Laurikainen E, Valpas A, Kivela A et al. Retropubic compared with transobturator tape placement in treatment of urinary incontinence: a randomized controlled trial. Obstetrics and Gynecology[2007] 109 (1) 4-11.
The main difference in safety between the (retropubic placement) of a Tensio-free Vaginal Tape [TVT] procedure and the Trans-Obturator Tape [TVT-O] procedure is that of complications of retropubic space accessing. Major vascular and bowel trauma have been reported with the TVT procedure. The TVT-O procedure was therefore designed to reduce the likelihood of these complications, as a well as that of bladder trauma.
From Finland comes the report of this timely randomised controlled trial. It compared 136 women who had a TVT procedure with 131 women who had TVT-O. The women were matched by age, parity, body mass index, previous surgery for prolapse and duration of perceived bladder neck weakness. The Urogynaecologists who operated on them, had been skilled in TVT procedures and had performed ‘at least 5 TVT-O procedures’ after a training period.
In ensuring uniformity, the investigators even went to the length of specifying angles of the patient’s thighs on the stirrups during the procedures. Post-operative evaluation was at 2 months.
The subjective and objective cure rates were similar in both groups. Thirteen percent of women in the TVT-O group and 8% in the TVT group had urinary tract infections. There was more post-operative pain in the TVT-O group(16% vs 1.5%), and a longer duration of such pain in the TVT-O group[up to 2 months in one patient] compared to 5-10 days in the TVT group.
The authors rightly point out that modifications to a successful procedure[such as the TVT] do not necessarily result in improvement in clinical outcome.
No papers are impeccable. It is puzzling why ‘either Cefuroxime or Metronidazole’ was given as prophylaxis. It is also a surprise that post-void urine volumes were measured either by catheterisation or by suprapubic ultrasound. Why is there such a difference between the episodes of check cystoscopies between the two groups? May be there was a little flexibility afterall.
Most Clinicians would perform a one-look cystoscopy, or none at tall for a TVT-O, where there is no cystocoele.
These are admittedly, ‘irritating’ observations that do not, in any way, belittle the results of this important study.