Lower Urinary Tract InjuryNCT01261819

"Laparoscopic" Cystoscopy Versus Traditional Cystoscopy

A study testing cystoscopy in people with Lower Urinary Tract Injury, run by AdventHealth at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Any age, women onlyHealthy volunteers can take part
Conditions the study is for: Lower Urinary Tract Injury
What is being tested?: cystoscopy
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 66 participants
Where: 1 siteUnited States
Study dates: Jan 2009to Jul 2009
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages Any age
Women only
Healthy volunteers accepted
Child, Adult, Older adult

Who may be able to join

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

Who cannot join

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 locations and contacts

1 site in 1 country.

United States1 site

Florida Hospital
Winter Park and Celebration, Florida

Other trials in United States

About this study

Official title: "Laparoscopic" Cystoscopy Versus Traditional Cystoscopy in Patients Undergoing Minimally Invasive Hysterectomy: A Prospective Comparison Study

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.

Conditions: Lower Urinary Tract Injury
Being tested: cystoscopy
Keywords: cystoscopy, minimally invasive hysterectomy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

cystoscopyDevice

Study groups in NCT01261819
Study group	Role	What they receive
transurethral laparoscope	Experimental	These patients had cystoscopy performed with the transurethral laparoscope. Receives: Device: cystoscopy
Traditional cystoscopy	Active comparator	These patients had cystoscopy performed with the traditional cystoscope, which is considered to be the "gold standard." Receives: Device: cystoscopy

What is being measured

The primary outcome is the main question the study is designed to answer.

Time Required to Perform Procedure (in Seconds)
Time required to perform cystoscopy with a laparoscope or a cystoscope after laparoscopic hysterectomy.
Measured: During Procedure (Up to 15 minutes)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 2009Jul 2009

First posted17 Dec 2010 (estimated)
Study startJan 2009
Primary completionJul 2009
Study completionJul 2009

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Lower Urinary Tract InjuryStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Diagnosis
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Participant
Enrolment: 66 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01261819
Sponsor's protocol ID: FH Project #2142-4860
Status last verified: Sep 2020
First submitted: 28 Oct 2010
Last updated: 8 Oct 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Kratz KG, Spytek SH, Caceres A, Lukman R, McCarus SD. A randomized, single-blinded pilot study evaluating use of a laparoscope or a cystoscope for cystoscopy during gynecologic surgery. J Minim Invasive Gynecol. 2012 Sep-Oct;19(5):606-14. doi: 10.1016/j.jmig.2012.06.002. Epub 2012 Jul 17.
PubMed 22818539

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 2
CBD for Lower Urinary Tract Dysfunction in Spinal Cord Injury
Supra-sacral Spinal Cord Injury, Spinal Cord Injury
Recruiting
Study on Preliminary Safety and Efficacy of Epidural Electrical Stimulation to Manage Lower Urinary Tract Dysfunction After Spinal Cord Injury
Spinal Cord Injuries (SCI), Spinal Cord Injury
RecruitingObservational study
Urine Incontinence Occurrence and Sexual Hormones in Women With Chronic Spinal Cord Injury/Disease - a Pilot Study
Spinal Cord Injury, Urinary Incontinence
Active, not recruitingPhase 2
Sildenafil for Treatment of Urinary Incontinence in Patients With Spinal Cord Injuries
Spinal Cord Injuries, Urinary Incontinence
Not yet recruitingEarly Phase 1
Coupled Gentamicin-Lactobacillus Rhamnosus in NLUTD
Spinal Cord Injury, Neurogenic Bladder (NB)

All Lower Urinary Tract Injury trials

Study at a glance

From the registry record, last updated by the sponsor on 8 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: "Laparoscopic" Cystoscopy Versus Traditional Cystoscopy in Patients Undergoing Minimally Invasive Hysterectomy: A Prospective Comparison Study
ClinicalTrials.gov ID: NCT01261819
Acronym / sponsor ID: FH Project #2142-4860
Conditions: Lower Urinary Tract Injury
Keywords: cystoscopy, minimally invasive hysterectomy
Study type: Interventional
Recruitment status: Completed
Enrolment: 66 participants (actual)
Lead sponsor: AdventHealthUniversity, hospital or other
Study start: Jan 2009
Primary completion: Jul 2009 (actual)
Study completion: Jul 2009 (actual)
First posted: 17 Dec 2010 (estimated)
Results: Posted 8 Oct 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Diagnosis
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 2

Arm	Type	Receives
transurethral laparoscope	Experimental	Device: cystoscopyThese patients had cystoscopy performed with the transurethral laparoscope.
Traditional cystoscopy	Active comparator	Device: cystoscopyThese patients had cystoscopy performed with the traditional cystoscope, which is considered to be the "gold standard."

Who may qualify

Sex: Female only
Healthy volunteers: Accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (4 listed)

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

Key exclusion criteria (4 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
cystoscopy	Device	Traditional cystoscopy, transurethral laparoscope

Primary outcome

Time Required to Perform Procedure (in Seconds)
Time frame: During Procedure (Up to 15 minutes)
Time required to perform cystoscopy with a laparoscope or a cystoscope after laparoscopic hysterectomy.

Results and safety

Results posted to the registry on 8 Oct 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Transurethral Laparoscope	33	33
Traditional Cystoscopy	33	33

Primary outcome: Time Required to Perform Procedure (in Seconds)

Time frame: During Procedure (Up to 15 minutes). Mean (95% Confidence Interval). Unit: seconds

Measure	Transurethral Laparoscope n = 33	Traditional Cystoscopy n = 33
Value	137 (21.1 to 249.9)	451 (204.63 to 697.37)

Adverse events

Time frame: Adverse event data was collected for the duration of the study January-July 2009, and up to 6 weeks after the surgical intervention for each subject.. Other adverse events reported at 3% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Transurethral Laparoscope	0 of 33 (0%)	1 of 33 (3%)	0 of 33
Traditional Cystoscopy	0 of 33 (0%)	6 of 33 (18.2%)	0 of 33

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 22818539Kratz KG, Spytek SH, Caceres A, Lukman R, McCarus SD. A randomized, single-blinded pilot study evaluating use of a laparoscope or a cystoscope for cystoscopy during gynecologic surgery. J Minim Invasive Gynecol. 2012 Sep-Oct;19(5):606-14. doi: 10.1016/j.jmig.2012.06.002. Epub 2012 Jul 17.
Publication of studyLink provided by the sponsor.

Related trials for Lower Urinary Tract Injury

RecruitingPhase 2
CBD for Lower Urinary Tract Dysfunction in Spinal Cord Injury
Supra-sacral Spinal Cord Injury, Spinal Cord Injury
Recruiting
Study on Preliminary Safety and Efficacy of Epidural Electrical Stimulation to Manage Lower Urinary Tract Dysfunction After Spinal Cord Injury
Spinal Cord Injuries (SCI), Spinal Cord Injury
RecruitingObservational study
Urine Incontinence Occurrence and Sexual Hormones in Women With Chronic Spinal Cord Injury/Disease - a Pilot Study
Spinal Cord Injury, Urinary Incontinence
Active, not recruitingPhase 2
Sildenafil for Treatment of Urinary Incontinence in Patients With Spinal Cord Injuries
Spinal Cord Injuries, Urinary Incontinence
Not yet recruitingEarly Phase 1
Coupled Gentamicin-Lactobacillus Rhamnosus in NLUTD
Spinal Cord Injury, Neurogenic Bladder (NB)

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Katherine Kratz, M.D. principal investigator

AdventHealth

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing cystoscopy in people with Lower Urinary Tract Injury, run by AdventHealth at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 8 Oct 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Time Required to Perform Procedure (in Seconds) (time frame: During Procedure (Up to 15 minutes)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01261819, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2020.