comparing Outpatient Flexible to Rigid Cystoscopy in Females

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Jul 24, 2009
Registry last updated
Jun 6, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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