The Feasibility of Practical Training in Minimally Invasive Surgery at Medical School-A Prospective Study on the Pelvitrainer.

Background and Objectives: The acquisition of practical skills at medical school is an important part of the multidimensional education program of future physicians. However, medical schools throughout the world have been slow in incorporating practical skills in their curriculum. Therefore, the aims of the present prospective study were (a) to demonstrate the feasibility of such surgical training, (b) to objectify its benefit in medical education, and (c) to investigate the impact of such training on subsequent career choices. Material and Methods: We introduced a two-day laparoscopy course on the pelvitrainer as part of the curriculum of the gynecological internship of fifth year medical students from 2019 to 2020. The results of the students' training were matched to those of surgeons who completed the same curriculum in a professional postgraduate laparoscopy course from 2017 to 2020 in a comparative study design. Additionally, we performed a questionnaire-based evaluation of the impact of the course on medical education and subsequent career choices directly before and after completing the course. Results: A total of 261 medical students and 206 physicians completed the training program. At baseline, the students performed significantly more poorly than physicians in a median of three of four exercises (p < 0.001). However, this evened out in the final runs, during which students performed more poorly than physicians only in one exercise and even better than physicians in one. The general integration of surgical training in medical school curricula was rated very low (12.4% on the VAS, IQR 3-16%) despite the high demand for such training. In the survey, the course was deemed very beneficial for medical education (median VAS 80.7%, IQR 73-98%), but did not appear to influence the students' subsequent career preferences. Conclusions: The acquisition of practical surgical skills during medical school is significantly under-represented in many medical faculties. The benefits of such training, as demonstrated in our study, would improve the education of future physicians.

Factors influencing surgical performance and learning progress in minimally invasive surgery - results of an interdisciplinary multicenter study.

BACKGROUND: Advancing surgical techniques require a high level of adaptation and learning skills on the part of surgeons. The authors need selection procedures and decision support systems for the recruitment of medical students and young surgeons. The authors aimed to investigate factors influencing the surgical performance and learning abilities of surgeons and medical students. MATERIALS AND METHODS: The training scores of persons attending 16 standardized training courses (at three training centers) of the German Working Group for Gynecological Endoscopy (AGE e.V.) from 2017 to 2020, individual characteristics, and the results of psychomotor tests of three-dimensional imagination and hand-eye coordination were correlated. Similar analyses were performed for medical students in their final clinical year from 2019 to 2020. The training concept was evaluated in a prospective, multicenter, interdisciplinary, multinational setting. RESULTS: In all, 180 of 206 physicians (response rate 87.4%) and 261 medical students (response rate 100%) completed the multistage training concept successfully. Of personal characteristics, the strongest correlation was noted for good surgical performance and learning success, and the absolute number of performed laparoscopic surgeries ( r =0.28-0.45, P <0.001/ r =0.1-0.28, P <0.05). A high score on the spatial visualization ability test was also correlated with good surgical performance ( r =0.18-0.27, P <0.01). Among medical students with no surgical experience, however, age was negatively correlated with surgical performance, that is the higher the age, the lower the surgical performance ( r =0.13/ r =0.22, P <0.05/ P <0.001). CONCLUSION: Individual factors (e.g. surgical experience, self-assessment, spatial visualization ability, eye-hand coordination, age) influence surgical performance and learning. Further research will be needed to create better decision support systems and selection procedures for prospective physicians. The possibilities of surgical training should be improved, promoted, and made accessible to a maximum number of surgical trainees because individual learning curves can be overcome even by less talented surgeons. Training options should be institutionalized for those attending medical school.

Characterization in respect to degradation of titanium-coated polypropylene surgical mesh explanted from humans.

Titanium-coated polypropylene (Ti-PP) mesh was introduced in 2002 as a surgical mesh for the treatment of hernias and shortly after for pelvic floor surgery, with the aim of improving biocompatibility when compared to non-titanised/regular PP mesh implants. The application of a titanium coating could also be beneficial to address concerns regarding the exposure of PP in an in vivo environment. Many studies have shown that PP, although it is widely accepted as a stable polymer, is subject to oxidation and degradation, such degradation affects the mechanical behavior, that is, the stiffness and tensile strength of PP mesh. Despite the wide clinical use of Ti-PP surgical meshes, no study has yet investigated the residual material properties post clinical deployment and subsequent explantation. In this study, two explanted Ti-PP mesh samples each having different incorporation durations from two patients were examined. Material analysis conducted within this study includes the following techniques: attenuated total reflectance-Fourier transform infrared spectroscopy (ATR-FTIR), Raman spectroscopy, low voltage - scanning electron microscopy (LV-SEM), backscattered electron (BSE) imaging, energy dispersive X-ray spectroscopy (EDS) and secondary election hyperspectral imaging (SEHI). The hypothesis of this study is that the Ti coating successfully shields the PP mesh from oxidative stress in vivo and thus protects it from degradation. The results of this analysis show for the first time evidence of bulk oxidation, surface degradation, and environmental stress cracking on explanted Ti-PP meshes.

The pelvitrainer for training in laparoscopic surgery - A prospective, multicenter, interdisciplinary study: Experimental research.

BACKGROUND: Minimally invasive surgical procedures have a flat learning curve, especially in the initial period of a surgeon's training. Pelvitrainers enable the prospective surgeon to drill the surgical technique, including camera navigation, instrument manipulation, and the individual steps of the operation, on a model rather than a patient. Integrating the pelvitrainer into standardized surgical training programs is challenging, but would be essential to achieve optimum effects of long duration in surgical education. MATERIAL AND METHODS: The pelvitrainer Realsimulator 2.0 (Endodevelop) was evaluated in 16 standardized training courses (at three training centers) of the German Working Group for Gynecological Endoscopy (AGE e.V.) from 2017 to 2020, The training concept was implemented and evaluated in a prospective, multicenter, interdisciplinary, multinational setting. RESULTS: One hundred and eighty of 206 physicians (response rate 87.4%) completed the multi-stage training concept successfully. A significant (p < 0.001) objective improvement (positive learning curve) was observed for all exercises on the pelvitrainer. The trainer's subjective evaluation revealed positive ratings for design (median 82%, IQR 71-91%), camera navigation (87%, IQR 76-95%), and instrument manipulation (median 87%, IQR 77-94%). A follow-up survey performed six months after the course confirmed its sustainable and high benefits in clinical routine (median 82%, IQR 70-97%). CONCLUSION: The present investigation proved the high educational value of pelvitrainers, which can be enhanced by using a structured training concept. The benefit of training courses for health care justifies their incorporation into a standardized training curriculum. The completion of such training courses should be regarded as a prerequisite for a doctor to qualify as an independent surgeon.

Laparoscopic versus vaginal native tissue repair in combination with pectopexy. Sub-analysis from an international, prospective, and multi-centre study: short term results.

INTRODUCTION: The use of mesh for vaginal repairs is currently problematic and as a consequence, there is increased interest in native tissue repair. We describe the follow-up data of a sub-analysis of a prospective and multi-center study focusing on the combination of pectopexy and native tissue repair. Patients were followed up for 12-18 months after surgery (+ SD: 15). Two-hundred and sixty-four patients attended the clinics for physical examination and were integrated into the follow-up. Cystocele repair was performed laparoscopically in 84 patients and vaginally in 52 patients. Posterior repair was performed vaginally in 40 patients and laparoscopically in 53 patients. RESULTS: Clinical success rate, patient recommendations and patient satisfaction rates were similar in both groups. The laparoscopic anterior repair resulted in an 89% cure or anatomical improvement rate; this compared to 94.2% for the vaginal approach. In the posterior group, laparoscopy resulted in a 94.3% cure or improvement rate compared to 97.5% in the second group. CONCLUSIONS: The outcomes of both strategies showed satisfactory results in our study. Consequently, surgeons may choose between the two strategies according to their preference and skill. The two approaches only differed with regard to vaginal scarring. We suggest future research investigating the long-term impact of scarring.

Preclinical safety testing and initial experience of a morcellation bag with four sealable ports.

Electromechanical morcellation-so called power morcellation-is a minimally invasive approach to remove bulky lesions such as uterine fibroids. The spread of benign and malignant tissue due to morcellation is a major concern that might limit the use of laparoscopic interventions. We present an in vitro evaluation of the safety characteristics of a four-port endobag with closable trocar sleeves, and describe physical properties of the bag that may or may not allow passage through the hole. In addition, we report our preliminary experience of this tool when used for laparoscopic supracervical hysterectomies. The behavior of the endobag during the extraction process was analyzed by extracting opened and re-sealed bags filled with 20 ml blue dye solution through a wooden template, with incisions measuring 10 to 24 mm. The endobag was used in 50 subtotal hysterectomies during the morcellation procedure. In the in vitro test, no dye loss was recorded for incisions measuring 11-24 mm. The mean force required to pull the bag through the template was inversely proportional to incision size. No bag rupture occurred during the surgical procedures. The mean time taken to prepare the bag for morcellation was 7.1 min (range, 4-14 min), the mean duration of subtotal hysterectomy was 53.4 min (range, 20-194 min). The mean weight of the removed body of the uterus was 113.8 g (range, 13-896 g), the mean weight of tissue and fluid remaining in the bag after morcellation 7.9 g (range, 0-39 g). In the in vitro setting, the improved endobag signifies greater patient safety during bag extraction, along with less tissue traumatization due to a smaller incision in the abdominal wall. The improved ergonomic features of the bag permit the insertion of three trocars in the lower abdomen and avoid closure of unused access ports. Our preliminary experience has shown that the device can be used under routine conditions. Failure rates will be evaluated in future studies.

The influence on resection line during supracervical hysterectomy: physiological extension of endometrial cells in the cervix uteri

Objective: A straight resection of corpus uteri using the sacrouterine ligament as landmark is a common method during supracervical hysterectomy. Subsequent spotting rates of up to 25% suggest the existence of residual endometrial glands in the remaining cervical tissue, casting doubt on the landmark qualities of the sacrouterine ligament. Fifty-one females who underwent total laparoscopic hysterectomy for benign diseases were investigated. Material and Methods: Macroscopic uterine parameters were determined during operation. First appearance of endometrium cells, complete disappearance of endometrial cells in the cervix and others were measured microscopically with reference to the external cervical orifice. Associations were described using odds ratio with 95% confidence interval and p-value <0.05. Results: The region of the cervix, in which exclusively cervical glands are found, is relatively small but varies considerably around the mean (mean, 23.3 mm, range, 10 to 35 mm). In this cohort in a remnant cervical stump of 23 mm length, endometrial glands would be found in 51%. There was no correlation between full cervical length and uterine parameters but smaller uteri tended to be associated with deeper endometrial penetration. Conclusion: There is a discrepancy between common definition and histological findings concerning the cervix uteri. Our findings indicate that the sacral uterine ligament is not suitable as an anatomic landmark for the laparoscopic supracervical hysterectomy operation. Regarding the distribution pattern of endometrial glands in the isthmic zone, a deep conical excision seems to better prevent subsequent spotting than a straight resection with thermocoagulation of the remaining cervical canal.

Prospective International Multicenter Pelvic Floor Study: Short-Term Follow-Up and Clinical Findings for Combined Pectopexy and Native Tissue Repair.

Efforts to use traditional native tissue strategies and reduce the use of meshes have been made in several countries. Combining native tissue repair with sufficient mesh applied apical repair might provide a means of effective treatment. The study group did perform and publish a randomized trial focusing on the combination of traditional native tissue repair with pectopexy or sacrocolpopexy and observed no severe or hitherto unknown risks for patients (Noé G.K. J Endourol 2015;29(2):210-5.). The short-term follow-up of this international multicenter study carried out now is presented in this article. MATERIAL AND METHODS: Eleven clinics and 13 surgeons in four European counties participated in the trial. In order to ensure a standardized approach and obtain comparable data, all surgeons were obliged to follow a standardized approach for pectopexy, focusing on the area of fixation and the use of a prefabricated mesh (PVDF PRP 3 × 15 Dynamesh). The mesh was solely used for apical repair. All other clinically relevant defects were treated with native tissue repair. Colposuspension or TVT were used for the treatment of incontinence. Data were collected independently for 14 months on a secured server; 501 surgeries were registered and evaluated. Two hundred and sixty-four patients out of 479 (55.1%) returned for the physical examination and interview after 12-18 months. MAIN OUTCOME AND RESULTS: The mean duration of follow-up was 15 months. The overall success of apical repair was rated positively by 96.9%, and the satisfaction score was rated positively by 95.5%. A positive general recommendation was expressed by 95.1% of patients. Pelvic pressure was reduced in 95.2%, pain in 98.0%, and urgency in 86.0% of patients. No major complications, mesh exposure, or mesh complication occurred during the follow-up period. CONCLUSION: In clinical routine, pectopexy and concomitant surgery, mainly using native tissue approaches, resulted in high satisfaction rates and favorable clinical findings. The procedure may also be recommended for use by general urogynecological practitioners with experience in laparoscopy.

Laparoscopic approaches to the retropubic space: three alternatives with anatomical considerations.

INTRODUCTION: Many urogynecological and surgical laparoscopic interventions require access to the retropubic space, also known as the space of Retzius. Especially in patients with a history of previous surgery in this area or in general in the lower abdomen, the preparation may be complicated by adhesions and scar tissue. The necessity to combine several laparoscopic procedures in one surgical session may require consideration of the most appropriate way to approach the retropubic space. MATERIAL AND METHODS: We describe and discuss three different options to access the space of Retzius via laparoscopy: the medial transperitoneal, the extraperitoneal and the lateral transperitoneal approach. For all approaches, we used one umbilical trocar and two trocars in the lower abdomen. RESULTS: An algorithm was developed to select the most appropriate access route to the retropubic space, depending on the history of previous surgeries and accompanying interventions. CONCLUSION: The knowledge of different access routes to the retropubic space offers the possibility of adjusting the surgical procedure to the individual constellation of the patient.

Prospective international multicenter pectopexy trial: Interim results and findings post surgery.

The technique of laparoscopic pectopexy was published in 2010. A subsequent randomized trial focused on pectopexy versus sacropexy revealed no new risks for patients and significant advantages in terms of operating time and de novo defecation disorders compared to sacrocolpopexy. The present international multicenter trial was performed to evaluate the applicability of the technique in clinical routine. MATERIAL AND METHOD: Eleven clinics and 13 surgeons in four European counties participated in the trial. To ensure a standardized approach and obtain comparable data, all surgeons followed the same rules in placing the apical tape, no further mesh was used. Data were collected for 14 months on a secured server; 501 surgeries were documented and evaluated. RESULTS: Patients treated at the leading center (2 surgeons) contributed 44 % of the patient population. We made a distinction between high-volume (48-135 surgeries annually) (n = 4), intermediate-volume (28-37 surgeries annually) (n = 4), and low-volume (7-22 surgeries annually) (n = 5) surgeons. 97.3 % of the patients (n = 501) had delivered children; 5.6 % had had a Caesarian section. 29.7 % of the patients had undergone a hysterectomy. The operating time for pectopexy was less than 60 min in 79 % of cases. The procedures were completed in less than 159 min in 71 % of cases. Severe complications (n = 5) included four cases of organ damage (related to concomitant surgeries or adhesions) and one case of relevant bleeding. De novo incontinence was registered in two cases and voiding dysfunction in three. No intestinal obstruction or defecation disorder was observed. Two complicated infections were noted. Urinary infection occurred in 2 % of patients. CONCLUSION: In clinical routine severe complications occurred in 1 %. The latter were unrelated to pectopexy, but occurred due to concomitant procedures or adhesions. The overall operating time as well as the operating time for pectopexy were similar to those reported in published studies on sacrocolpopexy.

[Comparison of International Guidelines For the Application of Cardiotocography]. / Vergleich internationaler Leitlinien zur Anwendung der Cardiotokografie.

OBJECTIVE: This study examines the recommendations of international guidelines on the use of antepartum and intrapartum cardiotocography. MATERIAL AND METHODS: The guidelines of Germany, Canada, UK, USA, Sri Lanka, Australia as well as FIGO have been compared. The recommendations on the use of cardiotocography were separately evaluated for antepartum and intrapartum use. RESULTS: Antepartum: In risk-free pregnancies the use of cardiotocography is not recommended in all countries. On the other hand the use of cardiotocography is indicated in the presence of a defined maternal and fetal risk factors. While the NICE guidelines recommend cardiotocography in the case of maternal hypertension, as well as preeclampsia, the German guidelines as well as SOGC list considerably more risk factors. Intrapartually, the recommendations vary greatly from country to country. While German guidelines suggest the use of cardiotocography from late 1st stage of labor, the other countries strongly recommend the auscultation of the fetal heart rate of non-risk pregnancies. This is due to the current study situation, which does not show any advantage of cardiotocography as opposed to intermittent auscultation. Furthermore studies have indicated that the use of cardiotocography caused an increase in iatrogenic induced cesarean sections. In high risk pregnancies the use of cardiotocography is strongly recommended in the compared countries, however there are major differences in the definition of high risk pregnancy and therefore the indication for cardiotocographic monitoring. CONCLUSION: Intermittent auscultation is a more cost-effective alternative compared to cardiotocography. However, in the case of legal litigation intermittent auscultation is harder to reconstruct the well-being of the newborn during birth. On the other hand cardiotocography might result in a higher cesarean section rate, but can be more helpful to prove fetal well-being during birth for a legal litigation process. Despite the lack of evidence only German guidelines recommend cardiotocographic monitoring from the late 1st stage of labor for risk-free pregnancies.

Preclinical safety testing for morcellation and extraction for an endobag with sealable ports: in vitro pilot study.

BACKGROUND: Electromechanical power morcellation is an important tool of modern laparoscopy. Recent reports on the spread of previously undetected malignancy by power morcellation indicate the need for additional protective devices to reduce this risk. We conducted a study to obtain the first data concerning the safety of an endobag with three closable ports during morcellation and subsequent bag extraction under in vitro conditions, mimicking the settings in our operating theater. The second purpose of the study was to establish a minimal width of the skin incision necessary to safely extract the sealed bag after morcellation. METHODS: The morcellation test was carried out on 11 stained porcine muscle tissue samples with one additional sample as a control. The insufflation pressure was set at 12 mmHg. After filling the endobag with blue dye solution, an additional extraction test was conducted by pulling the closed bag through a template with apertures of various diameters. For each opening, a series of ten bag extractions was carried out. RESULTS: No loss of solid material or fluid was recorded during the morcellation test. The extraction test showed a loss of fluid for template openings smaller than 18 mm. The force necessary to extract the bag was inversely related to the width of the aperture. CONCLUSIONS: The data suggest that under the evaluated conditions, the use of a closable morcellation bag can considerably improve the patient's safety during morcellation. Further studies are necessary to evaluate the influence of the bag on operating time, intervention costs and complications.

Power morcellation inside a secure endobag: a pilot study.

INTRODUCTION: Unprotected power morcellation can lead to a spread of previously undiagnosed malignancy. We present a new containment bag with two closable trocar insertion sites to reduce this risk. This pilot study was designed to assess the feasibility of this device under everyday conditions. MATERIAL AND METHODS: The containment bag was used in ten laparoscopic supracervical hysterectomies. We evaluated time requirement for bag insertion into the abdominal cavity and in-bag morcellation. A 2000 ml polyurethane morcellation bag was used for all interventions. All surgeries were carried out in a three-trocar setting. RESULTS: We carried out ten supracervical hysterectomies. No intraoperative complications and no bag ruptures occurred. The meantime requirement to insert the bag and prepare the specimen for morcellation was 10.5 min (range, 7-19 min). The mean specimen weight was 191.9 g (range, 32-710 g). Mean morcellation time was 10.5 min (range, 3-28 min), mean weight of remaining tissue and fluid in the bag after morcellation was 12.1 g (range, 7-19 g). CONCLUSIONS: The presented data demonstrate that the endobag can be successfully applied in the clinical routine. Further studies are required to evaluate additional characteristics, such as individual learning curve and time requirements.

Abdominal anatomy in the context of port placement and trocars.

Although the anatomy of the human being has not changed, technical developments in operating materials and methods demand a simultaneous development in operative management. Developments in electronic and optical technologies permit many gynecological operations to be performed laparoscopically. One fundamental distinction between any other operating method and laparoscopy is the hurdle that the initial entry, whether with a needle, cannula, or trocar, is mostly performed blind. However, there is a risk that blind entry may result in vascular or organ damage. One of the difficulties associated with entry complications is that any damage may not be immediately recognized, leading to major abdominal reparative surgery, and at worst, a temporary colostomy. Therefore, the technical and operative quality of laparoscopic surgery begins with port placement and trocars. Visual access systems are available but are not yet widely used. The aim of this review was to introduce the different port placement and trocar systems as well as their correct and professional usage in correlation with the abdominal functional anatomy.

Value of clinical and laboratory inflammation factors in the postoperative period after laparoscopic urogynecological surgery.

BACKGROUND/AIMS: Leukocytes and C-reactive protein (CRP) levels are often used to detect infections. The aim of this study was to evaluate the diagnostic and screening validity of leukocytes and CRP levels as well as body temperature >38° C to predict infections after laparoscopic sacrocolpopexy. METHODS: The study included 287 patients suffering from genital prolapse higher than POP-Q I. In addition to the sacrocolpopexy, a laparoscopic supracervical hysterectomy was performed in cases of preexisting uterus (n = 171). Leukocytes and CRP levels were analyzed preoperatively and 4 days after surgery. Early and late onset of infections was documented. RESULTS: Urinary tract infection was identified as the most frequent early postoperative complication (11.4%). Early wound infections were found in 2.8% of the patients (8/287). Late onset of infections was found in 1% of patients (3/287). Areas under ROC curves were low for both leukocytes (0.52, 95% CI: 0.37-0.66) and CRP levels (0.60, 95% CI: 0.44-0.77). CONCLUSION: Our findings question the benefit of routine determination of leukocytes and CRP levels 4 days after surgery. The sensitivity and specificity of leukocytes and CRP levels are probably more significant after normalization of the initial tissue response (days 8-10).

Laparoscopic hysterectomy and prolapse: a multiprocedural concept.

BACKGROUND AND OBJECTIVES: Today, laparoscopic intrafascial hysterectomy and laparoscopic supracervical hysterectomy are well-accepted techniques. With our multimodal concept of laparoscopic hysterectomy for benign indications, preservation of the pelvic floor as well as reconstruction of pelvic floor structures and pre-existing prolapse situations can be achieved. METHODS: The multimodal concept consists of 3 steps: 1. Intrafascial hysterectomy with preservation of existing structures. A. Technique 1: Primary uterine artery ligation. B. Technique 2: Classic intrafascial hysterectomy. 2. A technique for the stable fixation of the vaginal or cervical stump. 3. A new method of pectopexy to correct a pre-existing descensus situation. RESULTS AND CONCLUSTION: This well-balanced concept can be used by advanced endoscopic gynecologic surgeons as well as by novices in our field.

Sexual impairment in women undergoing laparoscopic surgery for genital prolapse: a hospital-based cohort study.

INTRODUCTION: No data regarding sexuality following laparoscopic prolapse surgery are available to date. Our hypothesis is that laparoscopic sacropexy does not influence sexuality negatively, whereas concomitant (vaginal) surgery negatively influences sexuality. METHODS: Participants were 132 patients who underwent laparoscopic sacropexy. We compared pre- and postoperative sexual scores by 2 validated questionnaires. RESULTS: The response rate was 84% (111/132). No change in sexual activity was reported after surgery. In the sexually active group (56.8%; 63/111) the impairment of sexuality was significantly reduced in all age groups independently of concomitant vaginal surgery. In the sexually inactive group, only 4.3% (2/48) were inactive because of vaginal symptoms before operation. After the operation these patients stayed inactive; however, 1 reported reasons unrelated to prolapse. CONCLUSIONS: Laparoscopic prolapse surgery reduces sexual impairment in sexually active patients. There appears to be no benefit for patients who are not sexually active for reasons related to the prolapse. Concomitant surgery does not affect sexual activity.

The German version of the 'ICIQ Vaginal Symptoms Questionnaire' (German ICIQ-VS): an instrument validation study.

INTRODUCTION: No validated questionnaire that evaluates vaginal symptoms is currently available in the German language. Here, we report the translation and validation process of the German ICIQ-VS. SUBJECTS: Pilot study: 10 patients without any specific disease. MAIN STUDY: 58 Patients (cases) suffering from genital descensus higher than grade 1 pelvic organ prolapse quantification (POPQ) and 51 patients (controls) without vaginal affections. METHODS: To establish a cultural-adaptive equivalent in German, recommendations from Guillemin et al. [J Clin Epidemiol 1993;46:1417-1432] were carefully followed. Participants of the main study were asked to fill in the questionnaire at three time points [baseline (T1), 7 days later (T2) and 1 year later (T3)]. Reliability, validity and sensitivity to change were evaluated. RESULTS: In our pilot study, all questionnaire items were correctly interpreted and answered. In the main study, no changes from the original format were observed after translation and cultural adaptation. For the cases, internal consistency was acceptable (Cronbach's alpha 0.72-0.79) and test-retest reliability was moderate to near-perfect for single items (weighted kappa 0.67-0.94). Sensitivity to change and content validity were excellent. Construct validity revealed statistically significant differences between groups. CONCLUSION: The ICIQ-VS has successfully been translated and validated into the German language.