Trials / Completed
CompletedNCT04246996
Gentamicin Intravesical Efficacy for Infection of Urinary Tract
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 370 (actual)
- Sponsor
- Kaiser Permanente · Academic / Other
- Sex
- Female
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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 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).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | gentamicin sulfate | 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. |
| OTHER | Catheter clamping only | 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. |
Timeline
- Start date
- 2020-01-29
- Primary completion
- 2021-12-05
- Completion
- 2021-12-05
- First posted
- 2020-01-29
- Last updated
- 2022-11-08
- Results posted
- 2022-11-08
Locations
2 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04246996. Inclusion in this directory is not an endorsement.