Durasphere^® Clinical Evidence Library

Design

Multicenter, randomized, controlled, double-blind trial; n=355 women with stress urinary incontinence due to intrinsic sphincteric deficiency; Durasphere compared to bovine collagen (Contigen); 12-month primary endpoints.

Findings

At 12 months after the first injection, the two materials produced equivalent improvement in continence grade and pad-weight testing. A smaller volume of Durasphere was required to achieve comparable results. Adverse events were similar between groups, though the Durasphere group showed a higher short-term incidence of urinary urgency and retention.

Authors’ conclusion

Durasphere was as effective as bovine collagen for SUI due to intrinsic sphincteric deficiency while using less material.

Design

Extended follow-up of carbon-coated zirconium beads (Durasphere) versus bovine glutaraldehyde cross-linked collagen for intrinsic sphincter deficiency; continence and satisfaction outcomes at 12, 24, and 36 months.

Findings

Efficacy declined over time for both agents. Durasphere remained effective in approximately 35%, 33%, and 21% of patients at 12, 24, and 36 months, compared to 33%, 19%, and 9% for collagen. The authors attributed the decline in both groups partly to physiologic change at the bladder neck and urethra rather than agent breakdown alone.

Authors’ conclusion

Both agents lost durability over extended follow-up, with the decline reflecting factors beyond the bulking material itself. Interpreting urethral bulking long-term outcomes requires accounting for more than the injected material, including physiologic change at the bladder neck and urethra over time.

Design

Long-term follow-up comparison of Durasphere and Contigen; n=52 women with SUI due to intrinsic sphincter deficiency; mean follow-up 2.6 years (Durasphere) and 2.8 years (Contigen).

Findings

Of 26 patients in each group, 25 of 26 (96%) Durasphere patients and 21 of 26 (81%) Contigen patients were available at follow-up. At a mean of 2.6 years, 80% of Durasphere patients and 62% of Contigen patients showed improvement of at least one continence grade.

Authors’ conclusion

Durasphere demonstrated durable long-term continence outcomes comparable to Contigen in this randomized, double-blinded cohort.

Design

Retrospective database review; 56 patients receiving Durasphere injection after a failed urethral sling; mean follow-up 64.3 months (over five years).

Findings

Success, defined as one or fewer SUI episodes per week or at least 70% patient-perceived improvement, was reached in 39.3% of patients at long-term follow-up. Within the subgroup that responded and completed repeat questionnaires, 16 of 20 (80%) maintained success over time.

Authors’ conclusion

Durasphere injection is a viable minimally invasive option for recurrent SUI after a failed sling, with a long-term success rate approaching 40% at more than five years.

AUA 2012 Annual Meeting, Abstract 1360

Design

PRISMA-guideline systematic review of urethral bulking agents for SUI in women; 583 articles screened, 56 included; qualitative analysis across Bulkamid, Macroplastique, Durasphere, Coaptite, and Urolastic.

Findings

Newer synthetic agents were not inferior to Contigen, with short-term success rates of 30% to 80%. De novo urgency was most commonly associated with Durasphere (mean 24.7%). Migration into lymph nodes was reported with Durasphere; erosion was reported with other agents.

Authors’ conclusion

Available data support Bulkamid and Macroplastique, with Bulkamid showing a favorable safety profile. The authors noted that data directly comparing agents are limited.

Design

Pilot study; 20 consecutive patients (13 women, 7 men), mean age 62.5 years; transurethral submucosal Durasphere injection. The 13 women had type III stress urinary incontinence due to intrinsic sphincter deficiency, each with at least one prior failed incontinence operation.

Findings

At six months, 76.9% of female patients reported improvement, declining to 33% at twelve months; male outcomes followed a similar pattern. At follow-up, the authors observed migration of carbon-coated beads into local and distant lymph nodes and into the urethral mucosa.

Authors’ conclusion

The authors concluded that, given the observed decline in efficacy and the documented particle migration, the beads did not demonstrate an advantage over existing bulking materials, and that the clinical significance of bead migration warranted further investigation.

Design

Retrospective review of 135 women (mean age 69.4) who underwent Durasphere periurethral injection; patients who developed a periurethral mass were identified and analyzed.

Findings

Four patients (2.9%) developed periurethral mass formation 12 to 18 months after injection (average 14.7 months), presenting with irritative voiding symptoms, pelvic pain, or recurrent incontinence. All had a tender, tense periurethral mass; one showed a radiopaque mass on videourodynamics. Masses were managed by incision and drainage or transvaginal excision.

Authors’ conclusion

These symptoms in a patient with prior Durasphere or other bulking agent injection should prompt consideration of periurethral mass formation; the true incidence of this late complication remains undetermined.

Design

Case series; 20 patients on therapeutic warfarin anticoagulation receiving carbon bead (Durasphere) injection across 36 occasions between 1999 and 2004.

Findings

Two anticoagulation-related complications occurred: one minor periurethral hematoma and one more severe case involving urinary retention and intravesical hemorrhage.

Authors’ conclusion

The series examined the procedural safety of carbon bead injection during therapeutic anticoagulation.

Design

Retrospective review of a modified periurethral injection technique for Durasphere; n=70, of whom 46 with full contact information were assessed.

Findings

The modified technique used a single needle stick at the 4 o’clock position, submucosal hydrodissection with lidocaine, and a held-needle interval after coaptation to limit bead leakage at the puncture site. Outcomes were assessed by patient perception, 24-hour pad test, and voiding diary.

Authors’ conclusion

The modified technique was described as a means of easing implantation and supporting consistent placement.

Design

Animal study of polytetrafluoroethylene (polytef/Teflon) paste injected periurethrally in dogs and monkeys, with migration tracked over 10.5 months.

Findings

Polytef particles migrated from the injection site to pelvic lymph nodes, lungs, and brain, with granuloma formation at the injection and migration sites. The work established that particles below roughly 80 microns are subject to migration.

Authors’ conclusion

The authors cautioned against periurethral polytef until long-term human effects were understood.

Design

Prospective multicenter study; 33 patients; submucosal anal injection of carbon-coated microbeads (Durasphere); median follow-up 20.8 months.

Findings

Median Cleveland Clinic continence score improved significantly, with improvement in anal manometry measures. Reported events included transient anal pain and distal migration of material along the dentate line in two patients.

Authors’ conclusion

Anal Durasphere injection improved continence scores in this cohort, with some procedural complications noted.

Design

Randomized trial; 40 patients; injectable silicone biomaterial (PTQ) versus Durasphere for passive fecal incontinence due to internal sphincter dysfunction; follow-up to 12 months.

Findings

Both agents improved continence, with Durasphere showing a more rapid early effect. More PTQ patients achieved greater than 50% improvement in Wexner score at each interval. Durasphere-group complications included rectal mucosal erosion (10%) and a hypersensitivity reaction (5%).

Authors’ conclusion

For internal sphincter dysfunction, the silicone biomaterial was safer and more effective than Durasphere in this trial.

A separate preclinical canine study has examined Durasphere for vocal-fold (glottic) augmentation. As animal-only data, it is noted here for awareness rather than summarized as clinical evidence.