Rigi10™ Malleable Penile Prosthesis
Also Known As
Calcium hydroxylapatite urethral bulking agent, CaHA urethral bulking agent, Coaptite® Injectable Implant, Calcium hydroxylapatite soft tissue augmentation material
Definition
Coaptite® is an injectable, sterile, non-pyrogenic implant composed of spherical particles of calcium hydroxylapatite (CaHA) (75-125 microns in diameter), suspended in an aqueous-based gel carrier.1 The gel carrier is composed of sodium carboxymethylcellulose, sterile water for injection, and glycerin.1 This biocompatible material is injected sub-mucosally at the bladder neck and/or mid-urethra, creating increased tissue bulk and soft tissue augmentation.2
The primary purpose of Coaptite is to treat stress urinary incontinence (SUI) due to intrinsic sphincteric deficiency (ISD) in adult females.1,2 When injected, the gel carrier suspends the CaHA particles and allows delivery through injection needles, after which it dissipates in vivo.3 The CaHA particles remain at the injection sites and provide tissue bulking to cause coaptation of the urethra, increasing urethral resistance to urine leakage.3 This mechanism creates a scaffold for possible tissue ingrowth, facilitating the development of new tissue in the injected area.4
Coaptite provides a long-lasting yet non-permanent option for treatment, with clinical studies demonstrating maintained efficacy through 3 years.4 As a urethral bulking agent, it offers a less invasive alternative to surgical interventions for appropriate candidates with stress urinary incontinence.2
Clinical Context
Coaptite is clinically used for the treatment of stress urinary incontinence (SUI) due to intrinsic sphincteric deficiency (ISD) in adult females.1 This condition is characterized by involuntary leakage of urine during physical activities that increase abdominal pressure, such as coughing, sneezing, or exercising, due to weakened urethral sphincter function.
Patient selection criteria typically include adult women with documented stress urinary incontinence due to ISD without associated urethral hypermobility.2 Candidates should have failed conservative treatments and demonstrated a willingness to undergo minimally invasive procedures. The procedure is contraindicated in patients with significant history of urinary tract infections without resolution, current or acute conditions of cystitis or urethritis, and those with fragile urethral mucosal lining.1
The surgical procedure involves injecting Coaptite sub-mucosally at the bladder neck and/or mid-urethra using a small, 21-gauge needle designed for patient comfort.3 The circumferential needle markings help guide placement, and the procedure can be performed under local anesthesia in an outpatient setting. Multiple injection sites may be used to achieve optimal coaptation of the urethra.
Clinical studies have demonstrated that Coaptite maintains high success rates through 3 years4 with efficacy comparable to traditional bovine collagen.2 In a multicenter, prospective, randomized 52-week trial comparing Coaptite to bovine dermal collagen, 63.4% of Coaptite patients showed improvement of one Stamey grade or more at 12 months.2 Additionally, more Coaptite patients required only one injection (38.0%) compared to collagen patients (26.1%), and the average total volume of material injected was less for Coaptite than for collagen (4.0 mL versus 6.6 mL).2
Expected outcomes include reduced urinary leakage, improved quality of life, and potential durability of results compared to other bulking agents.2 The procedure offers a less invasive option compared to surgical interventions, with minimal recovery time and fewer complications.4