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.

[Increased risk of gastrointestinal bleeding or ulcers when using spironolactone: a case-control study]. / Toegenomen kans op gastro-intestinale bloedingen of ulcera bij gebruik van spironolacton: patiënt-controlestudie.

OBJECTIVE: To study the association between the use of spironolactone and the risk of upper gastrointestinal bleeding or ulcers. DESIGN: Case-control study. METHOD: The study used the computerized 'integrated primary care information' (IPCI) database in the Netherlands. All persons, 18 years or older during the study period from January 1st 1996 through September 30th 2003 with at least one year of valid case history were included. Patients with a medical history of alcoholism or gastrointestinal cancer were excluded. For each case of gastroduodenal ulcer or upper gastrointestinal bleeding, 10 controls were sampled from the same database, matched on age (year of birth), gender and index date. The association between the use ofspironolactone, calculated from the number of general practitioners' prescriptions, and the occurrence of an upper gastrointestinal event (upper gastrointestinal bleeding or ulcers) was analysed by means of a conditional logistic regression analysis. RESULTS: Within the source population of 306,645 patients, 523 cases with gastric or duodenal ulcers or upper gastrointestinal bleeding were identified and matched with 5,230 controls. Current use of spironolactone was associated with a 2.7-fold (adjusted odds ratio (OR); 95% CI: 1.2-6.0) increased risk of gastrointestinal events. This risk was higher in patients on high dosages and was the highest in patients using spironolactone in combination with an ulcerogenic drug (NSAIDs, platelet aggregation inhibitors, corticosteroids or vitamin K antagonist) (adjusted OR: 7.3; 95% CI: 2.9-18.7). CONCLUSION: The risk of upper gastrointestinal bleeding or ulcer was increased 2.7 times when spironolactone was used.

Treatment strategies, patterns of drug use and treatment discontinuation in men with LUTS suggestive of benign prostatic hyperplasia: the Triumph project.

OBJECTIVES: We aimed to describe treatment strategies for lower urinary tract symptoms suggestive of benign prostatic hyperplasia (LUTS/BPH), adherence to and persistence with pharmacological treatment and the association between the type of LUTS/BPH complaints and early treatment discontinuation. METHODS: Within a large GP database (IPCI) in the Netherlands we identified all males > or =45 years newly diagnosed with LUTS/BPH during 1995-2000. Details on treatment were assessed from the electronic patient records. Logistic regression analysis was used to estimate the association between the type of main urinary complaints and early treatment discontinuation. RESULTS: Of the 2214 men with incident LUTS/BPH, 1075 received pharmacological treatment and 238 underwent prostate surgery. The average adherence differed slightly between drugs: 67% for alpha-blockers, 73% for 5alpha-reductase inhibitors and 71% for combination therapy. 26% of the treated patients discontinued treatment early. The probability of early discontinuation was higher if patients mainly expressed one type of complaint: voiding (OR(adj) 3.38; 95%CI: 1.89-6.04), post micturition (OR(adj) 2.37; 95%CI: 1.15-4.87) or storage symptoms (OR(adj) 1.85; 95%CI: 1.16-2.95) as compared to patients expressing a combination of symptoms. The risk of early discontinuation was higher if patients had a normal PSA measurement. Older age and a higher chronic disease score protected against early treatment discontinuation. CONCLUSIONS: Almost half of newly diagnosed LUTS/BPH patients are pharmacologically treated, and a quarter discontinues very rapidly. Stopping early is more frequent among younger persons, persons with only one type of main urinary complaint, no other co-morbidity and a normal PSA.