Mid-term perceived health after pelvic organ prolapse surgery for 2038 women in the VIGIMESH registry, and comparison with the French population of the same age

Fritel X1, Cosson M2, Ferry P3, Campagne-Loiseau S4, De Tayrac R5, Curinier S4, Deffieux X6, Lucot J P7, Fatton B5, Carlier-Guerin C8, Garbin O9, Wagner L5, Panel L10, Giraudet G2, Thirouard Y3, Debodinance P11, Ramanah R12, Thubert T13, Gauthier T14, Bosset P15, Hocke C16, Lamblin G17, Pizzoferrato A18, Fauconnier A19

Research Type

Clinical

Abstract Category

Pelvic Organ Prolapse

Abstract 384
Open Discussion ePosters
Scientific Open Discussion Session 23
Friday 9th September 2022
15:25 - 15:30 (ePoster Station 4)
Exhibition Hall
Pelvic Organ Prolapse Prospective Study Quality of Life (QoL) Questionnaire Surgery
1. Université de Poitiers, France, 2. CHRU de Lille, France, 3. CH de La Rochelle, France, 4. CHU de Clermont-Ferrand, France, 5. CHU de Nîmes, France, 6. AP-HP, Clamart, France, 7. Groupe Hospitalier de l'Institut Catholique de Lille, France, 8. CH de Châtellerault, France, 9. CHRU de Strasbourg, France, 10. Clinique Beau Soleil, Montpellier, France, 11. CH de Dunkerque, 12. Université de Franche-Comté, France, 13. CHU de Nantes, France, 14. CHU de Limoges, France, 15. CH Foch, Suresnes, France, 16. CHU de Bordeaux, France, 17. HCL, Lyon, France, 18. CHU de Caen, France, 19. CHI Poissy-Saint-Germain, France
In-Person
Presenter
A

Arnaud Fauconnier

Links

Poster

Abstract

Hypothesis / aims of study
The use of a mesh in prolapse surgery reduces the risk of recurrence but exposes the woman to specific complications. We observed in the VIGIMESH registry that 0.9% of the meshes had to be removed [1].
Our objective is to measure the perceived health of women included in the registry according to the type of surgical repair (vaginal repair, transvaginal mesh, and sacropexy by laparoscopy), and to compare the perceived health of the operated women to that of women of the same age in the French population.
Study design, materials and methods
Since 2017, in 26 surgical centres, participation was offered to all women who underwent pelvic organ repair. Women with a known postal address were sent a health questionnaire to measure impression of improvement (PGI-I), quality of life (EuroQoL-5D) and perceived health status (Minimum European Health Module, MEHM). Women were encouraged to express themselves freely on their health status; their free answers were classified in several domains including pain potentially related to the index surgery, urinary disorders (incontinence, urgency, obstructed micturition, or urinary tract infections), anorectal disorders (incontinence, difficult defecation, constipation, diarrhea), and possible recurrence of the prolapse.
The woman was considered improved if she responded "much better" or "very much better" (versus "a little better", "no change", "a little worse", "much worse", or "very much worse", PGI-I). Perceived health status was considered good when the woman responded "very good" or "good" (versus "fair", "bad", or "very bad") to: "How is your health in general?" (MEHM). The presence of one or more comorbidities was defined as a positive response to: "Do you have any longstanding illness or health problem?" (MEHM). The woman was considered severely limited if responding "severely limited" (versus "not limited at all" or "limited but not severely)" to: "For at least the past 6 months, to what extent have you been limited because of a health problem in activities people usually do?" (MEHM). She was considered extremely painful if she reported an "extreme pain or discomfort" (EuroQoL-5D.
The women's responses were analysed according to the woman's age, comorbidities, type of surgical repair (vaginal repair, transvaginal mesh, and sacropexy by laparoscopy), the need for further surgery for incontinence or prolapse, and the occurrence of a Clavien-Dindo grade III or higher complication (multivariate analysis by logistic regression). We also compared the perceived health of the operated women to French women of the same age surveyed by EuroStat (https://appsso.eurostat.ec.europa.eu/nui/submitViewTableAction.do).
Results
Among the 3530 women who underwent surgery between 2017 and 2020 and received the questionnaire, we received 2038 responses (58%) within an average of 28 months after surgery. Our analysis focuses on these 2038 respondents. The average age of the respondents was 68 years; 23% had a history of urinary incontinence or prolapse surgery; 481 women had undergone vaginal repair, 532 had undergone transvaginal mesh, 1007 had undergone laparoscopic sacropexy, and 18 had undergone other abdominal surgery (index surgery); 5% had a previous complication (Clavien-Dindo Grade III or IV) of urinary incontinence or genital prolapse surgery (before or after the index surgery); and 45% reported one or more comorbidities. 
The women considered themselves improved by the surgery (better or much better) in 81% of cases, while 5% considered themselves worsened (Figure). They considered their health status to be good or very good in 68% of cases, which was much higher than the rate of good or very good health status observed in the population of French women of the same age (52% according to EuroStat data for the year 2020). The median of the quality-of-life scale was 80 (out of 100). 7.0% of them felt severely limited in their activities. 4.2% reported extreme pain or discomfort.
Good health was less frequent in women who were older (OR 0.99 by year), had comorbidity (OR 0.23), or a history of complication (OR 0.45); there was no significant difference by type of surgical repair (multivariate analysis). Impression of improvement was less frequent in women with comorbidity (OR 0.53) or previous complication (OR 0.32); there was no significant difference according to type of surgical repair (multivariate analysis). Severe limitation was more frequent in case of comorbidity (OR 4.80), or new surgery for urinary incontinence or prolapse (OR 1.94); there was no significant difference according to the type of surgical repair (multivariate analysis). Extreme pain or discomfort was more frequent in cases of comorbidity (OR 4.36) or previous complication (OR 2.64); there was no significant difference according to the type of surgical repair (multivariate analysis). The mean quality-of-life scale was similar in the three main surgical groups (vaginal repair, transvaginal mesh, and laparoscopic sacropexy).
In the free part of the questionnaire, 5.7% of women reported pain potentially related to surgery, 14% reported urinary disorders, 5.4% reported anorectal disorders, and 5.0% reported recurrence of prolapse. Pain was reported more often in case of comorbidity (7.8 versus 4.0%, OR 2.21). Urinary disorders were reported more often in case of comorbidity (16 versus 12% OR 1.38), or new surgery for incontinence or prolapse (20 versus 13%, OR 1.70). Anorectal disorders were reported more often in case of comorbidity (6.6 versus 4.5%, OR 1.60). Recurrence of prolapse was reported less often in the transvaginal mesh group than in the vaginal repair group (3.0 versus 6.4%, OR 0.53).
Interpretation of results
A large majority of women were improved by the repair of the prolapse. Perceived health status was most often good and higher than in the general population. A poor health status was associated with ageing, comorbidities, and complications, but not with the type of surgical repair of prolapse.
Concluding message
In the medium term and in routine care, pelvic organ repair improves the health status of a significant proportion of women. The use of a mesh is not associated with poorer health. The occurrence of a post-operative complication worsens health status. This information is useful for women and surgeons.
Figure 1 Perceived health and improvement after pelvic organ prolapse repair in VIGIMESH registry
References
  1. Fritel X, de Tayrac R, de Keizer J, Campagne-Loiseau S, Cosson M, Ferry P, Deffieux X, Lucot JP, Wagner L, Debodinance P, Saussine C, Pizzoferrato AC, Carlier-Guérin C, Thubert T, Panel L, Bosset PO, Nkounkou E, Ramanah R, Boisramé T, Charles T, Raiffort C, Charvériat A, Ragot S, Fauconnier A. Serious complications and recurrences after pelvic organ prolapse surgery for 2309 women in the VIGI-MESH registry. BJOG 2022
Disclosures
Funding The French national medicines agency (Agence Nationale de Sécurité du Médicament et des produits de santé, ANSM) provided the funding for the study Clinical Trial No Subjects Human Ethics Committee Comité de Protection des Personnes Ouest III Helsinki Yes Informed Consent Yes
17/04/2024 19:41:42