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Volume : 40 Issue : 4 Year : 2021
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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 WATERMANN9
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


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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