pelviperineology. 2014; 33(3): 74-79 | DOI:

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

JULIANE FARTHMANN¹, BORIS GABRIEL², ACHIM NIESEL³, CHRISTIAN FÜNFGELD⁴, ALFONS KRAUS⁵, FLORIAN LENZ⁶, HANS-JOERG AUGENSTEIN⁷, ERIKA GRAF⁸, DIRK WATERMANN^9
1Medical Center - University of Freiburg, Department of Obstetrics & Gynecology, Germany, ²Medical Center - University of Freiburg, Department of Obstetrics & Gynecology, Germany; St. Josefs-Hospital, Wiesbaden, Germany, ³Kreiskrankenhaus Preetz, Germany, ⁴Klinikum Tettnang, Germany, ⁵Klinikum Fulda, Frauenklinik, Germany, ⁶Krankenhaus Hetzelstift, Neustadt, Germany, ⁷Evangelisches Krankenhaus, Frauenklinik, Oldenburg, Germany, ⁸Medical Center - University of Freiburg, Clinical Trials Unit, Germany, ⁹Diakoniekrankenhaus Freiburg, Germany

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

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Cite This Article

FARTHMANN J, GABRIEL B, NIESEL A, FÜNFGELD C, KRAUS A, LENZ F, AUGENSTEIN H, GRAF E, WATERMANN D. Pelvic floor related quality of life after vaginal mesh implantation. Secondary endpoint of a prospective randomized trial. 2014; 33(3): 74-79

Corresponding Author: FARTHMANN J.

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