The impact of embedment of the side arms of 52 mg levonorgestrel-intrauterine device on bleeding and pain: A prospective cohort study.

PURPOSE: The purpose of this study was to analyse the impact of embedment of side arms of the levonorgestrel 52 mg intrauterine device (LNG-IUD) in the myometrium (assessed by three-dimensional transvaginal ultrasound (3D-TVUS)) on uterine bleeding and pain. MATERIALS AND METHODS: We performed a prospective cohort study in a large Dutch teaching hospital between February 2015 and December 2016. Participants over 18 years of age who selected a LNG-IUD for contraception or because of heavy menstrual bleeding were eligible for inclusion. Six weeks after insertion, a 3D-TVUS was performed to diagnose embedment of the side arms. At that moment participants filled in questionnaires about their bleeding pattern and pelvic pain. Menstruation patterns 'no bleeding', 'regular menstruation', 'sometimes a day of spotting (maximum once a week)' were classified as favourable bleeding pattern. Menstruation patterns 'heavy menstrual bleeding', 'several days a week bleeding days', 'several days a week spotting days', 'continuously spotting', and 'completely irregular cycle' were classified as unfavourable bleeding pattern. Univariate and multivariate logistic regression analysis was used to calculate odds ratios (OR) and 95 %-confidence intervals (CI). The multivariate analysis included endometrial thickness, reason for insertion and parity. The analysis of pelvic pain additionally included previous insertion. RESULTS: A total of 220 participants were evaluated for the study of whom 176 returned the questionnaires. Embedment of the side arms was observed in 43 of the 176 responding participants (24.4 %). Favourable bleeding pattern was reported by 25/43 (58.1 %) participants with embedment and 53/133 (39.8 %) participants without embedment (ORadj 1.8, 95 % CI 0.9-3.9). Pelvic pain was reported by 4/43 (9.3 %) participants with embedment and 24/133 (18.1 %) participants without embedment (ORadj 0.3; CI 0.1-1.2). CONCLUSIONS: The present study suggests that embedment of the side arms of the LNG-IUD in the myometrium assessed by 3D-TVUS is not associated with a unfavourable bleeding pattern nor pelvic pain six weeks after insertion. From this point of view, we do not recommend to perform standard 3D-TVUS for the purpose of excluding or demonstrating embedment.

Current uptake and barriers to wider use of the International Ovarian Tumor Analysis (IOTA) models in Dutch gynaecological practice.

OBJECTIVE: Correct referral of women with an ovarian tumor to an oncology department remains challenging. The International Ovarian Tumor Analysis (IOTA) consortium has developed models with higher diagnostic accuracy than the alternative Risk of Malignancy Index (RMI). This study explores the uptake of the IOTA models in Dutch hospitals and factors that impede or promote implementation. Optimal implementation is crucial to improve pre-operative classification of ovarian tumors, which may lead to better patient referral to the appropriate level of care. STUDY DESIGN: In February 2021, an electronic questionnaire consisting of 37 questions was sent to all 72 hospitals in the Netherlands. One pre-selected gynaecologist per hospital was asked to respond on behalf of the department. RESULTS: The study had a response rate of 93% (67/72 hospitals). All respondents (100%) were familiar with the IOTA models with 94% using them in practice. The logistic regression 2 (LR2)-model, Simple ultrasound-based rules (SR) and Assessment of Different NEoplasias in the adneXa (ADNEX) model were used in respectively 40%, 67% and 73% of these hospitals. Respondents rated the models overall with an 8.2 (SD 1.8), 8.3 (SD 1.6) and 8.9 (SD 1.3) respectively for LR2, SR and ADNEX on a scale from 1 to 10. Moreover, 89% indicated to have confidence in the results of the IOTA models. The most important factors to improve further implementation are more training (43%), research on sensitivity, specificity and cost-effectiveness in the Dutch health care system (27%), easier usability (24%) and more consultation time (19%). CONCLUSION: The IOTA ultrasound models are adopted in the majority of Dutch hospitals with the ADNEX model being used the most. While Dutch gynecologists have a strong familiarity and confidence in the models, the uptake varies in reality. Areas that warrant improvement in the Dutch context are more uniformity, education and more research. These findings can be helpful for other countries considering adopting the IOTA models.

Endometrial polypectomy using tissue removal device or electrosurgical snare: a randomised controlled trial.

Background: Hysteroscopic transcervical resection of endometrial polyps is a widely used method and is increasingly performed in office or outpatient care. To ensure patient comfort is key, smaller instruments are preferred while also achieving a complete resection of the pathology. Objectives: To evaluate the effectiveness of the electrosurgical polyp snare (DPS) in comparison with a tissue removal device (TRD). Materials and Methods: This was a randomised controlled non-inferiority trial which included 66 women with symptomatic endometrial polyps who had been referred to the gynaecological outpatient clinic at the Máxima Medical Centre, Veldhoven, the Netherlands. The patients were randomly allocated by using sealed envelopes to treatment with either the DPS (Duckbill®, Cook) or the TRD (Truclear™, Medtronic). Clinicians and patients were not blinded to the treatment performed. An independent observer blindly assessed the results. Main outcome measures: The primary outcome was the complete removal of the endometrial polyp. Secondary outcomes were woman acceptability and pain during the procedure, operating time, peri-operative and immediate postoperative complications. Results: 57% of the polyps in the DPS group and 95% in the TRD group were completely removed (risk difference -0.39; 95% CI: -0.60 to -0.15). Average operating time was longer with DPS compared to the TRD (11.7 min. vs. 6.8 min., p = 0.018). The number of insertions of the hysteroscope was higher with the DPS compared to the TRD (3.9 vs. 1.7, p <0.001). One serious adverse event, a uterine perforation, occurred in the DPS group. Conclusion: The TRD was superior to the DPS in completeness of polyp removal. What is new?: TRD has a higher rate of complete polyp resection, overall safety and higher patient satisfaction, this instrument should be considered as the preferred option in outpatient and office gynaecology.

Short-term recovery after NovaSure® endometrial ablation: a prospective cohort study.

Background: Endometrial ablation is a frequently performed treatment for heavy menstrual bleeding, but detailed information about recovery to help inform patients is lacking. Objective: To gain more insight into the short-term recovery after NovaSure® endometrial ablation, with the goal of improving preprocedural counselling. Materials and Methods: A total of 61 women who underwent endometrial ablation between March 2019 and November 2021 in a teaching hospital in the Netherlands were included in this prospective cohort study. Main outcome measures: Short-term recovery was investigated through questionnaires in the first week after the procedure. The primary outcome was the Recovery Index (RI-10). Secondary outcomes included health-related quality of life (EQ-5D-5L), pain intensity, use of analgesics, nausea, vaginal discharge, capability of performing activities (domestic chores, sports, work), self-rated health (EQ-VAS) and the feeling of full recovery. Results: A total of 33 women underwent the procedure under local anaesthesia and 28 women under procedural sedation. The RI-10 increased in the first week; median scores on day one, two and seven were 34 (IQR 28.5-41.5), 38.5 (IQR 31-47), and 42 (IQR 37.5-48), respectively. The median time for full recovery was five days. However, 23% of all women were not fully recovered within seven days. Women needed a median time of two days for returning to their work and 5.5 days for sporting activities. There were no differences in recovery between both anaesthesia techniques. Conclusions: Women undergoing endometrial ablation can be informed that most will fully recover within the first week of the procedure and that there is no difference in expected recovery time according to whether the procedure is undertaken with local anaesthesia or conscious sedation. What is New?: The short-term recovery after endometrial ablation has been mapped in this trial. This information can be used in counselling women with heavy menstrual bleeding.

The levonorgestrel intrauterine system versus endometrial ablation for heavy menstrual bleeding: a cost-effectiveness analysis.

OBJECTIVE: To evaluate the costs and non-inferiority of a strategy starting with the levonorgestrel intrauterine system (LNG-IUS) compared with endometrial ablation (EA) in the treatment of heavy menstrual bleeding (HMB). DESIGN: Cost-effectiveness analysis from a societal perspective alongside a multicentre randomised non-inferiority trial. SETTING: General practices and gynaecology departments in the Netherlands. POPULATION: In all, 270 women with HMB, aged ≥34 years old, without intracavitary pathology or wish for a future child. METHODS: Randomisation to a strategy starting with the LNG-IUS (n = 132) or EA (n = 138). The incremental cost-effectiveness ratio was estimated. MAIN OUTCOME MEASURES: Direct medical costs and (in)direct non-medical costs were calculated. The primary outcome was menstrual blood loss after 24 months, measured with the mean Pictorial Blood Assessment Chart (PBAC)-score (non-inferiority margin 25 points). A secondary outcome was successful blood loss reduction (PBAC-score ≤75 points). RESULTS: Total costs per patient were €2,285 in the LNG-IUS strategy and €3,465 in the EA strategy (difference: €1,180). At 24 months, mean PBAC-scores were 64.8 in the LNG-IUS group (n = 115) and 14.2 in the EA group (n = 132); difference 50.5 points (95% CI 4.3-96.7). In the LNG-IUS group, 87% of women had a PBAC-score ≤75 points versus 94% in the EA group (relative risk [RR] 0.93, 95% CI 0.85-1.01). The ICER was €23 (95% CI €5-111) per PBAC-point. CONCLUSIONS: A strategy starting with the LNG-IUS was cheaper than starting with EA, but non-inferiority could not be demonstrated. The LNG-IUS is reversible and less invasive and can be a cost-effective treatment option, depending on the success rate women are willing to accept. TWEETABLE ABSTRACT: Treatment of heavy menstrual bleeding starting with LNG-IUS is cheaper but slightly less effective than endometrial ablation.

Intrauterine fundal anaesthesia during endometrial ablation in the office: A randomised double-blind, non-inferiority trial.

OBJECTIVE: To evaluate the effect of intrauterine fundal anaesthesia during outpatient endometrial ablation. STUDY DESIGN: A randomised, double-blinded non-inferiority trial was performed in one hospital and one independent treatment center in the Netherlands. A total of 96 women who were planned for a NovaSure® endometrial ablation under local anaesthesia between December 2015 and February 2018 were included in this trial. These women were randomised to paracervical anaesthesia combined with hysteroscopic fundal infiltration with anaesthestics or paracervical anaesthesia combined with hysteroscopic fundal infiltration with saline. The primary outcome was pain during ablation. To study non-inferiority of paracervical anaesthesia without fundal anaesthesia, we assessed the co-primary endpoints Faces Pain Score and Numeric Rating Score. Secondary outcomes included pain scores at other moments during and after the procedure, postoperative use of analgesics, satisfaction, side-effects and complications. The primary outcomes were tested with a non-inferiority margin (2.0 points on changes in pain), and the secondary outcomes were compared using conventional statistical methods. RESULTS: Paracervical anaesthesia without fundal anaesthesia did not establish non-inferiority to the combination of paracervical anaesthesia and fundal infiltration with anaesthetics when both primary outcome variables of pain were taken into account (Numeric Rating Scale 5.0 versus 3.9 (mean difference 1.2 (95% CI 0.1-2.2)) and Faces Pain Score 5.4 versus 4.8 (mean difference 0.6 (95% CI -0.3-1.5))). Secondary pain scores measured during the procedure were higher or similar in women receiving fundal infiltration with saline as compared to women who received fundal infiltration with anaesthetics. After the procedure, there were no differences in reported pain scores, satisfaction, and side-effects. In the group who received fundal infiltration with saline, more women were admitted to the hospital because of severe pain (3 versus 0 women) and endometritis (1 versus 0 women). CONCLUSION: This study did not confirm non-inferiority of paracervical anaesthesia without fundal anaesthesia to the combination of paracervical anaesthesia with fundal anaesthesia in the reduction of pain during endometrial ablation and therefore provides no reason to leave out fundal anaesthesia. We recommend to use fundal anaesthesia combined with paracervical anaesthesia to reduce pain during endometrial ablation in the office.

What is the best drug treatment for premenopausal women with bleeding irregularities using the levonorgestrel-releasing intrauterine system? A systematic review.

OBJECTIVE: Up to 60% of women discontinue using the levonorgestrel-releasing intrauterine system (LNG-IUS) within 5 years because of bleeding irregularities, pain and/or systemic progestogenic adverse effects. The aim of the study was to assess treatment options for bleeding irregularities in women using the 52 mg LNG-IUS. METHODS: Database searches of Medline, Embase/Ovid and the Cochrane Library were carried out, and journals were searched by hand, for relevant studies published from database inception to March 2020. Inclusion criteria were randomised controlled trials (RCTs), prospective cohort studies and case-control studies of premenopausal women using the LNG-IUS and receiving medical treatment for bleeding irregularities. Screening, data extraction and quality assessment of retrieved articles were carried out independently by two pairs of reviewers. The primary outcome was the reduction of bleeding/spotting days. RESULTS: Of the 3061 studies identified, eight met our inclusion criteria: six RCTs and two prospective cohort studies. The eight studies enrolled a total of 677 women who were treated with tamoxifen, mifepristone, ulipristal acetate, naproxen, oestradiol, mefenamic acid, tranexamic acid or the progesterone receptor modulator CDB 2914. The results of our analysis indicated that naproxen may be effective for the prophylactic treatment of bleeding immediately (<12 weeks) after LNG-IUS insertion (high level of evidence). Oestradiol may be effective in treating ongoing bleeding irregularities >6 months after insertion (low level of evidence). CONCLUSION: Evidence for the medical treatment of (ongoing) bleeding irregularities during use of the LNG-IUS is lacking and more research is needed on the topic.

Diagnostic accuracy of saline contrast sonohysterography in detecting endometrial polyps in women with postmenopausal bleeding: systematic review and meta-analysis.

OBJECTIVE: In women with postmenopausal bleeding, endometrial polyps are a frequent finding and the risk of a focal (pre)malignancy in a polyp is up to 6%. Because of this reported risk, the detection of polyps in these women, preferably by a minimally invasive method, is important. The aim of this systematic review was to assess the accuracy of saline contrast sonohysterography (SCSH) for diagnosis of endometrial polyps in women with postmenopausal bleeding. METHODS: In August 2018, an electronic search was performed of MEDLINE, EMBASE and Web of Science databases to identify all diagnostic studies in which SCSH was used to detect endometrial polyps in postmenopausal women. Studies were included if SCSH was performed to detect endometrial polyps in women with postmenopausal bleeding and if detection of a polyp on hysteroscopy or diagnosis on histopathology was used as a reference standard. Two reviewers assessed methodological quality using the quality assessment of diagnostic accuracy studies (QUADAS-2) tool. Two separate analyses were performed for each reference standard. Pooled sensitivity and specificity were calculated using the hierarchical summary receiver-operating characteristics (HSROC) model and HSROC curves were plotted. RESULTS: After selection and quality assessment, five studies were included. Using 'polyps diagnosed with histopathology' as the reference standard, the pooled sensitivity of SCSH was 86.5% (95% CI, 63.6-100%) and the pooled specificity was 91.1% (95% CI, 63.2-100%). Using 'polyps seen on hysteroscopy' as the reference standard, the pooled sensitivity of SCSH was 85.1% (95% CI, 66.9-100%) and the pooled specificity was 84.5% (95% CI, 68.1-100%). Excluding the one study that included women in whom the SCSH examination was reported to be suboptimal, the pooled sensitivity increased to 90.7% (95% CI, 72.8-100%) using hysteroscopy as the reference standard. The sensitivity of hysteroscopy to detect polyps, as reported in two studies, was 81-98%. CONCLUSIONS: Provided that the SCSH examination is of optimal quality, it can be considered as a method to stratify women with postmenopausal bleeding for further diagnostic workup and treatment with hysteroscopy. In women without suspicion of a polypoid lesion on SCSH, and with a benign endometrial sample, expectant management should be considered. Copyright © 2019 ISUOG. Published by John Wiley & Sons Ltd.

Precisión del diagnóstico de la sonohisterografía con contraste salino en la detección de pólipos endometriales en mujeres con hemorragia postmenopáusica: revisión sistemática y metaanálisis OBJETIVO: En las mujeres con hemorragia postmenopáusica, los pólipos endometriales son frecuentes y el riesgo de una (pre)malignidad focal en un pólipo es de hasta el 6%. Debido a este riesgo reportado, es importante la detección de pólipos en estas mujeres, preferiblemente por un método mínimamente invasivo. El objetivo de esta revisión sistemática fue evaluar la precisión de la sonohisterografía con contraste salino (SCSH, por sus siglas en inglés) para el diagnóstico de pólipos endometriales en mujeres con hemorragia postmenopáusica. MÉTODOS: En agosto de 2018 se realizó una búsqueda electrónica en las bases de datos MEDLINE, EMBASE y Web of Science para identificar todos los estudios diagnósticos en los que se utilizó la SCSH para detectar pólipos endometriales en mujeres postmenopáusicas. Los estudios se incluyeron cuando la SCSH se realizó para detectar pólipos endometriales en mujeres con hemorragia postmenopáusica o cuando la detección de un pólipo en la histeroscopia o el diagnóstico sobre la histopatología se utilizó como estándar de referencia. Dos revisores evaluaron la calidad metodológica mediante la evaluación de calidad de la herramienta de estudios de precisión diagnóstica (QUADAS-2). Se realizaron dos análisis separados para cada estándar de referencia. La sensibilidad y especificidad combinadas se calcularon utilizando el modelo jerárquico de resumen de las características operativas del receptor (HSROC, por sus siglas en inglés) y se trazaron las curvas HSROC. RESULTADOS: Después de la selección y la evaluación de calidad, se incluyeron cinco estudios. Utilizando los 'pólipos diagnosticados con histopatología' como estándar de referencia, la sensibilidad combinada de la SCSH fue del 86,5% (IC 95%, 63,6-100%) y la especificidad combinada fue del 91,1% (IC 95%, 63,2-100%). Utilizando como estándar de referencia los 'pólipos observados en la histeroscopia', la sensibilidad combinada de la SCSH fue del 85,1% (IC 95%: 66,9-100%) y la especificidad combinada fue del 84,5% (IC 95%: 68,1-100%). Excluyendo el único estudio que incluyó mujeres en las que se reportó que el examen por SCSH no fue adecuado, la sensibilidad combinada aumentó al 90,7% (IC 95%: 72,8-100%), usando la histeroscopia como estándar de referencia. La sensibilidad de la histeroscopia para detectar pólipos, tal y como se informó en dos estudios, fue del 81-98%. CONCLUSIONES: Siempre que el examen por SCSH sea de calidad óptima, puede considerarse como un método para estratificar a las mujeres con hemorragia postmenopáusica para su posterior diagnóstico y tratamiento con histeroscopia. En mujeres sin sospecha de una lesión polipoide mediante SCSH y con una muestra endometrial benigna, se debe considerar el tratamiento expectante. Copyright © 2019 ISUOG. Published by John Wiley & Sons Ltd.

Misoprostol for cervical priming prior to hysteroscopy in postmenopausal and premenopausal nulliparous women; a multicentre randomised placebo controlled trial.

OBJECTIVE: To evaluate the reduction of pain by misoprostol compared with placebo prior to hysteroscopy in postmenopausal and premenopausal nulliparous women. DESIGN: Randomised multicentre double-blind placebo controlled trial. SETTING: Two Dutch teaching hospitals and one Dutch university medical centre. POPULATION: Postmenopausal and premenopausal nulliparous women undergoing office hysteroscopy. METHODS: Patients were randomised to receive either 400 microgram misoprostol or placebo 12 and 24 hours before hysteroscopy. Pain was quantified by the use of real time pain measurement using the continuous pain score meter (CPSM) and VAS scores. MAIN OUTCOME MEASURES: Primary outcome was pain measured by the CPSM during passage of the hysteroscope through the cervical canal, quantified by the area under the curve (AUC). Secondary outcomes included VAS scores, other CPSM parameters, failures and side effects. RESULTS: In all, 149 patients were randomly assigned to either misoprostol (n = 74) or placebo (n = 75). The AUC during introduction did not significantly differ between the intervention and the placebo group. The VAS score during introduction, however, demonstrated a significant difference in premenopausal nulliparous women favouring misoprostol: 2.9 (95% CI 1.3-4.4) versus placebo 5.5 (95% CI 3.9-7.1), P = 0.02, as well as the AUC during the entire procedure: 618 (95% CI 410-827) versus 1126 (95% CI 671-1580), P = 0.04. Failures were equally distributed between the misoprostol (16%) and placebo group (13%). Intestinal side effects occurred significantly more frequently in the misoprostol group (67%) than in the placebo group (32%) [OR 4.2 (95% CI 2.1-8.3), P < 0.01]. CONCLUSION: Misoprostol prior to hysteroscopy reduces pain in premenopausal nulliparous women but not in postmenopausal women. It does cause side effects. TWEETABLE ABSTRACT: RCT: misoprostol versus placebo prior to hysteroscopy in 149 women significantly reduces some pain parameters.

POstLAparoscopic Reduction of pain By combining intraperitoneal normal salinE And the pulmonary Recruitment maneuver (POLAR BEAR trial). RCT to estimate reduction in pain after laparoscopic surgery when using a combination therapy of intraperitoneal normal saline and the pulmonary recruitment maneuver.

BACKGROUND: Shoulder pain and pain in the upper abdomen are common complaints after laparoscopy, sometimes surpassing the pain at incision sites. The incidence of shoulder pain ranges from 35 to 80%. Post-laparoscopic pain is caused by retention of carbon dioxide in the abdomen, which irritates the phrenic nerve and diaphragm, causing referred pain in the shoulder and in the upper abdomen. A promising strategy to reduce this post-laparoscopic pain is the pulmonary recruitment maneuver, which indirectly increases intraperitoneal pressure and thereby facilitates removal of residual carbon dioxide. An alternative strategy is the infusion of intraperitoneal normal saline. With normal saline infusion, carbon dioxide rises and escapes through the port sites. In addition, normal saline offers a physiologic buffer system to dissolve excess carbon dioxide. METHODS/DESIGN: This multicenter randomized controlled trial is conducted in two teaching hospitals in the Netherlands. Women between 18 and 65 years of age, with an ASA classification of I-II who are scheduled to undergo an elective laparoscopic procedure with benign gynecologic indication can participate. Following informed consent, participants are randomly allocated into two groups at the end of the surgical procedure. In the intervention group, the upper abdomen is filled with normal saline infusion with the patient in the Trendelenburg position. Then the anesthesiologist performs a standardized pulmonary recruitment maneuver with a pressure of 40 cm H2O. The trocar sleeve valves will be left open, so carbon dioxide can escape the abdominal cavity. With the patient in a neutral position the instruments are removed from the abdomen. In the control group, carbon dioxide is removed from the abdominal cavity at the end of surgery, with gentle abdominal pressure and passive exsufflation through the port sites, with open sleeve valves. The primary outcomes are the incidence and intensity of post-laparoscopic pain in the shoulder, upper abdomen and at the operation sites, at 8, 24 and 48 h after surgery. Secondary outcomes are postoperative use of analgesics, nausea, vomiting and pulmonary complications. DISCUSSION: This study may reduce post-laparoscopic pain in women undergoing laparoscopy. TRIAL REGISTRATION: Dutch trial register, number NTR4812 .

[A pregnant woman with acute shoulder pain]. / Een zwangere vrouw met acute schouderpijn.

A 34-year-old woman presented with abdominal pain, vaginal blood loss and severe shoulder pain. Ultrasound revealed an ectopic pregnancy. The shoulder pain was due to irritation of the diaphragm caused by bleeding from a ruptured fallopian tube into the abdominal cavity.

Is the Pictorial Blood Loss Assessment Chart (PBAC) score associated with treatment outcome after endometrial ablation for heavy menstrual bleeding? A cohort study.

OBJECTIVE: The Pictorial Blood Loss Assessment Chart (PBAC) is a validated tool that is used to diagnose heavy menstrual bleeding (HMB). Knowledge of the effect of its score and its relationship with outcome could have implications for using the PBAC as an outcome measurement in future HMB studies, and as a tool to evaluate the treatment effect in research and clinical practice. Our aim was to relate PBAC scores to other measures of success after endometrial ablation for HMB. DESIGN: Analysis of individual patient data (IPD) of randomised controlled trials studying women with HMB. SETTING: Women with HMB consulting their gynecologists. POPULATION OR SAMPLE: Individual patient data (IPD) of randomised controlled trials studying women with HMB. METHODS: We included studies if they had studied second-generation endometrial ablation techniques and had collected PBAC scores for both baseline and follow-up. The effectiveness of treatment was scored as satisfaction or re-intervention (yes/no) 12 months after treatment. We related these outcomes to the PBAC score at 12 months after treatment, and to PBAC decrease between baseline and 12 months of follow-up. RESULTS: We studied data for 900 patients included in nine studies. The median PBAC score at 12 months was 7 (0-2500). The overall satisfaction rate was 89% and the overall re-intervention rate was 7.2%. A clear association was found between absolute PBAC score at the 12-month follow-up and satisfaction (odds ratio, OR 0.16; 95% confidence interval, 95% CI 0.11-0.24) and surgical re-intervention (OR 2.3, 95% CI 1.8-2.8). A change in PBAC score was also associated with satisfaction (OR 2.0, 95% CI 1.7-2.3) and surgical re-intervention (OR 0.69, 95% CI 0.63-0.75). Both the absolute PBAC scores and the changes in score show high accuracy for both treatment outcomes. CONCLUSIONS: PBAC scores at 12 months after treatment are significantly associated with satisfaction and re-intervention rates. We propose to use the PBAC in research as a primary end point in studies on HMB, and in clinical practice as a measure to assess the effectiveness of treatment. TWEETABLE ABSTRACT: PBAC scores 12 months after treatment are significantly associated with satisfaction and reintervention rates.

Choice of primary outcomes evaluating treatment for heavy menstrual bleeding.

BACKGROUND: Heavy menstrual bleeding (HMB) is a common problem with a variety of treatment options and many studies have been performed evaluating treatment effects. Consistency in the choice and definition of primary and secondary outcomes is important for the interpretation of data and for the synthesis of data in systematic reviews or individual patient data meta-analysis (IPDMA). OBJECTIVE: To give insight into the primary endpoints and outcome measures chosen in randomised controlled trials (RCTs) and systematic reviews regarding the treatment of HMB. SEARCH STRATEGY: Published systematic reviews and RCTs. SELECTION CRITERIA: Full reports of RCTs or systematic reviews. DATA COLLECTION AND ANALYSIS: For RCTs, we used the primary outcomes, as they were used for the sample size calculation. For systematic reviews, all outcomes listed as primary were included. Four authors selected the studies. RESULTS: Twelve different primary outcomes were reported by 66 RCTs, most blood loss- related (44/66 studies). Amenorrhoea was the most common blood loss primary outcome (16/44 studies) and the Pictorial Blood Loss Assessment Chart (PBAC) was the most used measurement tool (27/44 studies). Satisfaction was the second most prevalent primary outcome measure (13/66 studies). In all, 14/26 (54%) systematic reviews prespecified a single primary outcome, whereas all other reviews used composite primary outcomes. Blood loss was the most studied outcome (12/26 reviews). CONCLUSIONS: The most used primary outcomes in HMB studies relate to blood loss but there is no consistency regarding the endpoints chosen or measurement tools used to describe blood loss. Standardising outcomes will aid valid comparison and interpretation of data pertaining to the treatment of HMB. TWEETABLE ABSTRACT: A standardised collection of outcomes in heavy menstrual bleeding research is urgently needed.

Parasitic myoma after laparoscopic morcellation: a systematic review of the literature.

BACKGROUND: Laparoscopic morcellation is frequently used for tissue removal after laparoscopic hysterectomy or myomectomy and may result in parasitic myomas, due to seeding of remained tissue fragments in the abdominal cavity. However, little is known about the incidence and risk factors of this phenomenon. OBJECTIVES: To identify the incidence and risk factors for the development of parasitic myoma after laparoscopic morcellation. SEARCH STRATEGY: A systematic review of the literature in Pubmed (MEDLINE) and Embase was conducted. Reference lists of identified relevant articles were checked for missing case reports. SELECTION CRITERIA: Studies reporting on incidence or cases of parasitic myoma diagnosed after laparoscopic morcellation were selected. Studies were excluded when history of laparoscopic morcellation was lacking or final pathology demonstrated a malignancy or endometriosis. DATA COLLECTION AND ANALYSIS: Data were extracted and analysed on incidence of parasitic myomas and characteristics of case reports. MAIN RESULTS: Fourty-four studies were included. Sixty-nine women diagnosed with parasitic myomas after laparoscopic morcellation were identified. Mean age was 40.8 (± 7.5) years (range 24-57), median time between surgery and diagnosis was 48.0 months (range 1-192) and mean number of parasitic myomas was 2.9 (± 3.3) (range 1-16). The overall incidence of parasitic myomas after laparoscopic morcellation was 0.12-0.95%. CONCLUSION: Although the incidence is relatively low, it is important to discuss the risk of parasitic myoma after laparoscopic morcellation with women and balance towards alternative treatment options. The duration of steroid exposure after laparoscopic morcellation might be a risk factor for development of parasitic myomas. TWEETABLE ABSTRACT: Systematic review on the incidence and risk factors for parasitic myoma after laparoscopic morcellation.

The HysNiche trial: hysteroscopic resection of uterine caesarean scar defect (niche) in patients with abnormal bleeding, a randomised controlled trial.

BACKGROUND: A caesarean section (CS) can cause a defect or disruption of the myometrium at the site of the uterine scar, called a niche. In recent years, an association between a niche and postmenstrual spotting after a CS has been demonstrated. Hysteroscopic resection of these niches is thought to reduce spotting and menstrual pain. However, there are no randomised trials assessing the effectiveness of a hysteroscopic niche resection. METHODS/DESIGN: We planned a multicentre randomised trial comparing hysteroscopic niche resection to no intervention. We study women with postmenstrual spotting after a CS and a niche with a residual myometrium of at least 3 mm during sonohysterography. After informed consent is obtained, eligible women will be randomly allocated to hysteroscopic resection of the niche or expectant management for 6 months. The primary outcome is the number of days with postmenstrual spotting during one menstrual cycle 6 months after randomisation. Secondary outcomes are menstrual characteristics, menstruation related pain and experienced discomfort due to spotting or menstrual pain, quality of life, patient satisfaction, sexual function, urological symptoms, medical consultations, medication use, complications, lost productivity and medical costs. Measurements will be performed at baseline and at 3 and 6 months after randomisation. A cost-effectiveness analysis will be performed from a societal perspective at 6 months after randomisation. DISCUSSION: This trial will provide insight in the (cost)effectiveness of hysteroscopic resection of a niche versus expectant management in women who have postmenstrual spotting and a niche with sufficient residual myometrium to perform a hysteroscopic niche resection. TRIAL REGISTRATION: Dutch Trial Register NTR3269 . Registered 1 February 2012. ZonMw Grant number 80-82305-97-12030.

Do patients prefer a pessary or surgery as primary treatment for pelvic organ prolapse.

BACKGROUND/AIMS: To assess whether patients prefer surgery or a pessary as treatment for pelvic organ prolapse (POP). METHODS: A structured interview was performed among treated and untreated women with POP. We conducted fictive scenarios of potential disadvantages of surgery and pessary use. Our main outcome was the willingness to alter treatment preference (by increasing percentages of defined disadvantages) and determine conditions at which treatment preference changes to alternative treatment. RESULTS: Three groups of 25 patients were interviewed: (1) untreated patients, (2) patients who underwent surgery, and (3) patients treated with a pessary. In the treatment-naive group, 48% preferred surgery, 36% a pessary and 16% had no preferable treatment. Patients switched preference from surgery to a pessary at a median risk of stress urinary incontinence of 22% and of recurrent prolapse of 43%. Patients switched preference from pessary to surgery at a median risk of vaginal irritation of 32%, of placing problems of 32% and of incomplete symptom relief of 17%. CONCLUSIONS: Patients tend to prefer surgery for POP. When realistic assumptions for (dis)advantages are made, most women consider the disadvantages following both treatment options to be acceptable as they do not exceed the risks described in the literature.

Paraneoplastic cerebellar degeneration: neurological symptoms pointing to occult ovarian cancer.

Paraneoplastic cerebellar degeneration with anti-Yo antibodies is a rare but disabling neurodegenerative disease that may point to an occult ovarian cancer. Symptoms usually accompanying paraneoplastic cerebellar degeneration include truncal and limb ataxia, dysarthria, dysphagia, nystagmus, vertigo, and diplopia. The pathogenesis of paraneoplastic neurological syndromes is unknown. Treatment results of the neurological symptoms are disappointing. The present case illustrates how neurological symptoms pointed to an occult ovarian cancer.

Vaginal vault suspension by abdominal sacral colpopexy for prolapse: a follow up study of 40 patients.

OBJECTIVES: Vaginal vault prolapse is a rare event after hysterectomy. Vaginal repair often results in a narrowed and shortened vagina with diminished function. Abdominal sacral colpopexy attaches the vaginal apex to the sacral promontory and restores the physiological position of the vagina. The objective of the study was to evaluate follow up results of the abdominal sacral colpopexy in 40 patients by a questionnaire and a gynaecologic examination. METHODS: We performed a cohort study. Between 1992 and 1998, 45 consecutive patients with a vaginal vault prolapse treated with an abdominal sacral colposcopy were included. RESULTS: Forty patients were included in the study. No serious complications occurred during surgery. Two patients per- or postoperative hemorrhage required blood transfusion. In two patients, one with a concomittant hysterectomy, the Gore-tex graft infected within 3 months after the operation. If vaginal 'protrusion' was the only preoperative complaint, in 93% (13/14) of the cases, surgery resulted in a condition without any complaint, related to the vaginal prolapse. If initially a combination of complaints (vaginal protrusion, urinary incontinence, defecation problems, sexual dysfunction) was the reason for surgery, only ten of 27 (37%) patients were symptom-free at follow up (P=0.002, Yates corrected). In the whole group 34 (85%) patients noticed before the operation a feeling of vaginal protrusion. At follow-up, 23 patients (56%) had no symptoms at all that could be related to the vaginal prolapse. Problems concerning defecation, like constipation were present before surgery in eight patients. In six of them, these complaints were resolved after surgery. However, in five patients de novo constipation developed after surgery. There were no cases of de novo urinary incontinence. At gynaecological examination in three patients, the vaginal vault prolapse recurred within the follow-up period, accounting for a success rate of 93%. In ten more patients a moderate enterorectocele developed or persisted. No reoperations were performed for that reason. CONCLUSIONS: Abdominal sacral colpopexy is a safe and efficacious treatment of the posthysterectomy vaginal vault prolapse. To prevent the persistence or development of an enterorectocele, a culdoplasty according to Halban or McCall might possibly be helpful. Peritonisation of the graft seems not to be necessary. The use of banked collagen tissue as graft material is promising and needs further investigation.