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

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 ULg; Waltregny, David ULg; de Leval, Jean ULg

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 ULg; Hinoul, Piet; Krofta, Ladislav et al

in International Urogynecology Journal & Pelvic Floor Dysfunction (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 ULg; Thomas, Alexandre ULg; Waltregny, David ULg

in International Urogynecology Journal & Pelvic Floor Dysfunction (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 ULg; de Leval, Jean ULg; Hamaide, Annick ULg

in Veterinary Surgery : The Official Journal of the American College of Veterinary Surgeons (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 ULg; Ruel, Hélène; De Leval, Jean ULg et al

in Veterinary Surgery : The Official Journal of the American College of Veterinary Surgeons (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 du traitement chirurgical de l'incontinence urinaire féminine: la voie transoburatrice de dedans en dehors (TVT-O)
Waltregny, David ULg; THOMAS, Alexandre ULg; de Leval, Jean ULg

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 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 ULg; Thomas, Alexandre ULg; de Leval, Jean ULg

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

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

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

in Veterinary Surgery : The Official Journal of the American College of Veterinary Surgeons (2009, June), 38(4), 2

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See detailLa place des spasmolytiques dans la colique néphrétique
Duquenne, Sébastien ULg; Hellel, Majed; Godinas, Laurent ULg et al

in Revue Médicale de Liège (2009), 64(1), 43-46

Les différents spasmolytiques sont souvent prescrits par les médecins généralistes ou dans les services d’urgence dès que le diagnostic de colique néphrétique est posé. Une pratique cependant contestée ... [more ▼]

Les différents spasmolytiques sont souvent prescrits par les médecins généralistes ou dans les services d’urgence dès que le diagnostic de colique néphrétique est posé. Une pratique cependant contestée. Cet article a pour but de faire une revue de la littérature de l’efficacité des spasmolytiques dans la colique néphrétique, et d’opposer celle-ci à la pratique quotidienne, ainsi que de faire le point sur les effets secondaires. Conclusion : la revue de l’EBM sur le sujet ne permet pas de prouver l’efficacité des spasmolytiques, et montre qu’il est préférable d’utiliser le diclofenac en monothérapie et de traiter les patients non contrôlés par tramadol et antalgiques. Il faudra adjoindre du tamsulosine pour les calculs du bas uretère. [less ▲]

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See detailThe inside-out transobturator sling for the surgical treatment of post-radical prostatectomy urinary incontinence: Short term results of a prospective study
Waltregny, David ULg; Leruth, Julie ULg; de Leval, Jean ULg

in European Urology Supplements (2009), 4(8), 336

Introduction and Objective: To prospectively evaluate the short-term safety and efficacy of a new transobturator sling procedure for treating post-radical prostatectomy (RP) stress urinary incontinence ... [more ▼]

Introduction and Objective: To prospectively evaluate the short-term safety and efficacy of a new transobturator sling procedure for treating post-radical prostatectomy (RP) stress urinary incontinence (SUI). Methods: The sling technique uses specific instruments and a polypropylene mesh with 2 arms that are passed inside to outside through the obturator foramens, pulled for compressing the bulbar urethra upward, and tied to each other across the midline. Inclusion criteria were clinically and urodynamically demonstrated SUI, positive bulbar compression test, and signed informed consent. Patients with detrusor overactivity were excluded. Baseline and followup evaluations included uroflowmetry, and continence and quality of life (QoL) questionnaires. Cure was defined by no pad use and improvement by a number of pads/d ≤ 2 and reduced by at least 50%. Complications were recorded. Results: From 04/2006 through 10/2008, 70 consecutive patients who fulfilled inclusion and exclusion criteria underwent the sling procedure using the same operative protocol. As of October 2008, 55 and 35 patients who consecutively underwent the sling procedure were expected to have a minimum followup of 6 months and 1 year, respectively. Preoperatively, 13 (24%), 25 (45%), and 17 (31%) patients were using 2, 3 to 5, and >5 pads/d, respectively. Nine and 6 patients had undergone prior surgery for SUI and/or previous pelvic irradiation, respectively. The sling procedure was preceded by an endoscopic urethrotomy in 5 (9%) patients. No perioperative complication was noted. Seven (13%) patients required suprapubic catheterization; normal voiding resumed in all 7 patients except 1 who underwent urinary diversion for radiation-induced complete anastomotic stricture. Six-month and 1-year minimum followup was available on 51 (93%) and 33 (94%) patients, respectively (Table 1). Of note, at 6 months, among the 17 patients with preoperative severe incontinence (> 5 pads/day), 9 (53%) patients were cured and 6 others (35%) were improved (1 pad/d). Overall, QoL was significantly enhanced and 85% patients were moderately to completely satisfied with the procedure. Preoperative and postoperative max flow rate and postvoid residual values were not statistically different. No sling infection, urethra erosion, persistent pain or neurological complication was observed. No sling was withdrawn or cut. Conclusions: The inside-out transobturator sling procedure appears to be safe and efficient at short term. [less ▲]

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See detailThe inside-out transobturator sling for the surgical treatment of post-radical prostatectomy urinary incontinence: Interim results of a prospective, observational study after a 1-year minimum follow-up
Waltregny, David ULg; Leruth, Julie ULg; de Leval, Jean ULg

in Neurourology and Urodynamics (2009), 28(7), 687-688

Hypothesis / aims of study The aim of this study was to prospectively evaluate the short-term safety and efficacy of the inside-out transobturator sling procedure for treating post-radical prostatectomy ... [more ▼]

Hypothesis / aims of study The aim of this study was to prospectively evaluate the short-term safety and efficacy of the inside-out transobturator sling procedure for treating post-radical prostatectomy (RP) stress urinary incontinence (SUI). Study design, materials and methods The sling technique uses specific instruments and a polypropylene mesh with 2 arms that are passed inside to outside through the obturator foramens, pulled for compressing the bulbar urethra upward, and tied to each other across the midline. Intra-operative urodynamic evaluation is performed to record the urethral pressure profile (UPP) and to measure the abdominal leak point pressure (ALPP) and maximal urethral pressure (MUP) before and after sling tensioning. Urodynamic measurements are repeated until tension on both arms of the mesh increases ALPP to approximately 100 cm H2O. In case of associated urethral stenosis, classic endoscopic urethrotomy is performed first. Inclusion criteria were clinically and urodynamically demonstrated SUI, positive bulbar compression test, and signed informed consent. Patients with detrusor overactivity or active urinary infection were excluded. Baseline evaluation included detailed history, physical examination with a bulbar urethra compression test, urine analysis, multichannel urodynamics, administration of self-questionnaires assessing urinary continence (questions 1 through 3 of the urinary section of the UCLA-PCI-SF questionnaire (1)) and quality of life (QoL) (Ditrovie questionnaire (2)), flexible urethrocystoscopy, and urethrocystography. The degree of incontinence was arbitrarily categorized as mild (1–2 pads/day), moderate (3–5 pads/day) or severe (>5 pads/day), as previously described (3). Follow-up evaluation at 1, 6, 12 months, and yearly thereafter included physical examination, uroflowmetry with PVR measurement, and administration of the self-questionnaires assessing urinary continence and QoL. All patients were also asked to self-evaluate their satisfaction with the treatment. Cure was defined by no pad use and improvement by a number of pads/day ≤ 2 and reduced by at least 50%. Peri- and post-operative complications were recorded. Results From April 2006 through March 2009, 95 consecutive patients who fulfilled inclusion and exclusion criteria underwent the sling procedure using the same operative protocol. As of March 2009, 58 patients who consecutively underwent the sling procedure were expected to have a minimum follow-up of 1 year. Mean age of the patients was 67.6 ± 6.5 years (range 52-79). Mean body mass index was 27.0 ± 3.6 (range 21.3 – 39.0). Of the 58 patients, 9 (16%) patients had undergone prior surgery for SUI: bulking agent injection in 5 patients, prior sling implantation in 1 patient and artificial urinary sphincter (AUS) implantation in 4 patients. A previous urethrotomy or urethral dilatation for urethral stenosis had been performed in 8 (14%) patients and 8 (14%) patients had had pelvic irradiation. Preoperatively, 14 (24%), 26 (45%), and 18 (31%) patients were using 2 (mild SUI), 3 to 5 (moderate SUI), and >5 pads/day (severe SUI), respectively. The sling procedure was performed under general and spinal anesthesia in 22 (38%) and 36 (62%) patients, respectively, and was preceded by an endoscopic urethrotomy in 5 (9%) patients. Penile prostheses were implanted concomitantly to the sling in 2 patients. Before sling tensioning, mean MUP and ALPP were 40 ± 21 cm H2O (range 5-101) and 45 ± 22 cm H2O (range 10-100). After sling tensioning, mean MUP and ALPP were 89 ± 24 cm H2O (range 44-141) and 109 ± 26 cm H2O (range 60-165). Mean increase in MUP and ALPP between post- and pre-tensioning of the sling was 49 ± 29 cm H2O (range 1-125) and 64 ± 32 cm H2O (range 20-135), respectively. Mean operative time was 65 ± 18 minutes. No intra-operative complication was noted. Seven (12%) patients required suprapubic catheterization; normal voiding resumed in all 7 patients except 1 who underwent urinary diversion for complete radiation-induced anastomotic stenosis. Mild perineal hematoma not requiring therapy was observed in 6 patients. Six-month and 1-year minimum follow-up was available on 54 (93%) and 56 (96%) of the 58 patients, respectively (Table 1). Two patients were completely lost to follow-up after the 1-month visit. At this 1-month visit, one patient was cured while the other was improved. Table 1. Postoperative pad usage Follow-up 6-month visit 1-year visit Preoperative SUI severity / Outcome Mild to moderate SUI (≤5 pads/d) Severe SUI (> 5 pads/d) Entire cohort (≥ 2 pads/d) Mild to moderate SUI (≤ 5 pads/d) Severe SUI (> 5 pads/d) Entire cohort (≥ 2 pads/d) Cure 22 (55.0%) 9 (50.0%) 31 (53.5%) 23 (57.5%) 8 (44.5%) 31 (53.5%) Improvement 13 (32.5%) 5 (27.8%) 18 (31.0%) 14 (35.0%) 6 (33.3%) 20 (34.4%) Failure 1 (2.5%) 4 (22.2%) 5 (8.6%) 1 (2.5%) 4 (22.2%) 5 (8.6%) Data not available 4 (10.0%) 0 (0.0%) 4 (6.9%) 2 (5.0%) 0 (0.0%) 2 (3.5%) Of note, at 12 months, among the 18 patients with preoperative severe incontinence, 8 (44.5%) were cured and 6 (35%) others were improved. In addition, SUI cure/improvement rates appeared to be similar at the 6 and 12 months time points. The 3 failures included one patient who had undergone post-RP radiation therapy. This man later developed a complete urethral anastomotic closure and underwent cystectomy with transileal ureterostomy 9 months after the sling procedure. The two other failed patients had a vesico-urethral anastomotic stricture before sling implantation. Both patients were implanted with an AUS after the sling procedure. After cutting the mesh arms laterally to the bulb, the AUS cuff was placed without difficulty around the bulbar urethra. The 4th failed patient had undergone previous radiation therapy and had a bulbar urethral stenosis. He is now wearing penile collectors. The 5th patient had a vesico-urethral stenosis that underwent urethrotomy just before the sling implantation. The patient has been offered the placement of an artificial urinary sphincter. Preoperative and postoperative max flow rate and postvoid residual values were not different (Table 2). Overall, QoL was substantially enhanced and 85% patients were satisfied with the procedure. Table 2. Postoperative evolution of QoL scores and voiding parameters QoL and voiding parameters Baseline (mean ± SD [range]) 6-month visit (mean ± SD [range]) 1-year visit (mean ± SD [range]) Ditrovie QoL scores (scale from 10 [best] to 50 [worst]) 32 ± 7 (17-50) 16 ± 8 (10-40) 17 ± 8 (10-42) Max flow rate (mL/sec) 20 ± 9 (6-46) 18 ± 9 (6-44) 17 ± 10 (4-51) Post void residual (mL) 17 ± 32 (0-160) 21 ± 51 (0-243) 6 ± 21 (0-87) No sling infection, urethra erosion, persistent pain or neurological complication was observed. No sling was withdrawn or cut. Interpretation of results The inside-out transobturator sling was associated with a minimal risk of intra- and post-operative complications. Postoperative SUI cure/improvement rates were found to remain stable over a 1-year period. The sling procedure appeared to be efficient at short term even in the group of patients with severe SUI before surgery. The sling procedure does not compromise concomitant penile prostheses or subsequent AUS implantation. Longer follow-up times are required to determine the long-term efficacy of this sling procedure. Concluding message The one-year results of this prospective study suggest that the inside-out transobturator sling is a safe and efficient surgical procedure at short term for the treatment of post-RP SUI. [less ▲]

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