Postoperative Urinary Tract InfectionPhase 2GIVEITNCT04246996
Gentamicin Intravesical Efficacy for Infection of Urinary Tract
A Phase 2 study testing gentamicin sulfate and Catheter clamping only in people with Postoperative Urinary Tract Infection and Pelvic Organ Prolapse, run by Kaiser Permanente at 2 sites in United States.
Trial summary
Urinary tract infection (UTI) is a common problem after surgery for pelvic organ prolapse and stress urinary incontinence. This prospective, randomized, single-masked (subject), two-parallel armed study aims to determine the effect of a single postoperative intravesical instillation of 80 mg of gentamicin sulfate in… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Postoperative Urinary Tract Infection, Pelvic Organ Prolapse, Stress Urinary Incontinence
- What is being tested?
- gentamicin sulfate and Catheter clamping only
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 370 participants
- Where
- 2 sitesUnited States
- Study dates
- 29 Jan 2020to 5 Dec 2021
- Phase
- Phase 2
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult women undergoing pelvic organ prolapse surgery and/or stress urinary incontinence surgery with surgical plan for at least 1 cystoscopy and will leave the operating room with a standard-of-care transurethral catheter.
- Negative urine culture within 4 weeks or completion of UTI treatment ≥48 hours prior to surgery
Who cannot join
- History of allergic reaction or anaphylaxis to gentamicin sulfate or to sodium metabisulfite (one of the preservatives in the gentamicin sulfate product)
- Abnormal intraoperative urinary tract finding (e.g. bladder mass, stone, or fistula)
- Intraoperative urinary tract injury
- Suppressive recurrent UTI treatment
- Chronic indwelling catheter/self-catheterization
- Unable to provide informed consent
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- Severe renal impairment - glomerular filtration rate of less than 30 mL / minute
- Current pregnancy
- Currently incarcerated
Trial locations and contacts
2 sites in 1 country.
United States2 sites
UC San Diego Health
La Jolla, California, 92037
Kaiser Permanente San Diego
San Diego, California, 92123
About this study
Urinary tract infection (UTI) is a common problem after surgery for pelvic organ prolapse and stress urinary incontinence. This prospective, randomized, single-masked (subject), two-parallel armed study aims to determine the effect of a single postoperative intravesical instillation of 80 mg of gentamicin sulfate in 50 mL of saline versus usual care on the proportion of women treated for UTI within 6 weeks following surgery for pelvic organ prolapse (POP) or stress urinary incontinence (SUI).
- Being tested
- gentamicin sulfate, Catheter clamping only
- Keywords
- gentamicin sulfate, pelvic organ prolapse surgery, midurethral sling, bladder instillation
- Medical subject headings
- Pelvic Organ Prolapse, Urinary Incontinence, Stress
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
gentamicin sulfateDrug
Also called gentamicin sulfate transurethral bladder instillation with catheter clamping for 1 hour
Subjects in the gentamicin arm will receive an bladder instillation of 80mg of gentamicin sulfate in 50 mL of normal saline through a standard-of-care Foley catheter.
Catheter clamping onlyOther
Subjects in the control arm will have their standard-of-care transurethral catheter clamped for 1 hour post-placement to maintain subject masking to study arm.
| Study group | Role | What they receive |
|---|---|---|
| Gentamicin Arm | Active comparator | At the completion of the subjects surgery but prior to awakening from anesthesia, 80mg of gentamicin in 50 mL of normal saline will be infused into the subject's bladder through the standard-of-care transurethral catheter by the surgeon. The surgeon will then clamp the catheter and label the catheter with the clamping time. The catheter will be clamped to prevent the gentamicin from immediately flowing out of the bladder and thus allow the gentamicin time to have an effect. The subject will then proceed as usual to the postoperative anesthesia care unit. A member of the subject's care team will unclamp the catheter after 1 hour. The subject will otherwise have usual pre-operative and post-operative care. Receives: Drug: gentamicin sulfate |
| Control Arm | Sham comparator | If the patient is randomized to no instillation, at the end of the surgery but prior to awakening from anesthesia, the surgeon will clamp the catheter and label the catheter with the clamping time. The purpose of clamping the catheter for subjects receiving usual care will be to ensure patients are masked to study arm assignment if they wake up and notice their catheter. The subject will then proceed as usual to the postoperative anesthesia care unit. A member of the subject's care team will unclamp the catheter after 1 hour. The subject will otherwise have usual pre-operative and post-operative care. Receives: Other: Catheter clamping only |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-operative Urinary Tract Infection
Number of participants in each arm treated with antibiotics for urinary tract infection symptoms
Measured: Within 6 weeks after surgery
Secondary outcomes (2)
Adverse Events
Hospital readmissions
Measured: Within 6 weeks after surgery
Number of Participants With Isolated Uropathogen on Post-operative Urine Culture
Measured: Within 6 weeks after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2020
- Study start29 Jan 2020
- Primary completion5 Dec 2021
- Study completion5 Dec 2021
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 Postoperative Urinary Tract InfectionStudies of the same condition, open and under way.
- More trials run by Kaiser PermanenteThe 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 370 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kaiser Permanente
- Sponsor type
- University, hospital or other
- Collaborators
- University of California, San Diego
- Responsible party
- Sponsor
- Investigators
- Kimberly L Ferrante, M.D., M.A.S., Principal investigator, Kaiser PermanenteMarianna Alperin, M.D., M.S., Principal investigator, UC San Diego Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04246996
- Sponsor's protocol ID
- GIVEIT
- Other IDs
- 12297, 191835
- Acronym
- GIVEIT
- Status last verified
- Oct 2022
- First submitted
- 27 Jan 2020
- Last updated
- 8 Nov 2022
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Rieger MM, Shah NM, Ferrante KL, Tan-Kim J, Jacobs MB, Brubaker L, Alperin M. Intraoperative Gentamicin Intravesical Instillation for Prevention of Urinary Tract Infection After Urogynecologic Surgery: A Randomized Controlled Trial. Urogynecology (Phila). 2022 Dec 1;28(12):825-833. doi: 10.1097/SPV.0000000000001233. Epub 2022 Aug 23.
PubMed 36409639
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gentamicin Intravesical Efficacy for Infection of Urinary Tract
- ClinicalTrials.gov ID
- NCT04246996
- Acronym / sponsor ID
- GIVEIT / GIVEIT
- Keywords
- gentamicin sulfate, pelvic organ prolapse surgery, midurethral sling, bladder instillation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 370 participants (actual)
- Lead sponsor
- Kaiser PermanenteUniversity, hospital or other
- Collaborators
- University of California, San Diego
- Study start
- 29 Jan 2020 (actual)
- Primary completion
- 5 Dec 2021 (actual)
- Study completion
- 5 Dec 2021 (actual)
- First posted
- 29 Jan 2020 (actual)
- Results
- Posted 8 Nov 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Urinary tract infection (UTI) is a common problem after surgery for pelvic organ prolapse and stress urinary incontinence. This prospective, randomized, single-masked (subject), two-parallel armed study aims to determine the effect of a single postoperative intravesical instillation of 80 mg of gentamicin sulfate in 50 mL of saline versus usual care on the proportion of women treated for UTI within 6 weeks following surgery for pelvic organ prolapse (POP) or stress urinary incontinence (SUI).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Gentamicin Arm | Active comparator | Drug: gentamicin sulfateAt the completion of the subjects surgery but prior to awakening from anesthesia, 80mg of gentamicin in 50 mL of normal saline will be infused into the subject's bladder through the standard-of-care transurethral catheter by the surgeon. The surgeon will then clamp the catheter and label the catheter with the clamping time. The catheter will be clamped to prevent the gentamicin from immediately flowing out of the bladder and thus allow the gentamicin time to have an effect. The subject will then proceed as usual to the postoperative anesthesia care unit. A member of the subject's care team will unclamp the catheter after 1 hour. The subject will otherwise have usual pre-operative and post-operative care. |
| Control Arm | Sham comparator | Other: Catheter clamping onlyIf the patient is randomized to no instillation, at the end of the surgery but prior to awakening from anesthesia, the surgeon will clamp the catheter and label the catheter with the clamping time. The purpose of clamping the catheter for subjects receiving usual care will be to ensure patients are masked to study arm assignment if they wake up and notice their catheter. The subject will then proceed as usual to the postoperative anesthesia care unit. A member of the subject's care team will unclamp the catheter after 1 hour. The subject will otherwise have usual pre-operative and post-operative care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adult women undergoing pelvic organ prolapse surgery and/or stress urinary incontinence surgery with surgical plan for at least 1 cystoscopy and will leave the operating room with a standard-of-care transurethral catheter.
- Negative urine culture within 4 weeks or completion of UTI treatment ≥48 hours prior to surgery
Key exclusion criteria (9 listed)
- History of allergic reaction or anaphylaxis to gentamicin sulfate or to sodium metabisulfite (one of the preservatives in the gentamicin sulfate product)
- Abnormal intraoperative urinary tract finding (e.g. bladder mass, stone, or fistula)
- Intraoperative urinary tract injury
- Suppressive recurrent UTI treatment
- Chronic indwelling catheter/self-catheterization
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 |
|---|---|---|
| gentamicin sulfateAlso: gentamicin sulfate transurethral bladder instillation with catheter clamping for 1 hourSubjects in the gentamicin arm will receive an bladder instillation of 80mg of gentamicin sulfate in 50 mL of normal saline through a standard-of-care Foley catheter. | Drug | Gentamicin Arm |
| Catheter clamping onlySubjects in the control arm will have their standard-of-care transurethral catheter clamped for 1 hour post-placement to maintain subject masking to study arm. | Other | Control Arm |
Primary outcome
Post-operative Urinary Tract Infection
Time frame: Within 6 weeks after surgery
Number of participants in each arm treated with antibiotics for urinary tract infection symptoms
2 secondary outcomes
Adverse Events
Time frame: Within 6 weeks after surgery
Number of Participants With Isolated Uropathogen on Post-operative Urine Culture
Time frame: Within 6 weeks after surgery
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 36409639Rieger MM, Shah NM, Ferrante KL, Tan-Kim J, Jacobs MB, Brubaker L, Alperin M. Intraoperative Gentamicin Intravesical Instillation for Prevention of Urinary Tract Infection After Urogynecologic Surgery: A Randomized Controlled Trial. Urogynecology (Phila). 2022 Dec 1;28(12):825-833. doi: 10.1097/SPV.0000000000001233. Epub 2022 Aug 23.
- 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.
Kimberly L Ferrante, M.D., M.A.S. principal investigator
Kaiser Permanente
Marianna Alperin, M.D., M.S. principal investigator
UC San Diego Health
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing gentamicin sulfate and Catheter clamping only in people with Postoperative Urinary Tract Infection and Pelvic Organ Prolapse, run by Kaiser Permanente at 2 sites 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 9 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 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 8 Nov 2022). 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?
Post-operative Urinary Tract Infection (time frame: Within 6 weeks after surgery). 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 NCT04246996, 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 Nov 2022.