Protocol for the value of urodynamics prior to stress incontinence surgery (VUSIS) study: a multicenter randomized controlled trial to assess the cost effectiveness of urodynamics in women with symptoms of stress urinary incontinence in whom surgical treatment is considered

BACKGROUND: Stress urinary incontinence (SUI) is a common problem. In the Netherlands, yearly 64.000 new patients, of whom 96% are women, consult their general practitioner because of urinary incontinence. Approximately 7500 urodynamic evaluations and approximately 5000 operations for SUI are performed every year. In all major national and international guidelines from both gynaecological and urological scientific societies, it is advised to perform urodynamics prior to invasive treatment for SUI, but neither its effectiveness nor its cost-effectiveness has been assessed in a randomized setting. The Value of Urodynamics prior to Stress Incontinence Surgery (VUSIS) study evaluates the positive and negative effects with regard to outcome, as well as the costs of urodynamics, in women with symptoms of SUI in whom surgical treatment is considered. METHODS/DESIGN: A multicentre diagnostic cohort study will be performed with an embedded randomized controlled trial among women presenting with symptoms of (predominant) SUI. Urinary incontinence has to be demonstrated on clinical examination and/or voiding diary. Physiotherapy must have failed and surgical treatment needs to be under consideration. Patients will be excluded in case of previous incontinence surgery, in case of pelvic organ prolapse more than 1 centimeter beyond the hymen and/or in case of residual bladder volume of more than 150 milliliter on ultrasound or catheterisation. Patients with discordant findings between the diagnosis based on urodynamic investigation and the diagnosis based on their history, clinical examination and/or micturition diary will be randomized to operative therapy or individually tailored therapy based on all available information. Patients will be followed for two years after treatment by their attending urologist or gynaecologist, in combination with the completion of questionnaires. Six hundred female patients will be recruited for registration from approximately twenty-seven hospitals in the Netherlands. We aspect that one hundred and two women with discordant findings will be randomized. The primary outcome of this study is clinical improvement of incontinence as measured with the validated Dutch version of the Urinary Distress Inventory (UDI). Secondary outcomes of this study include costs, cure of incontinence as measured by voiding diary parameters, complications related to the intervention, re-interventions, and generic quality of life changes. TRIAL REGISTRATION: Clinical Trials NCT0081474

Development and measurement of guidelines-based quality indicators of caesarean section care in the Netherlands: A RAND-modified delphi procedure and retrospective medical chart review

Background There is an ongoing discussion on the rising CS rate worldwide. Suboptimal guideline adherence may be an important contributor to this rise. Before improvement of care can be established, optimal CS care in different settings has to be defined. This study aimed to develop and measure quality indicators to determine guideline adherence and identify target groups for improvement of care with direct effect on caesarean section (CS) rates. Method Eighteen obstetricians and midwives participated in an expert panel for systematic CS quality indicator development according to the RAND-modified Delphi method. A multi-center study was performed and medical charts of 1024 women with a CS and a stratified and weighted randomly selected group of 1036 women with a vaginal delivery were analysed. Quality indicator frequency and adherence were scored in 2060 women with a CS or vaginal delivery. Results The expert panel developed 16 indicators on planned CS and 11 indicators on unplanned CS. Indicator adherence was calculated, defined as the number of women in a specific obstetrical situation in which care was performed as recommended in both planned and unplanned CS settings. The most frequently occurring obstetrical situations with low indicator adherence were: 1) suspected fetal distress (frequency 17%, adh

Risk factors at caesarean section and failure of subsequent trial, of labour

Objective: To identify risk factors at caesarean section (CS), related to failure of a trial of labour (TOL) in subsequent pregnancy. Study design: Hospital records (1988-1999) of the index pregnancy were reviewed at caesarean delivery for oxytocine use, indication for caesarean, dilatation of cervix, speed of dilatation, duration of contractions and birth weight. The records of the subsequent pregnancy were reviewed for successful vaginal birth after caesarean (VBAC), maternal and neonatal outcome. Data were tested for statistical significance with a Mantel-Haenszel equation for odds ratios (OR, with 95% confidence interval (CI)), a Fisher exact test or a Student's T-test. Results: From 214 women with a previous caesarean section, 68.7% underwent a TOL, which was successful in 71.4%. A labour pattern during the index pregnancy characterised by oxytocine use (OR = 3.1; 95% Cl = 1.4-7.1), contractions for more than 12 h (OR = 3.0; 95% Cl = 1.3-7.0) and cervical dilatation less than 1 cm/h (OR = 5.6; 95% Cl = 1.1-39.4) increased the risk of a failed TOL at subsequent labour significantly. Conclusion: Women who attempt VBAC may be informed that a labour pattern of their index pregnancy characterised by oxytocine use, contractions for more than 12 h and slow dilatation is associated with a reduced chance of success. A partograph obtained during first labour can be a managerial tool for subsequent labour. (C) 2002 Elsevier Science Ireland Ltd. All rights reserve

Survey on surgery for stress urinary incontinence in an era mid-urethral slings are being questioned

INTRODUCTION: Concerns about vaginal mesh have reduced the use of mid-urethral slings (MUS) in some countries. In view of their potential withdrawal in Belgium and The Netherlands, we polled urogynaecologists on their practice for treating stress urinary incontinence (SUI) and what their experience is with alternative procedures, and we asked them how their patients perceive the risk and success rates. METHODS: A survey among members of the pelvic floor special interest group of the Flemish Society for Obstetrics and Gynaecology, Belgian Association of Urology and Dutch Society of Obstetrics and Gynaecology. RESULTS: Their primary procedure of choice is the MUS (99%). Sixty-five per cent performs at least 25 MUS yearly; they report high success (90%; IQR [85-92]) and low adverse outcome rates. Physicians anticipate complications as reported in the literature: 5% (IQR [410]) overactive bladder, 5% (IQR [2-10]) voiding problems, 2% (IQR [15]) exposures, 2% (IQR [1-5]) dyspareunia and 1% (IQR [1-3]) chronic pain. Eighty-five per cent of physicians report their patients express fears about having a MUS though usually they cannot precisely tell why. Reportedly they tell their physicians of concerns about pain (54%), exposure (45%), dyspareunia (25%), voiding problems (15%) or overactive bladder (8%). Only half of respondents had ever performed a colposuspension. The majority of these were older and performed colposuspension via laparotomy. Only six (4%) had performed > 20 colposuspensions yearly. CONCLUSION: Dutch and Belgian urogynaecologists estimate success and adverse effect rates of MUS in line with the literature. Their patients most cited worries were fear of chronic pain and exposure. Only half of respondents had ever performed a colposuspension. They were older and performed the procedure via laparotomy.status: publishe

Trial of labour after two or three previous caesarean sections

Objective: To investigate the safety of a trial of labour (TOL) after two or three previous caesarean sections. Study design: Retrospective analysis of medical records of women with a history of more than one previous caesarean section who gave birth during a 10-year period (1988-1997) in two large university hospitals in The Netherlands. Results: Women numbering 30,132 gave birth with a hospital caesarean birth rate of 14.8%. There were 246 women with a history of more than one previous caesarean section: 187 (76%) delivered by elective repeat caesarean section (ERCS); 59 (24%) had a trial of labour, of whom 49 (83%) had a vaginal birth. Three uterine ruptures occurred after previous lower segment caesarean sections without maternal or perinatal mortality related to the uterine rupture; only one rupture was during a trial of labour. In the study group there was no maternal mortality. Maternal morbidity did not differ between women with an elective repeat caesarean or a failed trial of labour. Perinatal mortality was not related to the mode of delivery. Conclusion: Elective repeat caesarean section is not the only answer to a woman with two or three previous caesarean sections. A trial of labour can be a safe option for a selected group of women. (C) 2003 Elsevier Science Ireland Ltd. All rights reserve

Variation in the practice of laparoscopic sacrohysteropexy and laparoscopic sacrocolpopexy for the treatment of pelvic organ prolapse: a Dutch survey

INTRODUCTION AND HYPOTHESIS: Laparoscopic techniques for pelvic organ prolapse surgery using mesh are gaining interest. A standard approach or published guideline for the laparoscopic sacrohysteropexy (LSH) or laparoscopic sacrocolpopexy (LSC) is lacking. The purpose of this study is to assess the variation between Dutch gynecologists in executing LSH and LSC. METHODS: A questionnaire was developed to evaluate the technique of LSH and LSC. All members of the Dutch Society for Gynecological Endoscopy and Minimally Invasive Surgery and the Dutch Society for Urogynecology were invited by email to participate in a web-based survey. RESULTS: With 357 respondents, the response rate was 71%. Of the respondents, a total of 49 gynecologists (13.7%) perform LSH and/or LSC. Gynecologists who perform both procedures use the same surgical technique for LSH and LSC. There are variations among gynecologists on several key points such as the level of dissection along the anterior and posterior walls of the vagina, the type of mesh used, the type of sutures used, the tension of the implanted mesh and reperitonealization of the mesh. CONCLUSIONS: There is a high practice variation in LSH and LSC performed by a selected group of Dutch gynecologists. Different methods have been described in the literature and there is no consensus on how to perform these procedures. A well-designed prospective study or randomized controlled trial with regard to the specific parts of these procedures is needed to provide evidence for the best surgical technique. The outcomes of these studies will help to establish evidence-based guidelines

Treatment of vaginal vault prolapse in The Netherlands: a clinical practice survey

Introduction and hypothesis: A great variety of conservative and surgical procedures to correct vaginal vault prolapse have been reported. The aim of this study was to describe practice pattern variation—the difference in care that cannot be explained by the underlying medical condition—among Dutch gynecologists regarding treatment of vaginal vault prolapse. Methods: A clinical practice survey was conducted from March to April 2017. The questionnaire was developed to evaluate treatment of vaginal vault prolapse. All members of the Dutch Society for Urogynaecology were invited to participate in a web-based survey. Results: One hundred four Dutch gynecologists with special interest in urogynecology responded to the survey (response rate, 44%). As first-choice therapy for vaginal vault prolapse, 78% of the respondents chose pessary treatment, whereas sacrospinous fixation was the second most common therapy choice according to 64% of the respondents. Preferences on how to approach vaginal vault prolapse surgically are conflicting. Overall, the most performed surgery for vaginal vault prolapse is sacrospinous fixation, followed by laparoscopic and robotic sacrocolpopexy. Conclusions: Gynecologists in The Netherlands manage vaginal vault prolapse very differently. No standardized method could be determined for the treatment of vaginal vault prolapse in The Netherlands, and we observed practice pattern variations

Patient-Reported Outcome Measure for Real-time Symptom Assessment in Women With Endometriosis:Focus Group Study

BACKGROUND: Symptoms related to endometriosis have a significant impact on the quality of life, and symptoms often recur. The experience sampling method (ESM), a digital questioning method characterized by randomly repeated momentary assessments, has several advantages over traditionally used measurements, including the ability to assess the temporal relationship between variables such as physical, mental, and social factors. OBJECTIVE: The aim of this study is to develop an ESM tool for patients with endometriosis to accurately measure symptoms and their course over time, allowing for personalized treatment and adequate monitoring of treatment efficacy in individual patients. METHODS: On the basis of international guidelines, items from validated questionnaires were selected through a literature review and during focus groups and multidisciplinary expert meetings. Data analysis was conducted using ATLAS.ti (ATLAS.ti Scientific Software Development GmbH). The feasibility and usability of the newly developed momentary assessment tool were tested for 28 consecutive days in 5 patients with endometriosis-related pain symptoms. RESULTS: Momentary assessment items contained questions concerning endometriosis symptoms, general somatic symptoms, psychological symptoms, contextual information, and the use of food and medication. A morning questionnaire on sleep and sexuality was included. In a pilot study, the patients considered the tool easy to use but time consuming. The average compliance rate of momentary assessments was 37.8% (106/280), with the highest completion rate during the first week (39/70, 56%). Therefore, it is advisable to use the ESM for a maximum of 7 days. CONCLUSIONS: A new digital tool for endometriosis symptom assessment was developed using the ESM, which may help overcome the limitations of current retrospective questionnaires. After validation and testing, future studies will be planned to evaluate the use of this tool in a clinical setting in order to propose a personalized treatment plan for women with endometriosis

The (cost) effectiveness of procedural sedation and analgesia versus general anaesthesia for hysteroscopic myomectomy, a multicentre randomised controlled trial : PROSECCO trial, a study protocol

BACKGROUND: In women with abnormal uterine bleeding, fibroids are a frequent finding. In case of heavy menstrual bleeding and presence of submucosal type 0-1 fibroids, hysteroscopic resection is the treatment of first choice, as removal of these fibroids is highly effective. Hysteroscopic myomectomy is currently usually performed in the operating theatre. A considerable reduction in costs and a higher patient satisfaction are expected when procedural sedation and analgesia with propofol (PSA) in an outpatient setting is applied. However, both safety and effectiveness - including the necessity for re-intervention due to incomplete resection - have not yet been evaluated. METHODS: This study is a multicentre randomised controlled trial with a non-inferiority design and will be performed in the Netherlands. Women > 18 years with a maximum of 3 symptomatic type 0 or 1 submucosal fibroids with a maximum diameter of 3.5 cm are eligible to participate in the trial. After informed consent, 205 women will be randomised to either hysteroscopic myomectomy using procedural sedation and analgesia with propofol in an outpatient setting or hysteroscopic myomectomy using general anaesthesia in a clinical setting in the operating theatre. Primary outcome will be the percentage of complete resections, based on transvaginal ultrasonography 6 weeks postoperatively. Secondary outcomes are cost effectiveness, menstrual blood loss (Pictorial blood assessment chart), quality of life, pain, return to daily activities/work, hospitalization, (post) operative complications and re-interventions. Women will be followed up to one year after hysteroscopic myomectomy. DISCUSSION: This study may demonstrate comparable effectiveness of hysteroscopic myomectomy under procedural sedation and analgesia versus general anaesthesia in a safe and patient friendly environment, whilst achieving a significant cost reduction. TRIAL REGISTRATION: Dutch trial register, number NTR5357 . Registered 11th of August 2015