O J Morris1, S Smith, B Draganic. 1. Hunter Colorectal Research, Newcastle Hospital Private Suites, New Lambton Heights, NSW, 2305, Australia, owenjamesmorris@hotmail.com.
Abstract
BACKGROUND: We sought to compare two synthetic injectable bulking agents, with known efficacy (PTQ™: 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.
RCT Entities:
BACKGROUND: We sought to compare two synthetic injectable bulking agents, with known efficacy (PTQ™: 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.
Authors: C Feretis; P Benakis; A Dailianas; C Dimopoulos; C Mavrantonis; K M Stamou; A Manouras; N Apostolidis; G Androulakis Journal: Dis Colon Rectum Date: 2001-11 Impact factor: 4.585
Authors: Victoria Garcia; Rebecca G Rogers; Suzy S Kim; Rebecca J Hall; Dorothy N Kammerer-Doak Journal: Am J Obstet Gynecol Date: 2005-05 Impact factor: 8.661