Laparoscopic sacrocolpopexy versus vaginal sacrospinous fixation for vaginal vault prolapse: a randomised controlled trial and prospective cohort (SALTO-2 trial).

OBJECTIVE: To determine whether laparoscopic sacrocolpopexy (LSC) or vaginal sacrospinous fixation (VSF) is the most optimal surgical treatment in patients with POP-Q stage ≥2 vaginal vault prolapse (VVP). DESIGN: Multicentre randomised controlled trial (RCT) and prospective cohort study alongside. SETTING: Seven non-university teaching hospitals and two university hospitals in the Netherlands. POPULATION: Patients with symptomatic post-hysterectomy vaginal vault prolapse, requiring surgical treatment. METHODS: Randomisation in a 1:1 ratio to LSC or VSF. Evaluation of prolapse was done using the pelvic organ prolapse quantification (POP-Q). All participants were asked to fill in various Dutch validated questionnaires 12 months postoperatively. MAIN OUTCOME MEASURES: Primary outcome was disease-specific quality of life. Secondary outcomes included composite outcome of success and anatomical failure. Furthermore, we examined peri-operative data, complications and sexual function. RESULTS: A total of 179 women, 64 women randomised and 115 women, participated in a prospective cohort. Disease-specific quality of life did not differ after 12 months between the LSC and VSF group in the RCT and the cohort (RCT: P = 0.887; cohort: P = 0.704). The composite outcomes of success for the apical compartment, in the RCT and cohort, were 89.3% and 90.3% in the LSC group and 86.2% and 87.8% in the VSF group, respectively (RCT: P = 0.810; cohort: P = 0.905). There were no differences in number of reinterventions and complications between both groups (reinterventions RCT: P = 0.934; cohort: P = 0.120; complications RCT: P = 0.395; cohort: P = 0.129). CONCLUSIONS: LSC and VSF are both effective treatments for vaginal vault prolapse, after a follow-up period of 12 months.

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.

Cost-Effectiveness of perioperative Vaginally Administered estrogen in postmenopausal women undergoing prolapse surgery (EVA trial): study protocol for a multicenter double-blind randomized placebo-controlled trial.

BACKGROUND: Surgery for pelvic organ prolapse (POP) is associated with high recurrence rates. The costs associated with the treatment of recurrent POP are huge, and the burden from women who encounter recurrent POP, negatively impacts their quality of life. Estrogen therapy might improve surgical outcome for POP due to its potential beneficial effects. It is thought that vaginal estrogen therapy improves healing and long-term maintenance of connective tissue integrity. Hence, this study aims to evaluate the cost-effectiveness of perioperative vaginal estrogen therapy in postmenopausal women undergoing POP surgery. METHODS: The EVA trial is a multi-center double-blind randomized placebo-controlled trial conducted in the Netherlands comparing the effectiveness and costs-effectiveness of vaginal estrogen therapy. This will be studied in 300 postmenopausal women undergoing primary POP surgery, with a POP-Q stage of ≥ 2. After randomization, participants administer vaginal estrogen cream or placebo cream from 4 to 6 weeks preoperative until 12 months postoperative. The primary outcome is subjective improvement of POP symptoms at 1 year follow-up, measured with the Patient Global Impression of Improvement (PGI-I) scale. Secondary outcomes are POP-Q anatomy in all compartments, re-interventions, surgery related complications, general and disease specific quality of life, sexual function, signs and complaints of vaginal atrophy, vaginal pH, adverse events, costs, and adherence to treatment. Follow up is scheduled at 6 weeks, 6 months and 12 months postoperative. Data will be collected using validated questionnaires and out-patient visits including gynecological examination performed by an independent gynecologist. DISCUSSION: This study investigates whether perioperative vaginal estrogen will be cost-effective in the surgical treatment of POP in postmenopausal women. It is hypothesized that estrogen therapy will show a reduction in recurrent POP symptoms and a reduction in reoperations for POP, with subsequent improved quality of life among women and cost savings. Trial registrationNetherlands Trial Registry: NL6853; registered 19-02-2018, https://www.trialregister.nl/trial/6853 . EudraCT: 2017-003144-21; registered: 24-07-2017.

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.

Evaluation of two vaginal, uterus sparing operations for pelvic organ prolapse: modified Manchester operation (MM) and sacrospinous hysteropexy (SSH), a study protocol for a multicentre randomized non-inferiority trial (the SAM study).

BACKGROUND: Pelvic organ prolapse (POP) affects up to 40% of parous women which adversely affects the quality of life. During a life time, 20% of all women will undergo an operation. In general the guidelines advise a vaginal operation in case of uterine descent: hysterectomy with uterosacral ligament plication (VH), sacrospinous hysteropexy (SSH) or a modified Manchester operation (MM). In the last decade, renewed interest in uterus sparing techniques has been observed. Previous studies have shown non-inferiority between SSH and VH. Whether or not SSH and MM are comparable concerning anatomical and functional outcome is still unknown. The practical application of both operations is at least in The Netherlands a known cause of practice pattern variation (PPV). To reveal any difference between both techniques the SAM-study was designed. METHODS: The SAM-study is a randomized controlled multicentre non-inferiority study which compares SSH and MM. Women with symptomatic POP in any stage, uterine descent and POP-Quantification (POP-Q) point D at ≤ minus 1 cm are eligible. The primary outcome is the composite outcome at two years of absence of prolapse beyond the hymen in any compartment, the absence of bulge symptoms and absence of reoperation for pelvic organ prolapse. Secondary outcomes are hospital parameters, surgery related morbidity/complications, pain perception, further treatments for prolapse or urinary incontinence, POP-Q anatomy in all compartments, quality-of-life, sexual function, and cost-effectiveness. Follow-up takes place at 6 weeks, 12 and 24 months. Additionally at 12 weeks, 6 and 9 months cost-effectiveness will be assessed. Validated questionnaires will be used and gynaecological examination will be performed. Analysis will be performed following the intention-to-treat and per protocol principle. With a non-inferiority margin of 9% and an expected loss to follow-up of 10%, 424 women will be needed to prove non-inferiority with a confidence interval of 95%. DISCUSSION: This study will evaluate the effectiveness and costs of SSH versus MM in women with primary POP. The evidence will show whether the existing PPV is detrimental and a de-implementation process regarding one of the operations is needed. TRIAL REGISTRATION: Dutch Trial Register (NTR 6978, http://www.trialregister.nl ). Date of registration: 29 January 2018. Prospectively registered.

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.

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.

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%, adherence 46%), 2) non-progressive labour (frequency 12%, CS performed too early in over 75%), 3) continuous support during labour (frequency 88%, adherence 37%) and 4) previous CS (frequency 12%), with adequate counselling in 15%. CONCLUSIONS: We identified four concrete target groups for improvement of obstetrical care, which can be used as a starting point to reduce CS rates worldwide.

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.

Value of urodynamics before stress urinary incontinence surgery: a randomized controlled trial.

OBJECTIVE: To estimate whether a strategy of immediate surgery was noninferior to a strategy based on discordant urodynamic findings followed by individually tailored therapy in women with stress urinary incontinence (SUI). METHODS: A multicenter diagnostic cohort study with an embedded noninferiority randomized controlled trial was conducted in six academic and 24 nonacademic Dutch hospitals. Women with predominant SUI eligible for surgical treatment based on clinical assessment were included between January 2009 and November 2010. All patients underwent urodynamics. In patients in whom urodynamics were discordant with clinical assessment, participants were randomly allocated to receive either immediate surgery or individually tailored therapy based on urodynamics. The primary outcome was clinical improvement assessed by the Urogenital Distress Inventory 12 months after baseline. Analysis was by intention to treat; a difference in mean improvement of 5 points or less was considered noninferior. RESULTS: Five hundred seventy-eight women with SUI were studied, of whom 268 (46%) had discordant findings. One hundred twenty-six patients gave informed consent for randomization and were allocated to receive immediate surgery (n=64) or individually tailored therapy (n=62). The mean improvement measured with the Urogenital Distress Inventory after 1 year was 44 points (±24) in the group receiving immediate surgery and 39 (±25) points in the group receiving individually tailored treatment. The difference in mean improvement was 5 points in favor of the group receiving immediate surgery (95% confidence interval -∞ to 5). There were no differences with respect to cure or complication rate. CONCLUSION: In women with uncomplicated SUI, an immediate midurethral sling operation is not inferior to individually tailored treatment based on urodynamic findings. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, www.clinicaltrials.gov, NCT00814749. LEVEL OF EVIDENCE: I.

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 NCT00814749.

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.

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% CI=1.4-7.1), contractions for more than 12h (OR=3.0; 95% CI=1.3-7.0) and cervical dilatation less than 1cm/h (OR=5.6; 95% CI=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 12h 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.