Rigi10™ Malleable Penile Prosthesis
Also Known As
Narrow‑diameter penile implant, Restricted‑expansion inflatable penile prosthesis, Controlled‑expansion penile implant, Narrow‑base inflatable penile prosthesis
Definition
A Controlled Expansion Device is a specialized type of inflatable penile prosthesis specifically designed for patients with corporal fibrosis, featuring narrower cylinders that facilitate implantation in scarred or fibrotic corpora cavernosa1. Introduced in 1990, this narrow‑diameter design represented a ground‑breaking advancement in penile prosthesis technology2. By reducing the cylinder diameter compared with standard prostheses, the device can be inserted and accommodated within fibrotic corporal bodies more easily3. Its primary purpose is to restore erectile function in patients with severe corporal fibrosis who would otherwise face significant challenges with standard‑sized implants4.
Clinical Context
The Controlled Expansion Device is primarily indicated for patients with significant corporal fibrosis, which presents a challenging scenario for penile prosthesis implantation1. The most common causes of severe penile fibrosis include prior explant for infection (67.3%), ischemic priapism (16.3%), and idiopathic fibrosis (16.3%)1.
Patient selection criteria focus on individuals with erectile dysfunction who have failed conservative treatments and present with corporal fibrosis that would make standard prosthesis implantation difficult or impossible3. Pre‑operative evaluation often includes penile ultrasound to assess the degree of fibrosis, which helps set realistic patient expectations regarding post‑operative outcomes3.
The surgical implantation procedure typically involves a transverse scrotal approach, with careful dilation of the fibrotic corpora4. Due to the narrower cylinder design, the device can be successfully implanted even in severely fibrotic cases where standard cylinders would not fit4. Specialized surgical techniques and instruments, such as cavernotomes, may be employed to create adequate space within the fibrotic corpora3.
Expected outcomes include satisfactory penile rigidity sufficient for penetration in approximately 73.5% of patients1. However, patients should be counselled about potential limitations, as over half may report some dissatisfaction due to perceived loss of penile length and girth after implantation2. Post‑operative complications occur in approximately 16.3% of cases and may include infections (6.1%), cylinder herniations (4.1%), mechanical failures (4.1%), and rarely, glans necrosis (2.0%)1. The device shows acceptable surgical outcomes with moderate patient acceptability over long‑term follow‑up1.