coloplast titan inflatable penile prosthesis with one touch release pump: initial results bruce b....

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Coloplast Titan inflatable penile Coloplast Titan inflatable penile prosthesis with One Touch Release prosthesis with One Touch Release pump: initial results pump: initial results Bruce B. Garber, MD, FACS Bruce B. Garber, MD, FACS Clinical Associate Professor Clinical Associate Professor Drexel University College of Medicine Drexel University College of Medicine Philadelphia, PA Philadelphia, PA 215-247-3082 215-247-3082 Website: Website: www.garber-online.com www.garber-online.com Email: [email protected] Email: [email protected]

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Page 1: Coloplast Titan inflatable penile prosthesis with One Touch Release pump: initial results Bruce B. Garber, MD, FACS Clinical Associate Professor Drexel

Coloplast Titan inflatable penile prosthesis Coloplast Titan inflatable penile prosthesis with One Touch Release pump: initial resultswith One Touch Release pump: initial results

Bruce B. Garber, MD, FACSBruce B. Garber, MD, FACS

Clinical Associate ProfessorClinical Associate Professor

Drexel University College of MedicineDrexel University College of Medicine

Philadelphia, PAPhiladelphia, PA

215-247-3082215-247-3082

Website: Website: www.garber-online.comwww.garber-online.com

Email: [email protected]: [email protected]

Page 2: Coloplast Titan inflatable penile prosthesis with One Touch Release pump: initial results Bruce B. Garber, MD, FACS Clinical Associate Professor Drexel

The Coloplast Titan inflatable penile prosthesis (IPP) was recently The Coloplast Titan inflatable penile prosthesis (IPP) was recently modified with a One Touch Release (OTR) pump, to facilitate modified with a One Touch Release (OTR) pump, to facilitate deflationdeflation

The OTR pump became available in September of 2008The OTR pump became available in September of 2008 OTR pumps are now available as separate units, or pre-connected OTR pumps are now available as separate units, or pre-connected

to cylindersto cylinders The The objectivesobjectives of this investigation were to assess the ease of of this investigation were to assess the ease of

implantation of this new pump, and to assess it’s functionality and implantation of this new pump, and to assess it’s functionality and ease of patient use, compared to the prior (Genesis) pump.ease of patient use, compared to the prior (Genesis) pump.

Page 3: Coloplast Titan inflatable penile prosthesis with One Touch Release pump: initial results Bruce B. Garber, MD, FACS Clinical Associate Professor Drexel

Coloplast Titan with Genesis pumpColoplast Titan with Genesis pump

Page 4: Coloplast Titan inflatable penile prosthesis with One Touch Release pump: initial results Bruce B. Garber, MD, FACS Clinical Associate Professor Drexel

Coloplast Titan with One Touch Release (OTR) pumpColoplast Titan with One Touch Release (OTR) pump

Page 5: Coloplast Titan inflatable penile prosthesis with One Touch Release pump: initial results Bruce B. Garber, MD, FACS Clinical Associate Professor Drexel

Engineering changes:Engineering changes:Genesis pump vs. OTR pumpGenesis pump vs. OTR pump

April 18, 2023 5

Page 6: Coloplast Titan inflatable penile prosthesis with One Touch Release pump: initial results Bruce B. Garber, MD, FACS Clinical Associate Professor Drexel

MethodsMethods

50 consecutive patients were implanted with a Titan IPP containing an OTR 50 consecutive patients were implanted with a Titan IPP containing an OTR pump; some received a primary implant, others received an OTR pump pump; some received a primary implant, others received an OTR pump during an IPP replacement procedure during an IPP replacement procedure

Implantation was either via standard trans-scrotal or infrapubic techniqueImplantation was either via standard trans-scrotal or infrapubic technique All procedures were done as an outpatient, by an experienced (>1000 All procedures were done as an outpatient, by an experienced (>1000

cases) surgeoncases) surgeon All patients received IV vancomycin and gentamicin pre-opAll patients received IV vancomycin and gentamicin pre-op Intra-op antibiotic irrigation and device soaking was carried out with rifampin Intra-op antibiotic irrigation and device soaking was carried out with rifampin

and gentamicin, 1.0 mg. of each per ml of sterile waterand gentamicin, 1.0 mg. of each per ml of sterile water Follow-up was obtained by retrospective chart review Follow-up was obtained by retrospective chart review The control group consisted of 50 consecutive patients implanted with a The control group consisted of 50 consecutive patients implanted with a

Titan IPP containing a Genesis pump, immediately prior to the availability of Titan IPP containing a Genesis pump, immediately prior to the availability of the OTR pumpthe OTR pump

Page 7: Coloplast Titan inflatable penile prosthesis with One Touch Release pump: initial results Bruce B. Garber, MD, FACS Clinical Associate Professor Drexel

Objective resultsObjective results

Control Group (N=50)Control Group (N=50) OTR group (N=50)OTR group (N=50)

Mean follow up (mos.) 13.5 4.8Mean follow up (mos.) 13.5 4.8

% follow-up 100 100% follow-up 100 100

# of IPP infections 0 0# of IPP infections 0 0

Average # of teaching visits 1.9 1.1 Average # of teaching visits 1.9 1.1

(p=.0004)(p=.0004)

Range of teaching visits 1-4 1-3Range of teaching visits 1-4 1-3

# of pump malfunctions 0 0 # of pump malfunctions 0 0

Page 8: Coloplast Titan inflatable penile prosthesis with One Touch Release pump: initial results Bruce B. Garber, MD, FACS Clinical Associate Professor Drexel

Subjective resultsSubjective results

OTR pump just as easy to implant as Genesis pumpOTR pump just as easy to implant as Genesis pump OTR pump easier for surgeon and patient to deflateOTR pump easier for surgeon and patient to deflate Genesis and OTR pumps equally easy to inflateGenesis and OTR pumps equally easy to inflate Genesis pump deflation requires continuous pressure on deflate Genesis pump deflation requires continuous pressure on deflate

bars, which some patients find difficult or painfulbars, which some patients find difficult or painful OTR pump deflation requires only one firm squeeze of the release OTR pump deflation requires only one firm squeeze of the release

padspads

Page 9: Coloplast Titan inflatable penile prosthesis with One Touch Release pump: initial results Bruce B. Garber, MD, FACS Clinical Associate Professor Drexel

Conclusions Conclusions

With short term follow-up:With short term follow-up: OTR pump functioned as specified by the manufacturerOTR pump functioned as specified by the manufacturer No instance of OTR pump malfunctionNo instance of OTR pump malfunction OTR pump resulted in a statistically significant reduction in the OTR pump resulted in a statistically significant reduction in the

number of post-op inflate/deflate patient teaching sessions number of post-op inflate/deflate patient teaching sessions (p=.0004)(p=.0004)

OTR pump was subjectively easier for patient and surgeon to OTR pump was subjectively easier for patient and surgeon to deflate; equally easy to inflate, compared to Genesis pumpdeflate; equally easy to inflate, compared to Genesis pump

A larger series with longer follow-up is needed to confirm these A larger series with longer follow-up is needed to confirm these initial resultsinitial results