Background and objectiveOur aim was to report the first clinical trial of TENSI+, a new device for transcutaneous posterior tibial nerve stimulation (TNS) for treatment of overactive bladder (OAB).MethodsA prospective, multicentre clinical trial was conducted in adults with OAB in seven French centres. The main exclusion criteria were prior percutaneous or transcutaneous TNS or invasive OAB treatment, current antimuscarinic use, 24-h polyuria, known bladder disease, postvoid residual volume >150 ml, and pelvic organ prolapse stage >2. Patients self-administered daily TTNS sessions of 20 min with TENSI+ at home after education by a specialized nurse. A bladder diary, Urinary Symptom Profile and OAB-q questionnaires, and Patient Global Impression of Improvement (PGI-I) scores were evaluated at baseline and 3 and 6 mo. The primary endpoint was efficacy, based on PGI-I and variations in bladder diary parameters. Success was defined as a PGI-I score ≤3 and any improvement ≥30% in bladder diary parameters.Key findings and limitationsThe study included 78 patients (13 males). Nine patients had neurological disease, 21 had previously tried antimuscarinics, and 41 had wet OAB at baseline. At 3 mo, 65/78 patients had a full analysis set. Treatment was successful in 44/65 patients (67%), with 25/65 (38%) reporting both an objective improvement and high satisfaction. All OAB-related endpoints were significantly improved, except bladder capacity and total voided volume per 24 h. At 6 mo, only five of 44 patients had interrupted their treatment. No factor predictive of success was identified. Two adverse events (pain at stimulation site and/or pelvic pain) were reported and spontaneously resolved without treatment interruption.Conclusions and clinical implicationsTENSI+ is a safe and effective TTNS treatment option for OAB management.Patient summaryTENSI+ is a new device for nerve stimulation in patients with overactive bladder. Patients use the device at home every day. In our short-term trial, TENSI+ use improved symptoms in 67% of patients. Further evaluation over a longer period of time is needed.
INTRODUCTION:Inflammatory and sensory chronic bladder diseases have a significant impact on quality of life. These pathologies share alteration of the layer between urine and urothelium, making the use of topical agents appropriate. OBJECTIVES:Review the efficacy and tolerance of intravesical treatments for these pathologies. Give practical guidelines for the use of agents currently available in France. METHOD:A narrative review was performed in March 2021 using PubMed/MEDLINE, Google Scholar and the international guidelines. Pharmaceutical companies and pharmacies were interviewed. RESULTS:Although numerous molecules were tested over the last 5 decades, only dimethylsulfoxyde and glycosaminoglycans are available in France today. Results are promising: response rates are up to 95% and 84% respectively in bladder pain syndrome. In urinary tract infections, glycosaminoglycans could decrease annual number of cystitis by 2.56 (95% confidence interval (CI) -3.86, -1.26; P<0.001) and increase the time to first cystitis recurrence by 130 days (95% CI: 5.84 - 254.26; P=0.04). In radiation cystitis, results could be comparable to hyperbaric oxygen regarding pain and frequency of voiding (-1.31±1.3 visual analogic scale et -1.5±1.4 voiding per day, respectively, at 12 months, P<0.01). However, literature has a low level of evidence. CONCLUSION:Chronic bladder diseases have limited treatment options. Intravesical agents are a good alternative, although their cost is significant and their outcome uncertain.
IntroductionLes cystopathies chroniques inflammatoires et douloureuses sont des pathologies impactant lourdement la qualité de vie des patients qui en sont atteints. Bien qu’avec des physiopathologies différentes, les cystopathies chroniques ont en commun une altération de la couche, faisant interface entre l’urine et l’urothélium, rendant appropriée l’utilisation d’agents topiques.ObjectifsFaire une revue de l’efficacité et de la tolérance des traitements endovésicaux pour ces pathologies, ainsi qu’un guide pratique pour l’utilisation des molécules actuellement disponibles sur le marché français.MéthodeUne revue narrative de la littérature a été effectuée en mars 2021 sur PubMed/MEDLINE et Google Scholar, ainsi qu’une revue des recommandations françaises et internationales. Les laboratoires et pharmacies ont été interrogés.RésultatsDe nombreuses molécules ont été essayées au cours des 50 dernières années, mais ne sont disponibles, actuellement, que le diméthylsulfoxyde et les glycosaminoglycanes. Les résultats en sont prometteurs : leurs taux d’amélioration des douleurs vont jusqu’à 95 % et 84 % de réponse, respectivement dans le syndrome douloureux vésical. Dans les cystites bactériennes, les glycosaminoglycanes permettent de réduire le nombre moyen annuel de cystites de 2,56 (intervalle de confiance (IC) à 95 % −3,86 – −1,26 ; p<0,001), avec une augmentation du délai avant récidive de 130 jours (IC à 95 % : 5,84–254,26 ; p=0,04). Dans la cystite radique, ils ont montré des résultats comparables à l’oxygénothérapie hyperbare sur l’amélioration de la douleur et de la pollakiurie (−1,31±1,3 points sur l’échelle EVA et −1,5±1,4 mictions par jour respectivement, à 12 mois, p<0,01). La littérature reste cependant à faible niveau de preuve.ConclusionLes cystopathies chroniques ont des options de traitement limitées. Les instillations endovésicales sont une option de traitement à ne pas négliger avec, pour limite, un coût non négligeable pour un résultat incertain.
La stimulation du nerf tibial postérieur (PTNS) est une option thérapeutique validée pour le traitement des symptômes du bas appareil urinaire SBAU, avec une efficacité d'environ 60 % à court terme et peu d'effets secondaires. L'objectif de cette étude était d'évaluer les résultats du nouveau dispositif de PTNS transcutané TENSI+ dans le cadre du soin courant. Une étude multicentrique rétrospective a été réalisée dans 7 centres français. Les patients traités par le dispositif TENSI+ (Stimuli Technology, Boulogne-Billancourt, France) entre septembre 2021 et février 2022 ont été inclus. Les patients avaient reçu une éducation thérapeutique à domicile par un prestataire, avec prescription d'une séance quotidienne de 20 minutes. Les données recueillies comprenaient les données démographiques, les antécédents, les symptômes cliniques initiaux et les traitements antérieurs (anticholinergiques). Le succès était défini par la persistance du traitement après la première visite à 3 mois. L'efficacité était évaluée par le score Patient Global Impression of Improvement (PGI-I). Les effets secondaires ont été recueillis. Cent trois patients ont été inclus. Les caractéristiques cliniques sont résumées dans le Tableau 1. L'indication principale était l'hyperactivité vésicale. Après un suivi médian de 12 [10–21] semaines, le taux de succès était de 68 %. Cinquante-deux pour cent des patients avaient un score PGI-I égal à 1 ou 2, et 18 % un score PGI-I à 3 (Tableau 2). Aucun des paramètres initiaux testés (âge, sexe, indice de masse corporelle, maladie neurologique, fuites par urgenturies, antécédents de traitement anticholinergique) n'était significativement associé au taux de succès. Quatre patients ont rapporté des effets secondaires réversibles à l'arrêt du traitement (deux cas de douleur pelvienne et deux cas de douleur de jambe au site de la stimulation). Le traitement par stimulation du nerf tibial postérieur par le dispositif TENSI+ était associé à un taux de succès d'environ 68 % à court terme, avec un taux très faible d'effets secondaires réversibles. De plus amples études, notamment comparatives, sont nécessaires pour confirmer le rôle de TENSI+ dans l'arsenal thérapeutique.
INTRODUCTION:Placement of a mid-urethral sling is the gold standard in the surgical management of stress urinary incontinence in women in France. The cure rate of this material is no longer to be demonstrated, but the per- and post-operative complications are currently the subject of a growing controversy not only in Europe but also across the Channel and across the Atlantic, having led to the modification of operative indications. In France, recommendations are also evolving with a stricter framework for indications for surgery by multidisciplinary consultation meeting and an obligation for postoperative follow-up in the short and long term. OBJECTIVES:In this context, CUROPF realized a review of the literature bringing together the available scientific evidence concerning the occurrence of per- and post-operative complications relating to the installation of mid urethral sling. The bibliographic search was carried out using the Medline database and 123 articles were selected. RESULTS:Analysis of the data highlights various complications, depending on the implanted material, the patient and the indication for surgery. The retro-pubic mid urethral sling provides more bladder erosion during surgery (up to 14%), more suprapubic pain (up to 4%) and more acute urinary retention (up to 19,7%) and postoperative dysuria (up to 26%). The trans obturator mid-urethral sling is responsible for more vaginal erosion during the operation (up to 10,9%), more lower limb pain of neurological origin (up to 26,7%). The risk of developing over active bladder is similar in both procedures (up to 33%). But these risks of complications must be balanced by the strong impact of urinary incontinence surgery on the overall quality of life of these women. CONCLUSION:Thus, surgical failure and long term complications exist but should not limit the surgical management of stress urinary incontinence with mid urethral tape. Women should be treated with individualized decision-making process and long-term follow -up is necessary.
Introduction. - Vaginal LASER therapy is increasingly used in the field of urogynecology, but several points remain unclear. Our goal was to produce a systematic review of available evidence and provide a critical appraisal of available data. Methods. - A systematic review until march 2020 was conducted using PubMed/MEDLINE. Cochrane and Embase databases. All studies about vaginal LASER use in the field of urogynecology were included. Results. - Forty studies have been included (8 for genitourinary syndrome of menopause, 19 for stress urinary incontinence, 3 for overactive bladder, 7 for urogenital prolapse, 3 for other indications). Data were heterogeneous, and level of evidence was weak or very weak. Few studies were comparative, and only 3 were randomized). Mild improvement of symptoms and quality of life and limited satisfaction were seen for genitourinary syndrome, stress urinary incontinence, overactive bladder and prolapse. Few adverse events were reported. However, major methodological biases were noted regarding efficacy and safety evaluation. No long-term results were available. Conclusions. - While Vaginal LASER therapy seem to provide encouraging results, the level of evidence supporting its use was weak, especially regarding long-term outcomes. Studies of better quality are warranted before any recommendation can be made. Current use should be limited to clinical research. (C) 2020 Elsevier Masson SAS. All rights reserved.
OBJECTIVE:To determine the usefulness of mid-urethral slings (MUS) in the surgical management of women presenting with urinary stress incontinence (USI) METHOD: A consensus committee of multidisciplinary experts (CUROPF) was convened and focused on PICO questions concerning the efficacy and safety of MUS surgery compared to other procedures and concerning which approach (retropubic (RP) vs transobturator (TO)) should be proposed as a first-line MUS surgery for specific subpopulations (obese; intrinsic sphincteric deficiency (ISD); elderly) RESULTS: As compared to other procedures (urethral bulking agents, traditional slings and open colposuspension), the MUS procedure should be proposed as the first-line surgical therapy (strong agreement). MUS surgery can be associated with complications and proper pre-operative informed consent is mandatory (strong agreement). Mini-slings (SIS/SIMS) should only be proposed in clinical trials (strong agreement). Both RP and TO approaches may be proposed for the insertion of MUS (strong agreement). However, if the woman is willing to accept a moderate increase in per-operative risk, the RP approach should be preferred (strong agreement) since it is associated with higher very long-term cure rates and as it is possible to completely remove the sling surgically if a severe complication occurs. The RP approach should be used for the insertion of MUS in a woman presenting with ISD (strong agreement). Either the RP or TO approach should be used for the insertion of MUS in an obese woman presenting with USI (strong agreement). In very obese women (BMI ≥35-40kg/m2), weight loss should be preferred prior to MUS surgery and bariatric surgery should be discussed (strong agreement) CONCLUSION: The current Opinion provides an appropriate strategy for both the selection of patients and the best therapeutic approach in women presenting with USI.
Introduction. - Adjuvant hormone therapy is the standard treatment after total prostatectomy with positive lymph node. However, this treatment has side effects and at the time of the PSA era and extensive lymph node dissection, this principle is questioned. The aim of this study is to describe the ontological characteristics of patients that may explain the delay in introducing hormone therapy in patients with positive lymph node. Methods. - Monocentric, retrospective study of 161 patients from November 1988 to February 2018 in a single French University Hospital, having undergone radical prostatectomy with positive lymph nodes on pathology. For each patient, preoperative data (age, clinical stage, biopsy results, d'Amico classification) and postoperative data (pathological results, number of lymph nodes removed, number of positive lympnodes, recurrence free survival, specific survival and overall survival) were collected. The date of introduction of hormone therapy was noted and survival without hormonal therapy was established according to the Kaplan Meier curve. The pre- and post-operative ontological factors that could influence hormone therapy introduction were investigated with Chi 2 and Student tests (statistically significant when P< 0.05). Results. - The mean number of lymph nodes removed was 12 [1-40]. The mean number of positive lymph nodes was 2.5 [1-24], the mean percentage of positive lymph nodes was 25% (2.5-100). After a mean follow-up of 95 months (3-354), 88 patients (54.6%) had no hormonal treatment. The average time to hormonal treatment was 40 months [0-310]. At 3 years, survival without hormone therapy was 52% and 51% at 5 years. Only the percentage of positive lymphnodes appeared to be a significant predictor of the introduction of hormone therapy. (29.32% vs. 21.99%, P= 0.047). Hormone-free survival was significantly higher in patients with lymph node involvement less than 25% (P < 0.0001) or with less than 2 positive lymph nodes (P=0.0294). Conclusion. - Lymph node invasion is a factor of poor prognosis after total prostatectomy and leads to introduce hormone therapy. Our study identified the percentage and number of positive lymph nodes as factors that identify patients who may be delayed in introducing this hormone therapy. (C) 2019 Elsevier Masson SAS. All rights reserved.
Les injections intracaverneuses d’alprostadil (IIA) représentent l’un des traitements reconnu pour la réhabilitation sexuelle (RS) après prostatectomie radicale (PR). L’efficacité sur l’érection des IIA n’a été évaluée que sur un nombre limité de patients et ses déterminants restent mal connus. Notre objectif était d’étudier la fonction sexuelle des patients utilisant des IIA pendant au moins 1 an après PR et identifier les sous-groupes pouvant en bénéficier. Cent quatre-vingt-quatorze patients qui avaient des érections normales en préopératoire, ont eu une PR par voie mini-invasive avec une RS consistant en des IIA systématiques en postopératoire pendant un an. À l’issue de la RS, à un an, les fonctions sexuelles étaient évaluées avec les scores UCLA-PCI, IIEF-15, et EHS. Étaient également étudiés, le taux de satisfaction avec traitement et la douleur secondaires aux IIA. La fonction érectile fut également analysée en rétrospectif selon la conservation des bandelettes vasculonerveuses, l’association à des IPDE5, les traitements complémentaires (hormonothérapie, radiothérapie) et l’agressivité de la maladie prostatique. Au total, le score IIEF-EF moyen était à un an de 5 sans IIA et 15 avec. Huit patients (4,1 %) avaient un score EHS >2 sans traitement. Cent trente-huit patients (73,8 %) ont considéré que le traitement avait amélioré leurs érections (GAQ-Q1) et 98 (52,7 %) que les IIA augmentaient leur capacité à engager une activité sexuelle (GAQ-Q2). Une association significative a été retrouvée entre la réponse aux IIA (IIEF-EF et satisfaction globale) et la conservation des bandelettes vasculonerveuses (IIEF-EF : 6,5[2–25] vs 18,5 [5–28,25], p = 0,04 pour la conservation vs pas de conservation des bandelettes). Les patients ayant reçu un traitement complémentaire avaient des scores significativement plus altérés (IIEF-EF avec IIA [p = 0,017] ou sans [p = 0,0259], IIEF-IS avec IIA [p = 0,025] ou sans [p = 0,016], satisfaction globale [p = 0,0055] et EHS avec IIA [p = 0,02] sauf le EHS sans IIA [p = 0,08]). Le taux d’abandon des IIA était de 6,2 % (Tableau 1, Tableau 2). La réponse moyenne aux IIA un an après PR reste peu satisfaisante et est liée à la sévérité de la maladie prostatique et à la préservation les bandelettes.
Upper urinary tract urothelial carcinoma (UTUC) is a rare disease. Thus, little evidence-based data are available to guide clinical decision-making. The aim of the study was to provide an overview of the currently available prognostic factors for UTUC.A systematic literature search was conducted using the PubMed databases to identify original articles regarding prognostic factors in patients with UTUC.We divided the prognostic factors for UTUC in four different categories: clinical factors, preoperative characteristics, intraoperative/surgical factors and postoperative/pathologic factors. Prognostic factors described in order of importance are: tumor stage and grade, lymph node involvement, a concomitant cis, age at the diagnostic, lymphovascular invasion, tumor architecture and necrosis, tumor location and multifocality, gender. The impact of obesity, smoking and other comorbidities (ECOG, ASA) on outcomes has been recently reported but needs to be validated. The endoscopic approach of distal ureter management during radical nephroureterectomy has been shown to be at higher risk of bladder recurrence.The incorporation of such prognosticators into clinical prediction models might help to guide decision-making with regard to timing of surveillance, type of treatment, performance of lymphadenectomy, and consideration of neoadjuvant or adjuvant systemic therapies.
Objective. - Ureteric injuries (IU) are common complications occurring during abdomino-pelvic surgical procedures. Our aim was to review risk factors, treatment and methods of prevention of these iatrogenic UI.Material and methods. - A literature review in English and French by Medline (R) was performed using the keywords: ureter; iatrogenic; injury; ureteroscopy; morbidity and endoscopy.Results. - The analysis of the epidemiology of IU shows that the first two causes are gynecological and urological surgery. In 80% of cases, the pelvic ureter was concerned. Mechanisms of injury were essentially ligation, section and ischemia by altering the ureteral vasculature. The main risk factors found were pelvic inflammation (endometriosis, radiation ... ) and the occurrence of bleeding during surgery. In the presence of risk factors, placing a double J stent or a CT may be useful preoperatively. The choice of reparation technique depended on the location of the PU, the circumstances of the occurrence and experience of the surgical team.Conclusion. - Pelvic surgery is a provider of iatrogenic PU. Knowledge of the management of PU once occurred must be mastered before carrying out any risk surgery. (C) 2012 Elsevier Masson SAS. All rights reserved.
Objective. - To evaluate the value of multiparametric MRI-targeted prostate biopsies in patients with suspected low-risk prostate cancer.Patients and method. - Patients with normal digital rectal examination and a PSA level between 4 and 10 ng/mL were prospectively included. A multiparametric MRI of the prostate was performed prospectively before the biopsies. 12-core randomized biopsies were performed, with additional targeted samples in each suspicious area identified on MRI. Detected cancers and their histological characteristics were compared between those two biopsy protocols. A micro focal cancer (MFC) was defined by the presence of less than 4 mm of Gleason score 3 + 3 cancer on a single core.Results. - Seventy-one consecutive patients were included. The overall detection rate was of 53% (38/71). It was of 70% (26/37) in the presence of suspicious area on MRI versus 35% (12/34) in the absence of any suspicious area (P = 0.004). MRI-targeted biopsies alone detected three cancers, none of which was a MFC. 12-core biopsies alone detected 14 cancers, including ten MFC (71%). In 21 patients, prostate cancer was detected by both the MRI-targeted and 12-core biopsies. The Gleason score in the MRI-targeted area was the highest Gleason score in 90% of the cases. It was high (> 6) in 76% (16/21) of the patients.Conclusions. - MRI-targeted biopsies detected less micro focal cancers than randomized 12-core biopsies. They did not seem however to decrease the detection of clinically significant cancers. (C) 2012 Elsevier Masson SAS. All rights reserved.