Andonian 2007.
Methods | RCT of TOT (Obtape) versus distal urethral polypropylene sling (DUPS) versus TVT | |
Participants | 190 women Inclusion criteria: women with SUI with or without POP or pelvic surgery; previous failed anti‐incontinence surgeries or bulking agent treatments permitted; women with MUI were not excluded as long as their cystometrogram showed normal capacity; compliance and no uninhibited contractions Exclusion criteria: obstruction; unstable bladder function, or neurogenic bladder; UTI |
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Interventions | Group A: Obtape (n = 78) Group B: DUPS (n = 32) Group C: TVT (n = 80) 1 participant in the Obtape group had a urethral diverticulum, which was repaired, but the Obtape procedure was cancelled, leaving 77 patients in the Obtape group for the final analysis |
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Outcomes | Primary outcome: objective cure defined by 1‐h pad test of ≤ 2 g Secondary outcome: subjective cure rates determined by the ICIQ‐SF Postoperatively, all women were re‐evaluated by history and physical examination at 1, 6, and 12 months. At the 12‐month visit, participants completed the ICIQ‐SF, and underwent the 1‐h pad test conducted by the dedicated UDS nurse who was blinded to the procedure |
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Notes | Mentor's Obtape is a non woven monofilament thermally bonded micropore (50 µm) polypropylene mesh which was withdrawn by its manufacturers in 2006. There have been many reports of tape erosions and some cases of ischiorectal abscess and necrotizing fasciitis DUPS is not a minimally invasive sling, but a woven polypropylene mesh (by Ethicon, New Jersey). Absorbable sutures are used to fix the sling into position until adhesions form and adhere it naturally to the retropubic space. As it was not a minimally invasive sling there was no need to compare DUPS in the review The DUPS procedure was discontinued because of a higher postoperative retention rate combined with several complaints of suprapubic abdominal discomfort on straining |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Quote: "Randomization was performed by an envelope method immediately before the start of surgery." |
Allocation concealment (selection bias) | Unclear risk | Not mentioned |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | The patients were blinded to the procedure |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Outcome assessors blinded, but how this was achieved was not explained |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Unclear |