Abstract
STUDY QUESTION
Is the Sexual Activity Questionnaire (SAQ) a valid tool for patients treated for symptomatic endometriosis?
SUMMARY ANSWER
For women having surgical treatment for ...endometriosis, we determined that the SAQ is a valid and responsive tool.
WHAT IS KNOWN ALREADY
Endometriosis adversely affects sexual quality of life. Suitable validated sexual quality of life instruments for endometriosis are lacking both in clinical practice and for research.
STUDY, DESIGN, SIZE, DURATION
A total of 367 women with proven endometriosis undergoing medical or surgical treatment were included in an observational study conducted between 1 January 2012 and 31 December 2014 in two French tertiary care centers. Both hospitals are reference centers for endometriosis treatment. Of these 367 women, 267 were sexually active and constituted the baseline population.
PARTICPANTS/MATERIALS, SETTINGS, METHODS
Women >18 years old with histological or radiological proven endometriosis, consulting for painful symptoms of at least 3 months duration, infertility, or other symptoms (bleeding, cysts) were invited to complete self-administered questionnaires before (T0) and 12 months after treatment (T1). Tests of data quality included descriptive statistics of the data, missing data levels, floor and ceiling effects, structural validity and internal consistency.
The construct validity was obtained by testing presupposed relationships between previously established SAQ scores and prespecified characteristics of the patients by comparing different subgroups of patients at T0. Sensitivity to change was subsequently calculated by comparing the SAQ score between T1 and T0 overall and for different subgroups of treatment. Effect sizes (to T1) were calculated according to Cohen's method. The minimally important difference was estimated by a step-wise triangulation approach (including anchor-based method).
MAIN RESULTS AND THE ROLE OF CHANCE
In total, 267 sexually active patients (204 surgical and 63 medical treatment) completed the SAQ at T0 and 136 (50.9%) at T1. The SAQ score ranged from 2.0 to 28.0 (mean ± SD: 16.8 ± 5.7).
The SAQ score was one-dimensional according to the scree plot with good internal consistency (Cronbach alpha = 0.78, 95% CI 0.74-0.81) and had good discriminative ability according to pain descriptors and quality of life in endometriosis. The SAQ was responsive in patients treated by surgery but the effect size was low (0.3, 95% CI (0.0-0.6), P = 0.01). The minimally important difference was determined at 2.2.
LIMITATIONS, REASONS FOR CAUTION
The effect size for medical treatment was non-significant. Other effect sizes were low but statistically significant. This could be explained by lower libido due to progestin intake, which was used for both surgically and medically treated patients.
WIDER IMPLICATIONS OF THE FINDINGS
The SAQ is easy to use, valid and effective in assessing sexual quality of life in patients with endometriosis. This patient-reported score could be used as a primary outcome for future clinical studies. The minimally important difference estimation will be useful for future research. We recommend using 2.2 for the minimally important difference of the SAQ.
STUDY FUNDING/COMPETING INTEREST(S)
This work was funded by the 'Direction à la Recherche Clinique et à l'Innovation' of Versailles, France and the 'Institut de Recherche en Santé de la Femme' (IRSF). The authors have no conflicts of interest to declare.
Objective
To compare the effectiveness and safety of laparoscopic sacropexy (LS) and transvaginal mesh (TVM) at 4 years.
Design
Extended follow up of a randomised trial.
Setting
Eleven centres.
...Population
Women with cystocele stage ≥2 (pelvic organ prolapse quantification POP‐Q, aged 45–75 years without previous prolapse surgery.
Methods
Synthetic non‐absorbable mesh placed in the vesicovaginal space and sutured to the promontory (LS) or maintained by arms through pelvic ligaments and/or muscles (TVM).
Main outcome measures
Functional outcomes (pelvic floor distress inventory PFDI‐20 as primary outcome); anatomical assessment (POP‐Q), composite outcome of success; re‐interventions for complications.
Results
A total of 220 out of 262 randomised patients have been followed at 4 years. PFDI‐20 significantly improved in both groups and was better (but below the minimal clinically important difference) after LS (mean difference −7.2 points; 95% CI −14.0 to −0.05; P = 0.029). The improvement in quality of life and the success rate (LS 70%, 61–81% versus TVM 71%, 62–81%; hazard ratio 0.92, 95% CI 0.55–1.54; P = 0.75) were similar. POP‐Q measurements did not differ, except for point C (LS −57 mm versus TVM −48 mm, P = 0.0093). The grade III or higher complication rate was lower after LS (2%, 0–4.7%) than after TVM (8.7%, 3.4–13.7%; hazard ratio 4.6, 95% CI 1.007–21.0, P = 0.049)).
Conclusions
Both techniques provided improvement and similar success rates. LS had a better benefit–harm balance with fewer re‐interventions due to complications. TVM remains an option when LS is not feasible.
Tweetable
At 4 years, Laparoscopic Sacropexy (LS) had a better benefit–harm balance with fewer re‐interventions due to complications than Trans‐Vaginal Mesh (TVM).
Tweetable
At 4 years LS had a better benefit–harm balance with fewer re‐interventions due to complications than TVM.
Objective
To assess the short‐term incidence of serious complications of surgery for urinary incontinence or pelvic organ prolapse.
Design
Prospective longitudinal cohort study using a surgical ...registry.
Setting
Thirteen public hospitals in France.
Population
A cohort of 1873 women undergoing surgery between February 2017 and August 2018.
Methods
Preliminary analysis of serious complications after a mean follow‐up of 7 months (0–18 months), according to type of surgery. Surgeons reported procedures and complications, which were verified by the hospitals’ information systems.
Main outcome measures
Serious complication requiring discontinuation of the procedure or subsequent surgical intervention, life‐threatening complication requiring resuscitation, or death.
Results
Fifty‐two women (2.8%, 95% CI 2.1–3.6%) experienced a serious complication either during surgery, requiring the discontinuation of the procedure, or during the first months of follow‐up, necessitating a subsequent reoperation. One woman also required resuscitation; no women died. Of 811 midurethral slings (MUSs), 11 were removed in part or totally (1.4%, 0.7–2.3%), as were two of 391 transvaginal meshes (0.5%, 0.1–1.6%), and four of 611 laparoscopically placed mesh implants (0.7%, 0.2–1.5%). The incidence of serious complications 6 months after the surgical procedure was estimated to be around 3.5% (2.0–5.0%) after MUS alone, 7.0% (2.8–11.3%) after MUS with prolapse surgery, 1.7% (0.0–3.8%) after vaginal native tissue repair, 2.8% (0.9–4.6%) after transvaginal mesh, and 1.0% (0.1–1.9%) after laparoscopy with mesh.
Conclusions
Early serious complications are relatively rare. Monitoring must be continued and expanded to assess the long‐term risk associated with mesh use and to identify its risk factors.
Tweetable
Short‐term serious complications are rare after surgery for urinary incontinence or pelvic organ prolapse, even with mesh.
Tweetable
Short‐term serious complications are rare after surgery for urinary incontinence or pelvic organ prolapse, even with mesh.
•Quality of methodologies of guidelines in urinary incontinence in women is quite different from one society to another.•The recommendations of urinary incontinence in women are quite consistent and ...their differences are mainly ones of grade.•Common sense over evidence-based medicine, publication chronology, semantics of grade and discrepancies of grades can explain grade differences in guidelines.
Urinary incontinence in women is the subject of multiple recommendations all over the world. The aim of our study was to compare methodologies and search for inconsistencies in texts and grades in these guidelines.
Seventeen recommendations from different medical societies in English, French and German were included. Their methodologies were analyzed, including writing methods, cyclicity, level of evidence (LE) and grades. The recommendations were synthesized and inconsistencies in texts and grades were studied. The quality of recommendations was evaluated with the Appraisal of Guidelines for Research and Evaluation (AGREE II) scale.
Methods, rigour and cyclicity varied depending on societies. LE and grades are broadly consensual for higher LE and grades and less so for lower LE and grades. The Collège National des Gynécologues et Obstétriciens Français, the Deutsche Gesellschaft für Gynäkologie und Geburtshilfe, the European Association of Urology, the International Consultation on Urological Diseases and the National Institute for Health and Care Excellence have an AGREE score ≥ 80 % (third quartile). Grading and textual inconsistencies are explained by the order of studies or the absence of high LE.
With the present study we closely explored comparatively the methods and semantics of recommendations for urinary incontinence in women.
The objective of this study was to compare mesh erosion after transvaginal repair of cystocele using Gynemesh or Gynemesh-Soft mesh. We retrospectively analyzed 138 consecutive cases of transvaginal ...repair of cystocele using synthetic mesh. The study endpoint was the pathological evidence of vaginal erosion. Multiple logistic regression was used to determine independent predictors of vaginal erosion. One hundred and thirty eight women (ages 30-83 years) with cystocele between October 1999 and October 2004, from a French University Hospital, participated in this study. Cystocele repair was performed in all patients according to the technique of tension-free polypropylene mesh. The median follow-up was 32.1 months (range 7.5-59.9) in the Gynemesh group and 7.1 months (range 1-21.9) in the Gynemesh-Soft group. Vaginal erosion was reported in 27 (20%) of the patients. Anatomically, the success rate was 95% (131/138). There was no statistically significant difference between the Gynemesh and the Gynemesh-Soft meshes the rate of vaginal erosion of the mesh was 16% (15/89) vs 24% (12/49), respectively, p=0.39. Univariate analysis only identified age class as factor significantly associated with the probability of vaginal erosion. Multivariate analysis revealed that age class is an independent predictive factor of vaginal erosion (age > 70 years, odds ratio (OR) 3.6, 95% confidence interval (CI) 1.3-9.7, p=0.010). Furthermore cystocele stage > 2 (Baden and Walker classification) is a protective factor against vaginal erosion (OR 0.3, 95% CI 0.1-0.8, p=0.016). Thirteen symptomatic patients (13/27, 48%) necessitated a partial excision of the mesh, associated with a vaginal mucosal closure. Two patients (2/27, 7%) underwent a complete excision of the mesh. The incidence of de novo dyspareunia was 9% in patients with vaginal erosion and 11% in patient without mesh erosion (p=0.85). There was no occurrence of bladder or urethral erosion and no vaginal or pelvic infection. Isolated vaginal erosion of the mesh did not prove to be problematic. Gynemesh-Soft mesh does not decrease the incidence of vaginal erosion. Age > 70 years is an independent predictive factor of vaginal erosion. We recommend that mesh placement by vaginal route should be avoided by women with moderate cystocele. Where possible, total hysterectomy and vertical incision should also be avoided. Management of vaginal erosion is simple and is associated with a low rate of morbidity. However, patients should be informed that vaginal erosion of the mesh can occur. A multivariate analysis reveals that the incidence of vaginal erosion is not significantly different between Gynemesh and Gynemesh-Soft meshes. Other factors of erosion are analyzed.
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