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Prospective study of the Transurethral Suprapubic endo-Cystostomy (T-SPEC(®)): an 'inside-out' approach to suprapubic catheter insertion.

Flynn BJ, Larke RJ, Knoll PB, Anderson KM, Siomos VJ, Windsperger AP - Int Urol Nephrol (2014)

Bottom Line: We successfully placed an 18 Fr suprapubic catheter using the T-SPeC(®) device in 98.2 % of patients.The T-SPeC(®) device is a novel, simple, accurate and minimally invasive device for SPC insertion from an inside-to-out approach.Our prospective study demonstrates that the T-SPeC(®) device can be placed safely and efficiently in a variety of patients with a need for urinary drainage.

View Article: PubMed Central - PubMed

Affiliation: Division of Urology, University of Colorado Denver, Academic Office One Bldg, 12631 East 17th Ave., Room L15-5602, Box C319, Aurora, CO, 80045, USA, Brian.Flynn@UCdenver.edu.

ABSTRACT

Objectives: To prospectively evaluate the new medical device Transurethral Suprapubic endo-Cystostomy (T-SPeC(®)), used for suprapubic catheter (SPC) placement via the transurethral (inside-to-out) approach, and examine the 30-day outcomes in the first US series.

Methods: IRB approval was obtained for this prospective study. We evaluated the first 114 consecutive cases of SPC placement using the T-SPeC(®) device by a single surgeon at in a 20-month period. We excluded patients who underwent alternative approaches to suprapubic catheter placement including open abdominal approach (12) and percutaneous approach (5). Preoperative patient demographics, operative detail, success rate and 30-day complication rate were recorded.

Results: We successfully placed an 18 Fr suprapubic catheter using the T-SPeC(®) device in 98.2 % of patients. During the procedure, the capture housing was missed twice. The mean patient age was 56.6, BMI 29.4 kg/m(2), skin to bladder distance 6.7 cm and operative time 3.6 min. There were 12 postoperative complications within 30 days of the procedure including urinary tract infections (6), SPC exit site infection (2), SPC blockage (2) and catheter expulsion (2). There were no Clavien-Dindo grade III-IV complications such as re-operation, small bowel injury, hemorrhage or death.

Conclusion: The T-SPeC(®) device is a novel, simple, accurate and minimally invasive device for SPC insertion from an inside-to-out approach. Our prospective study demonstrates that the T-SPeC(®) device can be placed safely and efficiently in a variety of patients with a need for urinary drainage.

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Related in: MedlinePlus

Schematic of the T-SPeC® Surgical System. The rear advancement handle advances the cutting blade (15 Fr) from inside the bladder, through the bladder wall and abdomen, and pulls the catheter connected to the bayonet connector on the coaxial coil back through the surgical pathway for placement in the bladder. The locking mechanism in the rear handle prevents the cutting blade and coaxial coil from being inadvertently advanced. The mast guides the alignment arm to the patient’s abdomen before creation of the surgical pathway. Abdominal thickness can be measured using the graduated mast. The alignment arm holding the capture housing provides the surgeon with the blade exit point. The cutting blade makes a small incision (15 Fr) through the bladder, fascia and abdominal wall. It is housed within the sound and is deployed by the rear advancement handle. The capture housing accepts the surgical blade once it has passed through the patient’s bladder wall and abdomen. The blade and capture housing can be removed for disposal by rotating the capture housing
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Fig1: Schematic of the T-SPeC® Surgical System. The rear advancement handle advances the cutting blade (15 Fr) from inside the bladder, through the bladder wall and abdomen, and pulls the catheter connected to the bayonet connector on the coaxial coil back through the surgical pathway for placement in the bladder. The locking mechanism in the rear handle prevents the cutting blade and coaxial coil from being inadvertently advanced. The mast guides the alignment arm to the patient’s abdomen before creation of the surgical pathway. Abdominal thickness can be measured using the graduated mast. The alignment arm holding the capture housing provides the surgeon with the blade exit point. The cutting blade makes a small incision (15 Fr) through the bladder, fascia and abdominal wall. It is housed within the sound and is deployed by the rear advancement handle. The capture housing accepts the surgical blade once it has passed through the patient’s bladder wall and abdomen. The blade and capture housing can be removed for disposal by rotating the capture housing

Mentions: The Transurethral Suprapubic endo-Cystostomy Device (T-SPeC®) is a novel disposable medical device used for insertion of a suprapubic catheter (SPC) via a transurethral approach (Fig. 1). The T-SPeC® device (Swan Valley Medical Inc. Bigfork, MT) has FDA 510(k) clearances. T-SPeC® device compensates for abdominal girth to allow accurate and efficient catheter placement from an ‘inside-out’ direction. T-SPeC® Surgical System comes in two models, T7 and T14. The T7 model can accommodate a bladder to skin distance of up to 7 cm, while the T14 can accommodate 14 cm. T-SPeC® is similar to the Lowsley retractor that was used commonly for suprapubic cystostomy catheterization before the development of percutaneous SPC kits [1]. However, unlike the Lowsley device that requires an incision to cut down to expose the tip of the curved metal sound, the T-SPeC® instrument initiates a 15 Fr surgical tract from within the bladder and exits the skin just cephalad to the pubic bone.Fig. 1


Prospective study of the Transurethral Suprapubic endo-Cystostomy (T-SPEC(®)): an 'inside-out' approach to suprapubic catheter insertion.

Flynn BJ, Larke RJ, Knoll PB, Anderson KM, Siomos VJ, Windsperger AP - Int Urol Nephrol (2014)

Schematic of the T-SPeC® Surgical System. The rear advancement handle advances the cutting blade (15 Fr) from inside the bladder, through the bladder wall and abdomen, and pulls the catheter connected to the bayonet connector on the coaxial coil back through the surgical pathway for placement in the bladder. The locking mechanism in the rear handle prevents the cutting blade and coaxial coil from being inadvertently advanced. The mast guides the alignment arm to the patient’s abdomen before creation of the surgical pathway. Abdominal thickness can be measured using the graduated mast. The alignment arm holding the capture housing provides the surgeon with the blade exit point. The cutting blade makes a small incision (15 Fr) through the bladder, fascia and abdominal wall. It is housed within the sound and is deployed by the rear advancement handle. The capture housing accepts the surgical blade once it has passed through the patient’s bladder wall and abdomen. The blade and capture housing can be removed for disposal by rotating the capture housing
© Copyright Policy - OpenAccess
Related In: Results  -  Collection

Show All Figures
getmorefigures.php?uid=PMC4309899&req=5

Fig1: Schematic of the T-SPeC® Surgical System. The rear advancement handle advances the cutting blade (15 Fr) from inside the bladder, through the bladder wall and abdomen, and pulls the catheter connected to the bayonet connector on the coaxial coil back through the surgical pathway for placement in the bladder. The locking mechanism in the rear handle prevents the cutting blade and coaxial coil from being inadvertently advanced. The mast guides the alignment arm to the patient’s abdomen before creation of the surgical pathway. Abdominal thickness can be measured using the graduated mast. The alignment arm holding the capture housing provides the surgeon with the blade exit point. The cutting blade makes a small incision (15 Fr) through the bladder, fascia and abdominal wall. It is housed within the sound and is deployed by the rear advancement handle. The capture housing accepts the surgical blade once it has passed through the patient’s bladder wall and abdomen. The blade and capture housing can be removed for disposal by rotating the capture housing
Mentions: The Transurethral Suprapubic endo-Cystostomy Device (T-SPeC®) is a novel disposable medical device used for insertion of a suprapubic catheter (SPC) via a transurethral approach (Fig. 1). The T-SPeC® device (Swan Valley Medical Inc. Bigfork, MT) has FDA 510(k) clearances. T-SPeC® device compensates for abdominal girth to allow accurate and efficient catheter placement from an ‘inside-out’ direction. T-SPeC® Surgical System comes in two models, T7 and T14. The T7 model can accommodate a bladder to skin distance of up to 7 cm, while the T14 can accommodate 14 cm. T-SPeC® is similar to the Lowsley retractor that was used commonly for suprapubic cystostomy catheterization before the development of percutaneous SPC kits [1]. However, unlike the Lowsley device that requires an incision to cut down to expose the tip of the curved metal sound, the T-SPeC® instrument initiates a 15 Fr surgical tract from within the bladder and exits the skin just cephalad to the pubic bone.Fig. 1

Bottom Line: We successfully placed an 18 Fr suprapubic catheter using the T-SPeC(®) device in 98.2 % of patients.The T-SPeC(®) device is a novel, simple, accurate and minimally invasive device for SPC insertion from an inside-to-out approach.Our prospective study demonstrates that the T-SPeC(®) device can be placed safely and efficiently in a variety of patients with a need for urinary drainage.

View Article: PubMed Central - PubMed

Affiliation: Division of Urology, University of Colorado Denver, Academic Office One Bldg, 12631 East 17th Ave., Room L15-5602, Box C319, Aurora, CO, 80045, USA, Brian.Flynn@UCdenver.edu.

ABSTRACT

Objectives: To prospectively evaluate the new medical device Transurethral Suprapubic endo-Cystostomy (T-SPeC(®)), used for suprapubic catheter (SPC) placement via the transurethral (inside-to-out) approach, and examine the 30-day outcomes in the first US series.

Methods: IRB approval was obtained for this prospective study. We evaluated the first 114 consecutive cases of SPC placement using the T-SPeC(®) device by a single surgeon at in a 20-month period. We excluded patients who underwent alternative approaches to suprapubic catheter placement including open abdominal approach (12) and percutaneous approach (5). Preoperative patient demographics, operative detail, success rate and 30-day complication rate were recorded.

Results: We successfully placed an 18 Fr suprapubic catheter using the T-SPeC(®) device in 98.2 % of patients. During the procedure, the capture housing was missed twice. The mean patient age was 56.6, BMI 29.4 kg/m(2), skin to bladder distance 6.7 cm and operative time 3.6 min. There were 12 postoperative complications within 30 days of the procedure including urinary tract infections (6), SPC exit site infection (2), SPC blockage (2) and catheter expulsion (2). There were no Clavien-Dindo grade III-IV complications such as re-operation, small bowel injury, hemorrhage or death.

Conclusion: The T-SPeC(®) device is a novel, simple, accurate and minimally invasive device for SPC insertion from an inside-to-out approach. Our prospective study demonstrates that the T-SPeC(®) device can be placed safely and efficiently in a variety of patients with a need for urinary drainage.

Show MeSH
Related in: MedlinePlus