RANDOMIZED CONTROLLED TRIAL
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Randomized comparative study between buccal mucosal and acellular bladder matrix grafts in complex anterior urethral strictures.

PURPOSE: Urethral strictures have been a reconstructive dilemma for many years due to the limited availability of tissue substitutes and incidence of recurrence. Buccal mucosal grafts have been a favored material in instances where penile skin is unavailable due to its durability and excellent graft survival. Recently collagen based matrices derived from the bladder have been used successfully in patients with stricture disease and hypospadias. We performed a randomized comparative study to assess the outcome of the acellular bladder matrix compared to buccal mucosa in patients with complex urethral strictures.

MATERIALS AND METHODS: Human demineralized bone matrix, obtained from cadaveric donors, was processed and prepared for use as an off-the-shelf material. Thirty patients with stricture 21 to 59 years old (mean 36.2) were enrolled and assessed using a standard protocol. The stricture length ranged from 2 to 18 cm (mean 6.9), of which 11 patients had bulbar, 7 had pendulous and 12 had combined bulbopendulous strictures. Of the 30 patients 7 had received no previous intervention while the remaining 23 had undergone 1 to 7 procedures (mean 1.9). All patients were randomized and alternatively assigned to receive either buccal mucosa or decellularized bladder [corrected] matrix and underwent an onlay procedure.

RESULTS: All patients except 2 who were lost during followup were followed for 18 to 36 months (mean 25). In patients with a healthy urethral bed (less than 2 prior operations) the success rate of buccal mucosa grafts (10 of 10) was similar to the bladder matrix grafts (8 of 9) in terms of patency. In patients with an unhealthy urethral bed (more than 2 prior operations) only 2 of 6 patients with a bladder matrix graft were successful, whereas all 5 patients with a buccal mucosa graft had a patent urethra. Postoperative uroflowmetry showed significant voiding improvement in both groups. Histology of the graft biopsies showed normal urethral tissue characteristics.

CONCLUSIONS: This study demonstrates that the use of acellular bladder matrix is a viable option for urethral repair. Demineralized bone matrix as an off-the-shelf biomaterial achieves the best results in patients with a healthy urethral bed, no spongiofibrosis and good urethral mucosa.

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