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"Laparoscopic" Cystoscopy Versus Traditional Cystoscopy

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ClinicalTrials.gov Identifier: NCT01261819
Recruitment Status : Completed
First Posted : December 17, 2010
Last Update Posted : December 21, 2010
Sponsor:
Information provided by:

Study Description
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
Lower Urinary Tract Injury Device: cystoscopy

Study Design

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
Primary Completion Date : July 2009
Study Completion Date : July 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hysterectomy
U.S. FDA Resources

Arms and Interventions

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


Outcome Measures

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

Eligibility Criteria

Information from the National Library of Medicine

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

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
Contacts and Locations

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 ClinicalTrials.gov identifier (NCT number): NCT01261819


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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Katherine Kratz, M.D.
ClinicalTrials.gov 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