"Laparoscopic" Cystoscopy Versus Traditional Cystoscopy

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AdventHealth

Status

Completed

Conditions

Lower Urinary Tract Injury

Treatments

Device: cystoscopy

Study type

Interventional

Funder types

Other

Identifiers

NCT01261819
FH Project #2142-4860

Details and patient eligibility

About

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.

Enrollment

66 patients

Sex

Female

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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

Trial design

66 participants in 2 patient groups

transurethral laparoscope
Experimental group
Description:
These patients had cystoscopy performed with the transurethral laparoscope.
Treatment:
Device: cystoscopy
Traditional cystoscopy
Active Comparator group
Description:
These patients had cystoscopy performed with the traditional cystoscope, which is considered to be the "gold standard."
Treatment:
Device: cystoscopy

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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