A pilot study on surgical reduction of the levator hiatus-the puborectalis sling.

Abstract

Female pelvic organ prolapse recurrence has been shown to be associated with levator hiatal distensibility. Reducing hiatal size surgically may reduce recurrence risk. This study aims to demonstrate a novel surgical procedure, the puborectalis sling (PR sling), designed to reduce the levator hiatal area, and to assess the medium-term safety and efficacy of this procedure. One hundred fifteen women undergoing prolapse repair with a pre-operative hiatal area on Valsalva of ≥ 35cm2 were recruited into this phase 1 prospective multicentre pilot study. All underwent a PR sling procedure after completion of standard repairs. Primary outcome was levator hiatal area measured on ultrasound. One hundred ten patients were evaluated at least 3months post-operatively. At 2.5yearsaverage follow-up, there was an average of 12cm2 (range 6-16cm2) reduction in hiatal area from a mean pre-operative hiatal area of 43.9 (35-63) cm2. Thirty per cent (28/93) were symptomatic of prolapse, 66% (61/93) had clinical prolapse recurrence whilst 49% (46/93) had sonographic recurrence. Three patients required a return to theatre; one case of infection resulted in mesh removal, one had severeobstructed defecation requiring sling loosening and another had buttock pain with faecal impaction that resolved after manual disimpaction. There were no long-term sequelae. The levator hiatal area can be reduced surgically, with almost 30% reduction in area seen in this pilot study. The reduction was significant and sustained up to 2years with no major long-term complications.