Perceived health status after sub-urethral sling revision, about 290 women from the VIGIMESH registry.

Camilli H1, Fatton B2, Gand E1, Campagne-Loiseau S3, De Tayrac R2, Wagner L2, Saussine C4, Rigaud J5, Thubert T5, Deffieux X6, Cosson M7, Ferry P8, Pizzoferrato A9, Capon G10, Panel L11, Chartier-Kastler E12, Fauconnier A13, Gauthier T14, Game X15, Bouynat C1, Zimolong A1, Fritel X1

Research Type

Clinical

Abstract Category

Female Stress Urinary Incontinence (SUI)

Abstract 433
Best Urogynaecology and Female & Functional Urology
Scientific Podium Session 27
Saturday 10th September 2022
10:35 - 10:50
Hall K1
Stress Urinary Incontinence Quality of Life (QoL) Grafts: Synthetic Surgery Female
1. Université de Poitiers, 2. CHU Carémeau, Nîmes, 3. CHU Estaing, Clermont-Ferrand, 4. Université de Strasbourg, 5. CHU de Nantes, 6. APHP, Clamart, 7. Université de Lille, 8. CH de La Rochelle, 9. CHU de Caen, 10. CHU de Bordeaux, 11. Languedoc Mutualité, 12. APHP, La Pitié Salpêtrière, 13. CHI Poissy-Saint-Germain, 14. CHU de Limoges, 15. CHU de Toulouse
In-Person
Presenter
H

Hugo Camilli

Links

Abstract

Hypothesis / aims of study
Following mid-urethral sling (MUS) insertion, a proportion of women experienced complications. Sling revision may be required in around 3.8% of women after MUS insertion [1]. The purpose of the VIGI-MESH observatory is to collect complications after surgery for urinary incontinence in 30 centers in France and to assess women’s health status. The aim of our analysis was to evaluate health status and recovery of women after mid-urethral sling revision.
Study design, materials and methods
Our sample came from the VIGI-MESH registry considering women who had grade-III complications (Clavien-Dindo classification [2]) after MUS insertion. Grade-IV complications were not included. In case of multiple complications, we considered the first occurrence. Each woman included received a health questionnaire. To appreciate global health status, we used the Minimum European Health Module (MEHM); the first question is about self-perceived health, the second is about chronic morbidity, and the third is the Global Activity Limitation Indicator. The MEHM is used by EuroStat to assess health in European countries every year : https://ec.europa.eu/eurostat/ (last update 2020). 

We modeled health status in our sample considering women characteristics, MUS type (retropubic or transobturator), and types of complication (logistic analysis). We compared health status in our sample to the survey of the French population by Eurostat. A good health status was determined by a “good” or “very good” self-perceived health. Women were considered as disabled if they answered “severely limited” in every-day activities. Improvement after MUS revision was defined as “Better” or “Much better” at the PGI-I scale. Physical pain was assessed by a question from the European Health Interview Survey. We added Pelvic Floor Distress Inventory (PFDI-20) to the health questionnaire and question 3 of the Urinary Distress Inventory (UDI-6) was used to assess stress urinary incontinence.

We encouraged women to express themselves freely. A qualitative textual analysis was performed to deduce if women linked their current health status to continence surgeries (MUS insertion and revision) or to persistent urinary trouble, or conversely, if women linked their current health status to other issues. All analysis were performed by an author who was not the women’s surgeon.
Results
Among the 393 women who received our questionnaire, 290 returned it (74%) and constitute our sample. MUS insertions took place between January 1998 and December 2020 and revisions between March 2017 and May 2021. Mean age at time of the MUS insertion was 53 +/- 14 and MUS revision was done 62 +/- 70 months (mean) after insertion. MUS were Trans-Vaginal Tape for 61% or Tans-Obturator Tape for 39%. Indications for MUS revision were pain in 127 cases (44%), pain-free exposition in 75 cases (26%) and pain-free urinary trouble in 101 cases (35%). MUS procedures at revision resulted in total or partial removal for 195 cases of the women (67%), MUS section for 38 cases (13%), MUS loosening for 30 cases (10%), or other procedures for 27 cases (9%).

At follow-up, half of women (51%, 144 cases) reported a good health status. It was lower than expected in the French population: 58% according to Eurostat (age standardized). Women noted improvement in 54% of the cases after MUS revision.  (Figure 1). Women classifying themselves as having a good health status did not differ from the other regarding Body Mass Index, MUS type, revision indication, revision procedure, and delay to revision (multivariate analysis). Have a good health status was associate with younger age (Odds Ratio (OR) per 10 years (95%CI)=0,73 (0,55-0,96) p=0,0248), less reported comorbidity (OR=0,31 (0,16-0,60) p=0,0005) and lower proportion of smokers (OR=0,18 (0,07-0,52) p=0,0013).

Nine-teen per-cent of women (54 cases) expressed severe limitations in their every-day activities. Comorbidity and smoker status were different between severely limited women and others. MUS type, revision indication, revision procedure and delay to revision were similar. Women who self-classified as severely limited more often encountered multiple revisions (26 vs. 8%, p<0.0001), more often reported physical pain (51 vs. 11%, p<0.0001), pelvic pain (70 vs. 50%, p=0.0177), and stress urinary incontinence (68 vs. 47%, p=0.0181).

The textual analysis shows us that among the 54 women severely limited, 30 linked their limitations to the MUS procedure or urinary trouble (10% of our sample, 30/290), and 24 to other health issues (Table 1).
Interpretation of results
After MUS revision, 54% of the women considered themselves improved by the revision and 51% considered themselves in good health. MUS type, revision indication, or revision procedure were not related to health. The health status was weaker than expected in the French population. In our sample, 10% linked their severe limitations to the MUS insertion or revision. If we exclude these women severely limited, a good health status was reported by 56%; this almost corresponds to the Eurostat data regarding the French population which is 58%. This last result suggests that most of women who experience complication after MUS insertion may have a comparable life to general population.
Concluding message
According to our results, a good recovery is achieved for half of women after MUS revision. Nevertheless, 10% remains disabled. Our results are useful to inform women before MUS insertion and after in cases of MUS revision.
Figure 1 Figure 1: Self perceived health and Patient Global Improvement Impression after mid-urethral sling revision. (n=290)
Figure 2 Table 1: Sample of free expressions about their health among severely limited women.
References
  1. X. Fritel et al., « Complications after pelvic floor repair surgery (with and without mesh): short-term incidence after 1873 inclusions in the French VIGI-MESH registry », BJOG Int. J. Obstet. Gynaecol., vol. 127, no 1, p. 88-97, janv. 2020, doi: 10.1111/1471-0528.15956.
  2. D. Dindo, N. Demartines, et P.-A. Clavien, « Classification of surgical complications: a new proposal with evaluation in a cohort of 6336 patients and results of a survey », Ann. Surg., vol. 240, no 2, p. 205-213, août 2004, doi: 10.1097/01.sla.0000133083.54934.ae.
Disclosures
Funding ANSM (Agence Nationale de Sécurité du Médicament) Clinical Trial No Subjects Human Ethics Committee CPP (Comité de Protection des Personnes) Ouest III Helsinki Yes Informed Consent Yes
Citation

Continence 2S2 (2022) 100407
DOI: 10.1016/j.cont.2022.100407

14/02/2024 18:56:08