"Laparoscopic" Cystoscopy Versus Traditional Cystoscopy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01261819
Recruitment Status : Completed
First Posted : December 17, 2010
Last Update Posted : December 21, 2010
Information provided by:
Florida Hospital

Brief Summary:
The study aimed to compare the use of a transurethral laparoscope to the use of a traditional cystoscope for evaluation of the bladder and ureters at the time of laparoscopic hysterectomy. The hypothesis was that visual inspection of the bladder and ureters can be done safely using a transurethral laparoscope, takes less time than traditional cystoscopy, and is more cost effective than traditional cystoscopy.

Condition or disease Intervention/treatment Phase
Lower Urinary Tract Injury Device: cystoscopy Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 68 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Diagnostic
Official Title: "Laparoscopic" Cystoscopy Versus Traditional Cystoscopy in Patients Undergoing Minimally Invasive Hysterectomy: A Prospective Comparison Study
Study Start Date : January 2009
Actual Primary Completion Date : July 2009
Actual Study Completion Date : July 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hysterectomy

Arm Intervention/treatment
Experimental: transurethral laparoscope
These patients had cystoscopy performed with the transurethral laparoscope.
Device: cystoscopy
Active Comparator: Traditional cystoscopy
These patients had cystoscopy performed with the traditional cystoscope, which is considered to be the "gold standard."
Device: cystoscopy

Primary Outcome Measures :
  1. Prospective assessment of safety of a novel technique called transurethral laparoscopic cystoscopy [ Time Frame: 6 weeks ]

Information from the National Library of Medicine

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, Learn About Clinical Studies.

Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  1. any female patient scheduled for a laparoscopic supracervical hysterectomy (LSH) or total laparoscopic hysterectomy (TLH) with or without adnexectomy for benign disease
  2. able to comprehend and sign the informed consent form
  3. able to provide clean-catch urine specimens
  4. able to complete a urinary symptom questionnaire pre- and post-operatively

Exclusion Criteria:

  1. participants in another research protocol involving an investigational product 30 days before planned randomization
  2. pregnant women
  3. patients undergoing concomitant incontinence or pelvic support procedures (e.g. transvaginal tape, transobturator tape, pelvic organ prolapse surgery)
  4. patients known to have a history of recurrent urinary tract infections

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01261819

United States, Florida
Florida Hospital
Winter Park and Celebration, Florida, United States
Sponsors and Collaborators
Florida Hospital
Principal Investigator: Katherine Kratz, M.D. Florida Hospital

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Katherine Kratz, M.D. Identifier: NCT01261819     History of Changes
Other Study ID Numbers: FH Project #2142-4860
First Posted: December 17, 2010    Key Record Dates
Last Update Posted: December 21, 2010
Last Verified: November 2009

Keywords provided by Florida Hospital:
cystoscopy, minimally invasive hysterectomy