COMMENTARY

Mini-Sling for Incontinence: Less Pain, Less Gain?

David Ginsberg, MD

Disclosures

May 20, 2011

A Randomized, Controlled Trial Comparing an Innovative Single-Incision Sling With an Established Transobturator Sling to Treat Female Stress Urinary Incontinence

Hinoul P, Vervest HAM, den Boon J, et al
J Urol. 2011;185:1356-1362

Study Summary

The past 10-15 years have brought a significant evolution in the treatment of stress urinary incontinence (SUI). Prior to the arrival of minimally invasive slings ("mini-slings"), we had options such as transvaginal needle suspension, Burch colposuspension, and the autologous fascial sling. A minimally invasive sling using polypropylene tension-free vaginal tape (TVT) was introduced in 1996.[1] Studies have shown the TVT to have good long-term durability and outcomes equivalent to those of the Burch colposuspension at 2-year follow-up.[2]

Since then, we have seen several attempts to make this procedure even less invasive. The first major adjustment, the transobturator approach, appears to have good long-term results, with comparative trials showing fairly equivalent efficacy between the retropubic and transobturator approaches.[3] The most recent adjustment we have seen is a transvaginal single-incision sling using polypropylene tape, but there are little long-term data on this approach.

Hinoul and colleagues prospectively compared the efficacy of the Gynecare TVT™ Obturator (TVT-O) sling with that of the single-incision Gynecare TVT Secur™ sling in 194 randomly assigned patients. The investigators excluded patients with a prior failed repair for SUI, prolapse stage II or greater, and those requiring concomitant surgery. The primary outcome measure was the 12-month objective SUI cure rate, which was determined using a standing cough stress test at a bladder volume of 300 mL or a volume greater than 70% of the maximum bladder capacity based on the patient's bladder diary. Secondary measures included subjective evaluation of voiding and SUI, visual analog scale (VAS) pain scores, and quality-of-life outcomes using the Dutch version of the Urogenital Distress Inventory (UDI).

Objective SUI cure rates were higher with TVT-O at both 6 and 12 months. At 6 months, SUI was identified in 24.4% of TVT Secur patients compared with none of the TVT-O patients (P < .0001); at 12 months, SUI was identified in 16.4% of TVT Secur patients compared with 2.4% of TVT-O patients (P = .002). A similar trend was seen with subjective SUI outcomes at 24 months, with 24% of TVT Secur patients complaining of SUI vs 8.3% of TVT-O patients (P = .008). Subjective reports of urgency and/or urge incontinence at 12 months were noted in 23% of TVT Secur patients and 16.7% of TVT-O patients; this was not statistically significant. During the first 12 months postsurgery, 12 TVT Secur and 14 TVT-O patients were prescribed anticholinergic therapy. A significantly greater improvement in the urinary incontinence subscale of the UDI was noted in TVT-O patients compared with TVT Secur patients.

Less pain was noted with TVT Secur. Patients in that arm had a lower VAS pain score the first 2 weeks after surgery (but not thereafter), and less need for analgesics the first 5 days after surgery (but not thereafter). Mesh exposures were noted in 7 of 96 TVT Secur patients, all of which required surgical closure. One TVT-O patient had a mesh exposure that resolved with local estrogen therapy. At 12 months postsurgery, 8 TVT Secur patients had undergone re-intervention (although the report did not specify which procedure) for unresolved SUI; 6 more patients were scheduled for another procedure. Two patients in the TVT-O arm underwent further intervention with a tape release for persistent voiding symptoms. There was no mention of a TVT-O patient requiring re-intervention for unresolved SUI, although 1 patient was scheduled to undergo pelvic floor repair.

Viewpoint

This report suggests that TVT Secur is not as efficacious as TVT-O. While TVT Secur is less invasive and less likely to cause pain during the early postoperative period, trade-offs may include a greater risk for mesh extrusion and recurrent or unresolved SUI requiring further intervention. Hinoul and colleagues discuss several factors that may contribute to the lower success rate: greater variability of the inserter with TVT Secur compared with the obturator procedure, resulting in variable (and perhaps suboptimal) placement of the tape; decreased tape length; wider dissection required for TVT Secur, allowing for more tape mobility early in the postoperative period; less postoperative pain with TVT Secur, possibly leading to greater patient activity that decreased tape fixation; and the possibility that the surgeons did not have enough experience with the newer procedure prior to study start (to participate, surgeons were required to have performed 5-10 TVT Secur procedures).

The authors also noted a significant limitation of the study, which was a much higher loss to follow-up in the TVT Secur arm: 92% of TVT-O patients were available for follow-up at 12 months, compared with 65% in the TVT Secur arm.

At first glance, this study seems to suggest that just because something is new does not mean it is better. However, it is probably premature to reach definitive conclusions about TVT Secur. More data on this and other single-incision slings are needed as we try to understand the procedure's true efficacy and durability, and as we try to identify the optimal patients to undergo this procedure.

Abstract

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