Efficacy, safety and acceptability of a benzalkonium chloride spermicide cream in women aged 40 years and over needing contraception: A prospective multicentre study.

OBJECTIVE: This multicenter prospective study (BZK40+) aims to determine the efficacy and tolerance of a benzalkonium chloride-containing spermicide as contraceptive among women aged 40 and over. PROCEDURE: Fertile women enrolled in this open single-arm study were instructed to systematically use the benzalkonium chloride spermicide before each intercourse. At the end of a 6-month mandatory period, participants were given the option of continuing the study for a further 6 months. The primary endpoint for contraceptive efficacy was the Pearl Index (PI) up to 12 months of typical use. MAIN FINDINGS: A total of 151 women (mean age: 45.9 years) were enrolled, 144 (95.4%) completed the initial 6-month period and 63 (41.7%) completed the optional 6-month period. The median number of intercourses ranged from 3 to 5 per month. The spermicide was applied before 96.3% of the 5,895 sexual intercourses. The PI up to 12 months of typical use was 0 pregnancies (95% confidence interval: 0-2.88). The cumulative treatment exposure was 1249.7 women-months. CONCLUSION: This first study in women aged 40 years and over shows that benzalkonium chloride spermicide (Pharmatex®) is effective, well tolerated and well accepted in this population. Although very interesting, these results with a PI equal to zero are surprising and not in accordance with the low efficacy of spermicides in the overall population according to the WHO. So, our results should be interpreted with caution and confirmed by future research. Clinical trial registration number (EudraCT): 2016-004,188-38.

The visual prostate symptom score is a simple tool to identify and follow up in general practice patients with lower urinary tract symptoms associated with benign prostatic hyperplasia (a study with 1359 patients).

INTRODUCTION: The IPSS (International Prostate Symptom Score), a structured self-administered questionnaire is the reference test for evaluation of lower urinary tract symptoms (LUTS). A 5-pictogram score entitled Score Visuel Prostatique en Images (SVPI) was proposed in France and evaluated by urologists. We assessed the interest of the SVPI for the identification and monitoring of benign prostatic hyperplasia (BPH)-related LUTS in general practice, and compared it with the IPSS. METHODS: A prospective observational survey was carried out with general practitioners (GPs) throughout France. The first 4consecutive patients aged over 60years, with BPH-related LUTS (IPSS score greater than 8) for whom the GP freely intended to prescribe an alpha-blocker, were enrolled. Two self-administered questionnaires were used at baseline and at follow-up visit (between 1 and 3months): French language version of the IPSS (8questions) and the SVPI. The 5pictograms of the SVPI were: How many times do you urinate during the day (score of 0 to 5)? How many times do you urinate during the night (score of 0 to 5)? Do you experience an urgent need to urinate (score of 0 to 4)? How strong is the stream (response from 0 to 4)? Do you urinate in a satisfactory manner (score of 0 to 6)? The primary objective was to assess and validate the sensitivity to change of the SVPI at baseline and follow-up visit by the study of the correlation of its changes according to the changes of LUTS evaluated with the IPSS. RESULTS: Five hundred and forty seven GPs enrolled at least one patient and returned information. 2261patients completed the inclusion questionnaire, and 1359 were included in the statistical analysis. Under treatment with alpha-blocker, the IPSS average decreased from 17.7±4.9 to 10.5±4.4 (P<0.0001) with an average diminution of 7.2±4.0, which corresponded to an improvement of 40.7%. This significant decrease of the IPSS involved all its components. The total SVPI was evaluated to 13.8±3.1, the irritative sub-score to 7.4±2.0, and the obstructive sub-score to 2.4±0.8. The internal consistency of the SVPI was good with a value of the Cronbach Alpha coefficient of 0.74. Under treatment with alpha-blocker, the value of the total SVPI decreased from 13.8±3.1 to 8.2±3.0 (P<0.0001) between enrolment and the follow-up visit. The Pearson coefficients assessing the correlations in 1359 patients with benign prostatic hypertrophy were statistically significant at enrolment, and at the follow-up visit. Their variations were all significant. The correlations were weak for the obstructive subscores. Four hundred and fifty-one GPs gave their opinion on the SVPI compared to IPSS: for 36.8% of them, the SVPI was completed a little more rapidly than the IPSS, for 34.6% more rapidly, and for 22.8% of them the SVPI was completed much more rapidly. For 5.8% of them, there was no difference. With regard to ease of understanding for the patient, the 451 GPs responded: much easier for 27.3%, easier for 37.3%, a little easier for 27.1%, and 8.4% had no opinion. CONCLUSION: This study showed the SVPI to be a simple and useful tool for identifying and monitoring BPH-related LUTS. Total SVPI was correlated with total IPSS, even if the obstructive subscore correlation was weaker. The good sensitivity of the SVPI to change showed its potential interest for monitoring LUTS. Given the underuse of the IPSS and the interest expressed by GPs and urologists, the SVPI might be used alone to analyse patient complaints.

[Application of the recommendations of the conference of consensus in front of symptoms ENT, respiratory or thoracic pains considered as due to a gastroesophageal reflux disease]. / Application des recommandations de la conférence de consensus devant des symptômes ORL, respiratoires ou des douleurs thoraciques considérés comme dus à un reflux gastro-œsophagien.

AIMS: The primary objectives of this observatory were: (1) to assess the prevalence of extradigestive symptoms (EDS) (asthma, pharyngeal pain, chronic hoarseness, nocturnal breathlessness, chronic or nocturnal cough, non-cardiac chest pain) which are suspected of being associated with gastro-oesophageal reflux (GERD) in a population consulting in general practice; (2) to compare the diagnostic and therapeutic approach adopted initially and at follow-up to the recommendations of the French-Belgian Consensus Conference on adult GERD (1999). METHODS: The survey was conducted among 578 general practitioners (GPs). All EDS were investigated in patients (≥ 18 y.o.) consulting over 3 days. Only patients considered a priori as having GERD related EDS were included in study. At each visit (initial and at 1 and 4 months), the diagnostic and therapeutic approach was analyzed, scored, and the GP's certainty regarding the accountability of GER in the EDS rated using the visual analogue scale (VAS). The criteria used by GPs to evaluate GER accountability as certain or doubtful were examined. RESULTS: Out of 33,487 consulting patients, 14% presented EDS (cough: 6.7%; ENT symptoms: 7.7%; chest pain: 2.3%). Among patients presenting EDS, 22% (1063) were included in the study based on suspicion of GERD, whereas 45% (481) had neither history nor digestive symptoms typically associated with GERD. The diagnostic approach did not vary whether the patient presented typical EDS associated symptoms (A+) or not (A-): 83.7% of patients (A+) versus 86.5% (A-) immediately received acid reflux treatment; 4.6% (A+) versus 7.9% (A-) underwent additional testing and 5.2% (A+) versus 4.4% (A-) were referred to a specialist. In 87% of cases, acid reflux treatment included a proton pump inhibitor (PPI) (half-dose: 47.2%, standard dose 50.3%, double dose 2.5%); in 8.1% of patients initial acid reflux treatment included an H2 antagonist while in 3.2% of patients treatment included prokinetic drugs. At 4 months of follow-up, GERD accountability was considered certain in 74.7% of the patients included in the assessment (794/1063). The GPs opinion was based on response to acid reflux treatment in 92% of cases, on endoscopy in 6.7% of cases, on pH monitoring in 0.3% of cases and on a specialist's opinion in 6% of cases. CONCLUSION: There is a considerable difference between the recommendations of the French-Belgian Consensus Conference on adult GERD and the practices observed in general medicine. The diagnostic and therapeutic approaches were empirical with recourse to additional exams in less than 10% of cases. The degree of certainty as to GERD accountability was based primarily on response to PPI treatment.

Gastroesophageal reflux disease: impact on work productivity and daily-life activities of daytime workers. A French cross-sectional study.

BACKGROUND: Few studies have evaluated the impact of gastroesophageal reflux disease symptoms on work productivity and no French data are available. AIM: To compare the impact of typical symptoms of nocturnal vs diurnal gastroesophageal reflux disease on work productivity and daily activities. METHODS: A French prospective, multicenter, observational study was performed in primary care setting. Patient characteristics, symptomatology and treatment were reported. Work productivity loss was assessed using the work productivity and activity impairment questionnaire, predictors were identified using multivariate regression models, and estimated cost was calculated. RESULTS: 716 eligible patients (mean age: 46.3 years) were included by 407 physicians. Nocturnal symptoms were reported in 50.8% of patients and exclusively diurnal symptoms in 49.2%. Mean work productivity and daily activities decreased by 31.4% and 32.6%, respectively (both p<0.001). Work productivity was influenced by symptom intensity, diurnal symptoms occurrence, regurgitation and diurnal sleepiness. The mean associated cost per patient/week (€313) was higher in patients with diurnal symptoms (without (€346) or with nocturnal (€312) symptoms) than in patients with exclusive nocturnal symptoms (€253) (p<0.001). CONCLUSION: Gastroesophageal reflux disease incurs high work productivity loss especially in patients with diurnal symptoms. Further medico-economic analyses are needed to estimate the cost effectiveness ratio according to therapeutic strategies.