SURGICAL REDUCTION OF THE LEVATOR HIATUS WITH A PUBORECTALIS SLING - A PILOT STUDY
WONG1, K. SHEK 2, J. DALY 3, A. R. KORDA 4, C. J. BENNESS 5, J. M. PARDEY 6, H. DIETZ 1;
1Sydney Med. Sch. Nepean, Sydney, Australia, 2O&G, Western Sydney Univ., Liverpool BC, Australia, 3Western Hlth., Kensington, Australia, 4Western Sydney Univ., Sydney, Australia, 5Urogynaecology, RPAH, Sydney, Australia, 6Nepean Hosp., Kingswood, Australia.
Introduction: Female pelvic organ prolapse, particularly of the anterior compartment, has been shown to be associated with levator avulsion as well as excessive hiatal distensibility (1) These factors also seem to affect recurrence risk. (2) This may be because support structures may be exposed to higher transmitted intra-abdominal pressure in someone with a larger hiatus. A method of reinforcing the levator hiatus to restrict distensibility may reduce prolapse recurrence.
Objective: To assess long-term safety and efficacy of a novel surgical procedure to reduce the levator hiatus, the 'puborectalis sling' (PR Sling).
Methods: We enrolled 116 women in this Phase 1 prospective surgical pilot study at 2 tertiary centres. Entry criteria were 1) patient requiring prolapse repair, and 2) levator hiatal ballooning of ≥ 35cm2. The primary outcome was levator hiatal area on valsalva measured on ultrasound, secondary outcome was recurrent prolapse on clinical examination and imaging. All patients underwent a mesh sling insertion through a post-anal tunnel created at the completion of their standard repair, see Fig 1.
All patients were followed up at 3, 6, 12 and 24 months post-operatively with a standardised physician- directed interview, POPQ clinical assessment and transperineal ultrasound were obtained using previously published methodology (3). Offline analysis of datasets was undertaken using ultrasound volumes obtained with GE Voluson systems.
Results: Of the one hundred and sixteen patients who were enrolled and operated, one hundred and eleven patients were evaluated at least 3 months post-operatively; eighty-nine women attended a two-year follow-up. Mean age was 60 (29 - 88) years; mean BMI 29 (17 - 44) kg/m2 and mean vaginal parity 3 (0 - 10). Mean duration of follow-up was 2.3 (1.0 - 4.6) years. Pre-operatively all patients had a clinical prolapse ≥ POPQ Stage 2, with the mean levator hiatal area measured at 43.9 (35 - 63) cm2. 76/116 (66%) had severe ballooning (≥ 40 cm2) and 73/116 (63%) had a complete levator avulsion; of those, 43 were unilateral and 30 bilateral. At 2 years post-operation, there was an average reduction in levator hiatal area of 11.9cm2, and this effect seemed stable over time. At 24 months post-operation, 28% (25/89) were symptomatic of prolapse, 65% (58/89) had clinical prolapse recurrence whilst 56% (50/89) had a sonographic recurrence, see Table 1. There were two cases that required a return to theatre; one case for sling removal due to mesh-related infection and another for sling release (cutting of anchoring sutures) due to de novo obstructed defecation. Both patients have had no long-term sequelae. There were no cases of sling erosion into the vagina or rectum.
Pre-operative N= 116
3 m postop N= 111
6 m postop N=103
12 m postop N=91
24 m postop N=89
ICS POP-Q ≥ stage 2 in any compartment
Significant prolapse on Ultrasound*
Hiatal area on Valsalva, mean (cm2, SD)
Table 1: Subjective and objective outcomes after prolapse repair with puborectalis sling at 3, 6, 12 and 24 months. *Cystocele ≥10 mm below symphysis pubis (SP), enterocele ≥ the level of the SP, rectal ampulla ≥15 mm below SP; **Reductions in hiatal area all P< 0.0001 at 3,6, 12 and 24 months.
Conclusions: Levator hiatal area can be reduced surgically, with almost 30% reduction seen in this pilot study. Proof of concept and feasibility of incorporating the procedure into standard repair has been demonstrated. The reduction in hiatal area was sustained to 2 years. The only major complications were one mesh infection requiring removal and one revision due to de novo obstructed defecation. Mesh erosion does not seem to be an issue, likely because the implant is distant from vaginal wounds.
A multicentre RCT is in progress to assess the impact of hiatal reduction on prolapse recurrence.
1. Ultrasound Obstet Gynaecol 2008; 31: 676 - 680.
2. Aust NZ J Obstet Gynaecol. 2014;54(3):206-11.
3. Int Urogynecol J 2011; 22 (9): 1085-1097.