While tension-free vaginal tape (TVT) is and single-incision mini-sling result in similar subjective cure rates for the treatment of stress urinary incontinence, the mini-sling is still inferior, according to a randomized study published in Obstetrics & Gynecology.
Dr. Matthew D. Barber, professor of surgery at the Cleveland Clinic Lerner College of Medicine at Case Western Reserve University and vice-chair of clinical research in the OB/Gyn and Women’s Health Institute, and colleagues recruited women (at least 21 years old) with urodynamic stress incontinence with or without genital prolapse from 7 medical centers across the US. Baseline assessments included a standardized evaluation as well as various patient-reported outcome measures and a bladder diary. The researchers randomized participants to receive TVT (N=127) or mini-sling (n=136); to maintain blinding, sham incisions were made in the suprapubic region in those individuals enrolled in the mini-sling arm to mimic the visible incisions of TVT. In the study, surgeons used the retropubic “U” approach; the tension of the mini-slings were set tightly so that the sling was directly opposed to the urethra such that a spacer could not be placed between the sling and the urethra.
In addition to asking patients to complete postoperative self-assessments, patients were evaluated at 6 weeks and again at 6, 12, 18, and 24 months to determine if subjective cure (i.e., absence of any urinary incontinence or retreatment) of urinary incontinence was obtained 12 months following surgery.
Barber and colleagues found positive results for both procedures. One year after surgery, 55.8% of women who received a mini-sling and 60.6% of women who received TVT experienced subjective cure. While they found a higher level of incontinence severity in women in the mini-sling group, Barber et al. believe this was due to a higher proportion of participants in this group with “severe” incontinence. The researchers found bothersome stress incontinence and bothersome urge incontinence symptoms in 18% and 25%, respectively, of the women in the mini-sling group and in 14% and 29%, respectively, in the TVT group.
Patients in the mini-sling group were less likely to have complications related to the treatment than their counterparts receiving the tension-free vaginal tape. For instance, bladder perforation occurred in 4.8% of the women who received TVT but in only 0.8% of the women the mini-sling group. In addition, Barber and colleagues found that women in the mini-sling group had a higher rate of being discharged without a catheter and also experienced less pain in the first 3 days after surgery as compared with the women who received TVT.
“In this trial, subjective cure rates were similar between the two procedures but the mini-sling placed in the ‘U’ position did not perform well enough to be able to confirm that its efficacy is not inferior to TVT by more than 12%,” Barber and colleagues explained. “Moreover, individuals who received a mini-sling had greater severity of their urinary incontinence 1 year after surgery, with a substantially higher rate of severe (i.e., daily) urinary incontinence. In essence, the proportion of patients who were completely continent after surgery was similar between the two procedures but, of those not continent, incontinence severity was significantly worse in those who received a mini-sling.”
“Physicians will need to counsel patients carefully about these risks and benefits when contemplating placing a mini-sling,” they concluded.