Five-year Results from the Prospective, Multicenter, Observational SOUNDS Study of Patients with Overactive Bladder Treated with the InterStim System for Sacral Neuromodulation.

BACKGROUND: Although sacral neuromodulation (SNM) for overactive bladder (OAB) is an established therapy, there is a lack of high-quality, long-term data on real-life practice. OBJECTIVE: To report on real-life therapeutic effectiveness, quality of life (QoL), disease severity, and safety as well as patient-reported symptom bother after approximately 5 yr of follow-up. DESIGN, SETTING, AND PARTICIPANTS: A total of 291 OAB patients were enrolled at 25 French sites according to local standard of care. Sacral neuromOdUlation with InterStim therapy for intractable lower uriNary tract DySfunctions (SOUNDS) enrolled both de novo and replacement patients, and a total of 229 patients were permanently implanted. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: Over the course of the study, patients were followed up six times with two follow-ups in the year after implantation and annually thereafter. Of the patients, 154 completed the final follow-up after a mean of 57.7 ± 3.9 mo. RESULTS AND LIMITATIONS: The mean number of daily leaks in urinary urge incontinence (UI) patients was reduced from 4.4 ± 3.3 at baseline to 1.8 ± 2.6 after 5 yr in de novo and from 5.4 ± 4.9 to 2.2 ± 3.0 in replacement patients (both p < 0.001). Likewise, the number of voids in urinary frequency patients was reduced compared with baseline (de novo: reduced from 12.6 ± 4.0 [baseline] to 9.6 ± 4.3 [5 yr]; replacements: reduced from 11.5 ± 4.3 [baseline] to 9.2 ± 3.1 [5 yr]; both p < 0.05). Complete continence rates after 5 yr were 44% (25/57) in de novo and 33% (5/15) in replacement UI patients, and 68% (39/57) and 67% (10/15) of UI patients were categorized as therapy responders by showing a >50% improvement in leaks. Disease severity (Urinary Symptom Profile domain 2), Numeric Rating Scale-based symptom bother, and disease-specific QoL (Ditrovie) improved significantly in both groups at all visits (p < 0.001). Adverse events related to device or procedure occurred in 51% (140/274) of patients, with 66% (152/229) of the events being classified as minor (Clavien-Dindo grade I and II). Surgical revisions were reported in 39% (89/229), which include permanent explants in 15% (34/229) of patients. CONCLUSIONS: SOUNDS demonstrates the sustained effectiveness and QoL improvements of SNM in OAB patients after 5 yr in real-world conditions while maintaining an acceptable safety profile consistent with literature. PATIENT SUMMARY: This study confirmed that French overactive bladder patients had a sustained symptom and bother reduction, and improvements in quality of life up to 5 yr after sacral neuromodulation device implantation.

Sacral Neuromodulation with the InterStim System for Overactive Bladder: 3-Year Results from the French Prospective, Multicenter, Observational SOUNDS Study.

BACKGROUND: SOUNDS strengthens the evidence basis of sacral neuromodulation (SNM) for overactive bladder (OAB) through real-world data. OBJECTIVE: To analyze diary-based effectiveness, quality of life (QoL), disease severity, symptom bother, and safety data for SNM with the InterStim system up to 3 yr after implantation. DESIGN, SETTING, AND PARTICIPANTS: Twenty-five representative French sites enrolled 291 patients with OAB followed according to the local standard of care. Overall, 229 patients received a de novo or replacement InterStim implant and had four follow-up visits, two within the first yr and annually thereafter. A total of 190 patients completed the fourth follow-up visit after a mean of 33.7 ± 3.7 mo. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: The effectiveness outcomes measured were changes in daily voids and leaks and the therapy responder rates. Other outcomes included validated QoL data (Ditrovie and EuroQol 5-dimension 5-level questionnaires), disease severity (Urinary Symptom Profile [USP]), symptom bother rated using a numeric rating scale (NRS), and safety data. Follow-up data were compared to baseline results using the Wilcoxon signed-rank test. RESULTS AND LIMITATIONS: Average daily voids and leaks were significantly reduced at all time points up to 3 yr after implantation (p < 0.05) except for voids at 21 mo in the group receiving a replacement device. The therapeutic response for urinary urge incontinence at the fourth follow-up was 72% for the de novo group and 86% for the replacement group. Disease-specific QoL (Ditrovie), OAB-specific symptom severity (USP domain 2), and NRS-rated disease bother were significantly improved at all visits (p < 0.001). Device- or procedure-related adverse events occurred in 49% of patients, with 68% of the events classified as minor (Clavien-Dindo grade I or II). Surgical revisions were performed in 33% of patients, including permanent removal in 13%, over a mean exposure time of 44.4 ± 15.3 mo. CONCLUSIONS: This study confirms the safety and effectiveness of SNM for OAB and improvements in QoL and disease bother in real life. PATIENT SUMMARY: Our study in French patients with overactive bladder showed that disease symptoms and bother were significantly reduced and quality of life was significantly improved over a study duration of approximately 3 yr after implantation of a device to stimulate nerves that control the bladder. This trial is registered at ClinicalTrials.gov as NCT02186041.

Sacral Neuromodulation with the InterStim™ System for Intractable Lower Urinary Tract Dysfunctions (SOUNDS): Results of Clinical Effectiveness, Quality of Life, Patient-Reported Outcomes and Safety in a French Multicenter Observational Study.

BACKGROUND: Real-world data that support the use of sacral neuromodulation (SNM) for lower urinary tract dysfunctions are of continued interest. OBJECTIVE: To evaluate the effectiveness, quality of life (QoL), patient-reported outcomes (PROs), and safety of SNM with the InterStim™ system in real life during 1-yr postimplant. DESIGN, SETTING, AND PARTICIPANTS: This is a prospective, multicenter, observational study at 25 representative public and private French sites. Eligible patients received SNM therapy for overactive bladder (OAB) and non-obstructive urinary retention based on local standard of care. Overall, 320 patients were enrolled; 247 received permanent implant or replacement; 204 implanted patients completed second follow-up after mean of 10.0±3.8 mo. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: Effectiveness outcomes were change in voids, leaks, and catheterizations/day. Other outcomes included validated QoL and disease severity scores as well as PROs and adverse event data. Outcomes at follow-ups were compared with baseline using the Wilcoxon signed-rank test. RESULTS AND LIMITATIONS: Voids in urinary frequency (UF) and leaks/day in urinary urge incontinence (UI) patients were significantly reduced after 10 mo in both de novo (mean baseline voids/day UF de novo: 12.7 vs 8.6 after 10 mo; p<0.001; mean baseline leaks/day UI de novo: 4.3 vs 1.1 after 10 mo; p<0.001) and replacement patients (mean baseline voids/day UF replacement: 11.5 vs 7.9 after 10 mo; p<0.001; mean baseline leaks/day UI replacement: 5.4 vs 1.0 after 10 mo; p<0.001). Disease bother, Urinary Symptom Profile score, and Ditrovie questionnaire score were also significantly improved. Revisions postimplant occurred in 20% of patients including in 9% due to permanent explantation during a mean exposure time of 24.3 mo. CONCLUSIONS: Through a real-life study, SOUNDS (Sacral neuromOdUlation with InterStim™ therapy for intractable lower uriNary tract DySfunctions) confirms the clinical effectiveness, safety, and positive effect of SNM on QoL and PROs for the treatment of OAB patients. PATIENT SUMMARY: These analyses on French patients who received sacral neuromodulation (SNM) for retention or OAB during a 10-mo period showed that SNM improved OAB symptoms, quality of life, and reduced disease bother. TRIAL REGISTRATION: ClinicalTrials.gov: NCT02186041.

Diagnostic ureteroscopy prior to nephroureterectomy for urothelial carcinoma is associated with a high risk of bladder recurrence despite technical precautions to avoid tumor spillage.

PURPOSE: There have recent reports in the literature of increased rates of bladder recurrence (BR) after radical nephroureterectomy (RNU) when diagnostic flexible ureteroscopy (DFU) was performed before RNU. The technical heterogeneity of DFU was a major bias in these studies. Our purpose was to evaluate the impact of a standardized DFU technique before RNU on the risk of BR. METHODS: A retrospective monocenter study including patients who underwent RNU for upper tract urothelial carcinoma (UTUC) between 2005 and 2017. 171 patients were identified. 78 patients were excluded owing to a history of bladder cancer before RNU or neo-adjuvant/adjuvant chemotherapy. 93 included patients were stratified according to pre-RNU ureteroscopy (DFU + 70 patients) or no pre-RNU ureteroscopy (DFU-23 patients). The standardized DFU technique consisted of systematic ureteral sheath (ch9-10), flexible ureteroscopy, biopsy, and drainage with a mono-J/bladder catheter to avoid contact of contaminated urine of the upper tract with the bladder. RESULTS: Epidemiological, initial staging, and postoperative tumoral characteristics were similar in both groups. Mean follow-up was 35 months [2-166], 47(50%) BR occurred with 41(87%) in the DFU + group, and pre-RNU-DFU was an independent predictive factor of BR (OR = 4[1.4-11.9], P = 0.01) (Cox regression model). The characteristics of BR were similar in both groups, although BR occurred earlier in DFU + (427 days vs. 226 days (P = 0.07)). CONCLUSION: Bladder recurrence after diagnostic ureteroscopy + nephroureterectomy was high despite technical precautions to avoid contact of bladder mucosa with contaminated urine from the upper urinary tract. Post-DFU endovesical instillation should be investigated.

Incidence, risk profile and morphological pattern of lower extremity venous thromboembolism after urological cancer surgery.

PURPOSE: We examined the incidence of asymptomatic and symptomatic lower extremity venous thromboembolism in patients who underwent urological surgery for cancer, and identified preoperative and operative risk factors predictive of the thromboembolism. MATERIALS AND METHODS: A cohort of 583 consecutive patients undergoing urological cancer surgery was prospectively assessed using complete lower limb ultrasound at postoperative day 7 from January 2005 to July 2009. In all patients heparin and mechanical thromboprophylaxis were prescribed until complete ambulation. Potential variables predictive of venous thrombosis were analyzed. RESULTS: Complete data were available in 538 patients (463 male and 75 female), of whom 177 underwent nephrectomy, 86 radical cystectomy and 275 radical prostatectomy. A total of 40 deep venous thrombosis cases were found (7.4%), most of which were asymptomatic (92%) and limited to deep calf veins (80%). Of those asymptomatic deep venous thrombosis cases 86% were limited to deep calf veins. In all, 12 pulmonary embolisms were diagnosed, of which 4 were lethal. On multivariate analysis history of venous thromboembolism (OR 5.16, p = 0.02) and radical cystectomy (OR 3.47, p = 0.002) were independently associated with venous thromboembolism. CONCLUSIONS: Lower extremity venous thromboembolism has a high rate of occurrence after urological surgery for cancer despite the recommended venous thromboembolism prophylaxis. Most cases are asymptomatic and limited to deep calf veins. Our results suggest that complete lower limb ultrasound should be performed early after radical cystectomy and in patients with a personal history of venous thromboembolism.

Continuous versus six months a year maximal androgen blockade in the management of prostate cancer: a randomised study.

OBJECTIVE: To evaluate systematically interrupted androgen suppression (SIAS) 6 mo a year compared with continuous androgen suppression (CAS) in prostate cancer treatment. PATIENTS AND METHODS: All patients underwent maximal androgen blockade for 6 mo. Then, depending on the randomisation arm, they continued (CAS) or stopped their treatment for 6 mo before they resumed it a year later and so on (SIAS). Primary end points were patient's health-related quality of life (HQOL) and time to progression. Secondary end points were cancer-specific and overall survival. Progression was defined by a clinical event or PSA value exceeding double the value obtained at the end of the first 6 mo of therapy. RESULTS: Sixty-two patients were randomised to CAS and 67 to SIAS. There were no significant differences between groups at baseline. Androgen suppression was associated with HQOL deterioration except for an improvement in urinary symptoms. The 6-mo off-therapy period was not long enough to regain normal testosterone values. There was no difference in HQOL scores between CAS and SIAS except that men in the latter group reported a greater need for painkillers but a better ability to have an erection. Progression occurred in 62 patients (48.1%) with no significant difference between CAS and SIAS with a mean follow-up of 44.8 mo. Death occurred in 41 patients and specific death in 19 patients (10% and 19% of the CAS and SIAS groups, respectively). CONCLUSIONS: Although patients in the SIAS group were maintained off-therapy 50% of the time, insufficient testosterone recovery in this group likely explains why differences between the two groups were moderate or absent with regards to HQOL and survival, respectively.

[Surgical treatment of penile curvature: primum non nocere]. / Traitement chirurgical des courbures de verge: a propos d'une série de 45 patients.

OBJECTIVE: This study was designed to evaluate the medium-term results of surgical treatment of penile curvature by tunica albuginea plication of tunica albuginea resection-prosthetic graft. MATERIALS AND METHODS: A retrospective study of 45 patients operated for penile curvature was performed: 38 were treated by tunica albuginea plication and 7 were treated by tunica albuginea resection-graft. Each patient returned for early (1 month), medium-term (3 months-1 year) and long-term (total mean follow-up of 34 months) postoperative review. RESULTS: Patients operated by plication were satisfied in 88.6% of cases. Significant shortening of the penis was observed in 52% of cases and one in five patients complained of disabling shortening; other complications were rare. The global satisfaction rate among patients operated by resection-graft was 29%, with 57% of residual curvature and 15% of postoperative erectile dysfunction. CONCLUSION: Tunica albuginea plication is a simple and effective technique with low morbidity for the treatment of penile curvature. Tunica albuginea resection followed by Goretex graft gives unsatisfactory results and is associated with considerable morbidity in the treatment of complex penile curvature.

Primary malignant melanoma of the adrenal gland.

Primary malignant melanoma of the adrenal gland is an established entity. Fewer than 20 cases have been reported in the published literature. Because of the high frequency of adrenal gland metastases from malignant melanoma and pigmented pheochromocytoma, several rigid diagnostic criteria have been established for accepting an adrenal melanoma as primary. A new case is reported in this article. This observation is an opportunity update the literature on the diagnostic difficulties in this rare pathology.

[Management of serious infectious complications of transobturator suburethral tape: report of 2 cases]. / Conduite a tenir face a une complication infectieuse grave d'une bandelette sous-uréthrale transobturatrice: a propos de 2 cas.

Suburethral TVT tape has become immensely popular since its invention in 1995. A new transobturator surgical approach was proposed in 2001, resulting in a modification of the quality of the tape available from various suppliers. The authors present 2 cases of obturator foramen abscess related to suburethral Uratape, occurring a long time after the procedure and requiring complete removal of the tape. These infections can be prevented by using good quality tape, which must be made from monofilament large-mesh woven polypropylene. The tape must be completely removed as early as possible in the case of vaginal erosion, even asymptomatic, via a transobturator approach, if necessary.

[Feasibility and value of the isotope sentinel node mapping technique in prostate cancer]. / Faisabilité et intérêt de la technique isotopique du ganglion sentinelle dans le cancer de la prostate.

OBJECTIVE: Use of an isotope sentinel node mapping technique in prostate cancer to study its feasibility, lymphatic prostate drainage and its value in pelvic lymph node staging. MATERIAL AND METHOD: The sentinel node mapping technique was performed in 34 patients with clinically localized prostate cancer. A transrectal intraprostatic injection of Technetium 99m-labelled nanocolloidal particles was performed on the day before radical prostatectomy. Sentinel node mapping was performed by intraoperative lymphoscintigraphy and gamma probe. A standard pelvic lymphadenectomy was systematically performed. RESULTS: Preoperative lymphoscintigraphy allowed identification of sentinel nodes in 85.3% of patients. Four of the five failures had a history of pelvic surgery. Sentinel node mapping and biopsy were possible in 23 patients (67.7%). The majority of sentinel nodes were located in the hypogastric region (58.4%). A microscopic lymph node metastasis was identified in 4 patients (11.7%), located in a sentinel node in 3 cases. In 2 cases, the micrometastasis was situated in a sentinel node outside of the pelvic chain. These four patients had a pretreatment PSA > 10 ng/ml and a Gleason score > or = 7 (on the prostatectomy specimen). CONCLUSION: This study confirms the feasibility of the sentinel node technique in prostate cancer and the diversity of lymphatic drainage of the prostate. Pelvic lymphadenectomy alone also appears to be insufficient for precise staging in patients with pretreatment PSA > 10 ng/ml and a Gleason score > 6. This isotope technique could therefore improve the yield of lymphadenectomy by limiting its extent.

[Evaluation of non-enhanced spiral CT in the assessment of renal colic: prospective series of 81 patients]. / Evaluation du scanner hélicoïdal non injecté dans la prise en charge des coliques néphrétiques: série prospective de 81 malades.

OBJECTIVE: For many years, intravenous urography has been the first-line investigation for renal colic. Since the middle of the 1990s, non-enhanced spiral CT has become a more efficient, less invasive and less expensive alternative to IVU. The aim of this study was to compare non-enhanced spiral CT and IVU in the assessment of renal colic and to evaluate the possibility of exclusive CT assessment in this disease. MATERIAL AND METHODS: Prospective study including 81 patients all undergoing urgent non-enhanced spiral CT, while the first 30 patients were investigated by non-enhanced spiral CT and IVU. RESULTS: Comparison of IVU versus CT: better sensitivity of CT for the diagnosis of renal colic (96% vs 92%) and for the detection of stones (95% vs 59%). CT diagnosis: A definitive diagnosis of renal colic was established in 72/81 patients: stone visualized in 64 cases and post colic syndrome in 8 cases, while the other 9 patients presented a non-urological abdominal disease. DISCUSSION: Comparison of our series with results reported in the literature confirms the superiority of CT over IVU with better visualization of the stone at a lower cost, with a shorter examination time, without injection and allowing the detection of non-urological disease. Analysis of CT signs emphasizes the importance of secondary signs for the diagnosis of renal colic (dilatation, perirenal or ureteric oedema, rim sign). Delayed excretion demonstrated by IVU and not directly evaluable by non-enhanced CT is no longer an argument in favour of IVU as first-line examination for the assessment of renal colic. CONCLUSION: The superiority of CT for the diagnosis of renal colic has now been demonstrated. Renal colic can now be assessed exclusively by first-line non-enhanced helical CT. IVU or contrast-enhanced CT may be indicated in rare cases when there is a doubt about the diagnosis on non-enhanced CT.

[Testicular epidermoid cyst]. / Kyste épidermoïde du testicule.

Epidermoid cyst of the testis is a rare benign tumour. The diagnosis is strongly suggested by ultrasound and MRI. Conservative surgery is possible in the case of a small isolated lesion and requires intraoperative histological confirmation. It is a constantly benign tumour that must be distinguished from testicular teratomas, justifying the search for associated neoplastic contingents requiring orchidectomy.

[Benign retroperitoneal schwannoma: report of three cases]. / Schwannome rétropéritonéal bénin: à propos de trois cas.

Schwannoma is a tumour arising from Schwann cells. It has a variable presentation and its preoperative diagnosis is difficult. Retroperitoneal schwannoma is an exceptional site. Although the great majority of schwannomas are benign, malignant forms also exist, frequently associated with Von Recklinghausen syndrome (4% of cases) or other neurofibromatoses. The authors report three cases of benign retroperitoneal schwannoma discovered in a context of low back pain, altered bowel habit or incidentally, The frequency, diagnosis, imaging and treatment of this rare tumour are discussed.

[TVT: prospective study comparing pre- and postoperative clinical, urodynamic and quality of life criteria]. / La bandelette TVT: étude prospective comparant des critères cliniques, urodynamiques et de qualité de vie pré et post-opératoire.

INTRODUCTION: This prospective study on TVT compared preoperative and postoperative urodynamic in order to evaluate the effects of TVT on the detrusor-sphincter synergy, and quality of life criteria by means of a validated questionnaire. MATERIAL AND METHOD: From August 2000 to March 2002, the authors conducted a prospective study on two sites, Nice and Marseille, on 37 patients. The inclusion criteria were clinical and urodynamic. A questionnaire evaluating the severity of incontinence and its impact on daily life was completed preoperatively and postoperatively. Thirty TVTs were placed under local anaesthesia and seven TVTs were placed under general anaesthesia. Patients were reviewed at least 6 months (mean: 9 months; range: 6 to 19 months) after the operation. Statistical analysis was based on a test for paired series, patient by patient, with an a risk of 5%. RESULTS: Eight cases of unilateral bladder perforation (21.6%) were treated by catheterization for 48 hours and 6 cases of transient acute urinary retention (16.2%) were also treated by catheterization. No haemorrhagic or infectious complications were observed. Thirty one (83.7%) patients were completely cured of their incontinence, 5 (13.5%) were improved and there was one failure. Six (75%) of the 8 patients with a urethral closing pressure less than 30 cm H2O, 6 were cured and 2 (25%) obtained a marked improvement. All criteria were compared in the same patient preoperatively and postoperatively. The maximum flow rate on uroflowmetry was significantly lower postoperatively, but no difference was observed for preoperative and postoperative detrusor sensitivity, urodynamic bladder capacity or urethral closing pressure. No de novo detrusor instability was observed. Mean severity scores and impact of incontinence scores were much lower postoperatively. CONCLUSION: The efficacy of TVT does not appear to be correlated with the severity of sphincter incompetence and did not modify the detrusor-sphincter synergy of the patients of our study. The use of a questionnaire appears to be useful and should be recommended in order to more accurately evaluate the efficacy of the surgical procedure and the improvement of the patient's quality of life.