Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to compare urinary tract infection rates among women undergoing urogynecological procedures with a silver-alloy suprapubic catheter compared to the standard suprapubic catheter.
Urinary catheters are used routinely in the postoperative care of urogynecology patients after surgery involving the genitourinary tract. However, Urinary tract infections(UTI) associated with indwelling catheter is the second leading cause of nosocomial infections. 20% of hospital acquired bacteremia arise from UTI with an associated mortality of 10%.
There are many different types of catheters available for use. Standard indwelling catheters are made from a variety of materials including polyvinyl chlorine, plastic, plain latex, polytetrafluoroethylene, silicone elastomer, pure silicone hydrogel and polymer hydromer. Specialized catheters have been developed with the aim of reducing infection. Strategies generally involved coating the inner, outer or both surfaces of the catheter with antimicrobial materials. These materials can be antibiotic or antiseptic with the most common antiseptic material used being silver. Silver ions are bactericidal, are used safely when applied topically to humans and used in controlling infections.
Previous studies comparing UTI rates in transurethral catheters have reported a significant reduction of UTI rate in silver-alloy catheters with a range of 5-12% compared to standard catheters with a range of 7-50%. There are no studies comparing the UTI rate in silver-alloy supra-pubic catheters to standard supra-pubic catheters. The investigators hypothesize that this study will show a statistically significant decrease in UTI rate among the individuals with a silver-alloy suprapubic catheter compared to the standard silver-alloy catheter.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| silver SPC | Experimental | Subjects randomized to receive silver-impregnated SPC. |
|
| standard SPC | Active Comparator | subjects randomized to receive standard SPC. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| silver SPC | Device | subject randomized to receive silver alloy impregnated catheter |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Urinary Tract Infection Rate | Number of subjects diagnosed with a urinary tract infection (UTI) within 6 weeks of surgery. A UTI is defined as any symptoms requiring antibiotic treatment, a urine culture with >10^5 cfu/mL, or a urine culture with >10^3 cfu/mL and evidence of pyuria. | within 6 weeks post surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Risk of Urinary Tract Infections in Diabetics | Number of diabetic subjects diagnosed with a urinary tract infection within 6 weeks post surgery. | within 6 weeks post surgery |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| John Gebhart, MD | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic | Rochester | Minnesota | 55905 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30145671 | Derived | Singh R, Hokenstad ED, Wiest SR, Kim-Fine S, Weaver AL, McGree ME, Klingele CJ, Trabuco EC, Gebhart JB. Randomized controlled trial of silver-alloy-impregnated suprapubic catheters versus standard suprapubic catheters in assessing urinary tract infection rates in urogynecology patients. Int Urogynecol J. 2019 May;30(5):779-787. doi: 10.1007/s00192-018-3726-z. Epub 2018 Aug 25. |
| Label | URL |
|---|---|
| Mayo Clinic Clinical Trials | View source |
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Silver SPC | Subjects randomized to receive silver-impregnated SPC. silver SPC: subject randomized to receive silver alloy impregnated catheter |
| FG001 | Standard SPC | subjects randomized to receive standard SPC. standard SPC: subject randomized to receive standard catheter |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Silver SPC | Subjects randomized to receive silver-impregnated SPC. silver SPC: subject randomized to receive silver alloy impregnated catheter |
| BG001 | Standard SPC | subjects randomized to receive standard SPC. standard SPC: subject randomized to receive standard catheter |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Urinary Tract Infection Rate | Number of subjects diagnosed with a urinary tract infection (UTI) within 6 weeks of surgery. A UTI is defined as any symptoms requiring antibiotic treatment, a urine culture with >10^5 cfu/mL, or a urine culture with >10^3 cfu/mL and evidence of pyuria. | Posted | Count of Participants | Participants | within 6 weeks post surgery |
|
Adverse events were captured and reported from enrollment to the 6 week post-operative period, which is the end of study treatment follow-up.
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Silver SPC | Subjects randomized to receive silver-impregnated SPC. silver SPC: subject randomized to receive silver alloy impregnated catheter |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Reoperation | Surgical and medical procedures | Systematic Assessment |
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. John Gebhart | Mayo Clinic | 507-266-7711 | gebhart.john@mayo.edu |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 25, 2011 | Mar 22, 2019 | Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D055499 | Catheter-Related Infections |
| D014552 | Urinary Tract Infections |
| ID | Term |
|---|---|
| D007239 | Infections |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| standard SPC |
| Device |
subject randomized to receive standard catheter |
|
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Body Mass Index | Mean | Standard Deviation | kg/m^2 |
|
|
|
|
| Secondary | Risk of Urinary Tract Infections in Diabetics | Number of diabetic subjects diagnosed with a urinary tract infection within 6 weeks post surgery. | Posted | Count of Participants | Participants | within 6 weeks post surgery |
|
|
|
|
| 0 |
| 137 |
| 3 |
| 137 |
| 0 |
| 137 |
| EG001 | Standard SPC | subjects randomized to receive standard SPC. standard SPC: subject randomized to receive standard catheter | 0 | 127 | 3 | 127 | 0 | 127 |
| Pulmonary embolism | General disorders | Systematic Assessment |
|
| Ureteral stent placement | General disorders | Systematic Assessment |
|
| Chest pain | General disorders | Systematic Assessment |
|
| Hernaturia | General disorders | Systematic Assessment |
|
Not provided
Not provided
Not provided
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |