Urinary Tract InfectionPhase 4NCT02034890
Intravesical Instillation of Hyaluronic Acid to Decrease Incidence of Urinary Tract Infection
A Phase 4 study testing Hyaluronic Acid in people with Urinary Tract Infection, run by Rabin Medical Center at 1 site in Israel.
Trial summary
Prospective trial which includes instillation of intravesical hyaluronic acid in an attempt to reduce the incidence of urinary tract infections in patients after orthotopic neobladder reconstruction. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Urinary Tract Infection
- What is being tested?
- Hyaluronic Acid
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteIsrael
- Study dates
- Jul 2015to Mar 2017
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients undergoing radical cystectomy and orthotopic neobladder reconstruction
Who cannot join
- patients <18 years and unwilling to participate in this study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Is Intra - Neobladder Installations of Hyaluronic Acid, Effective in Reducing Neobladder Orthotropic Reconstruction Post-operative Urinary Tract Infections?
Prospective trial which includes instillation of intravesical hyaluronic acid in an attempt to reduce the incidence of urinary tract infections in patients after orthotopic neobladder reconstruction.
- Conditions
- Urinary Tract Infection
- Being tested
- Hyaluronic Acid
- Keywords
- orthotopic neobladder, urinary tract infection, intravesical instillation, hyaluronic acid
- Medical subject headings
- Urinary Tract Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hyaluronic AcidDrug
intravesical instillation of 40 mg of hyaluronic acid in 6 specific time points: 1,2,3 and 4 weeks postoperatively (After radical cystectomy and orthotopic neobladder reconstruction) 2 and 3 months postoperatively
| Study group | Role | What they receive |
|---|---|---|
| hyaluronic acid | Experimental | intravesical instillation of 40 mg of hyaluronic acid at 6 specific time points: 1,2,3 and 4 weeks postoperatively 2 and 3 months postoperatively Receives: Drug: Hyaluronic Acid |
| retrospective control patients | No intervention | retrospective control patients |
What is being measured
The primary outcome is the main question the study is designed to answer.
positive urinary culture
Measured: 6 months
Secondary outcomes (1)
urinary tract infection
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2014 (estimated)
- Study startJul 2015
- Primary completionMar 2017 (estimated)
Why it stopped: Difficulty in recruiting patients
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urinary Tract InfectionStudies 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 4
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rabin Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hanan Goldberg, Rabin Medical Center
- Investigators
- Hanan Goldberg, MD, Principal investigator, Rabin Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02034890
- Sponsor's protocol ID
- RMC-7350
- Status last verified
- Apr 2016
- First submitted
- 10 Jan 2014
- Last updated
- 24 Apr 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is Intra - Neobladder Installations of Hyaluronic Acid, Effective in Reducing Neobladder Orthotropic Reconstruction Post-operative Urinary Tract Infections?
- ClinicalTrials.gov ID
- NCT02034890
- Acronym / sponsor ID
- RMC-7350
- Conditions
- Urinary Tract Infection
- Keywords
- orthotopic neobladder, urinary tract infection, intravesical instillation, hyaluronic acid
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Difficulty in recruiting patients
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Rabin Medical CenterUniversity, hospital or other
- Study start
- Jul 2015
- Primary completion
- Mar 2017 (estimated)
- First posted
- 14 Jan 2014 (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.
Prospective trial which includes instillation of intravesical hyaluronic acid in an attempt to reduce the incidence of urinary tract infections in patients after orthotopic neobladder reconstruction.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| hyaluronic acid | Experimental | Drug: Hyaluronic Acidintravesical instillation of 40 mg of hyaluronic acid at 6 specific time points: 1,2,3 and 4 weeks postoperatively 2 and 3 months postoperatively |
| retrospective control patients | No intervention | –retrospective control patients |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patients undergoing radical cystectomy and orthotopic neobladder reconstruction
Key exclusion criteria (1 listed)
- patients <18 years and unwilling to participate in this study
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 |
|---|---|---|
| Hyaluronic Acidintravesical instillation of 40 mg of hyaluronic acid in 6 specific time points: 1,2,3 and 4 weeks postoperatively (After radical cystectomy and orthotopic neobladder reconstruction) 2 and 3 months postoperatively | Drug | hyaluronic acid |
Primary outcome
positive urinary culture
Time frame: 6 months
1 secondary outcome
urinary tract infection
Time frame: 6 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2019.
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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.
Hanan Goldberg, MD principal investigator
Rabin Medical Center
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 Hyaluronic Acid in people with Urinary Tract Infection, run by Rabin Medical Center at 1 site in Israel.
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 1 inclusion and 1 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: withdrawn, as of the sponsor's last update on 24 Apr 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 Israel. 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.
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 was withdrawn before enrolling participants, so there are no results.
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?
positive urinary culture (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Apr 2019.