"Laparoscopic" Cystoscopy Versus Traditional Cystoscopy

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

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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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