"Laparoscopic" Cystoscopy Versus Traditional Cystoscopy

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

66 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-01-31

Study Completion Date

2009-07-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Lower Urinary Tract Injury

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

SINGLE

Participants

Study Groups

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transurethral laparoscope

These patients had cystoscopy performed with the transurethral laparoscope.

Group Type EXPERIMENTAL

cystoscopy

Intervention Type DEVICE

Traditional cystoscopy

These patients had cystoscopy performed with the traditional cystoscope, which is considered to be the "gold standard."

Group Type ACTIVE_COMPARATOR

cystoscopy

Intervention Type DEVICE

Interventions

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cystoscopy

Intervention Type DEVICE

Eligibility Criteria

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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

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes