The present study describes an extended follow-up study after 12 years and focusses on subjective outcomes of women who underwent surgery for recurrent pelvic organ prolapse in the randomized index study.
One hundred and ninety-four (194) women had been randomized in the original study and in the present study, 45 (47%) in the vaginal mesh repair versus 43 (43%) women with conventional vaginal native tissue repair completed the long-term questionnaires. The mesh used was a first-generation non-absorbable mesh kit. All types of conventional vaginal native tissue repairs were allowed, and additional vaginal native tissue repairs were allowed in the mesh group. The questionnaires as applied at baseline were used. The Patient Global Impression of Improvement questionnaire (PGI-I) was the primary outcome.
At 12 years, 30 (71%) women in the mesh group versus 23 (59%) women in the native tissue repair group reported to be PGI-I (very) much improved (p=0.24). There were no differences found in any of the questionnaire domains. There was, however, a higher number of women who had had additional operations for recurrent pelvic organ prolapse, stress urinary incontinence, and/or exposure in the mesh group: 18 women (40%) in the mesh group versus 8 women (19%) in the native tissue repair group (p=0.03).
There was no difference in subjective outcome between the groups, but there was a statistically significant higher number of women who had needed further operations. This study confirms that vaginal mesh should not be used in all women with recurrent pelvic organ prolapse.
International urogynecology journal. 2023 Jan 20 [Epub ahead of print]
Kirsten B Kluivers, Metteke Kamping, Alfredo L Milani, Joanna IntHout, Mariella I Withagen
Department of Obstetrics & Gynecology (623), Radboud University Medical Center, P.O. Box 9101, 6500, HB, Nijmegen, the Netherlands. ., Department of Obstetrics & Gynecology (623), Radboud University Medical Center, P.O. Box 9101, 6500, HB, Nijmegen, the Netherlands., Department of Obstetrics & Gynaecology, Reinier de Graaf Gasthuis, P.O. Box 5011, 2600, GA, Delft, the Netherlands., Department for Health Evidence, Radboud Institute for Health Sciences, Radboud University Medical Center, P.O. Box 9101, 6500, HB, Nijmegen, the Netherlands., Department of Obstetrics & Gynecology, University Medical Center Utrecht, Heidelberglaan 100, Room F05.126, P.O. Box 85500, Utrecht, the Netherlands.