Safety and Efficacy Report for the Use of Poly-4-Hydroxybutyrate as a Retropubic Mid-Urethral Sling (MUS) for Stress Urinary Incontinence: A Prospective 24 Months Follow-Up of New Poly-4-Hydroxybutyrate TephaFlex SUI Bioresorbable MUS.

STUDY OBJECTIVE: To investigate the feasibility and safety of the retropubic mid-urethral sling (MUS) procedure with a resorbable mesh implant made of poly-4-hydroxybutyrate (P4HB). DESIGN: A prospective clinical cohort study with 24 months follow-up. SETTING: A tertiary academic hospital. PATIENTS: Seventeen women with moderate to severe stress urinary incontinence (SUI). INTERVENTIONS: A retropubic MUS procedure with P4HB sling. MEASUREMENTS AND MAIN RESULTS: Seventeen women underwent an uncomplicated MUS procedure with a new sling made of resorbable P4HB. Following safety criteria, there has been no need to stop the study before 24 months' end point. Three serious adverse events were reported during follow-up: (1) inability to void urine after 1 week postsurgery, (2) a hysterectomy and bilateral oophorectomy performed due to a precancerous endometrial lesion at 16 months after initial MUS procedure and (3) exposed mesh with a part of device sheath left behind. These participants underwent an uncomplicated reintervention with no additional and/or permanent harm. Reinterventions because of failure of cure contained 3 second MUS procedures and one admission of urethral bulking agent. Seventy-six percent and 47 percent of patients were objectively cured of SUI at 12 and 24 months, respectively. CONCLUSIONS: Preliminary evidence suggests that a sling made of P4HB can be safely used for MUS procedures and could be an alternative for permanent polypropylene slings in patients that prefer the use of nonpermanent material.

The Microcirculation of Vaginal Tissue in Women with Obstetric Vesicovaginal Fistula and Short-Term Effects of Surgical Repair on Microvascular Parameters.

OBJECTIVES: The objective of the study was to better understand the extent of the ischemic trauma and the effects of surgical repair on the vaginal microcirculation in patients with obstetric vesicovaginal fistula (VVF). DESIGN: In this observational study, we evaluated the vaginal microvasculature surrounding VVF using handheld vital microscopy (HVM) before, during, and 2 weeks after surgical VVF repair. PARTICIPANTS: Seventeen women undergoing VVF repair were included in this study. SETTING: The study was conducted in the Fistula Care Centre in Lilongwe, Malawi. METHODS: We used HVM with incident dark-field imaging to non-invasively visualize the microvasculature of the vaginal tissue surrounding fistulas. The primary outcome was the presence of microvascular flow. Secondary outcomes included angioarchitecture, fistula closure (postoperative dye test), and urinary continence (pad weight test). RESULTS: Microvascular flow was present before, during, and after surgical repair in, respectively, 83.8%, 83.9%, and 93.4% of obtained image sequences. The angioarchitecture was normal in 75.8% of the image sequences before surgery, 69.4% at fistula closure, and 89.1% two weeks after VVF repair. Fourteen (82.4%) patients had a closed fistula after surgical repair. LIMITATIONS: The study was limited by the lack of a control group and the relatively small sample size. CONCLUSION: Although the vaginal microcirculation in women with VVF is compromised, extensive ischemic damage is not observed in the tissue surrounding fistulas. This suggests significant regenerative capacity of the vaginal vasculature in young women, or less extensive ischemic damage than presumed. Following surgical repair, we observed improvement of microcirculatory flow and angioarchitecture, suggesting that surgery is a good option for patients with obstetric VVF.

The effect of CO2 laser therapy on vaginal microcirculatory parameters in an animal model for genitourinary syndrome of menopause.

BACKGROUND: Vaginal laser therapy for the treatment of genitourinary syndrome of menopause (GSM) has been introduced to the market with limited (pre)clinical and experimental evidence supporting its efficacy. It is suggested that vaginal laser therapy increases epithelial thickness and improves vascularization, but the underlying biological working mechanism has not been substantiated yet. OBJECTIVE: To evaluate the effects of CO2 laser therapy on vaginal atrophy using noninvasive incident dark field (IDF) imaging in a large animal model for GSM. DESIGN, SETTING, AND PARTICIPANTS: An animal study was conducted between 2018 and 2019 and included 25 Dohne Merino ewes, of which 20 underwent bilateral ovariectomy (OVX) to induce iatrogenic menopause, and 5 did not. The total study duration was 10 months. INTERVENTIONS: Five months after OVX, ovariectomized ewes received monthly applications of CO2 laser (n = 7), vaginal estrogen (n = 7), or no treatment (n = 6) for 3 months. IDF imaging was performed monthly in all animals. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: The primary outcome was the proportion of image sequences containing capillary loops (angioarchitecture). Secondary outcomes included focal depth (epithelial thickness), and quantitative measures of vessel density and perfusion. Treatment effects were evaluated using ANCOVA and binary logistic regression. RESULTS AND LIMITATIONS: Compared to OVX-only, ewes treated with estrogen demonstrated a higher capillary loops proportion (4% vs. 75%, p < 0.01), and higher focal depth (60 (IQR 60-80) vs. 80 (IQR 80-80) p < 0.05). CO2 laser therapy did not change microcirculatory parameters. As the ewes' vaginal epithelium is thinner than that of humans, it may demand different laser settings. CONCLUSIONS: In a large animal model for GSM, CO2 laser therapy does not affect microcirculatory outcomes related to GSM, whereas vaginal estrogen treatment does. Until more homogeneous and objective evidence about its efficacy is available, CO2 laser therapy should not be adopted into widespread practice for treating GSM.

Non-invasive biomechanical assessment of the prolapsed vaginal wall: an explorative pilot study on cutometry and indentometry.

The clinical assessment of pelvic organ prolapse (POP) and associated treatment strategies is currently limited to anatomical and subjective outcome measures, which have limited reproducibility and do not include functional properties of vaginal tissue. The objective of our study was to evaluate the feasibility of using cutometry and indentometry for non-invasive biomechanical assessment of the vaginal wall in women with POP. Both techniques were applied on the vaginal wall of 20 women indicated for surgical correction of POP stage two or higher. The primary outcome was the measurement success rate. Measurements were considered successful if biomechanical parameters were generated after a maximum of three attempts. Secondary outcomes included acquisition time, number of attempts to obtain a successful measurement, and biomechanical parameters. Measurements were successfully performed on the anterior vaginal wall of 12 women with cystocele and the posterior vaginal wall of eight women with rectocele. The success rate was 100% for both techniques and acquisition time was under 1 minute for all 20 measurements. Tissue fast elasticity of the posterior vaginal wall (rectocele) was significantly higher than that of the anterior vaginal wall (cystocele) and negatively correlated with age (r = - 0.57, P < 0.05). In women with POP, measuring the biomechanical properties of the vaginal wall using cutometry and indentometry is technically feasible. Objective evaluation of biomechanical properties may help to understand the pathophysiology behind surgical outcomes, providing an opportunity for the identification of patients at risk for (recurrent) prolapse, and individualized treatment decisions.

Application of amniotic membranes in reconstructive surgery of internal organs-A systematic review and meta-analysis.

Amniotic membrane (AM) has great potential as a scaffold for tissue regeneration in reconstructive surgery. To date, no systematic review of the literature has been performed for the applications of AM in wound closure of internal organs. Therefore, in this systematic review and meta-analysis, we summarize the literature on the safety and efficacy of AM for the closure of internal organs. A systematic search was performed in MEDLINE-PubMed database and OVID Embase to retrieve human and controlled animal studies on wound closure of internal organs. The Cochrane Risk of Bias tool for randomized clinical trials and the SYRCLE risk of bias tool for animal studies were used. Meta-analyses (MAs) were conducted for controlled animal studies to assess efficacy of closure, mortality and complications in subjects who underwent surgical wound closure in internal organs with the application of AM. Sixty references containing 26 human experiments and 36 animal experiments were included. The MAs of the controlled animal studies showed comparable results with regard to closure, mortality and complications, and suggested improved mechanical strength and lower inflammation scores after AM application when compared to standard surgical closure techniques. This systematic review and MAs demonstrate that the application of AM to promote wound healing of internal organs appears to be safe, efficacious, and feasible.

The effects of oestrogen on vaginal wound healing: A systematic review and meta-analysis.

AIMS: To determine the effects of oestrogen or oestrogen deprivation on vaginal wound healing. Impaired wound healing following prolapse surgery may increase the risk of recurrent prolapse in the future. Vaginal oestrogen therapy may improve wound healing, hereby possibly improving surgical outcomes. METHODS: A systematic search of OVID MEDLINE, OVID Embase, and Web of Science was conducted up to January 28, 2020. We included original studies comparing wound healing-related outcomes of oestrogen exposed subjects (female animals and women) to hypo-oestrogenic subjects after vaginal surgery. Data on wound healing-related outcome measures were extracted. For each individual comparison, the standardised mean difference (Hedges' g; SMD) and 95% confidence interval (CI) were calculated. RESULTS: Of the 1474 studies reviewed, 14 studies were included for review, and 11 provided data for meta-analysis. Oestrogen improves neovascularisation (SMD: 1.13, 95% CI: 0.67-1.60), microscopic wound closure (SMD: 0.98, 95% CI: 0.66-1.29), collagen synthesis (SMD: 1.08, 95% CI: 0.42-1.74), and tissue strength (SMD: 1.26, 95% CI: 0.53-1.99) in animals. Oestrogen increases granulation (SMD: 1.67, 95% CI: 0.54-2.79) and accelerates macroscopic wound closure (SMD: 1.82, 95% CI: 1.22-2.42) in women and animals. Oestrogen decreases the inflammatory response (SMD: -0.58, 95% CI: -1.14 to -0.02) in women and animals and reduces levels of transforming growth factor (TGF)-ß1 (SMD: -1.68, 95% CI: -2.52 to -0.83) in animals. All results were statistically significant. CONCLUSIONS: Oestrogen therapy has a positive effect on vaginal wound healing. Future studies should determine whether oestrogen therapy has the potential to improve surgical outcomes.

The WOMEN-UP Solution, a Patient-Centered Innovative e-Health Tool for Pelvic Floor Muscle Training: Qualitative and Usability Study during Early-Stage Development.

e-Health may enhance self-management of pelvic floor muscle training (PFMT) to treat stress urinary incontinence (SUI). It is crucial to involve patients in planning, developing and monitoring the optimal e-Health solution. This research aims to describe patient-centered innovation in an early developmental stage of the WOMEN-UP solution. We conducted a qualitative study through a self-developed questionnaire in 22 women with SUI, to define system requirements from a patient's perspective. The first prototype of the WOMEN-UP solution was developed. It was tested by 9 patients in a usability study (think-aloud protocol and retrospective interviews). Patient preferences regarding the possible use of an e-Health solution with serious games for PFMT were: (1) to receive feedback about PFMT; (2) convenient home-use; (3) increasing motivation; (4) available in medical centers. Identified usability aids (31) reassured our design-development plan, which considered the biofeedback and serious games as key factors. Patient's perspective detected some unexpected issues related to the calibration and serious games, involving a change in the ongoing development to get an improved WOMEN-UP solution; the value of patient-centered innovation during the development of an e-Health solution for PFMT (WOMEN-UP solution). To identify patients' unmet needs, we proposed a longitudinal approach for the future eHealth-related patient-centered innovations.

Noninvasive, in vivo assessment of the cervical microcirculation using incident dark field imaging.

AIM: This study evaluates the feasibility of handheld vital microscopy for noninvasive, objective assessment of the microcirculation of the human uterine cervix. We qualitatively and quantitatively describe the microcirculation in healthy subjects in order to provide a basis for its application in cervical pathology. METHODS: Incident dark field imaging was used to image the microcirculation in four quadrants of the uterine ectocervix in ten healthy participants. If the squamocolumnar junction was visible, measurements were repeated on the endocervical columnar epithelium as well. Image acquisition time was recorded and participants scored the experienced level of discomfort. Angioarchitecture was classified according to Weber's classification. Quantitative parameters included capillary density (CD), total and perfused vessel density (TVD, PVD), proportion of perfused vessels (PPV) and microvascular flow index (MFI). RESULTS: Image acquisition was easy, fast and well tolerated. Angioarchitecture was characterized by two distinctive and organized patterns; capillary loops underneath the squamous epithelium of the ectocervix and vascular networks underneath the columnar epithelium. In the image sequences containing capillary loops, mean CD was 33.2 cpll/mm2 (95% CI 28.2-38.2 cpll/mm2). In the image sequences with vascular networks, mean TVD was 12.5 mm/mm2 (95% CI 11.2-13.77 mm/mm2), mean PVD was 12.2 (95% CI 11.0-13.5 mm/mm2), MFI was 3 and PPV was 100%. CONCLUSIONS: Incident dark field imaging allows for noninvasive, real time visualization and objective evaluation and quantification of the microcirculation of the uterine cervix. The organized vascular patterns and optimal perfusion observed in healthy subjects allow for comparison with cervical pathology, for example in patients with cervical dysplasia or cervical cancer.

Angiogenesis in gynecological cancers and the options for anti-angiogenesis therapy.

Angiogenesis is required in cancer, including gynecological cancers, for the growth of primary tumors and secondary metastases. Development of anti-angiogenesis therapy in gynecological cancers and improvement of its efficacy have been a major focus of fundamental and clinical research. However, survival benefits of current anti-angiogenic agents, such as bevacizumab, in patients with gynecological cancer, are modest. Therefore, a better understanding of angiogenesis and the tumor microenvironment in gynecological cancers is urgently needed to develop more effective anti-angiogenic therapies, either or not in combination with other therapeutic approaches. We describe the molecular aspects of (tumor) blood vessel formation and the tumor microenvironment and provide an extensive clinical overview of current anti-angiogenic therapies for gynecological cancers. We discuss the different phenotypes of angiogenic endothelial cells as potential therapeutic targets, strategies aimed at intervention in their metabolism, and approaches targeting their (inflammatory) tumor microenvironment.

Development of placental abnormalities in location and anatomy.

Low-lying placentas, placenta previa and abnormally invasive placentas are the most frequently occurring placental abnormalities in location and anatomy. These conditions can have serious consequences for mother and fetus mainly due to excessive blood loss before, during or after delivery. The incidence of such abnormalities is increasing, but treatment options and preventive strategies are limited. Therefore, it is crucial to understand the etiology of placental abnormalities in location and anatomy. Placental formation already starts at implantation and therefore disorders during implantation may cause these abnormalities. Understanding of the normal placental structure and development is essential to comprehend the etiology of placental abnormalities in location and anatomy, to diagnose the affected women and to guide future research for treatment and preventive strategies. We reviewed the literature on the structure and development of the normal placenta and the placental development resulting in low-lying placentas, placenta previa and abnormally invasive placentas.

Poor perfusion of the microvasculature in peritoneal metastases of ovarian cancer.

Most women with epithelial ovarian cancer (EOC) suffer from peritoneal carcinomatosis upon first clinical presentation. Extensive peritoneal carcinomatosis has a poor prognosis and its pathophysiology is not well understood. Although treatment with systemic intravenous chemotherapy is often initially successful, peritoneal recurrences occur regularly. We hypothesized that insufficient or poorly-perfused microvasculature may impair the therapeutic efficacy of systemic intravenous chemotherapy but may also limit expansive and invasive growth characteristic of peritoneal EOC metastases. In 23 patients with advanced EOC or suspicion thereof, we determined the angioarchitecture and perfusion of the microvasculature in peritoneum and in peritoneal metastases using incident dark field (IDF) imaging. Additionally, we performed immunohistochemical analysis and 3-dimensional (3D) whole tumor imaging using light sheet fluorescence microscopy of IDF-imaged tissue sites. In all metastases, microvasculature was present but the angioarchitecture was chaotic and the vessel density and perfusion of vessels was significantly lower than in unaffected peritoneum. Immunohistochemical analysis showed expression of vascular endothelial growth factor and hypoxia inducible factor 1α, and 3D imaging demonstrated vascular continuity between metastases and the vascular network of the peritoneum beneath the elastic lamina of the peritoneum. We conclude that perfusion of the microvasculature within metastases is limited, which may cause hypoxia, affect the behavior of EOC metastases on the peritoneum and limit the response of EOC metastases to systemic treatment.

The vaginal microcirculation after prolapse surgery.

AIMS: Oxygen plays a crucial role in wound healing after prolapse surgery. Trauma to the vaginal vasculature might limit the delivery of oxygen to the surgical wound, which may negatively affect wound healing and regeneration of connective tissue. This possibly increases the future risk of recurrence. We aimed to determine the effects of vaginal prolapse surgery on the microcirculation of the vaginal wall. METHODS: We evaluated the vaginal microcirculation in healthy participants without known vascular disease undergoing anterior and/or posterior colporrhaphy. We used incident dark-field imaging for in vivo assessment before and after (1 day, 2 weeks, and 6 weeks) surgery. We studied perfusion (microvascular flow index [MFI]), angioarchitecture (morphology/layout of microvessels) and capillary density. RESULTS: Ten women were included. Interindividual differences were observed 1 day postoperatively with regard to perfusion and angioarchitecture. Microvascular flow at the surgical site was absent or significantly reduced in some participants, whereas normal microvascular flow was observed in others (MFI range 0-3). Perfusion and angioarchitecture had been restored in all participants after 6 weeks (MFI range 2-3), regardless of the extent of vascular trauma 1 day postoperatively. CONCLUSIONS: The difference in the extent of vascular trauma between women undergoing seemingly identical surgical procedures suggests that some individuals are more susceptible to vascular trauma than others. Delivery of oxygen to the wound and subsequent wound healing may be compromised in these cases, which could be related to the development of anatomical recurrence. Future studies should investigate whether there is a relationship between the vaginal microvasculature and the recurrence of prolapse.

Validation of noninvasive focal depth measurements to determine epithelial thickness of the vaginal wall.

OBJECTIVE: This study investigates whether noninvasive focal depth (FD) measurements correlate with vaginal wall epithelial thickness (ET). If FD accurately reflects ET of the vaginal wall, this would allow noninvasive longitudinal assessment of (newly developed) treatment modalities aiming to increase ET, without the need for invasive biopsies. METHODS: Fourteen women, median age 62 years (inter quartile ranges: 57-65), undergoing vaginal prolapse surgery because of anterior and/or posterior compartment pelvic organ prolapse were included. We used the CytoCam, a handheld video microscope based on incident dark field imaging, and performed FD measurements of the vaginal wall before surgery. Histology was performed on tissue that was removed during the surgical procedure, and ET was measured in stained sections. We compared ET with FD interindividually, and determined the expected linear correlation and agreement between the two measurements. RESULTS: Seventeen ET measurements (mean 125 µm ±â€Š38.7, range 48-181 µm) were compared with 17 FD measurements (mean 128 µm ±â€Š34.3, range 68-182 µm). The lineair correlation between the two measurements was strong (r = 0.902, P < 0.01). Bland-Altman analysis demonstrated a mean difference of 13.5 µm when comparing ET to FD. CONCLUSIONS: The results demonstrate good agreement between ET and FD measurements. We consider the mean difference demonstrated with Bland-Altman analysis acceptable for these measurements. This suggests that FD accurately reflects ET, which further supports the use of FD to measure ET of the vaginal wall. For a complete assessment of the vaginal wall, FD measurements are preferably combined with the assessment of vaginal angioarchitecture.

Effects of topical estrogen therapy on the vaginal microcirculation in women with vulvovaginal atrophy.

AIMS: This study aims to assess vaginal wall angioarchitecture and function in women with vulvovaginal atrophy (VVA) and determine the effect of topical estrogen on the vaginal microcirculation. MATERIALS AND METHODS: In this prospective observational study, incident dark field imaging was used to assess the vaginal microcirculation. In patients with VVA, measurements were performed before and after treatment with topical estrogen and compared to measurements performed in women without VVA. Vaginal angioarchitecture was studied by assessing microcirculatory architecture and capillary tortuosity scores at four regions of the vaginal wall. In addition, the capillary density and microvascular flow index (MFI) were obtained. RESULTS: Seventeen women were included in this study. Of these, eight women were diagnosed with VVA and nine women were considered healthy controls. Significant differences were observed between groups with regard to microcirculatory architecture scores. The architecture of the microvasculature in women with VVA was characterized by the appearance of a vascular network without capillary loops, whereas an array of capillary loops was predominantly seen in women without VVA. After estrogen treatment, no difference in architecture scores between patients and healthy controls was observed. Capillary tortuosity, capillary density, and MFI were similar in both groups before and after estrogen treatment. CONCLUSIONS: The architecture of vaginal microvasculature is altered in patients with VVA. In case of similar vascular architecture, capillary tortuosity and density seem to be comparable. Treatment with topical estrogen results in restoration of the angioarchitecture.

Heterogeneity of cost estimates in health economic evaluation research. A systematic review of stress urinary incontinence studies.

INTRODUCTION AND HYPOTHESIS: There is increased demand for an international overview of cost estimates and insight into the variation affecting these estimates. Understanding of these costs is useful for cost-effectiveness analysis (CEA) research into new treatment modalities and for clinical guideline development. METHODS: A systematic search was conducted in Ovid MEDLINE & other non-indexed materials and Ovid Embase for articles published between 1995 and 2017. The National Health Service Economic Evaluation Database (NHS-EED) filter and the McMaster sensitive therapy filter were combined with a bespoke search strategy for stress urinary incontinence (SUI). We extracted unit cost estimates, assessed variability and methodology, and determined transferability. RESULTS: We included 37 studies in this review. Four hundred and eighty-two cost estimates from 13 countries worldwide were extracted. Descriptive analysis shows that hospital stay in gynecology ranged between €82 and €1,292 per day. Costs of gynecological consultation range from €30 in France to €158 in Sweden. In the UK, costs are estimated at €228 per hour. Costs of a tension-free vaginal tape (TVT) device range from €431 in Finland to €994 in Canada. TVT surgery per minute costs €25 in France and €82 in Sweden. Total costs of TVT range from €1,224 in Ireland to €5,809 for inpatient care in France. Variation was explored. CONCLUSIONS: Heterogeneity was observed in cost estimates for all units at all levels of health care. CEAs of SUI interventions cannot be interpreted without bias when the base of these analyses-namely costs-cannot be compared and generalized.

Embryology, anatomy, physiology and pathophysiology of the peritoneum and the peritoneal vasculature.

The peritoneum is a large serous membrane with both epithelial and mesenchymal features, and is essential for maintaining an intra-abdominal homeostatic equilibrium. The peritoneum plays a central role in the pathogenesis of a number of disorders. Pathological processes affecting the peritoneum such as inflammation and carcinomatosis can have serious clinical consequences, but the pathophysiology of these conditions is poorly understood. Understanding peritoneal embryology, anatomy and physiology is crucial to comprehend pathophysiological mechanisms and to devise a new focus for research. The vascular response to pathological processes appears to be of considerable importance, since the peritoneal vasculature plays a pivotal role in most associated diseases. Therefore, this review summarizes currently available literature with special emphasis on the development, anatomy and function of the peritoneal vasculature. Pathological processes are described to illustrate physiological and pathophysiological characteristics of the peritoneum.

Intraoperative Incident Dark Field Imaging of the Human Peritoneal Microcirculation.

BACKGROUND/AIMS: This study describes the peritoneal microcirculation, compares quantitative parameters and angioarchitecture to the standard of sublingual microcirculatory assessment, and determines the practical feasibility of this method. METHODS: Incident dark field imaging was performed of the peritoneum and sublingually to determine angioarchitecture, total and perfused vessel density (TVD and PVD), the proportion of perfused vessels (PPV), the microvascular flow index (MFI) and image acquisition time. RESULTS: Peritoneal angioarchitecture was characterized by a quadrangular network of longitudinally oriented capillaries, often flanked by fat cells. Differences between peritoneal and sublingual microcirculation were observed with regard to TVD (peritoneum 12 mm/mm2 [95% CI 10-14] vs. sublingual 23 mm/mm2 [95% CI 21-25]; p < 0.0001), PVD (peritoneum 11 mm/mm2 [95% CI 9-13] vs. sublingual 23 mm/mm2 [95% CI 21-25]; p < 0.0001), PPV (peritoneum 88% [95% CI 79-97] vs. sublingual 99% [95% CI 99-100]; p = 0.014), and MFI (peritoneum 3 [IQR 2.3-3.0] vs. sublingual 3 [IQR 3.0-3.0]; p = 0.012). There was no difference in image acquisition time (peritoneum 2: 34 min [95% CI 1: 49-3: 19] vs. sublingual 2: 38 [95% CI 1: 37-3: 32]; p = 0.916). CONCLUSION: The peritoneal microcirculation was characterized by a low capillary density and a distinctive angioarchitecture. The possibility of peri-toneal microcirculatory assessment offers promise for the study of peritoneal (patho-)physiology and (monitoring or detection of) associated diseases.

Obstacles to Successful Implementation of eHealth Applications into Clinical Practice.

eHealth can improve healthcare worldwide, and scientific research should provide evidence on the efficacy, safety and added value of such interventions. For successful implementation of eHealth interventions into clinical practice, barriers need to be anticipated. We identified seven barriers by interviewing health professionals in the Dutch healthcare system. These barriers covered three topics: financing, human factors and organizational factors. This paper discusses their potential impact on eHealth uptake. Bridging the gap between studies to assess effective eHealth interventions and their value-based implementation in healthcare is much needed.

Innovative treatment modalities for urinary incontinence: a European survey identifying experience and attitude of healthcare providers.

INTRODUCTION AND HYPOTHESIS: Urinary incontinence is a common condition in women, with a reported prevalence ranging from 25% to 51%. Of these women, an estimated 38% suffer from stress urinary incontinence (SUI). A European research consortium is investigating an innovative system based on information and communication technology for the conservative treatment of women with SUI. When introducing a new intervention, implementation barriers arise and need to be identified. Therefore, we investigated healthcare providers' experience with and attitude towards innovative care options. METHODS: We performed an online survey to assess (1) the characteristics and practice of healthcare providers, (2) current protocols for SUI, (3) current use of biofeedback, and (4) knowledge about serious gaming. The survey was sent to members of professional societies in Europe (EUGA), UK (BSUG) and The Netherlands (DPFS). RESULTS: Of 341 questionnaires analyzed (response rate between 18% and 30%), 64% of the respondents had access to a protocol for the treatment of SUI, and 31% used biofeedback when treating patients with SUI. However, 92% considered that biofeedback has a clear or probable added value, and 97% of those who did not use biofeedback would change their practice if research evidence supported its use. Finally, 89% of respondents indicated that they had no experience of serious gaming, but 92% considered that it could be useful. CONCLUSIONS: Although inexperienced, European urogynecologists and physical therapists welcome innovative treatment options for the conservative treatment of SUI such as portable wireless biofeedback and serious gaming. Scientific evidence is considered a prerequisite to incorporate such innovations into clinical practice.

Severe endocarditis and open-heart surgery during pregnancy.

A woman aged 36 years G2P1 presented at our outpatient clinic with symptoms of discomfort, dyspnoea and fever at a gestational age of 17 weeks. She was subsequently diagnosed with severe endocarditis with a large vegetation on the mitral valve. She underwent open chest mitral valve surgery while on cardiopulmonary bypass (CPB) within a few days. Such surgical intervention is not only associated with increased maternal risks, but also with severe fetal morbidity and mortality. In such patients, certain perioperative measures can diminish these risks. In this case, mitral valve plasty was successfully performed and no maternal complications occurred. 22 weeks later, she had an at term vaginal delivery of a healthy son.