Penile Prosthesis; Complications Clinical Trial
Official title:
Management of Urethral Injury During Penile Prosthesis Implantation: Urethral Sterilization With Chlorhexidine Digluconate to Facilitate Primary Repair and Same-Session Implantation
The introduction of penile implants has revolutionized the management of male erectile
dysfunction. However, a number of intraoperative complications may occur, which have a major
impact on clinical outcomes and patient satisfaction such as bleeding, infection and urethral
injury.
Patients undergoing penile implant surgery with fibrotic corpora (e.g., after priapism, after
infection, or with Peyronie disease) have a higher risk rates of urethral perforation. This
may be related to previous scarring, the difficultly in dilating scarred and fibrotic corpora
and its inherent risk of corporal crossover and urethral perforation.
This work examines the efficacy of pre-operative urethral sterilization in rendering the
urethra as sterile as the skin of the genital area, with the skin sterilized as per the ISSM
guidelines for penile prosthesis implantation, thereby allowing primary repair of urethral
injuries should they occur, and implantation in the same setting, without a higher risk of
infection.
The study will involve 100 male patients undergoing aseptic surgery (regardless the
procedure). Patients will be divided into two groups:
Group 1: control group, n=50 Group 2: Chlorhexidine group (Ch group), n=50 Pre-operatively,
urethral instillation with Chlorhexidine gel will be performed for the Ch group, while for
the control group, instillation will not be performed.
After conclusion of surgery and with the patient on the operative table, the following swabs
will be obtained:
- A penile skin swab.
- A urethral swab. Skin and urethral swabs will be compared for bacterial colonization by
culture and sensitivity, across the two groups.
study design Comparative experimental (interventional) study Sample size
The study will involve 100 male patients undergoing aseptic surgery (regardless the
procedure). Patients will be divided into two groups:
Group 1: control group, n=50 Group 2: Chlorhexidine group (Ch group), n=50
Pre-operatively, urethral instillation with Chlorhexidine gel will be performed for the Ch
group, while for the control group, instillation will not be performed.
Chlorhexidine gel will be prepared according to an international product; Instillagel®, used
prior to urethral catheterization as analgesic / anti-septic, with the following composition:
6ml of Instillagel® gel contain: 117.6mg lidocaine hydrochloride, 3.1mg chlorhexidine
digluconate, 3.8mg methyl hydroxybenzoate (E218), 1.6mg propyl hydroxybenzoate (E216) 11ml of
Instillagel® gel contain: 215.7mg lidocaine hydrochloride, 5.8mg chlorhexidine digluconate,
6.9mg methyl hydroxybenzoate (E218), 2.9mg propyl hydroxybenzoate (E216)
The other ingredients are:
Hyetellose, propylene glycol* (E 1520), sodium hydroxide and purified water.
Intra-operatively, the Ch group will receive Chlorhexidine instillation again before surgery,
while the control group will not.
For both groups, skin sterilization will be performed according to the ISSM "International
Society of Sexual Medicine" guidelines for skin preparation before penile prosthesis surgery
(Darren J. Katz et.al 2012)
After conclusion of surgery and with the patient on the operative table, the following swabs
will be obtained:
- A penile skin swab.
- A urethral swab.
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| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT04390230 -
Inflatable Penile Prostheses : Which Patients Can Correctly Use the Scrotal Pump ?
|