Publications of Jean DE LEVAL
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See detailÉvaluation des complications et échecs nécessitant réintervention chirurgicale après implantation initiale d’une bandelette transobturatrice pour incontinence urinaire d’effort chez la femme : résultats d’une série rétrospective avec suivi médian de 10 an.
de Leval, Jean ULiege; Waltregny, David ULiege

in Progres en urologie : journal de l'Association francaise d'urologie et de la Societe francaise d'urologie (2020), 30(13), 755-756

Introduction:Peu de données sont disponibles quant aux résultats à long terme de l’implantation des bandelettes sous-urétrales transobturatrices. Dans cette étude, nous avons recherché à évaluer, de ... [more ▼]

Introduction:Peu de données sont disponibles quant aux résultats à long terme de l’implantation des bandelettes sous-urétrales transobturatrices. Dans cette étude, nous avons recherché à évaluer, de manière rétrospective, les incidences et caractéristiques des complications et échecs ayant nécessité réintervention chirurgicale chez des patientes souffrant d’incontinence urinaire d’effort (IUE) traitées par pose de bandelette sous-urétrale transobturatrice « de dedans en dehors ». Méthodes: Les dossiers médicaux et de facturation hospitalière de toutes les patientes qui ont bénéficié de l’implantation d’une bandelette transobturatrice « de dedans en dehors » dans notre service entre le 1er janvier 2004 et le 31 décembre 2018 ont été évalués à la recherche d’une éventuelle chirurgie ultérieure en relation avec la procédure de pose de bandelette initiale. Les patientes opérées initialement d’une bandelette dans une autre institution ont été exclues de l’étude. Les détails de toutes les réopérations ont été recueillis et colligés durant le 1er trimestre 2020. Résultats: La cohorte a compris un total de 2293 femmes d’âge médian de 60.1 ans (intervalle interquartile (IIQ), 50.3-69.8 ans). Une chirurgie de prolapsus concomitante a été réalisée chez 380 patientes (16.6%). Après un suivi médian de 10.4 ans (IIQ, 6.6-13.2 ans), 65 patientes (2.83%) ont subi au moins une chirurgie additionnelle après pose initiale de la bandelette. Parmi celles-ci, 23 ont subi ≥ 2 procédures suplémentaires. En raison d’une obstruction infra-vésicale, 9 (0.39%) patientes on subi un abaissement ou une section de bandelette. Au moins une intervention pour érosion vaginale a été pratiquée chez 25 patientes (1.09%). La bandelette a fait l’objet d’une exérèse chez 3 autres patientes (0.13%) se plaignant de douleur sans évidence d’érosion vaginale ou d’infection. Au moins une réintervention pour IUE persistante/récidivante a été réalisée chez 28 patientes (1.22%). Conclusions: Dans cette large série de patientes consécutives, avec suivi médian de 10 ans, l’implantation d’une bandelette transobturatrice « de dedans en dehors » a été associée à un risque faible (<3%) de réintervention pour complication ou échec, suggérant son efficacité et sécurité à long terme. Les limitations de notre étude, outre sa nature monocentrique, sont celles habituellement associées à une analyse rétrospective de données. [less ▲]

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See detailUrodynamic evaluation of patients cured of their post-radical prostatectomy stress urinary incontinence following transobturator male sling implantation [Évaluation urodynamique de patients guéris d'incontinence urinaire d'effort post-prostatectomie radicale après implantation d'une bandelette sous-urétrale transobturatrice]
DEWANDRE, Manon ULiege; Waltregny, David ULiege; de Leval, Jean ULiege et al

in Progres en Urologie (2019), 29

Introduction: The mechanism(s) responsible(s) for continence recovery after male sling implantation for post-radical prostatectomy incontinence are imperfectly known. The goal of this study was to ... [more ▼]

Introduction: The mechanism(s) responsible(s) for continence recovery after male sling implantation for post-radical prostatectomy incontinence are imperfectly known. The goal of this study was to evaluate urodynamic parameters before and after male sling insertion, only in patients cured of their stress urinary incontinence. Patients and methods: In total, 10 continent patients after transobturator male sling, with no history of urethral stenosis or pelvic radiation, were randomly selected from a database for urodynamic studies. Urodynamic parameters included urethral pressure profiles (UPP), with measurements of maximal urethral closure pressure (MUCP) and functional urethral length (FUL), and were compared with preoperative urodynamic data. Paired sampled were compared with the use of the Wilcoxon signed-rank test (StatPlus®). Results: Urodynamic studies were performed after a median time of 9 months (min 4 – max 34) following sling implantation. Postoperatively, a rise of 11 cm H2O in median MUCP (P = 0.09) and an increase of 14 mm in median FUL (P = 0.13) were observed. None of the urodynamic changes was statistically significant. Conclusions: Following sling implantation, modifications in UPPs were observed, with increases in MUCP and FUL but these increments were not statistically significant. Limitations to our study include biases inherent to the interpretation and reproducibility of urethral profilometry, the sample size, and the variable delay between sling implantation and postoperative urodynamic studies. Level of evidence: 4. [less ▲]

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See detailNew surgical technique for treatment of stress urinary incontinence TVT-ABBREVO: From development to clinical experience
Waltregny, David ULiege; de Leval, Jean ULiege

in Surgical Technology International (2012), XXII(pii), 2223

Tension-free suburethral tapes have revolutionized the surgical treatment of female stress urinary incontinence (SUI). These tapes are inserted by way of a retropubic or transobturator route. The inside ... [more ▼]

Tension-free suburethral tapes have revolutionized the surgical treatment of female stress urinary incontinence (SUI). These tapes are inserted by way of a retropubic or transobturator route. The inside-out tension-free vaginal tape transobturator approach, or TVT-Obturator system (TVT-O®, Ethicon Women's Health and Urology, Somerville, NJ), was developed ten years ago with the aim of minimizing the risk of urinary tract injuries associated with retropubic and outside-in transobturator tapes while reproducibly ensuring minimal tissue dissection. Cadaveric studies have shown that the anatomical trajectory of the TVT-O tape is strictly perineal and courses away from neighboring obturator and pudendal neurovascular structures. Several meta-analyses have shown similar SUI cure rates after retropubic and transobturator tape procedures. Yet, the transobturator route may be associated with less voiding dysfunction, blood loss, bladder perforation, and shorter operating time. The original TVT-O procedure was modified with the aim of reducing the incidence of postoperative groin pain as well as the rather theoretical risk of obturator nerve injury. This modified procedure, named TVT-ABBREVO® (Ethicon Women's Health and Urology, Somerville, NJ), utilizes a shortened, 12-cm-long polypropylene tape. In addition, perforation of the obturator membrane with the scissors and guide is avoided in order to reduce the depth of lateral dissection, and consequently, to maximize securing of the tape within the obturator muscular/aponeurotic structures. In a comparative anatomical study, it was indeed observed that the shorter tape traversed less muscular structures (with no or only a minimal amount of tape lying in the adductor muscles) than its original counterpart, while still consistently anchoring in the obturator membrane at a similarly safe distance from the obturator canal. In a single-center randomized clinical trial, after a 3-year minimum follow-up, the modified TVT-O procedure with a shorter tape and reduced dissection was found to be as safe and efficient as the primal procedure for treating female SUI, with less severe and frequent groin pain in the immediate postoperative period. [less ▲]

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See detailThe Inside-Out Transobturator Male Sling for the Surgical Treatment of Stress Urinary Incontinence After Radical Prostatectomy: Midterm Results of a Single-Center Prospective Study.
LERUTH, Julie ULiege; Waltregny, David ULiege; de Leval, Jean ULiege

in European Urology (2012), 61(3), 608-615

BACKGROUND: Transobturator slings are currently promoted for the treatment of stress urinary incontinence (SUI) after radical prostatectomy (RP), but data on outcome remain limited. OBJECTIVE: To assess ... [more ▼]

BACKGROUND: Transobturator slings are currently promoted for the treatment of stress urinary incontinence (SUI) after radical prostatectomy (RP), but data on outcome remain limited. OBJECTIVE: To assess, at midterm, the efficacy and safety of the inside-out transobturator male sling for treating post-RP SUI and to determine factors associated with failure. DESIGN, SETTING, AND PARTICIPANTS: Prospective one-center trial involving 173 consecutive patients without detrusor overactivity, treated between 2006 and 2011 for SUI following RP. INTERVENTION: Placement of an inside-out transobturator sling. MEASUREMENTS: Baseline and follow-up evaluations included uroflowmetry and continence and quality-of-life (QoL) questionnaires. Cure was defined as no pad use and improvement as a number of pads per day reduced by >/=50% and two or fewer pads. Complications were recorded, and factors associated with treatment failure were evaluated. RESULTS AND LIMITATIONS: Preoperatively, 21%, 35%, and 44% of the patients were using two, three to five, and more than five pads per day, respectively. After a median follow-up of 24 mo (range: 12-60 mo), 49% were cured, 35% improved, and 16% not improved. QoL was enhanced (p<0.001), and 72% of patients were moderately to completely satisfied with the procedure. Maximum flow rates were slightly reduced (p=0.004); postvoid residual volumes were similar (p=0.097). Complications were urinary retention after catheter removal (15%), perineal/scrotal hematoma (9%), pain lasting >6 mo (3%), and sling infection (2%); all were managed conservatively. Severe SUI before sling surgery was not associated with a worse outcome, whereas obesity and a history of pelvic irradiation or bladder neck stenosis were independent risk factors of failure, with risk ratios of 7.9 (95% confidence interval [CI], 3.3-18.9), 3.3 (95% CI, 1.4-7.8), and 2.6 (95% CI, 1.1-6.5), respectively. CONCLUSIONS: The inside-out transobturator male sling is an efficient and safe treatment for post-RP SUI at midterm. Patients with prior pelvic irradiation may not be suitable candidates. [less ▲]

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See detailAn anatomic comparison of the original versus a modified inside-out transobturator procedure
Bonnet, Pierre ULiege; Hinoul, Piet; Krofta, Ladislav et al

in International Urogynecology Journal (2011)

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See detailThe original versus a modified inside-out transobturator procedure: 1-year results of a prospective randomized trial.
De Leval, Jean ULiege; Thomas, Alexandre ULiege; Waltregny, David ULiege

in International Urogynecology Journal (2011), 22(2), 145-156

INTRODUCTION AND HYPOTHESIS: The aim of this study is to compare a modified inside-out transobturator procedure with its original counterpart [inside-out transobturator (TVT-O)] for the treatment of ... [more ▼]

INTRODUCTION AND HYPOTHESIS: The aim of this study is to compare a modified inside-out transobturator procedure with its original counterpart [inside-out transobturator (TVT-O)] for the treatment of female stress urinary incontinence (SUI). METHODS: A prospective, randomized trial in women suffering from SUI was used. The modified procedure consisted of a shorter tape whilst the scissors or guide no longer perforated the obturator membrane. The primary outcome was the resolution of subjective and objective SUI at 1 year. Secondary outcome measures included adverse events, quality of life measures, and groin pain. RESULTS: One hundred seventy-five patients were randomized. No intraoperative complications were recorded. The SUI cure rate was 91.7% versus 90.7% (original versus modified, respectively; p = 0.824). Incidence and intensity of groin pain was higher in the original TVT-O group on day 0 and 1 (p < 0.05), requiring more analgesics (p = 0.015) but not thereafter. CONCLUSIONS: At 1 year follow-up, the modified inside-out transobturator tape procedure was as efficient and safe as the original technique but associated with less immediate postoperative groin pain. [less ▲]

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See detailTransobturator Vaginal Tape Inside Out for Treatment of Urethral Sphincter Mechanism Incompetence: Preliminary Results in 7 Female Dogs
Claeys, Stéphanie ULiege; de Leval, Jean ULiege; Hamaide, Annick ULiege

in Veterinary Surgery (2010), 39(8), 969-979

Objectives: To evaluate the clinical efficacy of the transobturator vaginal tape inside-out (TVT-O) in incontinent female dogs affected with urethral sphincter mechanism incompetence (USMI) and to ... [more ▼]

Objectives: To evaluate the clinical efficacy of the transobturator vaginal tape inside-out (TVT-O) in incontinent female dogs affected with urethral sphincter mechanism incompetence (USMI) and to determine its urodynamic and morphologic effects. Study Design: Case series. Animals: Incontinent spayed female dogs (n=7). Methods: TVT-O tape was inserted in 7 incontinent female dogs diagnosed with USMI. Urethral pressure profilometry (UPP) and vaginourethrograms were performed preoperatively, and 1 and 3 months postoperatively. Clinical efficacy of the technique was evaluated and complications reported. Follow-up information was evaluated by a telephone questionnaire. Results: All dogs were continent immediately after the procedure. Incontinence recurred 2 months after surgery in 1 dog and was treated by phenylpropanolamine administration. At mean follow-up time of 11.3 months, 6 of 7 dogs were continent. An iatrogenic urethral tear occurred intraoperatively in 1 dog. No postoperative complications were encountered. The postoperative UPPs showed significantly increased maximal urethral closure pressure and integrated pressure. Postoperative vaginourethrograms were unremarkable. The surgical procedure did not modify the location of the urinary bladder neck in dogs with a ‘‘pelvic urinary bladder’’ preoperatively. Conclusions: TVT-O was efficient in maintaining short term continence in 6 of 7 dogs affected with USMI. Urethral sphincter mechanism incompetence (USMI) is the most common cause of acquired urinary incontinence in female dogs.1 It mainly affects mostly middle-aged, large breed, spayed female dogs.2,3 Clinical signs such as urine leakage during sleep or periods of excitement may develop a few weeks to several years after spaying, most commonly after 2–3 years.2,4,5 The cause is multifactorial with numerous factors identified or suspected to contribute to incontinence, including urethral tone and length, position of the urinary bladder neck, breed, size, neutering, obesity, age, and tail docking.2,3,6–16 The initial treatment of USMI is usually medical. Alpha-adrenergic drugs (eg, phenylpropanolamine [PPA]) are commonly used17–19 and the reported success rate ranges from 85–97% continence.19–22 Short-acting estrogens (estriol) [less ▲]

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See detailTransobturator Vaginal Tape Inside Out for Treatment of Urethral Sphincter Mechanism Incompetence in Female Dogs: Cadaveric Study and Preliminary Study in Continent Female Dogs
Claeys, Stéphanie ULiege; Ruel, Hélène; De Leval, Jean ULiege et al

in Veterinary Surgery (2010), 39(8), 957-968

ABSTRACT Objectives – 1) To describe a surgical technique adapted from the “transobturator vaginal tape inside-out” (TVT-O) used in women and to define the trajectory of the tape on cadavers, and 2) To ... [more ▼]

ABSTRACT Objectives – 1) To describe a surgical technique adapted from the “transobturator vaginal tape inside-out” (TVT-O) used in women and to define the trajectory of the tape on cadavers, and 2) To determine the urodynamic and morphological effects of the TVT-O in continent bitches. Study Design – Cadaveric and experimental in vivo study. Animals – Fresh female canine cadavers (n = 12) and spayed female Beagle dogs (n = 2). Methods – 1) TVT-O was inserted in 12 cadavers. Dissection was performed and distances between the tape and neighboring structures were recorded. 2) TVT-O was inserted in 2 continent female Beagle dogs. Urethral pressure profilometry (UPP) and vaginourethrograms were performed preoperatively, immediately after surgery and 2, 4, and 6 months postoperatively. Histopathology was performed 6 months after surgery. Results – 1) TVT-O tape was consistently located in a perineal space before entering the obturator foramina and was located at a safe distance from major neurovascular structures including the femoral vessels and the obturator nerve. 2) UPP showed an increased integrated pressure postoperatively up to 4 postoperative months. Vaginourethrograms performed postoperatively showed a ventral displacement and narrowing of the distal urethra. Histopathological examination of the tissues surrounding the tape revealed a mild fibroblastic proliferation with a mild to minimal lympho-plasmocytic inflammatory infiltration. Conclusions - TVT-O is a feasible and accurate procedure which can be performed in continent bitches with a low risk of complications. [less ▲]

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See detailVers une approche moins invasive de la voie transoburatrice de dedans en dehors (TVT-O) pour le traitement de l’incontinence urinaire féminine: dissection réduite et bandelette plus courte
Waltregny, David ULiege; Thomas, Alexandre ULiege; de Leval, Jean ULiege

in Andrologic (2010), 6

Plusieurs essais randomisés et méta-analyses récentes ont montré que la voie transobturatrice est, à moyen terme, aussi efficace et plus sécurisante que la voie rétropubienne pour la mise en place d’une ... [more ▼]

Plusieurs essais randomisés et méta-analyses récentes ont montré que la voie transobturatrice est, à moyen terme, aussi efficace et plus sécurisante que la voie rétropubienne pour la mise en place d’une bandelette sous-urétrale pour traiter l’incontinence urinaire d’effort (IUE) féminine. En effet, la voie transobturatrice est associée à des taux de guérison subjective de l’IUE similaires (±85-90%) mais à un risque moindre de de saignement, de perforation vésicale et de troubles mictionnels postopératoires. La voie transobturatrice de dedans en dehors (‘Tension-free Vaginal Tape - Obturator’, TVT-O) a été développée en 2003 par Jean de Leval dans le but de réduire le risque de perforation de la vessie et de l’urètre tout en minimisant la dissection chirurgicale nécessaire pour insérer la bandelette. A ce jour, plus de 50 études cliniques, incluant 18 essais randomisés et 3 registres nationaux réalisés en France, Autriche, et Norvège, ont largement démontré les excellents résultats à moyen terme (2 à 5 ans de suivi) de la technique TVT-O. Plus récemment, nous avons apporté deux modifications à la procédure TVT-O, à savoir l’utilisation d’une bandelette plus courte, de 12 cm de long, insérée sans perforer la membrane obturatrice par les ciseaux ou le guide. Nos travaux anatomiques sur cadavres ont montré que cette bandelette plus courte est ancrée dans les muscles obturateurs et la membrane obturatrice mais évite dans une large mesure les muscles adducteurs. D’un point de vue clinique, nous avons comparé l’approche TVT-O originale à la version modifiée, potentiellement moins invasive, au travers d’un essai clinique prospectif randomisé. Les résultats de cet essai, présentés au congrès conjoint de l’International Continence Society (ICS) et de l’International Urogynecology Association (IUGA) à Toronto, ont montré qu’après suivi minimal d’1 an, les 2 approches génèrent des taux de guérison de l’IUE élevés et des taux de complications postopératoires très faibles, similaires pour les 2 procédures, la procédure modifiée étant néanmoins associée à une incidence et à une sévérité de douleurs de cuisse postopératoires immédiates significativement moindres. [less ▲]

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See detailVers une approche moins invasive du traitement chirurgical de l'incontinence urinaire féminine: la voie transoburatrice de dedans en dehors (TVT-O)
Waltregny, David ULiege; THOMAS, Alexandre ULiege; de Leval, Jean ULiege

in Andrologic (2010), 6(5), 1-4

Plusieurs essais randomisés et méta-analyses récentes ont montré que la voie transobturatrice est, à moyen terme, aussi efficace et plus sécurisante que la voie rétropubienne pour la mise en place d’une ... [more ▼]

Plusieurs essais randomisés et méta-analyses récentes ont montré que la voie transobturatrice est, à moyen terme, aussi efficace et plus sécurisante que la voie rétropubienne pour la mise en place d’une bandelette sous-urétrale pour traiter l’incontinence urinaire d’effort (IUE) féminine. En effet, la voie transobturatrice est associée à des taux de guérison subjective de l’IUE similaires (± 85-90%) mais à un risque moindre de saignement, de perforation vésicale et de troubles mictionnels postopératoires. La voie transobturatrice de dedans en dehors (‘Tension-free Vaginal Tape - Obturator’, TVT-O) a été développée en 2003 par Jean de Leval dans le but de réduire le risque de perforation de la vessie et de l’urètre tout en minimisant la dissection chirurgicale nécessaire pour insérer la bandelette. A ce jour, plus de 50 études cliniques, incluant 18 essais randomisés et 3 registres nationaux réalisés en France, Autriche et Norvège, ont largement démontré les excellents résultats à moyen terme (2-5 ans de suivi) de la technique TVT-O. Plus récemment, nous avons apporté deux modifications à la procédure TVT-O, à savoir l’utilisation d’une bandelette plus courte, de 12cm de long, insérée sans perforer la membrane obturatrice par les ciseaux ou le guide. Nos travaux anatomiques sur cadavres ont montré que cette bandelette plus courte est ancrée dans les muscles obturateurs et la membrane obturatrice mais évite dans une large mesure les muscles adducteurs. D’un point de vue clinique, nous avons comparé l’approche TVT-O originale à la version modifiée, potentiellement moins invasive, au travers d’un essai clinique prospectif randomisé. Les résultats de cet essai, présentés au congrès conjoint de l’International Continence Society (ICS) et de l’International Urogynecology Association (IUGA) à Toronto, ont montré qu’après suivi minimal d’1 an, les 2 approches génèrent des taux de guérison de l’IUE élevés et des taux de complications postopératoires très faibles, similaires pour les 2 procédures, la procédure modifiée étant néanmoins associée à une incidence et à une sévérité de douleurs de cuisse postopératoires immédiates significativement moindres. [less ▲]

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See detailAn anatomic comparison of the traditional TVT-O versus a modified TVT-O procedure
Hinoul, Piet; Bonnet, Pierre ULiege; De Roover, CHRISTOPHE ULiege et al

in Gynecological Surgery (2010), 7(Suppl 1), 121

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See detailIdentification and Validation of the Methylated TWIST1 and NID2 Genes through Real-Time Methylation-Specific Polymerase Chain Reaction Assays for the Noninvasive Detection of Primary Bladder Cancer in Urine Samples.
Renard, Isabelle; Joniau, Steven; van Cleynenbreugel, Ben et al

in European Urology (2010)

BACKGROUND: Accumulating evidence suggests that DNA methylation markers could serve as sensitive and specific cancer biomarkers. OBJECTIVE: To determine whether a panel of methylated genes would have the ... [more ▼]

BACKGROUND: Accumulating evidence suggests that DNA methylation markers could serve as sensitive and specific cancer biomarkers. OBJECTIVE: To determine whether a panel of methylated genes would have the potential to identify primary bladder cancer (BCa) in voided urine samples. DESIGN, SETTING, AND PARTICIPANTS: A pharmacologic unmasking reexpression analysis in BCa cell lines was initially undertaken to unveil candidate methylated genes, which were then evaluated in methylation-specific polymerase chain reaction (MSP) assays performed on DNA extracted from noncancerous and cancerous bladder tissues. The most frequently methylated genes in cancerous tissues, with 100% specificity, were retained for subsequent MSP analysis in DNA extracted from urine samples to build and validate a panel of potential methylated gene markers. Urine samples were prospectively collected at three urologic centres from patients with histologically proven BCa and processed for use in real-time MSP and cytologic analysis. Patients with nonmalignant urologic disorders were included as controls. MEASUREMENTS: A urine sample was classified as valid when >/=10 copies of the gene encoding ss-actin were measured in the urine sediment genomic DNA. Sensitivity, specificity, and predictive values of the MSP and cytology tests were assessed and compared. RESULTS AND LIMITATIONS: MSP assays performed on 466 of the 496 (94%) valid urine samples identified two genes, TWIST1 and NID2, that were frequently methylated in urine samples collected from BCa patients, including those with early-stage and low-grade disease. The sensitivity of this two-gene panel (90%) was significantly better than that of cytology (48%), with comparable specificity (93% and 96%, respectively). The positive predictive value and negative predictive value of the two-gene panel was 86% and 95%, respectively. CONCLUSIONS: Detection of the methylated TWIST1 and NID2 genes in urine sediments using MSP provides a highly (>/=90%) sensitive and specific, noninvasive approach for detecting primary BCa. TRIAL REGISTRATION: BlCa-001 study - EudraCt 2006-003303-40. [less ▲]

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See detailTransobturator Vaginal Tape Inside Out (TVT-O) For The Treatment of Female Canine Urinary Incontinence : Preliminary Results
Claeys, Stéphanie ULiege; De Leval, Jean ULiege; Ruel, Hélène et al

in Veterinary Surgery (2009, June), 38(4), 2

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