Original Article

Pelvic floor related quality of life after vaginal mesh implantation. Secondary endpoint of a prospective randomized trial

  • JULIANE FARTHMANN
  • BORIS GABRIEL
  • ACHIM NIESEL
  • CHRISTIAN FÜNFGELD
  • ALFONS KRAUS
  • FLORIAN LENZ
  • HANS-JOERG AUGENSTEIN
  • ERIKA GRAF
  • DIRK WATERMANN

Pelviperineology 2014;33(3):74-79

Objective:

To evaluate the impact of mesh implantation and the type of mesh used on pelvic floor related quality of life (QoL). Mesh implantation is commonly used for prolapse repair, but mesh exposure and chronic pain are risks.

Material and methods:

Pre- and postoperative QoL was evaluated as secondary endpoint of a prospectively randomized multicenter open-label trial; primary endpoint was the difference of exposure rates between a nonabsorbable and a partially absorbable mesh. QoL was evaluated after 3, 12, and 36 months using a validated pelvic floor questionnaire, together with visual analogue scales on pelvic floor pain and satisfaction with surgery and compared to baseline by paired t-tests. Mean scores within treatment groups at 36 months were compared adjusting for baseline values in a linear regression model.

Results:

Between 2007 and 2008, 200 patients with cystocele ≥ stage 2 were centrally randomized to the nonabsorbable (n=102) or the partially absorbable (n=98) mesh. QoL improved significantly after 3 months, remaining constant: mean±SD 8.3±3.2 preoperatively (n=193) to 3.9±2.9 (3 months, n=188), 3.6±2.5 (12 months, n=186), 3.8±2.7 (36 months, n=181). Change from baseline was significant (p≤0.002). There were no relevant differences among study arms; at 36 months, QoL improved by 0.6 points more for the partially absorbable (n=85) than for the nonabsorbable mesh (n=84; 95%, CI: -0.2 to 1.4).

Conclusions:

We demonstrate a clinically relevant improvement of pelvic floor related QoL together with improved pelvic floor pain and high satisfaction after 3 years, with an equal improvement in both study arms

Keywords: Quality of life; Pelvic organ prolapse; Sexuality; Polypropylene mesh; Pelvic floor pain