Management of lower urinary tract symptoms related to benign prostatic hyperplasia in real-life practice in france: a comprehensive population study.

BACKGROUND: Male lower urinary tract symptoms (LUTS) are one of the most treated diseases, but little is known about patient trajectories in current clinical practice. OBJECTIVE: To describe the dynamic treatment patterns of LUTS presumably due to benign prostatic obstruction (BPO). DESIGN, SETTINGS, AND PARTICIPANTS: All prescriptions of α1-adrenergic receptor blocking agents (α1-blockers), 5α-reductase inhibitors (5-ARIs), and phytotherapy, and all surgeries related to BPO performed in France from 2004 to 2008 were identified using two distinct administrative claim databases maintained by the National Health Insurance system that covers the entire population. After linking the two data sets, all consecutive treatment events were analyzed for each patient. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: Drug prescription details were assessed for each year, region, and prescriber qualification. Medical treatment initiation, interruption, evolution, and events after surgical management (hospital stay, reoperation, complication rates, and subsequent medical prescriptions) were also investigated. RESULTS AND LIMITATIONS: Overall, 2 620 269 patients were treated within 5 yr, with important geographic variations. Medical treatment was interrupted for approximately 16% of patients. The α1-blockers were prescribed most frequently, but phytotherapy surprisingly accounted for 27% of all monotherapies and 54% of all combination therapies. General practitioners and urologists (92% and 3.7% of overall prescribers, respectively) exhibited a similar prescription profile. Treatment initiation was medical in 95.4% of cases, consisting primarily of monotherapy using α1-blockers (60.3%), phytotherapy (31.8%), or 5-ARIs (7.9%). Treatment was modified at extremely high rates within 12 mo of initiation (8.7%, 14.6%, and 12.9%, respectively). The median hospital stay for surgical management was far higher than in clinical trials. Long-term surgical complications and reoperation rates favored open prostatectomy. Incidence of pharmacologic treatment after surgery was as high as 13.8% at 12 mo. CONCLUSIONS: This unique dynamic evaluation of clinical practice revealed unexpected results that contrast with previously published evidence from clinical trials. This approach may merit monitored and targeted measures to improve the level of care in the field.

Prospective short-term evaluation of transurethral needle ablation procedure in an ambulatory setting.

OBJECTIVE: To assess the results of transurethral needle ablation (TUNA) (Prostiva®, Medtronic, France) performed in an ambulatory setting in men with lower urinary tract symptoms (LUTS)/benign prostatic hyperplasia (BPH). MATERIALS AND METHODS: A multicenter open-label study was conducted. Short-term success was defined by ability to leave the hospital on the evening of the intervention, and absence of rehospitalization due to complications during the first postoperative month. Sexual and urinary functions were evaluated by validated questionnaires. RESULTS: The procedure was successful in 44/49 patients. Sexual and ejaculatory function was not affected or slightly improved in the majority of patients. Urinary parameters improved with a 32% decrease in the International Prostate Symptom Score. At 1 month postoperation, more than 80% of patients were satisfied, and 36/41 patients were prepared to undergo the procedure again if needed. Our study was limited by the short follow-up duration. CONCLUSIONS: TUNA can be successfully performed in an ambulatory setting under local and/or general anesthesia with a high level of patient satisfaction and a low short-term morbidity, especially on sexual function. Thus, the procedure is a suitable mini-invasive option for patients who cannot/do not want to take medical therapy or undergo invasive surgical procedures, or want to preserve their sexual function.

Photoselective vaporization of the prostate with GreenLight 120-W laser compared with monopolar transurethral resection of the prostate: a multicenter randomized controlled trial.

BACKGROUND: Evidence supporting the widespread use of GreenLight High Performance System (HPS) 120-W photoselective vaporization of the prostate (PVP) is lacking. OBJECTIVE: To assess the noninferiority of PVP compared with transurethral resection of the prostate (TURP) on urinary symptoms and the superiority of PVP over TURP on length of hospital stay. DESIGN, SETTING, AND PARTICIPANTS: A multicenter randomized controlled trial was conducted. INTERVENTION: Patients underwent monopolar TURP or PVP with the GreenLight HPS 120-W laser. MEASUREMENTS: International Prostate Symptom Score (IPSS), Euro-QOL questionnaire, uroflowmetry, Danish Prostate Symptom Score Sexual Function Questionnaire, sexual satisfaction, and adverse events were collected at 1, 3, 6, and 12 mo. The two groups were compared using the 95% confidence interval (CI) of median difference for testing noninferiority of the IPSS at 12 mo and the student t test for testing the difference in length of hospital stay. RESULTS AND LIMITATIONS: A total of 139 patients (70 vs 69 men in each group) were randomized. Median IPSS scores at 12-mo follow-up were 5 (interquartile range [IQR]: 3-8) for TURP versus 6 (IQR: 3-9) for PVP, and the 95% CI of the difference of the median was equal to -2 to 3. Because the upper limit of the 95% CI was >2 (the noninferiority margin), the hypothesis of noninferiority could not be considered demonstrated. Median length of stay was significantly shorter in the PVP group than in the TURP group, with a median of 1 (IQR: 1-2) versus 2.5 (IQR: 2-3.5), respectively (p<0.0001). Uroflowmetry parameters and complications were comparable in both groups. Sexual outcomes were slightly better in the PVP group without reaching statistical significance. CONCLUSIONS: The present study failed to demonstrate the noninferiority of 120-W GreenLight PVP versus TURP on prostate symptoms at 1 yr but showed that PVP was associated with a shorter length of stay in the hospital. TRIAL REGISTRATION: NCT01043588.

Assessment of dynamic humeral centering in shoulder pain with impingement syndrome: a randomised clinical trial.

OBJECTIVES: Treatment for degenerative rotator cuff disease of the shoulder includes physiotherapy. Dynamic humeral centering (DHC) aims at preventing subacromial impingement, which contributes to the disease. The goal of this study was to assess the effectiveness of DHC. METHOD: 69 patients with shoulder pain and impingement syndrome were prospectively included in a single-centre randomised trial with a 12-month follow-up. Patients and assessor were blinded to the study hypothesis and treatment, respectively. DHC and non-specific mobilisation as control were performed for 6 weeks, in 15 supervised individual outpatient sessions, and patients performed daily home exercises. The planned primary outcome was the Constant score including subscores for pain, activity, mobility and strength at 3 months. Secondary outcomes were the Constant score and subscores at 12 months, and medication use for pain at 3 and 12 months. RESULTS: The DHC group did not differ from the control group in the total Constant score at 3 months. However, the DHC group showed a higher Constant subscore for pain (12.2 (SD 2.8) vs 9.9 (2.9), least square means difference 2.1, 95% CI 0.7 to 3.5, p=0.004). At 3 months, the DHC group also showed a higher rate of no medication use (96.7% vs 71%, proportional difference 25.7, 95% CI 3.7 to 51.9, p=0.012). There was no other intergroup difference. CONCLUSIONS: There was no difference in the total Constant score between DHC and controls. However, pain was improved at 3 months after DHC. The differences found in subscores for pain should be explored in future studies. Trial registration clinicaltrials.gov Identifier: NCT 01022775.