Using prostate contrast retention (PCR) as the procedural endpoint in prostatic artery embolization for benign prostatic hyperplasia.

OBJECTIVES: The failure rate following prostate artery embolization (PAE) is around 20%, which may in part result from inadequate embolization. Prostate contrast retention (PCR) adequacy on immediate post-embolization cone-beam CT may provide better assessment of embolization completeness than arterial contrast stasis seen on fluoroscopy alone. The aim of this study was to evaluate outcomes of PAE using PCR adequacy as the procedural endpoint. METHODS: A retrospective cohort study of all PAE cases using this technique at a single large volume center was conducted. Following initial embolization of the main prostatic arteries, if PCR was inadequate, additional embolization was performed. Technical success (adequate PCR) was defined as > 75% global prostate gland contrast staining. Clinical success was determined in accordance to CIRSE standards of practice. RESULTS: One hundred sixty-five patients (mean age 68 ± 8.4 years) underwent PAE from June 2017 to March 2019. Technical and clinical success rates were 98.8% and 96.4% respectively. Clinical success rate was significantly higher in patients with adequate PCR. International Prostate Symptom Scores (IPSS) and Quality of Life (QoL) scores significantly improved at 1-, 3-, 6-, and 12-month follow-up when compared to baseline. Prostate volume (PV) and post-voiding residual bladder volume were significantly reduced at 3, 6, and 12 months in comparison to baseline. Mild (Clavien-Dindo grade I/II) and moderate (grade III) complication rates were 12.1% and 3.6% respectively. CONCLUSIONS: By using PCR adequacy as a guide to determine the procedure endpoint for PAE, it may be possible to achieve more complete embolization and thus higher clinical success rates. KEY POINTS: • By using PCR adequacy as a guide to determine the procedure endpoint for PAE, it may be possible to achieve more complete embolization and thus higher clinical success rates.

A randomized, placebo-controlled clinical development program exploring the use of litoxetine for treating urinary incontinence.

AIMS: To investigate the safety and efficacy of litoxetine, a serotonin reuptake inhibitor, in treating urinary incontinence (UI) and mixed urinary incontinence (MUI). METHODS: Two randomized, double-blind, placebo-controlled clinical trials (RCT1 and RCT2) were conducted. RCT1, which included 196 women aged 18-75 with MUI randomized 1:1:1:1 to receive 10, 20, or 40 mg litoxetine or placebo orally twice daily (BID) for 12 weeks, investigated the efficacy (including changes in patient reported outcomes) and safety of litoxetine compared to placebo. RCT2, which included 82 men and women aged 18-70 with any UI type randomly assigned 2:1 to receive 30 mg litoxetine or placebo orally BID for 8 weeks including a 2 week dose titration period, investigated the safety (including psychiatric safety) and efficacy of litoxetine compared to placebo. Efficacy was measured as the change in number of incontinence episodes per week and assessed using an analysis of covariance with missing data imputed by Predictive Mean Matching. Safety was assessed by adverse events (AEs) and physical examinations and analyzed using descriptive statistics. RESULTS: The 30-mg and placebo groups in RCT2 showed no difference in frequency of AEs, and litoxetine reduced the number of incontinence episodes per week compared to placebo. Although RCT1 suffered an unexpectedly high placebo response, and therefore did not meet the primary efficacy endpoint, 71% of participants receiving 40 mg litoxetine reported a clinically meaningful improvement in the King's Health Questionnaire. CONCLUSIONS: Litoxetine may be a safe, effective and well-tolerated treatment for patients with UI.

Efficacy and safety of artificial urinary sphincter (AUS): Results of a large multi-institutional cohort of patients with mid-term follow-up.

AIMS: To assess efficacy and safety as well as predictive factors of dry rate and freedom from surgical revision in patients underwent AUS placement. The artificial urinary sphincter (AUS) is still considered the standard for the treatment of moderate to severe post-prostatectomy stress urinary incontinence (SUI). However, data reporting efficacy and safety from large series are lacking. METHODS: A multicenter, retrospective study was conducted in 16 centers in Europe and USA. Only primary cases of AUS implantation in non-neurogenic SUI after prostate surgery, with a follow-up of at least 1 year were included. Efficacy data (continence rate, based on pad usage) and safety data (revision rate in case of infection and erosion, as well as atrophy or mechanical failure) were collected. Multivariable analyses were performed in order to investigate possible predictors of the aforementioned outcomes. RESULTS: Eight hundred ninety-two men had primary AUS implantation. At 32 months mean follow-up overall dry rate and surgical revision were 58% and 30.7%, respectively. Logistic regression analysis showed that patients without previous incontinence surgery had a higher probability to be dry after AUS implantation (OR: 0.51, P = 0.03). Moreover institutional case-load was positively associated with dry rate (OR: 1.18; P = 0.005) and freedom from revision (OR: 1.51; P = 0.00). CONCLUSIONS: The results of this study showed that AUS is an effective option for the treatment of SUI after prostate surgery. Moreover previous incontinence surgery and low institutional case-load are negatively associated to efficacy and safety outcomes.

A pooled analysis of the efficacy of fesoterodine for the treatment of overactive bladder, and the relationship between safety, co-morbidity and polypharmacy in patients aged 65 years or older.

Background: overactive bladder (OAB) is a common condition in older persons. Antimuscarinic treatment remains the mainstay of treatment of OAB but clinicians have been reluctant to prescribe this to older patients. This study examined efficacy and safety information from patients >65 in fesoterodine trials to reaffirm efficacy and to explore the relationships between treatment emergent adverse events (TEAEs), coexisting medication and co-morbidity. Methods: data from 10 double-blind, placebo-controlled studies were analysed. A logistic regression analysis, where TEAE incidence was predicted by treatment, prior antimuscarinic treatment, number of coexisting medications, number of concomitant diseases and all possible combinations of two-way interaction terms with treatment was conducted. Results: of 4,040 patients who participated in trials; fesoterodine treatment was associated with statistically significant reductions in all disease-related and patient-reported outcomes compared to placebo. There was a significant increase in the likelihood of reporting a TEAE in association with the number of coexistent medications (odds ratio (OR) = 1.028, 95% CI: 1.0143-1.044, P < 0.003). The OR of having a TEAE with increase in the number of concomitant diseases was 1.058 (95% CI: 1.044-1.072, P < 0.0001). Central nervous system (CNS) events were few. Discussion: fesoterodine treatment led to clinically meaningful improvements across all included patient reported outcomes. The number of concomitant conditions had the greatest influence on the likelihood of an adverse event being reported. CNS TEAE were not associated with fesoterodine dose and were low across all categories of concomitant disease and coexisting medication.

Pyonephrosis Caused by Salmonella Typhi: A Case Report.

INTRODUCTION: Salmonella is a rare cause of urinary tract infections. We report here a unique case of pyonephrosis due to Salmonella Typhi (S. Typhi) complication, a stone-related obstructive pyelonephritis. CASE REPORT: A 47-year-old man, without any history of typhoid fever or gastrointestinal symptoms, presented with a pyonephrosis and life-threatening bacteremia following an acute obstructive right pyelonephritis caused by S. Typhi. The patient was treated by urinary drainage (ureteral stent), antibiotics, and delayed right nephrectomy. We postulated that urolithiasis could explain asymptomatic chronic urinary carriage of S. Typhi. CONCLUSION: S. Typhi is one possible cause of life-threatening urinary tract infection, especially in the context of urolithiasis.

Bladder function after radical hysterectomy for cervical cancer.

AIM: To report the effects of radical hysterectomy and nerve-sparing techniques on lower urinary tract function in women. METHODS: A literature search was performed in Pubmed and Medline using the keywords bladder after radical hysterectomy, nerve sparing radical hysterectomy, and urinary dysfunction following radical hysterectomy. Significant results and citations were reviewed manually by the authors. RESULTS: The sympathetic and parasympathetic systems innervating the lower urinary tract may be disrupted due to resection of uterosacral and rectovaginal ligaments, the dorsal and lateral paracervix, the caudal part of the vesico-uterine ligaments, and the vagina. This supports the neurogenic etiology of early and late bladder dysfunction after radical surgery. Bladder disorders are also related to the extent of radical surgery. The neuropathopysiology of lower urinary tract symptoms after radical hysterectomy is not fully understood. Recent data have highlighted the role of urethral sphincter pressure in the etiology of postoperative incontinence. Various surgical approaches have been developed to preserve autonomic pelvic innervation. CONCLUSIONS: Nerve-sparing techniques appear to improve bladder function without compromising overall survival. Studies comparing the effects of nerve-sparing radical hysterectomy with standard surgery yielded encouraging results in respect of postoperative lower urinary tract function. Clinical trials with a long period of follow-up are required for better comprehension of the complex pathophysiology of bladder dysfunction after radical hysterectomy.

Superiority of fesoterodine 8 mg vs 4 mg in reducing urgency urinary incontinence episodes in patients with overactive bladder: results of the randomised, double-blind, placebo-controlled EIGHT trial.

OBJECTIVE: To assess the superiority of fesoterodine 8 mg vs 4 mg for improvement in urgency urinary incontinence (UUI) episodes and other diary variables, diary-dry rate (proportion of patients with >0 UUI episodes on baseline diary and 0 UUI episodes on post-baseline diary), and improvements in measures of symptom bother, health-related quality of life (HRQL), and other patient-reported outcomes (PROs). PATIENTS AND METHODS: This was a 12-week, randomised, double-blind, placebo-controlled, multinational trial of men and women aged ≥18 years with overactive bladder (OAB) symptoms including UUI (ClinicalTrials.gov ID NCT01302067). Patients were randomised (2:2:1) to receive fesoterodine 8 mg, fesoterodine 4 mg, or placebo once daily; those randomised to fesoterodine 8 mg started with fesoterodine 4 mg once daily for 1 week, then 8 mg once daily for the remaining 11 weeks. Patients completed bladder diaries at baseline and weeks 4 and 12 and the Patient Perception of Bladder Condition (PPBC), Urgency Perception Scale (UPS), and Overactive Bladder Questionnaire (OAB-q) at baseline and week 12. The primary endpoint was change from baseline to week 12 in UUI episodes per 24 h. RESULTS: At week 12, patients receiving fesoterodine 8 mg (779 patients) had significantly greater reductions from baseline in UUI episodes, micturitions, and urgency episodes than patients receiving fesoterodine 4 mg (790) or placebo (386); diary-dry rate was significantly higher in the fesoterodine 8-mg group vs the fesoterodine 4-mg and placebo groups (all P < 0.05). At week 12, patients receiving fesoterodine 8 mg also had significantly greater improvements in scores on the PPBC, UPS, and all OAB-q scales and domains than patients receiving fesoterodine 4 mg or placebo (all P < 0.01). Patients receiving fesoterodine 4 mg had significantly greater improvements in UUI episodes, urgency episodes, and micturitions; significantly higher diary-dry rates; and significantly greater improvement in PPBC scores and OAB-q scores than patients receiving placebo (all P < 0.05). Dry mouth was the most commonly reported adverse event (AE) in the fesoterodine groups (placebo group, 3.4%; fesoterodine 4-mg group, 12.9%; fesoterodine 8-mg group, 26.1%); most cases were mild or moderate in all treatment groups. Rates of serious AEs and discontinuations due to AEs were low in all groups. CONCLUSIONS: In a 12-week, prospectively designed, superiority trial, fesoterodine 8 mg showed statistically significantly superior efficacy vs fesoterodine 4 mg and placebo, as measured by reductions in UUI episodes and other diary variables, diary-dry dry rate, and improvements in measures of symptom bother, HRQL, and other PROs; clear evidence of dose-dependent efficacy is unique to fesoterodine among antimuscarinics and other oral agents for the treatment of OAB. Fesoterodine 4 mg was significantly more effective than placebo on all outcomes except for improvements in UPS scores. These data support the benefit of having two doses of fesoterodine in clinical practice, with the recommended starting dose of 4 mg for all patients and the fesoterodine 8-mg dose available for patients who require a higher dose to achieve optimal symptom relief.

Secondary chemoprevention of localized prostate cancer by short-term androgen deprivation to select indolent tumors suitable for active surveillance: a prospective pilot phase II study.

PURPOSE: To investigate the impact of 3-month androgen deprivation therapy (st-ADT) a secondary chemoprevention of indolent-localized prostate cancer (PCa). METHODS: A prospective phase II study enrolled men over 4 years with low-risk PCa and the following characteristics: PSA < 10 ng/mL, Gleason score of 6 (3 + 3) or less, three positive cores or less, and tumor stage T2a or less. Patients received a single sub-cutaneous injection of 22.5 mg of leuprolide acetate with Atrigel 3-month depot associated with a daily oral intake of bicalutamide 50 mg/day during 15 days around the injection. Follow-up included PSA and bioavailable testosterone blood tests every 3 months and yearly surveillance biopsies. Primary end point was the presence of PCa on biopsy at last follow-up. Secondary end points were detailed pathological features and adverse events. RESULTS: Overall, 98 men were included and 45 of them (45.9 %) had a negative biopsy after a median follow-up of 13 months [11-19.5]. Of the 53 patients with positive biopsy, 17 had pathologic progression because of upgraded Gleason score (11 patients), four or more positive cores (three patients) or both (three patients). The only significant predictive factor biopsy outcome was the number of positive cores at diagnosis. CONCLUSIONS: Secondary chemoprevention by st-ADT for localized PCa could be useful to pinpoint indolent tumors suitable for AS. Indeed, after st-ADT nearly one patient out of two had negative biopsies and 17 % had pathological progression. This is an innovative option to consider as an alternative to current AS protocols contingent upon confirmation in subsequent studies.

A pragmatic approach to the characterization and effective treatment of male patients with postprostatectomy incontinence.

PURPOSE OF REVIEW: To highlight the recent developments in the past 12 months in the field of postprostatectomy incontinence. RECENT FINDINGS: The evaluation of postprostatectomy incontinence is mainly based on clinical details and symptoms assessment. The situation in which urodynamics will change the management and influence clinical decision-making is still unknown. MRI may play a role in the future for postprostatectomy incontinence assessment. Artificial urinary sphincter is the most widely used treatment, and the literature is full of technical reports to improve the management of challenging cases and minimize the risk of complications. Advance male sling has been the subject of multiple reports that support its safety and efficacy. Many other innovative devices have been presented but not adequately tested. SUMMARY: Evaluation of postprostatectomy incontinence is based on clinical data, involving symptoms assessment, quality of life, and incontinence severity. Endoscopy is requested, and urodynamic study indications are debated. The treatment is mainly focused on surgical options, of which artificial urinary sphincter and transobturator male slings are the two leaders. The field is critically lacking of comparative studies.

Chapter 1: The conditions of neurogenic detrusor overactivity and overactive bladder.

Overactive bladder (OAB) is a symptom syndrome consisting of urinary urgency, usually accompanied by frequency and nocturia, with or without urgency urinary incontinence (UUI), in the absence of a causative infection or pathological conditions. The prevalence of OAB is approximately 11-19% in both men and women, and leads to a significant negative effect on a patient's health-related quality of life (HRQOL). OAB is also associated with comorbidities such as urinary tract infection (UTI) and an increased risk of falls. Following behavioral therapy, anticholinergic agents are commonly prescribed, but these often fail because of lack of efficacy and/or poor tolerability. Evaluation of treatment success in OAB should include pre-defined, patient-centered goals. Patients for whom oral therapy has failed to meet such goals may be considered refractory to oral therapy and candidates for minimally invasive therapy. Neurogenic detrusor overactivity (NDO) is a bladder dysfunction frequently observed in patients with conditions such as multiple sclerosis (MS) and spinal cord injury (SCI). Increased storage pressure can put the upper urinary tract at risk of deterioration and reducing this risk is a primary aim of therapy. Urinary incontinence (UI) is reported by approximately 50% of MS patients, and most SCI patients will develop some bladder dysfunction. NDO leads to a negative impact on HRQOL, independent of the impact of the primary condition. NDO patients in whom oral therapy has failed to normalize storage pressure may be considered refractory and are candidates for minimally invasive therapy.

Urine TMPRSS2:ERG fusion transcript integrated with PCA3 score, genotyping, and biological features are correlated to the results of prostatic biopsies in men at risk of prostate cancer.

BACKGROUND: Detection of fusion gene TMPRSS2:ERG transcripts in urine have been recently described in order to refine urine-based detection of prostate cancer (PCa), but data its clinical impact remain scarce. We aimed at investigating the correlation of TMPRSS2:ERG, prostate cancer antigen 3 (PCA3), prostate specific antigen (PSA) density, genetic variants, and androgenic status with outcome and pathological findings at prostatic biopsy. METHODS: Between 2007 and 2011, 291 patients at risk of PCa because of PSA > 3.0 ng/ml (55%) or candidate to active surveillance protocol justifying restaging biopsy management (45%) were recruited. TMPRSS2:ERG was detected by urine assay (Progensa™). PCA3-score, PSA level, bioavailable testosterone level, prostate volume, rs1447295 and rs6983267 genotypes were prospectively assessed. Univariate and multivariate analysis by logistic regression model (logit) were conducted to study the correlation of TMPRSS2:ERG status, PCA3, and PSA density with biopsy results, and Gleason score. RESULTS: Of 291 patients, 173 had PCa and 118 had negative biopsy. PCA3 score, PSA density and TMPRSS2:ERG-score were correlated with presence of PCa (P < 0.0001, P = 0.046, and P < 0.0001, respectively). This correlation remained strong on multivariable analysis model (area under curve 0.743). PCA3 score and PSA density were significantly associated with presence of Grade 4 through multivariable analysis. PCA3 score was also correlated to the percentage of positive cores at biopsy (P = 0.008). CONCLUSIONS: Integration of levels TMPRSS2:ERG transcripts in urine, with PCA3-score, androgenic status, genetic status and traditional clinical variables could significantly increase detection of high risk localized PCa.

Transcorporal artificial urinary sphincter implantation as a salvage surgical procedure for challenging cases of male stress urinary incontinence: surgical technique and functional outcomes in a contemporary series.

OBJECTIVES: To describe the surgical technique of transcorporal artificial urinary sphincter (AUS) implantation. To assess the efficacy of the AUS on continence and erectile function. PATIENTS AND METHODS: A prospective evaluation was conducted between December 2007 and October 2012 at a tertiary referral centre of all male patients treated by transcorporal AUS (AMS800™, AmericanMedicalSystems, Minnetonka, MN, USA) implantation for stress urinary incontinence (SUI) recurrence, after failure of previous anti-incontinence surgery. Functional urinary outcomes were assessed according to daily pad use, the Urinary Symptom Profile questionnaire, and International Consultation on Incontinence Questionnaire - Short-Form. Erectile function was evaluated using the five-item International Index of Erectile Function (IIEF-5) questionnaire and patient satisfaction was assessed by Patient Global Impression of Improvement questionnaire. Data were collected by telephone interview. RESULTS: A total of 23 patients were included. Their mean (sd; range) age was 70 (7; 60-85) years. Of these, 18 patients had urethral atrophy and/or erosion after placement of AUS (11 patients), male sling (four patients) or both (three patients), and five patients had severe urethral atrophy after pelvic radiation therapy. The implantation of the AUS with transcorporal cuff placement was successful in all patients, with no peri-operative complications. Follow-up data over 1 year were available for 17 patients. After a median (sd; range) follow-up of 20 (15; 2-59) months, eight patients were perfectly dry (no pad use and no symptoms), five achieved social continence (less than one pad/day), and four still had SUI (required two or more pads/day). Among six patients who had good preoperative erectile function and were sexually active, four had no decrease in their IIEF-5 score. CONCLUSIONS: Transcorporal AUS cuff placement is a useful alternative for challenging cases of male SUI after failure of previous surgical treatment, urethral atrophy or erosion. Erectile function can be maintained despite dissection of the corporal body.

Prospective, multidimensional evaluation of sexual disorders in men after laser photovaporization of the prostate.

INTRODUCTION: A few studies have investigated the impact of photovaporization of the prostate (PVP) on sexual function and were mainly focused on erectile function. AIMS: To comprehensively evaluate the impact of PVP on sexual function. METHODS: A prospective evaluation involved sexually active patients needing surgical relief of bladder outlet obstruction due to benign prostatic enlargement in a single center between August 2007 and November 2011. All patients underwent PVP using the GreenLight HPS™ 120W system (AmericanMedicalSystems, Minnetonka, MN, USA). MAIN OUTCOME MEASURES: Patients were evaluated preoperatively and postoperatively by International Prostate Symptom Score (I-PSS), I-PSS question 8, uroflowmetry parameters (maximum urinary flow rate [Qmax ] and postvoid residual [PVR] volume), Danish Prostate Symptom Score Sexual items (DAN-PSSsex), and overall sexual satisfaction using a seven-grade Likert scale. Operative parameters and postoperative complications were also assessed. Preoperative and postoperative values were compared using the Pearson chi-square test and the Wilcoxon paired test. A multivariable model was used to investigate the determinants of variation of global sexual satisfaction. RESULTS: One hundred and two consecutive patients with 12-month follow-up data were included in the analysis. Urinary parameters (I-PSS, Qmax , and PVR) were significantly improved compared with preoperative values. Compared with baseline, postoperative erection symptom score was not significantly different, whereas ejaculation symptom score was significantly worse. Global DAN-PSSsex score was unchanged, but DAN-PSSsex symptom score was worse (P = 0.04) and DAN-PSSsex bother score was significantly improved (P < 0.0001). Global sexual satisfaction was significantly improved compared with baseline (P = 0.02) and was significantly associated with I-PSS but not with erection and ejaculation score in a multivariable model. CONCLUSION: Ejaculation is the main sexual function impacted by PVP. Despite this, sexual satisfaction and bother due to sexual symptoms were significantly improved, probably due to the positive impact of urinary symptom relief.

Update in management of male urinary incontinence: injectables, balloons, minimally invasive approaches.

PURPOSE OF REVIEW: The surgical armamentarium for stress urinary incontinence in men ranges from minimally invasive endoscopic procedures to artificial urinary sphincter implantation. In this rapidly moving field, respective indications of surgical options are also evolving, as evidence for the use of innovative devices is growing. This review is focused on recent data about injectables, stem cells and periurethral balloons implantation. RECENT FINDINGS: Periurethral injections are probably the most minimally invasive options, but are considered of low efficacy, with a high recurrence rate in the short term. Reinjections are often needed. However, the market share of periurethral bulking is decreasing relatively slowly. Innovative, so-called regenerative therapies, including injection of biological material, stem cells, myoblasts and muscle strings implantation have shown promising results but did not yet reach maturity for daily use in the clinic. Periurethral balloons implantation shows an acceptable success rate at mid-term follow-up, but are associated with a high rate of complications and reoperations. SUMMARY: Indications of periurethral bulking are decreasing. Regenerative therapies are still under investigation in men, and long-term studies are still required. Comparative studies against male slings and other compression devices are still awaited to accurately determine the role of periurethral balloons implantation.

Update in management of vaginal mesh erosion.

Mesh erosion is one of the major complications of prolapse surgery conducted by transvaginal approach. Following the extensive use of meshes and warning about potential complications, a new classification of mesh-related adverse events has been proposed. Due to the wide scope of clinical features, no standardized approach has been proposed. Surgery is required after failure of conservative management, mostly based on mesh partial or total excision by transvaginal route, following the classic rules of re-do vaginal surgery. Complex cases are best managed in tertiary reference centers.

Investigation of a Ca2+ channel α2δ ligand for the treatment of interstitial cystitis: results of a randomized, double-blind, placebo controlled phase II trial.

PURPOSE: We investigated PD-0299685, a Ca(2+) channel α2δ ligand, for interstitial cystitis pain in a randomized, double-blind, placebo controlled phase IIa study. MATERIALS AND METHODS: Patients with interstitial cystitis/bladder pain syndrome received 30 or 60 mg PD-0299685 daily or placebo for 12 weeks. Primary end points were change in average daily worst pain severity score (on an 11-point numerical rating scale) and change in Interstitial Cystitis Symptom Index score from baseline to week 12. Secondary end points included global response assessment, micturition and urgency episode frequency per 24 hours and mean voided volume per micturition. Incidence of adverse events was also assessed. RESULTS: Of 161 patients 54 received 30 mg PD-0299685 daily, 55 received 60 mg PD-0299685 daily and 52 received placebo. At week 12 the 60 mg dose produced a clinically significant reduction in daily worst pain severity score from baseline compared to placebo (treatment difference [90% CI] -0.82 [-1.72, 0.08]). A greater proportion of patients taking 60 mg PD-0299685 daily demonstrated improvement in global response assessment. PD-0299685 had no clinically significant effect on the Interstitial Cystitis Symptom Index score or urinary end points. More patients discontinued due to treatment related adverse events with 30 or 60 mg PD-0299685 daily than with the placebo. CONCLUSIONS: PD-0299685 failed to demonstrate positive proof of concept for the treatment of pain and other urinary end points associated with interstitial cystitis/bladder pain syndrome.

75NC007 device for noninvasive stress urinary incontinence management in women: a randomized controlled trial.

INTRODUCTION AND HYPOTHESIS: Management of stress urinary incontinence (SUI) with intravaginal devices is an alternative to surgical management, but data of a high level of evidence remain scarce. Our goal was to assess efficacy, tolerance, and acceptability of the 75NC007 intravaginal device for SUI management. METHODS: A phase III, multicenter randomized controlled trial was conducted. After an initial washout period with no treatment, allowing baseline evaluation, women with SUI were randomly assigned to a treatment or control group (no treatment). The primary endpoint was the reduction of incontinence episode frequency (IEF), according to bladder diaries, as compared to baseline. Secondary endpoints were variation of the Urinary Symptom Profile (USP) score, of 24-h pad test, and of CONTILIFE questionnaire scores as compared to baseline. Intent-to-treat and per-protocol analyses were conducted. RESULTS: Fifty-five patients were enrolled and analyzed (26 controls and 29 treated). The mean relative variations of IEF, SUI USP subscore, and overactive bladder (OAB) USP subscore were more significant in the treatment group than in the control group (-31.7 ± 65.1 % vs -7.6 ± 24.5 %, p = 0.002, -2.4 ± 2.6 vs 0.2 ± 2.2, p = 0.004, and -1.5 ± 2.8 vs 0.2 ± 1.8, p = 0.016, respectively). The dysuria USP subscore was slightly decreased in the treatment group. CONTILIFE scores were slightly improved in the treatment group. Pad test variations were not different between groups. No serious adverse event was noted throughout the entire study. CONCLUSIONS: The 75NC007 intravaginal device is a safe and effective noninvasive treatment of SUI in women.

Ajust single incision transobturator sling procedure for stress urinary incontinence: results after 1-year follow-up.

INTRODUCTION AND HYPOTHESIS: Data on the Ajust, a new single-incision sling procedure for female stress urinary incontinence (SUI) management, remain scarce and limited to a 1-year follow-up. Our goal was to assess the efficacy of this procedure after a 1-year follow-up. METHODS: This prospective evaluation involved 95 consecutive patients implanted with Ajust at a single centre. All patients had SUI on urodynamics due to urethral hypermobility, 33 % had preoperative overactive bladder (OAB) symptoms and none had detrusor overactivity. Ninety-two patients were treated on an outpatient basis, and 3 patients had general anaesthesia. Postoperative assessment was conducted at 1, 6, 12 months, and yearly thereafter. The main outcome measure was pad usage. Secondary parameters were self-reported SUI episodes, OAB symptoms, data of clinical examination, satisfaction using the Patient Global Impression of Improvement (PGI-I) scale, postoperative pain, and adverse events. RESULTS: After a mean follow-up of 21 ± 6 months (12-32), 76 out of 95 patients used no pads or one dry security pad, showing a success rate of 80 %. Seventy-nine out of 95 patients had no more SUI-related leakage. Only 6 patients experienced late recurrence of SUI after 6 months' follow-up. Perioperative complications included 1 case of vaginal hematoma, 1 case of acute urinary retention, 2 cases of urinary tract infection, all managed conservatively. Half of the patients had no pain after day 1, free of medications. Late complications were vaginal erosion in 1 case, and pain during exertion in 2 cases. CONCLUSIONS: The Ajust single incision transobturator sling is a safe and effective procedure, with durable results after 1 year.

Pelvic organ prolapse transvaginal repair by the Prolift system: evaluation of efficacy and complications after a 4.5 years follow up.

OBJECTIVES: The Prolift system is a polypropylene device designed for pelvic organ prolapse repair by a transvaginal approach. Numerous studies have reported on short-term outcomes of this procedure, but long-term studies are lacking. METHODS: A retrospective study of patients who underwent pelvic organ prolapse repair by Prolift between September 2005 and September 2008 was carried out in two tertiary reference centers by two experienced surgeons. Preoperative and postoperative follow up was based on medical records of baseline and follow-up visits with complete clinical examination, including Pelvic Organ Prolapse Quantification stage. At last follow up, the Pelvic Floor Distress Inventory-20 questionnaire was assessed by telephone interview. Cure was defined as an anatomical success at last follow up, being a Pelvic Organ Prolapse Quantification stage ≤ 1 without further surgical intervention in any compartment. RESULTS: A total of 75 patients were included in this analysis with a mean follow up of 53.7 ± 8.8 months (range 36-72 months). Patients were treated with two-arm Prolift posterior, four-arm Prolift anterior and six-arm Prolift total in three (4%), 51 (69%) and 21 (27%) cases, respectively. At last follow up, 64 (85.3%) patients were cured, with no prolapse recurrence. Mesh exposure occurred in four (5.3%) patients. The Pelvic Floor Distress Inventory-20 symptom score was low at last follow up (median 8, range 3-18), in accordance with objective cure data. CONCLUSIONS: The Prolift system is safe and efficacious for pelvic organ prolapse repair by transvaginal approach after a 4.5-year follow up.

Impact of genotyping on outcome of prostatic biopsies: a multicenter prospective study.

Single nucleotide polymorphisms (SNPs) have been associated with prostate cancer (PCa) risk and tumor aggressiveness in retrospective studies. To assess the value of genotyping in a clinical setting, we evaluated the correlation between three genotypes (rs1447295 and rs6983267[8q24] and rs4054823[17p12]) and prostatic biopsy outcome prospectively in a French population of Caucasian men. Five hundred ninety-eight patients with prostatic-specific antigen (PSA) >4 ng/mL or abnormal digital rectal examination (DRE) participated in this prospective, multicenter study. Age, familial history of PCa, body mass index (BMI), data of DRE, International Prostate Symptom Score (I-PSS) score, PSA value and prostatic volume were collected prospectively before prostatic biopsy. Correlation between genotypes and biopsy outcome (positive or negative) and Gleason score (≤6 or >6) were studied by univariate and multivariable analysis. rs1447295 and rs6983267 risk variants were found to be associated with the presence of PCa in univariate analysis. rs6983267 genotype remained significantly linked to a positive biopsy (odds ratio [OR] = 1.66, 95% confidence interval [CI]: 1.06-2.59, P = 0.026) in multivariable analysis, but rs1447295 genotype did not (OR = 1.47, 95% CI: 0.89-2.43, P = 0.13).When biopsy outcome was stratified according to Gleason score, risk variants of rs1447295 were associated with aggressive disease (Gleason score ≥7) in univariate and multivariable analysis (OR = 2.05 95% CI: 1.10-3.79, P = 0.023). rs6983267 GG genotype was not related to aggressiveness. The results did not reach significance concerning rs4054823 for any analysis. This inaugural prospective evaluation thus confirmed potential usefulness of genotyping PCa assessment. Ongoing clinical evaluation of larger panels of SNPs will detail the actual impact of genetic markers on clinical practice.