Comparative study of urodynamic tests after AMS 800 and ZSI 375 insertion.

STUDY DESIGN: Retrospective, non-randomised, single-centre study. OBJECTIVES: Comparative study of urodynamic tests in patients presenting social continence after AMS 800 or ZSI 375 insertion. MATERIALS AND METHODS: Study was open to patients with social continence, implanted with AMS 800 or ZSI 375. Vesical pressure (VP), urethral functional length (FL), maximal urethral pressure (MUP), maximal urethral closure pressure (MUCP), maximal urinary flow rate (Qmax) were registered with standard urodynamic equipment. RESULTS: From March 2012 to September 2014, 27 male patients with AMS 800 and 28 with ZSI 375 were recruited. In the AMS 800 group mean VP was 25.03 cmH2O (range 13-47), mean FL 31.96 mm (range 20-52), mean MUCP 88.29 cmH2O (range 32-160), mean MUP 119.55 cmH2O (range 77-180), mean Qmax 22.86 mL/s (range 5.6-54.6). In the ZSI 375 group, mean VP was 24.89 cmH2O (range 6-40), mean FL 30.53 mm (range 12-87), mean MUCP 70.11 cmH2O (range 38-108), mean MUP 99.89 cm H2O (range 63-134), and mean Qmax 19.25 mL/s range (7.3-39.6). DISCUSSION: Results of urodynamic tests are similar for both artificial urinary sphincters. AMS 800 cuff pressure over 70 cmH2O could be explained by the pelvis pressure and the difference of altitude between the pressure-regulating balloon (PRB) and the cuff. ZSI 375 pressure-regulating tank (PRT) is not influenced by these factors. Very high MUP could be explained with too tightened cuffs. CONCLUSIONS: AMS 800 and ZSI 375 urodynamic tests are similar. Pressure of the pelvis and difference of altitude between the AMS balloon and the cuff can lead to high MUP.

Management of refractory overactive bladder in children by transcutaneous posterior tibial nerve stimulation: A controlled study.

OBJECTIVE: To assess the objective efficacy of transcutaneous posterior tibial nerve stimulation in children presenting with overactive bladder resistant to well conducted treatment. MATERIAL AND METHOD: This was a randomized, double-blind, controlled study on 20 children with OAB. All patients were previously treated with anticholinergic drugs associated with detrusor rehabilitation, diet advice, bladder-voiding hygiene and constipation treatment, with poor clinical results. Patients were randomized into two groups: -Group A: treatment with PTNS (n = 11). -Group B: sham treatment (n = 9). The program lasted 12 consecutive weeks with two 30-minutes sessions a week. Each patient underwent pre-stimulation urodynamic testing to validate bladder overactivity followed by a post-stimulation testing. Pre- and post-stimulation urodynamic parameters were compared in order to objectively evaluate the treatment's efficacy. The patients noted their incontinence episodes for 7 consecutive days in a diary before the beginning of the program, in the middle and at the end of it: this led to computing an incontinence score (score ranged from 0 to 13, from good to poor). The difference between the pre-stimulation and post-stimulation score enabled to express clinical results in terms of poor (less than a 3-point decrease), medium (a 3 to 5-point decrease), good (6 to 8-point decrease), very good (final score ranged between 0 and 3). Children were questioned regarding their impression of being stimulated or not. RESULTS: In Group A, there were five very good clinical results (45%), one medium (10%) and five poor results (45%). In group B, nine very good results (66%) and three poor results (33%) were noted. Regarding urodynamic testing, volume voided during urgency (184 mL to 265 mL), maximal cystomanometry volume (215 mL to 274 mL) and volume at the onset of the first overactive detrusor contraction (ODC) (48 mL to 174 mL) were significantly increased in Group A (p = 0.002, p = 0.024 and p = 0.001) and maximal bladder pressure during ODC had decreased (61 to 46) (p = 0.042). 85% children in group A thought they were being stimulated vs. 70% in group B. CONCLUSION: Even though we noticed urodynamics improvements in group A, which objectively supports the efficacy of TCTPNS, clinical results remained the same between the two groups. In spite of the small size of our sample, this underlines the placebo effect of any type management in this pediatric population. Studying precisely the maximal useful voltage and duration of stimulation should then be relevant in order to yield maximal benefits from this easy-to-use procedure.

Prostate cancer: what about reproducibility of decision made at multidisciplinary team management?

PURPOSE: The prostate cancer (PCa) treatment is multimodal. Thus multidisciplinary team management (MDTM) decision-making process appears as a tool to answer all aspects of PCa treatment. Our aim was to evaluate the reproducibility of therapeutic decisions made at MDTM. MATERIALS AND METHODS: We compared therapeutic decisions of PCa by presenting the same file of patient under a fake identity after 6 to 12 months from the first presentation. Forty-nine files of radical prostatectomy (RP) (28 pT2, 21 pT3) performed for clinical localized PCa were represented at MDTM which included urologist, oncologist, pathologist and radiologist. Analysis of therapeutic decisions comprised criteria such as: TNM stage, Gleason score, margin status and comorbidities. The reproducibility was assessed statistically by Kappa coefficient. RESULTS: Study subjects included 49 patients who underwent radical prostatectomy (RP). The mean age was similar in pT2 and pT3 groups (P = .09). The mean serum PSA value was 8.32 ng/mL (range, 3.56-19.5) in pT2 group and 9.4 ng/mL (range, 3.8-22) in pT3 group. The margin status in pT2 and pT3 groups was positive in 25.0% and 47.6%, respectively. The decisions made at first and second MDTM for pT2 group were the same in 100% of cases with a perfect kappa coefficient (k = 1). In the group of pT3 (n = 21), the decisions were different in 33% at the second MDTM in comparison to the first MDTM. Especially for pT3b only 29% were reproducible decision with a slight agreement (k = 0.1). Concerning pT3a, 86% of the decisions were reproducible with a substantial agreement (k = 0.74). CONCLUSION: We showed a reliability and reproducibility of decision made at MDTM when guidelines are well defined. The therapeutic attitudes were less reproducible in locally advanced PCa but decision concerning those cases should be made in the setting of guidelines.

Morbidity and functional mid-term outcomes using Prolift pelvic floor repair systems.

INTRODUCTION: We assess midterm morbidity and functional outcomes using the Prolift (Gynecare/Ethicon, Somerville, NJ) system and identify potential related risk factors. The Prolift mesh system to treat genital prolapse was introduced in 2005. It was withdrawn from the market in early 2013 after rising doubts about safety. METHODS: Over a 7-year period, we retrospectively analyzed a cohort of 112 consecutive patients who underwent the Prolift procedure since 2006. Intraoperative and postoperative complications, anatomical and functional outcomes were recorded. RESULTS: The median follow-up was 49.5 months (range: 16-85). The mean age was 64.7 ± 10.9 years (range: 40-86). Of the 112 patients, 74 patients had stage 3 (66.1%) and 8 patients had stage 4 (7.14%) vaginal prolapse. Prolift surgery was performed for pro-lapse recurrence for 26 patients (23.2%). Total mesh was used in 32 patients (29%), an isolated anterior mesh in 57 patients (51%) and an isolated posterior mesh in 23 patients (21%). Concomitant surgical procedures were performed for 44 patients (39.3%). Overall, 72% (18/25) of the complications were managed medically. We reported a failure rate of 8% (n = 9) occurring after a median follow-up of 9.5 months (range: 1-45). Among the 64 patients who had preoperative sexual activity (57.1%), de novo dyspareunia occurred in 9 patients (16.07%). We extracted predictive factors concerning failure, complications and sexuality. CONCLUSION: Despite its market withdrawal, the Prolift system was associated with good midterm anatomic outcomes and few severe complications. Long-term follow-up data are still lacking, but surgeons and patients may be reassured.

Salvage radiotherapy after high-intensity focused ultrasound treatment for localized prostate cancer: feasibility, tolerance and efficacy.

BACKGROUND: The objective of this study is to evaluate the feasibility, tolerance and efficacy of salvage external beam radiotherapy (EBRT) in persistent or recurrent prostate cancer after failed high intensity focused ultrasound (HIFU) therapy. METHODS: We reviewed data on tolerance and oncologic outcomes for all patients with biopsy-proven locally recurrent or persistent prostate cancer who underwent salvage EBRT in our department between April 2004 and June 2008. Minimum follow-up for inclusion was 2 years. Failure with EBRT was defined as biochemical relapse (Phoenix definition) or introduction of androgen deprivation therapy (ADT). Gastrointestinal and urinary toxicity and urinary stress incontinence were scored at 12 and 24 months (Radiation Therapy Oncology Group and Ingelman Sundberg rating, respectively). RESULTS: The mean age of the patients was 68.8 years (range: 60-79). Mean prostate-specific antigen (PSA) before EBRT was 5.57 ng/mL (range: 2.5-14.8). Median follow-up was 36.5 ± 10.9 months (range: 24-54). No patient received adjunctive ADT. The EBRT course was well-tolerated and completed by all patients. The mean PSA nadir was 0.62 ng/mL (range: 0.03-2.4) and occurred after a median of 22 months (range: 12-36). One patient experienced biochemical failure and was prescribed ADT 30 months after EBRT. The disease-free survival rate was 83.3% at 36.5 months. There was no major EBRT-related toxicity at 12 or 24 months. CONCLUSIONS: Our early clinical results confirm the feasibility and good tolerance of salvage radiotherapy after HIFU failure. Oncological outcomes were promising. A prospective study with longer follow-up is needed to identify factors predictive of success for salvage EBRT therapy after HIFU failure.

Six years' experience with high-intensity focused ultrasonography for prostate cancer: oncological outcomes using the new 'Stuttgart' definition for biochemical failure.

OBJECTIVE: • To determine oncological outcomes after high-intensity focused ultrasonography (HIFU) treatment in patients with localized prostate cancer using a new, more accurate, definition ('Stuttgart' definition) of biochemical failure. PATIENTS AND METHODS: • We performed a retrospective review of all patients in our centre who received first-line treatment with a second-generation Ablatherm™ device (EDAP-TMS, Lyon, France). • Oncological failure was given either by biochemical failure (prostate-specific antigen, PSA, nadir plus 1.2 g/mL) (Stuttgart definition) or the start of salvage therapy because of a persistently positive biopsy after the HIFU procedure. • The 5-year biochemical-free survival rate and 5-year disease-free survival rate were calculated. RESULTS: • In total, 53 patients were included (mean age, 72.5 ± 4.5 years, range 60-79 years; 28 low risk and 25 intermediate risk). None had undergone previous hormonal therapy. Mean ±sd follow-up was 45.4 ± 15.5 months (range 16-71 years). Mean (range) pre-treatment PSA was 8.5 ± 4 (0.29-18) ng/mL. The median (range) PSA nadir value was 1 (0.01-14) ng/mL and occurred after a mean (range) of 5.09 (3-24) months. • Overall, 36 patients (67.9%) experienced oncological failure. • These included 33 cases (62.2%) of biochemical failure. A PSA nadir of ≤0.2, 0.21-1.0 and >1 ng/mL was reached in 20.8%, 30.2% and 49% of patients, respectively, and was associated with biochemical failure in 9.1%, 30.3% and 60.6%, respectively. • The 5-year biochemical-free survival rate and disease-free survival rate were 21.7% and 13.5%, respectively. In multivariate analysis, a PSA nadir of >1 ng/mL was significantly associated with a risk of biochemical and oncological failure (P= 0.002 and P < 0.001). • Oncological failure was not associated with any risk group. • No patient died from prostate cancer. CONCLUSIONS: • In our experience, Ablatherm™ treatment for clinically localized prostate cancer was associated with a high rate of biochemical failure as determined by the 'Stuttgart' definition, and did not achieve effective cancer control. • The PSA nadir value after HIFU treatment was a significant predictor of treatment failure.