C. Saussine

Efficacy and Safety of Low Doses of OnabotulinumtoxinA for the Treatment of Refractory Idiopathic Overactive Bladder: A Multicentre, Double-Blind, Randomised, Placebo-Controlled Dose-Ranging Study

BACKGROUND In the treatment of patients with idiopathic overactive bladder (iOAB), high doses of botulinum toxin type A (BoNTA) were often associated with complications resulting from high postvoid residuals (PVR), leading to clean intermittent catheterisation (CIC) and urinary tract infections (UTI). OBJECTIVE Evaluate the efficacy and tolerability of low doses of onabotulinumtoxinA compared to placebo in patients with iOAB. DESIGN, SETTING, AND PARTICIPANTS Between 2005 and 2009, adults with persistent iOAB were included in a prospective, randomised, double-blind, placebo-controlled comparative trial. INTERVENTION Patients were randomised to undergo a single intradetrusor injection procedure of either placebo or onabotulinumtoxinA (50 U, 100 U or 150 U). MEASUREMENTS The initial evaluations (ie, clinical and urodynamic variables as well as quality of life [QoL]) were repeated at day 8 and months 1, 3, 5, and 6. RESULTS AND LIMITATIONS Ninety-nine patients were included in the efficacy analysis. Three months after the procedure, we observed>50% improvement versus baseline in urgency and urge urinary incontinence (UUI) in 65% and 56% of patients who respectively received 100 U (p=0.086) and 150 U (p=0.261) BoNTA injections and >75% improvement in 40% of patients of both groups (100 U [p=0.058] and 150 U [p=0.022]). Complete continence was observed in 55% and 50% patients after 100 U and 150 U BoNTA treatment, respectively, at month 3. Frequency symptoms and QoL improved up to the 6-mo visit. We observed only three patients with a PVR>200 ml in the 150 U group and a few UTIs. CONCLUSIONS 100 U and 150 U BoNTA injections were well tolerated and have both shown to improve symptoms and QoL in patients with iOAB. Nevertheless, 100 U injections showed a reasonable efficacy, with a lower risk of high PVR. TRIAL REGISTRATION ClinicalTrials.gov NCT00231491.

180-W XPS GreenLight Laser Vaporisation Versus Transurethral Resection of the Prostate for the Treatment of Benign Prostatic Obstruction: 6-Month Safety and Efficacy Results of a European Multicentre Randomised Trial—The GOLIATH Study

BACKGROUND The comparative outcome with GreenLight (GL) photoselective vaporisation of the prostate and transurethral resection of the prostate (TURP) in men with lower urinary tract symptoms due to benign prostatic obstruction (BPO) has been questioned. OBJECTIVE The primary objective of the GOLIATH study was to evaluate the noninferiority of 180-W GL XPS (XPS) to TURP for International Prostate Symptom Score (IPSS) and maximum flow rate (Qmax) at 6 mo and the proportion of patients who were complication free. DESIGN, SETTING, AND PARTICIPANTS Prospective randomised controlled trial at 29 centres in 9 European countries involving 281 patients with BPO. INTERVENTION 180-W GL XPS system or TURP. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS Measurements used were IPSS, Qmax, prostate volume (PV), postvoid residual (PVR) and complications, perioperative parameters, and reintervention rates. Noninferiority was evaluated using one-sided tests at the 2.5% level of significance. The statistical significance of other comparisons was assessed at the (two-sided) 5% level. RESULTS AND LIMITATIONS The study demonstrated the noninferiority of XPS to TURP for IPSS, Qmax, and complication-free proportion. PV and PVR were comparable between groups. Time until stable health status, length of catheterisation, and length of hospital stay were superior with XPS (p<0.001). Early reintervention rate within 30 d was three times higher after TURP (p=0.025); however, the overall postoperative reintervention rates were not significantly different between treatment arms. A limitation was the short follow-up. CONCLUSIONS XPS was shown to be noninferior (comparable) to TURP in terms of IPSS, Qmax, and proportion of patients free of complications. XPS results in a lower rate of early reinterventions but has a similar rate after 6 mo. TRIAL REGISTRATION ClinicalTrials.gov, identifier NCT01218672.

A European Multicenter Randomized Noninferiority Trial Comparing 180 W GreenLight XPS Laser Vaporization and Transurethral Resection of the Prostate for the Treatment of Benign Prostatic Obstruction: 12-Month Results of the GOLIATH Study

PURPOSE We present the 1-year results of the GOLIATH prospective randomized controlled trial comparing transurethral resection of the prostate to GreenLight XPS for the treatment of men with nonneurogenic lower urinary tract symptoms due to prostate enlargement. The updated results at 1 year show that transurethral resection of the prostate and GreenLight XPS remain equivalent, and confirm the therapeutic durability of both procedures. We also report 1-year followup data from several functional questionnaires (OABq-SF, ICIQ-SF and IIEF-5) and objective assessments. MATERIALS AND METHODS A total of 291 patients were enrolled at 29 sites in 9 European countries. Patients were randomized 1:1 to undergo GreenLight XPS or transurethral resection of the prostate. The trial was designed to evaluate the hypothesis that GreenLight XPS is noninferior to transurethral resection of the prostate on the International Prostate Symptom Score at 6 months. Several objective parameters were assessed, including maximum urinary flow rate, post-void residual urine volume, prostate volume and prostate specific antigen, in addition to functional questionnaires and adverse events at each followup. RESULTS Of the 291 enrolled patients 281 were randomized and 269 received treatment. Noninferiority of GreenLight XPS was maintained at 12 months. Maximum urinary flow rate, post-void residual urine volume, prostate volume and prostate specific antigen were not statistically different between the treatment arms at 12 months. The complication-free rate at 1 year was 84.6% after GreenLight XPS vs 80.5% after transurethral resection of the prostate. At 12 months 4 patients treated with GreenLight XPS and 4 who underwent transurethral resection of the prostate had unresolved urinary incontinence. CONCLUSIONS Followup at 1 year demonstrated that photoselective vaporization of the prostate produced efficacy outcomes similar to those of transurethral resection of the prostate. The complication-free rates and overall reintervention rates were comparable between the treatment groups.

A Multicenter Randomized Noninferiority Trial Comparing GreenLight-XPS Laser Vaporization of the Prostate and Transurethral Resection of the Prostate for the Treatment of Benign Prostatic Obstruction: Two-yr Outcomes of the GOLIATH Study

BACKGROUND The GOLIATH study is a 2-yr trial comparing transurethral resection of prostate (TURP) to photoselective vaporization with the GreenLight XPS Laser System (GL-XPS) for the treatment of benign prostatic obstruction (BPO). Noninferiority of GL-XPS to TURP was demonstrated based on a 6-mo follow-up from the study. OBJECTIVE To determine whether treatment effects observed at 6 mo between GL-XPS and TURP was maintained at the 2-yr follow-up. DESIGN, SETTING, AND PARTICIPANTS Prospective randomized controlled trial at 29 centers in nine European countries involving 281 patients with BPO. INTERVENTION Photoselective vaporization using the 180-W GreenLight GL-XPS or conventional (monopolar or bipolar) TURP. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS The primary outcome was the International Prostate Symptom Score for which a margin of three was used to evaluate the noninferiority of GL-XPS. Secondary outcomes included Qmax, prostate volume, prostate specific antigen, Overactive Bladder Questionnaire Short Form, International Consultation on Incontinence Questionnaire Short Form, occurrence of surgical retreatment, and freedom from complications. RESULTS AND LIMITATIONS One hundred and thirty-six patients were treated using GL-XPS and 133 using TURP. Noninferiority of GL-XPS on International Prostate Symptom Score, Qmax, and freedom from complications was demonstrated at 6-mo and was sustained at 2-yr. The proportion of patients complication-free through 24-mo was 83.6% GL-XPS versus 78.9% TURP. Reductions in prostate volume and prostate specific antigen were similar in both arms and sustained over the course of the trial. Compared with the 1(st) yr of the study, very few adverse events or retreatments were reported in either arm. Treatment differences in the Overactive Bladder Questionnaire Short Form observed at 12-mo were not statistically significant at 24-mo. A limitation was that patients and treating physicians were not blinded to the therapy. CONCLUSIONS Twenty-four-mo follow-up data demonstrated that GL-XPS provides a durable surgical option for the treatment of BPO that exhibits efficacy and safety outcomes similar to TURP. PATIENT SUMMARY The long-term effectiveness and safety of GLP-XLS was similar to conventional TURP for the treatment of prostate enlargement.

Bilan initial, suivi et traitement des troubles mictionnels en rapport avec hyperplasie bénigne de prostate : recommandations du CTMH de l’AFU

AIM To elaborate guidelines for the diagnosis, the follow-up, and the treatment of benign prostatic hyperplasia (BPH). METHOD A systematic review of the literature was conducted to select more relevant publications. The level of evidence was evaluated. Graded recommendations were written by a working group, and then reviewed by a reviewer group according to the formalized consensus technique. RESULTS Terminology of the International Continence Society was used. Initial assessment has several aims: making sure that lower urinary tract symptoms (LUTS) are related to BPH, assessing bother related to LUTS and checking for a possible complicated bladder outlet obstruction (BOO). Initial assessment should include: medical history, LUTS assessment using a symptomatic score, physical examination including digital rectal examination, urinalysis, flow rate recording, and residual urine volume. Frequency volume chart is recommended when storage symptoms are predominant. Serum PSA should be done when the diagnosis of prostate cancer can modify the management. When a surgical treatment is discussed, serum PSA, serum creatinine and ultrasonography of the urinary tract are recommended. BPH patients should be informed of the benign and possibly progressive patterns of the disease. When LUTS cause no bother, annual follow-up should be planned. Medical treatment includes some phytotherapy agents, alpha-blockers and 5-alpha reductase inhibitors. The last two can be associated. The association of antimuscarinics and alpha-blockers can be offered to patients with residual storage symptoms when already under alpha-blockers therapy, after checking for the absence of severe BOO (residual volume more than 200mL or max urinary flow less than 10mL/s). Phosphodiesterase-5 inhibitors could be used in patients complaining for both LUTS and erectile dysfunction. In case of complication, or when medical treatment is inefficient or not tolerated, then a surgical treatment should be discussed. Treatment decision should be done according to type of LUTS and related bother, prostate anatomy, level of obstruction and its consequences on urinary tract, patient co-morbidities, experience of practitioner, and choice of patient. Surgical treatments with the higher level of evidence of efficacy include monopolar or bipolar transurethral resection of the prostate, open prostatectomy, transurethral incision of the prostate, photoselective vaporization of the prostate, and Holmium laser enuclation of the prostate. CONCLUSION Here are the first guidelines of the French Urological Association for the initial assessment, the follow-up and the treatment of urinary disorders related to BPH.

I-STOP TOMS transobturator male sling, a minimally invasive treatment for post-prostatectomy incontinence: continence improvement and tolerability.

OBJECTIVE To prospectively evaluate the efficacy and tolerability of the I-STOP TOMS transobturator male sling in patients with post-prostatectomy stress urinary incontinence. Minimally invasive techniques, such as slings, are becoming the standard of care for mild to moderate post-prostatectomy incontinence. METHODS From March 2007 to June 2009, 122 patients with post-prostatectomy stress urinary incontinence were treated with the I-STOP TOMS sling and followed up for 1 year in the Phase IV HOMme INContinence trial. The preoperative and postoperative evaluation included daily pad use, pad test, questionnaires evaluating urinary function and bother (University of California, Los Angeles, Prostate Cancer Index--urinary function short form, and International Consultation on Incontinence Modular Questionnaire--urinary incontinence short form) and uroflowmetry, including the post-void residual urine volume. Patient satisfaction and perineal pain were also assessed. RESULTS A total of 103 patients were followed up for 12 months. The surgical procedure was considered easy to perform. The mean daily pad use decreased significantly from 2.4 to 0.6 at 12 months of follow-up; 87.0% of the patients reported improved continence (59.4% completely dry, 20.3% 1 pad/d, 7.3%>1 pad/d), and 13.0% reported no improvement. All quality-of-life scores (University of California, Los Angeles, Prostate Cancer Index--urinary function short form, and International Consultation on Incontinence Modular Questionnaire--urinary incontinence short form) improved significantly after sling implantation. Treatment satisfaction was >90%. The post-void residual urine volume did not increase substantially, and acute urinary retention did not occur. The perineal pain scores were very low at follow-up. Wound infection was seen in 2 patients at the 1-month follow-up visit. CONCLUSION The I-STOP TOMS is a good treatment option for patients with post-prostatectomy stress urinary incontinence. With follow-up≤12 months, most patients were continent or had improved continence. The intervention was well tolerated, with few infections.

RecommandationBilan initial, suivi et traitement des troubles mictionnels en rapport avec hyperplasie bénigne de prostate : recommandations du CTMH de l’AFUInitial assessment, follow-up and treatment of lower urinary tract symptoms related to benign prostatic hyperplasia: Guidelines of the LUTS committee of the French Urological Association

AIM To elaborate guidelines for the diagnosis, the follow-up, and the treatment of benign prostatic hyperplasia (BPH). METHOD A systematic review of the literature was conducted to select more relevant publications. The level of evidence was evaluated. Graded recommendations were written by a working group, and then reviewed by a reviewer group according to the formalized consensus technique. RESULTS Terminology of the International Continence Society was used. Initial assessment has several aims: making sure that lower urinary tract symptoms (LUTS) are related to BPH, assessing bother related to LUTS and checking for a possible complicated bladder outlet obstruction (BOO). Initial assessment should include: medical history, LUTS assessment using a symptomatic score, physical examination including digital rectal examination, urinalysis, flow rate recording, and residual urine volume. Frequency volume chart is recommended when storage symptoms are predominant. Serum PSA should be done when the diagnosis of prostate cancer can modify the management. When a surgical treatment is discussed, serum PSA, serum creatinine and ultrasonography of the urinary tract are recommended. BPH patients should be informed of the benign and possibly progressive patterns of the disease. When LUTS cause no bother, annual follow-up should be planned. Medical treatment includes some phytotherapy agents, alpha-blockers and 5-alpha reductase inhibitors. The last two can be associated. The association of antimuscarinics and alpha-blockers can be offered to patients with residual storage symptoms when already under alpha-blockers therapy, after checking for the absence of severe BOO (residual volume more than 200mL or max urinary flow less than 10mL/s). Phosphodiesterase-5 inhibitors could be used in patients complaining for both LUTS and erectile dysfunction. In case of complication, or when medical treatment is inefficient or not tolerated, then a surgical treatment should be discussed. Treatment decision should be done according to type of LUTS and related bother, prostate anatomy, level of obstruction and its consequences on urinary tract, patient co-morbidities, experience of practitioner, and choice of patient. Surgical treatments with the higher level of evidence of efficacy include monopolar or bipolar transurethral resection of the prostate, open prostatectomy, transurethral incision of the prostate, photoselective vaporization of the prostate, and Holmium laser enuclation of the prostate. CONCLUSION Here are the first guidelines of the French Urological Association for the initial assessment, the follow-up and the treatment of urinary disorders related to BPH.

Effect of Supine vs Prone Position on Outcomes of Percutaneous Nephrolithotomy in Staghorn Calculi: Results From the Clinical Research Office of the Endourology Society Study

OBJECTIVE To analyze the effect of patient positioning on outcomes of percutaneous nephrolithotomy (PNL) among patients with staghorn stones. The choice of optimal position for these patients undergoing PNL remains challenging. No previous studies exclusively addressing this point have been performed. METHODS From November 2007 to December 2009, prospective data were collected by the Clinical Research Office of the Endourological Society. We included all patients with staghorn stones. Patients were divided on the basis of the position used during PNL (prone/supine). Patient characteristics, stone burden, operative details, and outcomes were compared. Multivariate analysis was performed to evaluate the relationship between patient position and stone-free rate and complication rate adjusting for number of access puncture sites. RESULTS A total of 1079 PNLs were performed in prone and 232 in supine positions. There were no differences in comorbidities or preoperative stone burden. A higher percentage of patients in the prone position had access through the upper pole (P <.001). Surgical time was shorter (P <.001) and stone-free rate was higher (P <.001) for patients in the prone position. There were no differences in complication rates. In multivariate analysis, patients in prone position had a higher stone-free rates (P = .0013) after adjusting for the method used for determining stone-free status and number of renal access. CONCLUSION Higher stone-free rates are achieved in the prone position during PNL for patients with staghorn calculi. Complication rates were similar for both positions.

Le traitement de l'incontinence urinaire postopératoire de l'homme par la bandelette sous-urétrale à ancrage osseux

OBJECTIVE To evaluate the results of treatment of postoperative male stress urinary incontinence by placement of an AMS Invance bone-anchored male sling (BAMS). MATERIAL AND METHOD Between February 2005 and May 2007, 29 patients with stress urinary incontinence secondary to prostatic surgery were treated by Invance bone-anchored male sling. This BAMS consists of a silicone-coated polyester sling placed around the bulbar urethra and anchored to the ischiopubic rami by six titanium screws. According to the number of protections used per 24 hour, patients were considered to present mild (one to two), moderate (three to four) or severe (five or more, or penile sheath) incontinence. The number of protections, the continence rate and early and late complications were reported. Success or continence was defined by the absence of urine leaks and protections. RESULTS The mean age of the patients of this series was 67.5 years. Incontinence was mild for 12 patients (41.4%), moderate for six patients (20.7%) and severe for 11 patients (37.9%). The mean interval between prostatic surgery and BAMS placement was 47.9 months. The mean operating time was 65.8 minutes. There were no intraoperative complications. Two cases (7%) of spontaneously resolving acute urinary retention were observed. Explantation of the BAMS for chronic perineal pain or operative site infection was performed in five patients (17%) after a mean interval of 4.1 months (range: 1-8.5 months). The revision rate for repositioning of the screws was 10.3% (three patients). The continence rate at three months was 62.5%. After a mean follow-up of 11.5 months, this rate was 37.5%, corresponding to 77.8% of patients with initially mild or moderate incontinence and 22.2% with severe incontinence. Residual incontinence was mild in 41.7%, moderate in 8.3% and severe in 12.5%. Four patients with persistent urinary incontinence after BAMS placement were treated by artificial urinary sphincter. CONCLUSION Bone-anchored male sling is a minimally invasive treatment for postoperative male urinary incontinence, but is associated with significant morbidity (five explanations in a series of 29 patients). Better results were obtained for mild to moderate incontinence.

Neuromodulation sacrée avec le système InterStim™ : résultats du registre national français

AIM To analyse current practice patterns and to evaluate (long-term) effectiveness and adverse events of sacral neuromodulation with InterStim™ Therapy based on data collected in a national register and to discuss the strengths and weaknesses of the register. PATIENTS AND METHODS This is a French multicenter prospective observational trial including patients with a permanent implant (2003-2009). Voiding diary variables and patient satisfaction were analysed based on last follow-up visit since implantation. RESULTS One thousand four hundred and eighteen patients (median age: 63 years, 1206 females) were included in the database (median follow-up: 12 months). One thousand and eighty-nine patients had non-neurological disease. The principal diagnosis was overactive bladder syndrome ([OAB], n=1170) and retention (n=151). Implantation occurred in 1358 patients; 1172 patients had greater than or equal to one registered follow-up. Clinical improvement of greater than or equal to 50% was seen in 447/527 patients with OAB at 12 months follow-up (median number of voids per 24 hours decreased from 15 at baseline to 8 at 12 months) and in 42/54 of patients with retention (median number of catheterization per 24 hours dropped from 5 at baseline to 0 at 12 months). Clinical improvement remained relatively stable up to 60 months. Median patient satisfaction with treatment was between 60 and 80%. Five hundred and twenty-four patients had at least one adverse event; loss of efficacy (n=244) occurred most frequently. CONCLUSIONS In this large database sacral neuromodulation with InterStim™ Therapy seems to be an effective treatment through routine practice in the long-term (up to 60 months) for patients refractory to medical treatment.