NCT03108079 - Bladder Morphology Using 2 Different Catheter Designs | Biotech Hunter

Enrollment

3

Participants

Timeline

Start Date

April 30, 2017

Primary Completion Date

May 31, 2017

Study Completion Date

June 30, 2017

Conditions

Urologic InjuriesUrologic DiseasesBladder InfectionUrinary Tract InfectionsMucosal InflammationMucosal InfectionBladder InjuryCatheter-Related InfectionsCatheter ComplicationsCatheter; Infection (Indwelling Catheter)Pelvic Floor DisordersUrinary Incontinence

Interventions

DEVICE

Cystosure Urinary Access System

"1. Demonstrate the 3D bladder wall anatomy with 300 cc of fluid infused with each of the following bladder drainage mechanisms~ 1. The traditional Foley catheter (Catheter A)~ 2. The novel FDA approved Cystosure catheter (Catheter B)~2. Compare the fluid flow pattern during bladder drainage for~ 1. The traditional Foley catheter (Catheter A)~ 2. The novel FDA approved Cystosure catheter (Catheter B)~3. Compare the 3D bladder wall anatomy after emptying the bladder with~ 1. The traditional Foley catheter (Catheter A)~ 2. The novel FDA approved Cystosure catheter (Catheter B)"

DEVICE

Foley Catheter

"1. Demonstrate the 3D bladder wall anatomy with 300 cc of fluid infused with each of the following bladder drainage mechanisms~ 1. The traditional Foley catheter (Catheter A)~ 2. The novel FDA approved Cystosure catheter (Catheter B)~2. Compare the fluid flow pattern during bladder drainage for~ 1. The traditional Foley catheter (Catheter A)~ 2. The novel FDA approved Cystosure catheter (Catheter B)~3. Compare the 3D bladder wall anatomy after emptying the bladder with~ 1. The traditional Foley catheter (Catheter A)~ 2. The novel FDA approved Cystosure catheter (Catheter B)"

Trial Locations (1)

33609

RECRUITING

The Pelvic Floor Institute, Tampa