- Title
- Comparison of bulking agents in the treatment of fecal incontinence: a prospective randomized clinical trial
- Creator
- Morris, O. J.; Smith, S.; Draganic, B.
- Relation
- Techniques in Coloproctology Vol. 17, Issue 5, p. 517-523
- Publisher Link
- http://dx.doi.org/10.1007/s10151-013-1000-4
- Publisher
- Springer
- Resource Type
- journal article
- Date
- 2013
- Description
- Background: We sought to compare two synthetic injectable bulking agents, with known efficacy (PTQTM: a silicone biomaterial and Durasphere®: pyrolytic carbon-coated beads), in the form of a randomised clinical trial. Methods: Circumferential injection of either agent was performed under local anesthesia and sedation as a day-case procedure. The primary outcome measure was the Wexner incontinence scale. Secondary measures were the short-form 36 (SF-36) quality of life assessment and manometry (maximum resting and squeeze pressures). Follow-up was at 6 weeks, 6 and 12 months. Results: Thirty-five patients were randomised, 17 to PTQ® and 18 to Durasphere®. Early closure of the trial occurred, due to the removal of the agent PTQ®, from the Australian Pharmaceutical Benefits scheme. Wexner incontinence scores were significantly better than baseline, in both groups, at 6 weeks and 6 months (P < 0.05), although the improvements were not significant at 12 months. There was no significant improvement for either agent, from baseline, in mean SF-36 scores at any follow-up sessions. There was no significant difference between the two bulking agents, with regard to both Wexner and SF-36 scores, at any of the follow-up sessions. Complications occurred in one patient in the PTQ group (perianal abscess) and did not occur in any of the patients in the Durasphere group. Conclusions: This trial appears to show that both synthetic agents PTQ® and Durasphere® are effective and safe, although long-term improvement is limited. In this trial, there appears to be no difference in efficacy between the two agents, over a 12-month follow-up period.
- Subject
- silicone; PTQ<sup>®</sup>; Durashphere<sup>®</sup>; anal sphincter; fecal incontinence; quality of life
- Identifier
- http://hdl.handle.net/1959.13/1319140
- Identifier
- uon:23792
- Identifier
- ISSN:1123-6337
- Language
- eng
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