Urinary Tract InfectionsPhase 4NCT03099863
Cytoscopic Antibiotic Irrigant to Reduce Postoperative Urinary Tract Infection
A Phase 4 study testing Cystoscopic Fluid containing Neosporin G. U. Irrigant and Cystoscopy in people with Urinary Tract Infections, run by MetroHealth Medical Center at 1 site in United States.
Trial summary
Postoperative urinary tract infections (UTIs) affect 20-30% of patients undergoing elective gynecologic surgery and have a significant socioeconomic impact and cost. Preoperative antibiotics, sterile operating techniques, postoperative antibiotic and non-antibiotic medical therapies have been utilized to attempt to… 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
- Urinary Tract Infections
- What is being tested?
- Cystoscopic Fluid containing Neosporin G. U. Irrigant and Cystoscopy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 242 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2016to Jun 2020
- Phase
- Phase 4
- 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 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adult women at least 18 years of age
- Elective Female Pelvic Medicine and Reconstructive Surgery or Gynecologic Minimally Invasive surgeries including hysterectomy, suburethral sling, and pelvic organ prolapse repair that require cystoscopy.
Who cannot join
- Surgeries that include: intradetrusor Botox, vaginal mesh excision, and fistula repair
- Pregnancy
- History of nephrolithiasis
- Allergy to study medications
- Congenital urogenital anomaly
- Neurogenic bladder
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Cytoscopic Antibiotic Irrigant to Reduce Postoperative Urinary Infection: A Randomized Controlled Study
Postoperative urinary tract infections (UTIs) affect 20-30% of patients undergoing elective gynecologic surgery and have a significant socioeconomic impact and cost. Preoperative antibiotics, sterile operating techniques, postoperative antibiotic and non-antibiotic medical therapies have been utilized to attempt to decrease this rate with little improvement. Utilization of an intraoperative antibiotic cystoscopic irrigant may decrease postoperative UTIs. The investigators have designed a prospective randomized controlled study to evaluate the effectiveness of an antibiotic cystoscopic fluid in preventing postoperative urinary tract infections in women undergoing elective pelvic floor surgery with cystoscopy.
- Conditions
- Urinary Tract Infections
- Being tested
- Cystoscopic Fluid containing Neosporin G. U. Irrigant, Cystoscopy, Cystoscopic Fluid/Placebo
- 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.
Cystoscopic Fluid containing Neosporin G. U. IrrigantDrug
Normal saline cystoscopic fluid containing Neosporin G. U. Irrigant 1mL/1000mL
CystoscopyProcedure or surgery
Diagnostic cystoscopy performed during pelvic floor surgery
Cystoscopic Fluid/PlaceboDrug
Normal saline cystoscopic fluid
| Study group | Role | What they receive |
|---|---|---|
| Standard Care | Placebo comparator | Standard cystoscopy with normal saline solution. Receives: Procedure: Cystoscopy; Drug: Cystoscopic Fluid/Placebo |
| Neosporin G. U. Irrigant | Active comparator | Standard cystoscopy with normal saline solution containing Neosporin® G.U. at a 1mL/1000mL concentration. Receives: Drug: Cystoscopic Fluid containing Neosporin G. U. Irrigant; Procedure: Cystoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Urinary Tract Infection
Urinary tract infection defined as positive urinalysis, urine culture, and/or positive lower urinary tract symptoms requiring antibiotic treatment.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2017
- Study startApr 2016
- Primary completionJun 2020
- Study completionJun 2020
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.
- Other trials for Urinary Tract InfectionsStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 242 participants (actual)
Sponsor and investigators
- Lead sponsor
- MetroHealth Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jeffrey Mangel, MetroHealth Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03099863
- Sponsor's protocol ID
- IRB15-00769
- Status last verified
- Dec 2021
- First submitted
- 23 Mar 2017
- Last updated
- 30 Dec 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cytoscopic Antibiotic Irrigant to Reduce Postoperative Urinary Infection: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT03099863
- Acronym / sponsor ID
- IRB15-00769
- Conditions
- Urinary Tract Infections
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 242 participants (actual)
- Lead sponsor
- MetroHealth Medical CenterUniversity, hospital or other
- Study start
- Apr 2016 (actual)
- Primary completion
- Jun 2020 (actual)
- Study completion
- Jun 2020 (actual)
- First posted
- 4 Apr 2017 (actual)
- Results
- Posted 30 Dec 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Postoperative urinary tract infections (UTIs) affect 20-30% of patients undergoing elective gynecologic surgery and have a significant socioeconomic impact and cost. Preoperative antibiotics, sterile operating techniques, postoperative antibiotic and non-antibiotic medical therapies have been utilized to attempt to decrease this rate with little improvement. Utilization of an intraoperative antibiotic cystoscopic irrigant may decrease postoperative UTIs. The investigators have designed a prospective randomized controlled study to evaluate the effectiveness of an antibiotic cystoscopic fluid in preventing postoperative urinary tract infections in women undergoing elective pelvic floor surgery with cystoscopy.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard Care | Placebo comparator | Procedure: Cystoscopy, Drug: Cystoscopic Fluid/PlaceboStandard cystoscopy with normal saline solution. |
| Neosporin G. U. Irrigant | Active comparator | Drug: Cystoscopic Fluid containing Neosporin G. U. Irrigant, Procedure: CystoscopyStandard cystoscopy with normal saline solution containing Neosporin® G.U. at a 1mL/1000mL concentration. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adult women at least 18 years of age
- Elective Female Pelvic Medicine and Reconstructive Surgery or Gynecologic Minimally Invasive surgeries including hysterectomy, suburethral sling, and pelvic organ prolapse repair that require cystoscopy.
Key exclusion criteria (6 listed)
- Surgeries that include: intradetrusor Botox, vaginal mesh excision, and fistula repair
- Pregnancy
- History of nephrolithiasis
- Allergy to study medications
- Congenital urogenital anomaly
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 |
|---|---|---|
| Cystoscopic Fluid containing Neosporin G. U. IrrigantNormal saline cystoscopic fluid containing Neosporin G. U. Irrigant 1mL/1000mL | Drug | Neosporin G. U. Irrigant |
| CystoscopyDiagnostic cystoscopy performed during pelvic floor surgery | Procedure or surgery | Neosporin G. U. Irrigant, Standard Care |
| Cystoscopic Fluid/PlaceboNormal saline cystoscopic fluid | Drug | Standard Care |
Primary outcome
Urinary Tract Infection
Time frame: 4 weeks
Urinary tract infection defined as positive urinalysis, urine culture, and/or positive lower urinary tract symptoms requiring antibiotic treatment.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Dec 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Urinary Tract Infections
Recruiting
Diagnosis and Treatment of Urinary Tract Infection Using DNA Polymerase Chain Reaction Versus Urine Culture
Urinary Tract Infections
Active, not recruitingObservational study
Clinical Performance Evaluation of the QIAstat-Dx® cUTI Plus AMR
Complicated Urinary Tract Infection
Active, not recruitingPhase 1/2
A Beta-only IL-2 ImmunoTherapY Study
Advanced Solid Tumor, Unresectable Solid Tumor
Recruiting
INterest of the Negative Predictive Value of Integrons in the reduCtion of Large Broad-spectrum anTibiotics Consumption for Urinary Tract infectionS
Drug Resistance, Microbial, Biomarkers
Not yet recruitingObservational study
Comparative Study of the Genomic Characteristics of Uropathogenic Escherichia Coli According to the Severity of Community-Acquired Urinary Tract Infections in Guadeloupe (COLIGENURI)
Urinary Tract Infections
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 Cystoscopic Fluid containing Neosporin G. U. Irrigant and Cystoscopy in people with Urinary Tract Infections, run by MetroHealth Medical Center 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 2 inclusion and 6 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 30 Dec 2021. 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?
Yes. Results are posted in the registry (first posted 30 Dec 2021). 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?
Urinary Tract Infection (time frame: 4 weeks). 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 30 Dec 2021.