Lower Urinary Tract Injury
Conditions
Keywords
cystoscopy, minimally invasive hysterectomy
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.
Interventions
DEVICEcystoscopy
Sponsors
AdventHealth
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
FEMALE
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time Required to Perform Procedure (in Seconds) | During Procedure (Up to 15 minutes) | Time required to perform cystoscopy with a laparoscope or a cystoscope after laparoscopic hysterectomy. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Transurethral Laparoscope These patients had cystoscopy performed with the transurethral laparoscope.
cystoscopy | 33 |
| Traditional Cystoscopy These patients had cystoscopy performed with the traditional cystoscope, which is considered to be the gold standard.
cystoscopy | 33 |
| Total | 66 |
Baseline characteristics
| Characteristic | Transurethral Laparoscope | Traditional Cystoscopy | Total |
|---|---|---|---|
| Age, Continuous | 45.5 years STANDARD_DEVIATION 6.33 | 44.5 years STANDARD_DEVIATION 5.1 | 45 years STANDARD_DEVIATION 5.72 |
| BMI | 28.6 kg/m^2 STANDARD_DEVIATION 6.65 | 27.1 kg/m^2 STANDARD_DEVIATION 5.14 | 27.85 kg/m^2 STANDARD_DEVIATION 5.9 |
| Region of Enrollment United States | 33 Participants | 33 Participants | 66 Participants |
| Sex/Gender, Customized Female | 33 Participants | 33 Participants | 66 Participants |
| Sex/Gender, Customized Male | 0 Participants | 0 Participants | 0 Participants |
| Smoker (%) | 3 Participants | 3 Participants | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 33 | 0 / 33 |
| other Total, other adverse events | 1 / 33 | 6 / 33 |
| serious Total, serious adverse events | 0 / 33 | 0 / 33 |
Outcome results
Primary
Time Required to Perform Procedure (in Seconds)
Time required to perform cystoscopy with a laparoscope or a cystoscope after laparoscopic hysterectomy.
Time frame: During Procedure (Up to 15 minutes)
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Transurethral Laparoscope | Time Required to Perform Procedure (in Seconds) | 137 seconds |
| Traditional Cystoscopy | Time Required to Perform Procedure (in Seconds) | 451 seconds |