Complications of Synthetic Midurethral Slings: Is There a Relevant Discrepancy Between Observational Data and Clinical Trials?

CONTEXT: The complications of synthetic midurethral slings (MUSs) in women with stress urinary incontinence (SUI) have become a globally debated issue. OBJECTIVE: To systematically review the short- and long-term complications of mesh slings reported in observational data compared with clinical trial data, to determine whether the complication rates from clinical trials reflects "real-world" observational data. EVIDENCE ACQUISITION: PubMed and Cochrane Library were searched. Methods as detailed in Preferred Reporting Items for Systematic Reviews and Meta-analyses and Cochrane Handbook for Systematic Reviews of Interventions were followed. EVIDENCE SYNTHESIS: Thirty registries/databases including 709 335 MUS procedures (1-22 yr of follow-up) were identified. MUS procedures were associated with intraoperative bladder perforation in 0.86-3.6%, urethral perforation in 0-0.1%, vascular injury in 0.04-0.1%, voiding lower urinary tract symptoms (LUTS) in 1.47-3.5%, vaginal exposure in 0.2-1.9%, and reoperation in up to 9% of cases. Forty-three randomised clinical trials were identified, including 6284 women who underwent MUS procedures and 2177 women who underwent other interventions (1-10 yr of follow-up). MUS procedures were associated with urinary tract perforation in 2.58%, vaginal injury in 1.43%, de novo voiding LUTS in 4.37%, de novo storage LUTS in 5.41%, mesh extrusion/exposure (vaginal/urinary tract) in 2.54%, dyspareunia in 2.26%, pain (pelvic/suprapubic/perineal) in 2.83%, and reoperation for complications required in 1.82% of cases. Meta-analyses of the randomised controlled trials revealed that retropubic MUSs were associated with more events of urinary tract perforation (risk ratio [RR] 9.81, 95% confidence interval [CI] 5.05-19.04, high certainty of evidence [COE]) and voiding LUTS (RR 1.57, 95% CI 1.19-2.07, high COE) than transobturator MUSs. MUSs were associated with more events of pain than mini-slings (RR 1.72, 95% CI 1.04-2.87, moderate COE). CONCLUSIONS: Short- and long-term data on complications of polypropylene mesh used for female SUI are fairly comparable when using outcome data from well-designed clinical trials or from less structured prospective or retrospective registries. Comparisons have to be made with caution since the two systems of data collection are inherently incomparable. This knowledge should be incorporated in the discussion on how to implement polypropylene mesh for female stress incontinence. PATIENT SUMMARY: In order to know whether mesh tapes used for treating stress incontinence work well and are safe, high-quality information is important. It appears that well-designed clinical studies give similar results to large registration databases. These data should be interpreted with caution in view of the different ways the information was collected. These results will help physicians and patients understand the risks of mesh tapes.

[Use of synthetic slings and mesh implants in the treatment of female stress urinary incontinence and prolapse : Statement of the Working Group on Urological Functional Diagnostics and Female Urology of the Academy of the German Society of Urology]. / Einsatz von synthetischen Band- und Netzimplantaten bei der Behandlung von Belastungsinkontinenz und Descensus genitalis der Frau : Stellungnahme des Arbeitskreises Urologische Funktionsdiagnostik und Urologie der Frau der Akademie der Deutschen Gesellschaft für Urologie.

Due to a safety alert issued by the US Food and Drug Administration (FDA) in 2011 for transvaginal mesh implants to treat female prolapse as a result of numerous reports of complications such as infection, chronic pain, dyspareunia, vaginal erosion, shrinkage and erosion into other organs nearly all industrial products have been withdrawn from the market in the meantime. The United Kingdom, Australia, and New Zealand extended warnings and prohibitions even on the implantation of midurethral slings (TVT, TOT). In view of these current international controversies regarding the use of implanted materials for the treatment of stress incontinence and prolapse and the lack of clear guidelines for the use of biomaterials, the opinion of the Working Group on Urological Functional Diagnostics and Female Urology should provide clarity. The Opinion is based on the SCENIHR Report of the "European Commission's Scientific Committee on Emerging and Newly Identified Health Risks", the "Consensus Statement of the European Urology Association and the European Urogynaecological Association on the Use of Implanted Materials for Treating Pelvic Organ Prolapse and Stress Urinary Incontinence" and in compliance with relevant EAU and national guidelines and the opinion of the Association for Urogynaecology and Plastic Pelvic Floor Reconstruction (AGUB eV). In addition, recommendations are given for the future handling of implants of slings and meshes for the treatment of stress incontinence and prolapse from a urologic viewpoint.

[Ins and outs in the surgical treatment of female stress urinary incontinence]. / "Ins" und "outs" in der operativen Therapie der weiblichen Belastungsinkontinenz.

Proper indication, preoperative diagnostics and final choice of surgical technique in the operative management of female stress urinary incontinence are subject to somewhat irrational, trend-based changes. For various reasons (insufficient reimbursement, poor expertise, limited therapeutic spectrum) preoperative urodynamic tests are increasingly thought to be unnecessary and are progressively replaced by perineal ultrasound despite lack of evidence. Since the AWMF guidelines (AWMF: Association of the Scientific Medical Societies in Germany) for the diagnosis and treatment of stress urinary incontinence in women were published, individualized planning of therapy is "out". Unconditional guideline adherence in certified pelvic floor centers, which have become very popular in Germany, has furthermore restricted the spread of therapeutic options due to minimum procedure number requirements. With regard to suburethral tension-free alloplastic slings, the retropubic version, which was temporarily unfashionable, has been experiencing a renaissance at the cost of the transobturator alternative. Single-incision slings were developed for the outpatient US market and have never become established in Germany due to lack of proof of superiority. In the setting of a limited spectrum of surgical procedures, adjustable sling systems offer promising treatment options for risk groups with acceptance of higher infection and erosion rates, thus gaining popularity. Reliable and comprehensive preoperative patient information comprising the whole spectrum of therapeutic options with individual risks and opportunities is key to prevent the impending ban of alloplastic implants in female stress incontinence surgery.

Surgical treatment of large volume prostates: a matched pair analysis comparing the open, endoscopic (ThuVEP) and robotic approach.

OBJECTIVE: To compare open simple prostatectomy, endoscopic enucleation and laparoscopic, robot-assisted enucleation of high-volume prostate in terms of operation time, blood loss, transfusion and complication rates and early continence rates. MATERIAL AND METHODS: Patients with BPH treated endoscopically (ThuVEP, Hamburg and Hannover) or robotically (Mainz) were evaluated prospectively for prostate size, free flow and validated questionnaires (IPSS, QoL). 35 patients were matched to patients after open prostatectomy (Mainz) for age, prostate size, IPSS and QoL scores. Operation time was noted from the first cut to the last suture; blood loss was estimated by the drop of haemoglobin preoperatively and one day after surgery. Transfusion rates were documented. Early continence was estimated by pad use over the first 24 h after catheter removal. Statistical analysis was performed with SPSS 22.0. RESULTS: No significant differences in prostate size, age and preoperative questionnaires were found (p > 0.3). Postoperative flow and the results of the questionnaires were significantly improved (all p < 0.05), without difference between the approaches (p > 0.8). Endoscopic surgery showed superiority in operation time (both p < 0.05); blood loss and transfusion rates were significantly lower compared to open surgery (both p < 0.01) and lower than in robotic surgery without reaching significance (p = 0.18, p = 0.36). Similar results were seen in early continence rates. CONCLUSION: Due to our results, endoscopic surgery should be considered as first-line therapy unless there are comorbidities like diverticula and/or bladder calculi that can be easily treated simultaneously by robotic surgery. Against the background of these findings, indications favouring open surgery are getting sparse.

Long-term results of ProACT primary and repeat implantation for treatment of stress urinary incontinence in men.

INTRODUCTION: Urinary incontinence in men after radical prostatectomy affects strongly quality of life. If conservative treatment fails, surgical treatment consists of implantable devices. If the requirement of manual dexterity in the artificial sphincter is to be avoided, the ProACT system offers a readjustable system, which shows good continence, but also high revision rates. Aim of our single-centre, single-surgeon study was to evaluate the success and revision rates of ProACT over long-term follow-up and if repeat ProACT implantation after failure would be a reasonable strategy. MATERIALS AND METHODS: In May 2017, follow-up of all patients who underwent ProACT implantation between 2003 and 2013 was obtained. Parameters were numbers of pads used, filling volume of balloons, and patient-reported satisfaction. Furthermore, revisions were noted. RESULTS: Between 2003 and 2013, 134 patients were implanted a ProACT system. Median age was 71 years; median follow-up was 118 months. 112 implantations were successful (82.6%) and the number of pads used decreased significantly (p < 0.005). 63 patients were revised and 49 were successful (77.8%). No differences in success rate, pads used, or filling volume were seen (all p > 0.8). In a second revision, again, no differences in success rate or pads used were noted (all p > 0.7). Patients' personal satisfaction was high despite the high revision rate. CONCLUSION: In the hands of an experienced surgeon, ProACT is a safe and effective therapy for post-prostatectomy incontinence especially if mayor surgery is to be avoided. Revision rates are high, but the results of ProACT reimplantation are comparable to the results after the first implantation.

[Implants for genital prolapse : Contra mesh surgery]. / Implantate bei Genitalprolaps : Kontra Mesh-Operation.

Alloplastic transvaginal meshes have become very popular in the surgery of pelvic organ prolapse (POP) as did alloplastic suburethral slings in female stress incontinence surgery, but without adequate supporting data. The simplicity of the mesh procedure facilitates its propagation with acceptance of higher revision and complication rates. Since attending physicians do more and more prolapse surgeries without practicing or teaching alternative techniques, expertise in these alternatives, which might be very useful in cases of recurrence, persistence or complications, is permanently lost. It is doubtful that proper and detailed information about alternatives, risks, and benefits of transvaginal alloplastic meshes is provided to every single prolapse patient according to the recommendations of the German POP guidelines, since the number of implanted meshes exceeds the number of properly indicated mesh candidates by far. Although there is no dissent internationally about the available mesh data, thousands of lawsuits in the USA, insolvency of companies due to claims for compensation and unambiguous warnings from foreign urological societies leave German urogynecologists still unimpressed. The existing literature in pelvic organ prolapse exclusively focusses on POP stage and improvement of that stage with surgical therapy. Instead, typical prolapse symptoms should trigger therapy and improvement of these symptoms should be the utmost treatment goal. It is strongly recommended for liability reasons to obtain specific written informed consent.

[Perioperative Outcomes in Correlation to the Learning Curve for Robotic Assisted Partial Nephrectomy: The First 109 Cases of our Clinic]. / Perioperatives Outcome in Korrelation zur Lernkurve bei robotisch assistierter partieller Nephrektomie: Die ersten 109 Fälle unserer Klinik.

BACKGROUND: In contrast to conventional laparoscopic partial nephrectomy, the approach of robot-assisted partial nephrectomy (RAPN) shows a steep learning curve with shorter warm ischaemia times (WIT) and comparable postoperative outcomes. Therefore RAPN is considered a good minimally-invasive surgical procedure for patients presenting with a renal cell carcinoma in clinical stage cT1a. The aim of the presented study was to evaluate the perioperative outcomes of our patients after RAPN and to illustrate the learning curve based on characteristic perioperative parameters such as WIT. MATERIAL AND METHODS: The data of 109 patients treated by RAPN in our clinic between January 2010 and April 2015 were retrospectively analysed regarding perioperative, laboratory and oncological outcomes. Postoperative complications until 30 days after surgery were documented. We analysed the data of the largest patient population treated by a single urologist, comparing WIT, operating time, blood loss and decline of the glomerular filtration rate between the first and the second 30 consecutive cases. RESULTS: Mean WIT was 18.4 min (SD±10.2), mean operating time was 199 min (SD±20), and mean estimated blood loss was 657 millilitres (SD±715 ml). Mean loss of GFR was reported to be 4.99 mg/dl/1.73 m (2) (SD±15.44). 83 (76%) malignant lesions were removed. 11 patients (10%) had a R1 resection, one patient had a R2 resection and in 2 cases the resection status was Rx. 22% of patients developed postoperative complications. Intraoperative complications were documented in 2 cases. According to the Clavien-Dindo Classification, 6% of patients had grade 1 and 2 complications and 13% developed grade 3 and 4 complications. WIT was significantly lower after 30 consecutive cases treated by one urologist. Regarding operating time, GFR or blood loss no significant correlation was found. CONCLUSION: Our data is in line with the surgical outcomes described in the literature. RAPN is a safe surgical technique with a steep learning curve. In our experience, 30 surgical cases provide a urologist with sufficient expertise to achieve good perioperative results. Weaknesses of this report include the retrospective design and insufficient documentation in some cases.

[Gap between postulated and real outcome quality of radical prostatectomy]. / Kluft zwischen postulierter und realitätsbezogener Ergebnisqualität nach radikaler Prostatektomie.

BACKGROUND: Certified Prostate Centers proclaim congruent process and outcome quality results for treatment of prostate carcinoma. Therapy in accordance with the guidelines after presentation of the patient in an interdisciplinary conference and regular documented follow up are not in themselves a guarantee for good quality results (complication free, continence, erectile function, negative surgical margins, biochemical recurrence free), and are significantly influenced by factors not contained within the certification framework. DISCUSSION: An association between exceeding the minimum number of operations and quality assurance exists, if at all, only vaguely and on no account justifies the absolute numbers necessary for certification. Although good measuring instruments for a Pentafecta analysis are available, the gathering of quality results for a center are limited to questionnaires for functional quality results and in the non-differentiated request for a pT2R1 rate of under 10 % for oncological quality results. CONCLUSIONS: The reasons for this systematic ignoring of the for the patient so important quality results with a simultaneous excessive regard for standardizing organizational procedure processes are manifold. They comprise valid verifiability of process quality, the unclear effects of standardized treatment pathways on actual operation quality and the capitulation to statistical and patient determined problems with sufficient acquisition of comparable functional OP results. Whereas the outcome quality is more important than the process quality for patients with prostate carcinoma, the certified centers conduct themselves in exactly the opposite manner, thus creating a virtually insoluble dilemma.

Haematopoietic toxicity of radium-223 in patients with high skeletal tumour burden.

UNLABELLED: In patients with metastasized, castration resistant prostate cancer (mCRPC) treatment with radium-223 (Xofigo) is an attractive therapeutic option. In particular, patients with high tumour load seem to profit from this treatment in regard of survival and quality of live. Aim of this study was to stratify mCRPC patients according to a quantitative imaging marker derived from routine bone scans (EXINI bone) and analyze haematopoietic toxicity of Xofigo in these patients. PATIENTS, METHODS: Toxicity and oncologic outcome were investigated in a cohort of 14 patients with high tumour load. Additionally, based on a web survey, experience of toxicity in 41 high tumour load patients in Germany in 2014 was collected. RESULTS: In patients with a bone scan index (BSI) greater than 5, significant toxicity occurred in more patients than expected from the ALSYMPCA trial. This was associated with application of fewer cycles. Similar experiences have been made in other centers in Germany. Approximately 7% of these patients will need very long time or will not recover from grade ≥ 3 toxicity. CONCLUSION: Close follow-up of haematopoietic indices and, in case of toxicity, early termination of therapy is in particular necessary in late stage disease where limited bone marrow reserve is likely.

[Asymptomatic kidney stones: active surveillance vs. treatment]. / Asymptomatische Nierensteine: Wann Active Surveillance, wann Therapie?

The prevalence of kidney stones is increasing worldwide. Asymptomatic non-obstructing kidney stones are increasingly detected as an incidental finding on radiologic imaging, which has been performed more frequently over the last decades. Beside the current interventional treatment modalities such as extracorporeal shockwave lithotripsy (ESWL), ureterorenoscopy (URS) and percutaneous nephrolithotomy (PNL), active surveillance of asymptomatic kidney stones has been a focus of discussion lately, not only for attending physicians, but even more so for patients. The current German and European guidelines recommend active surveillance for patients with asymptomatic kidney stones if no interventional therapy is mandatory because of pain or medical factors. Herein we review the current literature on risks and benefits of active surveillance of asymptomatic non-obstructing kidney stones.

[Vesicovaginal fistula. Incidence, etiology and phenomenology in Germany]. / Urogenitalfistel. Inzidenz, Ätiologie und Phänomenologie in Deutschland.

BACKGROUND: Vesicovaginal fistulae are much more common in developing countries along the equatorial fistula belt than in industrialized countries. However, although the classical obstetric fistula caused by lack of medical support through pregnancy and delivery in adolescent primiparae has almost vanished in Germany, we are now facing new and predominantly iatrogenic variants. Increasing frequency of gynecological surgery as well as pelvic radiation, forgotten vaginal foreign bodies, or uninhibited cancer growth are the modern causes for vesicovaginal fistula in elderly patients. Comorbidities and genital atrophy impair surgical therapy in view of a limited success rate of conservative transient transurethral catheterization. METHODS: Diagnostics should start early and should be initially limited to vaginal inspection, cystourethroscopy, and the blue dye test. Radiological investigations including CT and MRI are only indicated in patients suspicious for ureterovaginal fistula or with inconclusive findings or malignant fistula. The surgical armamentarium comprises vaginal, abdominal, and combined approaches, which all underlie basic principles of fistula repair: protection of the ureteral orifices, complete excision of the fistula canal, accurate separation of the organs connected to the fistula, sufficient tissue mobilization for tension-free suturing, interposition of padding material for prevention of recurrency. CONCLUSION: Depending on the degree of sphincter damage, stress urinary incontinence might persist despite successful fistula repair, requiring further incontinence surgery or ultimate urinary diversion in recurrent cases that are hopeless.

[General and method-specific complications of sacrocolpopexy]. / Allgemeine und methodenspezifische Komplikationen der Sakrokolpopexie.

Sacrocolpopexy has remained standard procedure for correction of pelvic organ prolapse regardless of the affected compartment. Assuming the appropriate indication, it is characterized by an excellent long-term cure rate. Asymptomatic pelvic organ prolapse is no indication for surgery and should not be corrected in view of possible complications. This article summarizes general and method-specific complications of sacrocolpopexy, identifies causes, and allows error management to be tailored to each individual patient to increase treatment and outcome quality.

[Robotic-assisted radical prostatectomy]. / Robotisch assistierte radikale Prostatektomie.

BACKGROUND: Robot-assisted laparoscopic radical prostatectomy (RALP) has been rapidly adopted as a standard approach for surgical treatment of organ-confined prostate cancer. Despite additional costs, RALP seems to provide better functional and oncological outcomes and less blood loss compared to open radical prostatectomy (ORP). However, prospective randomized studies are still missing. PURPOSE: Based on the current literature, this review reports about the role of RALP in prostate cancer treatment. Its functional and oncologic outcomes as well as complication rates are compared to ORP. Particularly, the role of RALP in nonorgan-confined tumors will be discussed. RESULTS: Based on the current literature, RALP provides better continence and potency rates as compared to ORP. Moreover, the incidence of positive surgical margins seems to be reduced. However, there is conflicting data regarding the role of RALP in nonorgan-confined prostate cancer. Regarding long-term oncologic outcomes, RALP seems to be comparable to ORP.

[Robot-assisted laparoscopic partial nephrectomy: functional and oncological outcomes]. / Robotisch assistierte laparoskopische partielle Nephrektomie : Funktionelle und onkologische Ergebnisse.

BACKGROUND: In recent years, small renal masses (SRM) have been increasingly detected as an incidental finding of radiological or ultrasound studies for other indications. Organ-sparing renal tumor resection as open partial nephrectomy (OPN) is the international standard for renal tumors <7 cm. RESULTS: Due to technical developments, minimally invasive procedures have emerged as an alternative to OPN. In experienced hands, conventional laparoscopic partial nephrectomy (LPN) has achieved good functional and oncological results comparable to OPN. Robot-assisted laparoscopic partial nephrectomy (RAPN) has been performed since 2004. Compared to LPN, RAPN provides a faster learning curve, better visualization and more versatile instrumentation due to the degrees of freedom of the articulated instruments. After about 30 procedures, a level of experience is reached, which is characterized by good functional results, less blood loss, and shorter warm ischemia time of the kidney as compared to LPN. This can relate to a shorter hospital stay and faster recovery. Complications according to the Clavien classification are mostly grade I and II and are mainly treated conservatively. CONCLUSION: Oncological long-term results are not available yet; so that RAPN cannot be considered as an equivalent treatment to LPN and OPN. Until long-term evidence is available, decisions regarding the surgical technique for organ-sparing renal tumor resection will be determined by patient's wishes and surgeon's preference.

[Complication management in prolapse and incontinence surgery]. / Komplikationsmanagement bei der Deszensus- und Inkontinenzchirurgie.

Tension-free alloplastic slings (TFAS) have revolutionized surgery for female stress urinary incontinence for more than 20 years. The procedure is easy to perform, minimally invasive with a short operating time in an outpatient setting and has proven efficacy comparable to retropubic colposuspension. The frequency of surgery for female stress incontinence has tripled within one decade which has to have an impact on the number of complications. In contrast, sacrocolpopexy has remained the gold standard in urological prolapse surgery as none of the new techniques has reached similar efficacy or safety; however, possible complications have to be named and their causes have to be understood to maintain the highest quality of care in the future. Possible complications of TFAS are potentially underestimated with respect to prevalence and manageability. Possible complications of prolapse and incontinence surgery are presented and the underlying causes are identified. Knowledge of the pathophysiology and the cause of complications together with the results of a postoperative diagnostic work-up, allow complication management to be tailored to each individual patient. To prevent complications all conservative treatment options should have been tried preoperatively and a complete evaluation (including urodynamics) should have been carried out for every patient. Postoperative urodynamics may help to document treatment success and to identify and quantify complications.

[Diagnosis and surgical treatment of postprostatectomy stress incontinence: recommendation of the working group Urologische Funktionsdiagnostik und Urologie der Frau]. / Diagnostik und operative Therapie der Postprostatektomie-Belastungsinkontinenz : Empfehlungen des Arbeitskreises Urologische Funktionsdiagnostik und Urologie der Frau.

Today, for the surgical treatment of postprostatectomy incontinence, several treatment options are available, e.g., adjustable and functional sling systems, artificial sphincter, bulking agents, and balloons. However, no recommendations in terms of specific diagnostic tools and differentiated treatment options for everyday life are available. Our aim is to provide some clinically relevant recommendations for the necessary diagnostic workup and different treatment options of postprostatetectomy incontinence to support clinical decisions in everyday life. Treatment selection should be based on contraindications. However, there is a broad overlap of the various surgical options.

Robot-Assisted Transvesical Enucleation of Benign Prostatic Hyperplasia: Lessons from a Single Surgeon's Learning Curve.

INTRODUCTION: Open simple prostatectomy is a well-established and effective operation for prostate volumes greater than 80 gm but also associated with bleeding and urinary incontinence. To benefit from the advances of laparoscopy, robot-assisted simple prostatectomy was established. We determined the learning curve of this minimally invasive surgery by evaluating the first procedures by an experienced robotic surgeon. METHODS: Patients presenting for surgical therapy with prostate volumes greater than 80 gm were considered for the study. Evaluation included validated questionnaires preoperatively, and at 6 and 12 weeks postoperatively. Blood loss, transfusions, operation time and pad use after catheter removal were documented. The experience based on the results from 18 cases treated with robot-assisted simple prostatectomy by one of us (JWT) is presented. RESULTS: Mean age of the 18 patients was 71.2 years, mean enucleated prostate volume was 91 gm and mean preoperative flow was 9.0 ml/second. I-PSS and QoL values improved significantly from 25 to 6.1 (p <0.005) and from 5 to 1.1 (p <0.005), respectively, and flow rate increased to 28.2 ml/second (p <0.005) postoperatively. There were no significant changes in sexual performance based on IIEF (p = 0.73). Of the 18 patients 14 had complete continence immediately after catheter removal, and at 6 weeks postoperatively 17 were completely continent. Decreases in operation time from 250 to 150 minutes and blood loss from 400 to 200 ml were noted after 5 procedures. Only minor complications occurred and 1 patient required transfusion postoperatively (Clavien-Dindo II). CONCLUSIONS: Robot-assisted simple prostatectomy is a safe and effective operation for benign prostatic hyperplasia, which can be learned with good results in a rather short time.

[Renal function in the elderly after radical tumor nephrectomy and partial nephrectomy]. / Nierenfunktion im Alter nach radikaler Tumornephrektomie und partieller Nephrektomie.

Due to rising life-expectancy and increasing use of tomography more elderly patients with incidental renal tumors are being diagnosed. The current article gives an overview of kidney function after renal surgery in the elderly and the aim is to give assistance in clinical practice for deciding how to adequately treat these patients.

[Extracorporeal magnetic innervation: a non-invasive therapy for urinary incontinence?]. / "Extracorporeal magnetic innervation" : Eine Ergänzung der konservativen Inkontinenztherapie?

OBJECTIVE: Extracorporeal magnetic innervation (ExMI) is a non-invasive therapy for treatment of urinary incontinence (UI). The aim of the current study was to evaluate the efficacy of ExMI in a prospective case series. PATIENTS AND METHODS: Over a period of 1.5 years 63 consecutive patients with a clinically and urodynamically confirmed diagnosis of urinary incontinence were enrolled. All patients requested an additional non-surgical therapy option and the ExMI system (Neo control™, Kitalpha, USA) was used. The therapy consisted of 12 treatment sessions two to three times a week. Primary outcome parameter was reduction of the number of pads per 24 h and secondary outcome parameters were patient satisfaction, adverse events and duration of the therapeutic effect. RESULTS: A total of 63 patients (57 male and 6 female), mean age 68±7.1 years were recruited. After completion a significant (p=0.001) reduction of the number of pads used per 24 h was observed (from 5.4±3.7 to 2.7±2.5) which persisted after a median follow-up of 12.5 months (2.3±2.2 pads per 24 h). Also patients suffering from UI after prostatectomy revealed a significant (p=0.001) reduction in the number of pads from 4.8±2.9 to 2.6±2.6 with persistence at 2.5±2.5 at follow-up. Transient, self-limiting perineal pain in three patients was the only reported side effect. CONCLUSIONS: The ExMI procedure is an additional non-invasive therapy option for patients with urinary incontinence. However, sham-controlled studies are required to corroborate the therapy effect.

[Sacropolpopexy - pro robotic]. / Sakrokolpopexie - pro robotisch.

Abdominal sacrocolpopexy is a standard procedure for the correction of pelvic organ prolapse of all three compartments and can also be performed minimally invasively without compromising efficacy as by open techniques. In comparison to conventional laparoscopy robotic-assisted laparoscopic sacrocolpopexy benefits from several technical stand-alone features, such as three-dimensional view, increased degrees of freedom through angulated instruments, tremor filter and up and down scaling of instrument movements. These advantages facilitate preparation of the vesicovaginal and rectovaginal spaces as well as suturing and reperitonealization, which should lead to decreased operation time and anesthesia time in extreme Trendelenburg position. Surgeon also benefit from the much more ergonomic working conditions of the da Vinci® system: however, comparative studies are rare and conclusions are preliminary. The German reimbursement system (DRG) does not adequately cover da Vinci expenses which, despite the obvious advantages represents the most significant obstacle in the propagation of this technique.