Trial Outcomes & Findings for Silver-impregnated Suprapubic Catheters (SPC) in Urogynecology (NCT NCT01359046)

Last Updated: 2019-05-09

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

288 participants

Primary outcome timeframe

within 6 weeks post surgery

Results posted on

2019-05-09

Participant Flow

Participant milestones

Participant milestones
Measure	Silver SPC Subjects randomized to receive silver-impregnated SPC. silver SPC: subject randomized to receive silver alloy impregnated catheter	Standard SPC subjects randomized to receive standard SPC. standard SPC: subject randomized to receive standard catheter
Overall Study STARTED	144	144
Overall Study COMPLETED	137	127
Overall Study NOT COMPLETED	7	17

Reasons for withdrawal

Reasons for withdrawal
Measure	Silver SPC Subjects randomized to receive silver-impregnated SPC. silver SPC: subject randomized to receive silver alloy impregnated catheter	Standard SPC subjects randomized to receive standard SPC. standard SPC: subject randomized to receive standard catheter
Overall Study Did not receive allocated intervention	6	6
Overall Study Physician Decision	1	11

Baseline Characteristics

Silver-impregnated Suprapubic Catheters (SPC) in Urogynecology

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Silver SPC n=137 Participants Subjects randomized to receive silver-impregnated SPC. silver SPC: subject randomized to receive silver alloy impregnated catheter	Standard SPC n=127 Participants subjects randomized to receive standard SPC. standard SPC: subject randomized to receive standard catheter	Total n=264 Participants Total of all reporting groups
Age, Continuous	64.7 years STANDARD_DEVIATION 10.5 • n=5 Participants	66.3 years STANDARD_DEVIATION 10.4 • n=7 Participants	65.5 years STANDARD_DEVIATION 10.4 • n=5 Participants
Sex: Female, Male Female	137 Participants n=5 Participants	127 Participants n=7 Participants	264 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race/Ethnicity, Customized White	131 Participants n=5 Participants	124 Participants n=7 Participants	255 Participants n=5 Participants
Race/Ethnicity, Customized Non-white	5 Participants n=5 Participants	2 Participants n=7 Participants	7 Participants n=5 Participants
Race/Ethnicity, Customized Unknown	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Region of Enrollment United States	137 participants n=5 Participants	127 participants n=7 Participants	264 participants n=5 Participants
Body Mass Index	27.6 kg/m^2 STANDARD_DEVIATION 5.0 • n=5 Participants	27.8 kg/m^2 STANDARD_DEVIATION 5.2 • n=7 Participants	27.7 kg/m^2 STANDARD_DEVIATION 5.1 • n=5 Participants

PRIMARY outcome

Timeframe: within 6 weeks post surgery

Outcome measures

Outcome measures
Measure	Silver SPC n=131 Participants Subjects randomized to receive silver-impregnated SPC. silver SPC: subject randomized to receive silver alloy impregnated catheter	Standard SPC n=123 Participants subjects randomized to receive standard SPC. standard SPC: subject randomized to receive standard catheter
Urinary Tract Infection Rate	24 Participants	29 Participants

SECONDARY outcome

Timeframe: within 6 weeks post surgery

Number of diabetic subjects diagnosed with a urinary tract infection within 6 weeks post surgery.

Outcome measures

Outcome measures
Measure	Silver SPC n=15 Participants Subjects randomized to receive silver-impregnated SPC. silver SPC: subject randomized to receive silver alloy impregnated catheter	Standard SPC n=16 Participants subjects randomized to receive standard SPC. standard SPC: subject randomized to receive standard catheter
Risk of Urinary Tract Infections in Diabetics	4 Participants	8 Participants

Adverse Events

Silver SPC

Serious events: 3 serious events

Other events: 0 other events

Deaths: 0 deaths

Standard SPC

Serious events: 3 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Silver SPC n=137 participants at risk Subjects randomized to receive silver-impregnated SPC. silver SPC: subject randomized to receive silver alloy impregnated catheter	Standard SPC n=127 participants at risk subjects randomized to receive standard SPC. standard SPC: subject randomized to receive standard catheter
Surgical and medical procedures Reoperation	0.73% 1/137 • Number of events 1 • Adverse events were captured and reported from enrollment to the 6 week post-operative period, which is the end of study treatment follow-up.	0.79% 1/127 • Number of events 1 • Adverse events were captured and reported from enrollment to the 6 week post-operative period, which is the end of study treatment follow-up.
General disorders Pulmonary embolism	0.00% 0/137 • Adverse events were captured and reported from enrollment to the 6 week post-operative period, which is the end of study treatment follow-up.	0.79% 1/127 • Number of events 1 • Adverse events were captured and reported from enrollment to the 6 week post-operative period, which is the end of study treatment follow-up.
General disorders Ureteral stent placement	0.00% 0/137 • Adverse events were captured and reported from enrollment to the 6 week post-operative period, which is the end of study treatment follow-up.	0.79% 1/127 • Number of events 1 • Adverse events were captured and reported from enrollment to the 6 week post-operative period, which is the end of study treatment follow-up.
General disorders Chest pain	0.73% 1/137 • Number of events 1 • Adverse events were captured and reported from enrollment to the 6 week post-operative period, which is the end of study treatment follow-up.	0.00% 0/127 • Adverse events were captured and reported from enrollment to the 6 week post-operative period, which is the end of study treatment follow-up.
General disorders Hernaturia	0.73% 1/137 • Number of events 1 • Adverse events were captured and reported from enrollment to the 6 week post-operative period, which is the end of study treatment follow-up.	0.00% 0/127 • Adverse events were captured and reported from enrollment to the 6 week post-operative period, which is the end of study treatment follow-up.

Other adverse events

Adverse event data not reported

Additional Information

Dr. John Gebhart

Mayo Clinic

Phone: 507-266-7711

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place