CystoscopyPhase 4NCT02960412
Effect of Furosemide on Confirmation of Ureteral Patency During Routine Cystoscopy
A Phase 4 study testing furosemide and Normal Saline in people with Cystoscopy, run by University of South Florida at 1 site in United States.
Trial summary
This study evaluates if administration of IV furosemide leads to expedited confirmation of ureteral patency when compared to placebo (IV saline) in routine cystoscopy performed after urogynecologic surgery. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cystoscopy
- What is being tested?
- furosemide and Normal Saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2017to 30 Jun 2018
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Undergoing any urogynecologic surgery
- No allergy or contraindication to receiving furosemide
- Normal Creatinine/glomerular filtration rate
Who cannot join
- Unable to consent, including if non English speaking
- Allergy or contraindication to receiving furosemide
- Intraoperative injury to the lower urinary tract
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Controlled Trial Evaluating Effect of Furosemide on Confirmation of Ureteral Patency During Routine Cystoscopy
This study evaluates if administration of IV furosemide leads to expedited confirmation of ureteral patency when compared to placebo (IV saline) in routine cystoscopy performed after urogynecologic surgery.
Read the detailed description
Cystoscopy is performed routinely after urogynecologic surgery to ensure there was no injury to the urinary tract (urethra, bladder, or ureters). In order to confirm that no damage occurred to the ureters, a jet of urine must be visualized from each ureteral opening.
The time it takes to confirm this ureteral patency is variable and some sources suggest using furosemide to decrease the time it takes to see these jets. This study will evaluate what effect, if any, this medicine has on time to confirming ureteral patency.
- Conditions
- Cystoscopy
- Being tested
- furosemide, Normal Saline
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
furosemideDrug
Also called Lasix
10mg lasix given intraoperatively
Normal SalineDrug
Normal saline given intraoperatively as placebo
| Study group | Role | What they receive |
|---|---|---|
| furosemide | Experimental | furosemide 10mg (1mL) IV push for one dose Receives: Drug: furosemide |
| placebo | Placebo comparator | normal saline 1mL IV push for one dose Receives: Drug: Normal Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
time to ureteral patency
time to confirmation of ureteral patency in seconds
Measured: intra-operative
Secondary outcomes (1)
adverse effects from furosemide administration
Measured: immediately post operative (1-3 days post operatively)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2016 (estimated)
- Study start1 May 2017
- Primary completion31 Mar 2018
- Study completion30 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for CystoscopyStudies of the same condition, open and under way.
- More trials run by University of South FloridaThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of South Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02960412
- Sponsor's protocol ID
- Pro00026976
- Status last verified
- Mar 2019
- First submitted
- 7 Nov 2016
- Last updated
- 28 Mar 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Patton S, Tanner JP, Prieto I, Jackson E, Greene K, Bassaly R, Wyman AM. Furosemide Use and Time to Confirmation of Ureteral Patency During Intraoperative Cystoscopy: A Randomized Controlled Trial. Obstet Gynecol. 2019 Apr;133(4):669-674. doi: 10.1097/AOG.0000000000003155.
PubMed 30870291
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial Evaluating Effect of Furosemide on Confirmation of Ureteral Patency During Routine Cystoscopy
- ClinicalTrials.gov ID
- NCT02960412
- Acronym / sponsor ID
- Pro00026976
- Conditions
- Cystoscopy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- University of South FloridaUniversity, hospital or other
- Study start
- 1 May 2017 (actual)
- Primary completion
- 31 Mar 2018 (actual)
- Study completion
- 30 Jun 2018 (actual)
- First posted
- 9 Nov 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study evaluates if administration of IV furosemide leads to expedited confirmation of ureteral patency when compared to placebo (IV saline) in routine cystoscopy performed after urogynecologic surgery.
Detailed description
Cystoscopy is performed routinely after urogynecologic surgery to ensure there was no injury to the urinary tract (urethra, bladder, or ureters). In order to confirm that no damage occurred to the ureters, a jet of urine must be visualized from each ureteral opening.
The time it takes to confirm this ureteral patency is variable and some sources suggest using furosemide to decrease the time it takes to see these jets. This study will evaluate what effect, if any, this medicine has on time to confirming ureteral patency.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| furosemide | Experimental | Drug: furosemidefurosemide 10mg (1mL) IV push for one dose |
| placebo | Placebo comparator | Drug: Normal Salinenormal saline 1mL IV push for one dose |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Undergoing any urogynecologic surgery
- No allergy or contraindication to receiving furosemide
- Normal Creatinine/glomerular filtration rate
Key exclusion criteria (3 listed)
- Unable to consent, including if non English speaking
- Allergy or contraindication to receiving furosemide
- Intraoperative injury to the lower urinary tract
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 |
|---|---|---|
| furosemideAlso: Lasix10mg lasix given intraoperatively | Drug | furosemide |
| Normal SalineNormal saline given intraoperatively as placebo | Drug | placebo |
Primary outcome
time to ureteral patency
Time frame: intra-operative
time to confirmation of ureteral patency in seconds
1 secondary outcome
adverse effects from furosemide administration
Time frame: immediately post operative (1-3 days post operatively)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2019.
- Derived from this study: PubMed 30870291Patton S, Tanner JP, Prieto I, Jackson E, Greene K, Bassaly R, Wyman AM. Furosemide Use and Time to Confirmation of Ureteral Patency During Intraoperative Cystoscopy: A Randomized Controlled Trial. Obstet Gynecol. 2019 Apr;133(4):669-674. doi: 10.1097/AOG.0000000000003155.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing furosemide and Normal Saline in people with Cystoscopy, run by University of South Florida 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 3 inclusion and 3 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 28 Mar 2019. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 to ureteral patency (time frame: intra-operative). 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 NCT02960412, 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 28 Mar 2019.