Cost-effectiveness of pessary therapy versus surgery for symptomatic pelvic organ prolapse: an economic evaluation alongside a randomised non-inferiority controlled trial.

OBJECTIVE: To evaluate the cost-effectiveness of pessary therapy as an initial treatment option compared with surgery for moderate to severe pelvic organ prolapse (POP) symptoms in secondary care from a healthcare and a societal perspective. DESIGN: Economic evaluation alongside a multicentre randomised controlled non-inferiority trial with a 24-month follow-up. SETTING: 21 hospitals in the Netherlands, recruitment conducted between 2015 and 2022. PARTICIPANTS: 1605 women referred to secondary care with symptomatic prolapse stage ≥2 were requested to participate. Of them, 440 women gave informed consent and were randomised to pessary therapy (n=218) or to surgery (n=222) in a 1:1 ratio stratified by hospital. INTERVENTIONS: Pessary therapy and surgery. PRIMARY AND SECONDARY OUTCOME MEASURES: The Patient Global Impression of Improvement (PGI-I), a 7-point scale dichotomised into successful versus unsuccessful, with a non-inferiority margin of -10%; quality-adjusted life-years (QALYs) measured by the EQ-5D-3L; healthcare and societal costs were based on medical records and the institute for Medical Technology Assessment questionnaires. RESULTS: For the PGI-I, the mean difference between pessary therapy and surgery was -0.05 (95% CI -0.14; 0.03) and -0.03 (95% CI -0.07; 0.002) for QALYs. In total, 54.1% women randomised to pessary therapy crossed over to surgery, and 3.6% underwent recurrent surgery. Healthcare and societal costs were significantly lower in the pessary therapy (mean difference=-€1807, 95% CI -€2172; -€1446 and mean difference=-€1850, 95% CI -€2349; -€1341, respectively). The probability that pessary therapy is cost-effective compared with surgery was 1 at willingness-to-pay thresholds between €0 and €20 000/QALY gained from both perspectives. CONCLUSIONS: Non-inferiority of pessary therapy regarding the PGI-I could not be shown and no statistically significant differences in QALYs between interventions were found. Due to significantly lower costs, pessary therapy is likely to be cost-effective compared with surgery as an initial treatment option for women with symptomatic POP treated in secondary care. TRIAL REGISTRATION NUMBER: NTR4883.

Sex differences in the association between (sexual) abuse and lower urinary tract symptoms.

OBJECTIVES: To study the possible association between (sexual) abuse and lower urinary tract symptoms (LUTS) in men and women. To study the differences in this association between men and women, and between the timing of the abuse. SUBJECTS AND METHODS: A Dutch observational population-based cross-sectional study was used, based on self-administered questionnaires. Respondents were included if they had answered all questions about abuse and LUTS. Logistic regression was used to analyse the data. RESULTS: Included were 558 men and 790 women, of whom 29% and 37%, respectively, reported a history of one of more types of abuse. Abuse was significantly associated with LUTS in both men (odds ratio [OR] 1.7; 1.2-2.5) and women (OR 1.4; 1.1-2.1). This association, testing by two-way interaction, was significantly stronger in men. No association was found between childhood abuse or adulthood abuse and LUTS, in men or women. The association of sexual abuse with LUTS was significant in both men (2.7; 1.4-5.2) and in women (1.5; 1.1-2.2), and this association (testing by two-way interaction) was significantly much stronger in men. CONCLUSION: In men more than in women, a history of any type of abuse is associated with LUTS, regardless of whether the abuse occurred during childhood or adulthood. In both sexes, a history of sexual abuse is also associated with experiencing LUTS, with a much stronger association in men than in women. Patients, in particular male patients, presenting with LUTS should therefore be asked about sexual abuse in the past.

The usefulness of uroflowmetry and ultrasound bladder scanning as diagnostic tools in primary care for new male patients with lower urinary tract symptoms; a cluster randomized controlled trial.

BACKGROUND: Uroflowmetry and ultrasound scanning of the post-void residual volume are diagnostic instruments in specialist urological care of men referred with lower urinary tract symptoms (LUTS). We hypothesized that implementing uroflowmetry and post-void ultrasound bladder scanning in primary care for men with LUTS will reduce the number of referrals to urologists. OBJECTIVE: To assess the effect on referrals to urologists for new male patients over 50 years of age with LUTS when performing uroflowmetry and post-void ultrasound bladder scanning in primary care. METHODS: A cluster randomized controlled trial was conducted among Dutch general practitioners (GPs). The GPs enrolled male patients with the first-time presentation of LUTS, these were randomized to primary-care treatment with or without uroflowmetry and post-void bladder scanning. Primary outcome: percentage of patients referred to urologists within 3 and 12 months. Secondary outcomes: changes in the International Prostate Symptom Score (IPSS) and the IPSS-Quality of Life, patient satisfaction and urologic medication usage after 12 months. RESULTS: Four GPs were randomly assigned to the intervention group (132 patients) and seven to the control group (212 patients). The percentage of patients referred to urologists did not differ significantly between the intervention group vs the control group: within 3 months 19.7% versus 10.4% (OR 1.9, 95% CI 0.8 to 5.0), and within 12 months 28.8% versus 21.2% (OR 1.5, 95% CI 0.9 to 2.5). CONCLUSIONS: Performing uroflowmetry and ultrasound bladder scanning in primary care as additional diagnostic tools do not reduce the number of referrals to urologists. We do not recommend using these diagnostic tools in general practice in the diagnostic work-up of these patients.

Attitudes of general practitioners and midwives towards ethnicity-based haemoglobinopathy-carrier screening.

Haemoglobinopathies (HbP) are severe autosomal recessive disorders with high prevalence among certain ethnic groups. World Health Organisation (WHO) advises implementing screening programmes for risk groups. Research in the Netherlands has shown that general practitioners and midwives do not perceive ethnicity as a risk factor for HbP. Moreover, registration of ethnicity is a controversial societal issue, which may complicate the introduction of a national preconception or antenatal carrier screening programme. This study investigates attitudes, intention and behaviour of general practitioners and midwives towards ethnicity-based HbP-carrier screening in general. A structured questionnaire based on the Theory of Planned Behaviour was sent by mail to a random selection of 2100 general practitioners and 1800 primary care midwives. Response was 35% (midwives 44.2%; GPs 27.6%). Although 45% of respondents thought that offering a carrier test on the basis of ethnicity alone should become national policy, it is currently not carried out. The main factor explaining lack of intention towards ethnicity-based HbP-carrier screening was subjective norm, the perception that their peers do not think they should offer screening (52.2% variance explained). If ethnicity-based HbP-carrier screening would become national policy, most professionals report that they would carry this out. Most respondents favoured ethnicity registration for health purposes. As most practitioners look for role models among peers, debate among general practitioners and midwives should be encouraged when new policy is to be developed, articulating the voices of colleagues who already actively offer HbP-carrier screening. Moreover, primary care professionals and professional organisations need support of policy at national level.

A case study of haemoglobinopathy screening in the Netherlands: witnessing the past, lessons for the future.

OBJECTIVES: In 2007 neonatal screening (NNS) was expanded to include screening for sickle cell disease (SCD) and beta-thalassaemia. Up until that year no formal recommendations for haemoglobinopathy (carrier) screening existed in the Netherlands. Although it has been subject to debate in the past, preconceptional and prenatal haemoglobinopathy carrier screening are not part of routine healthcare in the Netherlands. This study aimed to explore the decision-making process of the past: why was the introduction of a screening programme for haemoglobinopathy considered to be untimely, and did ethnicity play a role given the history in other countries surrounding the introduction of haemoglobinopathy screening? DESIGN: A witness seminar was organised, inviting key figures to discuss the decision-making process concerning haemoglobinopathy screening in the Netherlands, thereby adding new perspectives on past events. The transcript was content-analysed. RESULTS: The subject of haemoglobinopathy screening first appeared in the 1970s. As opposed to a long history of neglect of African-American health in the United States, the heritage of the Second World War influenced the decision-making process in the Netherlands. As a consequence, registration of ethnicity surfaced as an impeding factor. However, overall, official Dutch screening policy was restrained regarding reproductive issues caused by fear of eugenics. In the 1990s haemoglobinopathy screening was found to be 'not opportune' due to low prevalence, lack of knowledge and fear of stigmatisation. Currently the registration of ethnicity remains on the political agenda, but still proves to be a sensitive subject. DISCUSSION: Carrier screening in general never appeared high on the policy agenda. Registration of ethnicity remains sensitive caused by the current political climate. Complexities related to carrier screening are a challenge in Dutch healthcare. Whether carrier screening will be considered a valuable complementary strategy in the Netherlands, depends partly on participation of representatives of high-risk groups in policy making.