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

INTRODUCTION AND HYPOTHESIS: 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.

METHODS

One hundred fifteen women undergoing prolapse repair with a pre-operative hiatal area on Valsalva of ≥ 35 cm2 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.

RESULTS

One hundred ten patients were evaluated at least 3 months post-operatively. At 2.5 years average follow-up, there was an average of 12 cm2 (range 6-16 cm2) 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 severe obstructed defecation requiring sling loosening and another had buttock pain with faecal impaction that resolved after manual disimpaction. There were no long-term sequelae.

CONCLUSIONS

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 2 years with no major long-term complications.