Protocol for Physiotherapy Or TVT Randomised Efficacy Trial (PORTRET): a multicentre randomised controlled trial to assess the cost-effectiveness of the tension free vaginal tape versus pelvic floor muscle training in women with symptomatic moderate to severe stress urinary incontinence.

BACKGROUND: Stress urinary incontinence is a common condition affecting approximately 20% of adult women causing substantial individual (quality of life) and economic (119 million Euro/year spent on incontinence pads in the Netherlands) burden. Pelvic floor muscle training (PFMT) is regarded as first line treatment, but only 15-25% of women will be completely cured. Approximately 65% will report that their condition improved, but long term adherence to treatment is problematic. In addition, at longer term (2-15 years) follow-up 30-50% of patients will end up having surgery. From 1996 a minimal invasive surgical procedure, the Tension-free Vaginal Tape (TVT) has rapidly become the gold standard in surgical treatment of stress urinary incontinence. With TVT 65-95% of women are cured. However, approximately 3-6% of women will develop symptoms of an overactive bladder, resulting in reduced quality of life. Because of its efficacy the TVT appears to be preferable over PFMT but both treatments and their costs have not been compared head-to-head in a randomised clinical trial. METHODS/DESIGN: A multi-centre randomised controlled trial will be performed for women between 35-80 years old with moderate to severe, predominantly stress, urinary incontinence, who have not received specialised PFMT or previous anti-incontinence surgery. Women will be assigned to either PFMT by a specialised physiotherapist for a standard of 9-18 session in a period of 6 months, or TVT(O) surgery. The main endpoint of the study is the subjective improvement of urinary incontinence. As secondary outcome the objective cure will be assessed from history and clinical parameters. Subjective improvement in quality of life will be measured by generic (EQ-5D) and disease-specific (Urinary Distress Inventory and Incontinence Impact Questionnaire) quality of life instruments. The economical endpoint is short term (1 year) incremental cost-effectiveness in terms of costs per additional year free of urinary incontinence and costs per Quality Adjusted Life Years (QALY) gained. Finally, treatment strategy and patient characteristics will be combined in a prediction model, to allow for individual treatment decisions in future patients. Four hundred female patients will be recruited from over 30 hospitals in the Netherlands. TRIAL REGISTRATION: Nederlands trial register: NTR 1248.

Endovascular treatment of aneurysms in the cavernous sinus: a systematic review on balloon occlusion of the parent vessel and embolization with coils.

BACKGROUND AND PURPOSE: Balloon occlusion of the parent vessel and endosaccular coiling are both frequently used for treatment of intracavernous aneurysms of the carotid artery. We performed a systematic review of studies reporting on these two treatment modalities to assess the rate of complications, rate of successful aneurysm occlusion, and clinical condition after treatment. METHODS: We performed a MEDLINE search for studies published between January 1974 and May 1999 and hand-searched recent volumes of 21 journals. Two authors independently extracted data by means of a standardized data extraction form. RESULTS: We found 35 studies reporting on 316 patients. Only 9 of the 35 studies reported on more than 5 patients; in only 9 studies (totaling 85 patients), well-defined outcome measures were used. Twenty-five studies (with 78% of all patients included in the review) reported on balloon occlusion. Complications during or in the first 24 hours after the balloon occlusion occurred in 4 of 247 patients (1.6%; 95% CI, 0.01% to 3.2%) and late ischemic complications in 5 of 148 patients (3.4%; 95% CI, 0.43% to 6.4%). Clinical follow-up was performed in 21 of 25 studies on treatment by means of balloon occlusion (148 [60%] of the 247 patients). None of the 68 patients treated by embolization with coils had a complication (0%; 95% CI, 0% to 4.3%). Of 157 aneurysms treated by balloon occlusion, 153 were completely thrombosed (97.5%; 95% CI, 95% to 100%). After coiling, 52 of 65 aneurysms (80%; 95% CI, 70% to 90%) were occluded by >90%. CONCLUSIONS: Many studies included in this review had methodological weaknesses. The available data suggest that both balloon occlusion and endosaccular coiling are reasonably safe and result in occlusion of the aneurysm in the majority of patients. However, long-term outcomes have not yet been reported.

[Short-term rehabilitation of Parkinson's disease patients delays nursing home placement]. / Kortdurende gespecialiseerde revalidatie van parkinsonpatiënten stelt verpleeghuisopname uit.

OBJECTIVE: To evaluate the efficacy of the Groningen Parkinson Short-Stay (GPSS) treatment, a short-term and intensive clinical intervention, on delaying the definitive nursing home placement of patients with Parkinson's disease. DESIGN: Retrospective cohort study. METHOD: We included 65 patients with Parkinson's disease, of whom 39 were men and 26 were women with a mean age of 72 years (range: 43-88), who in 2009 were admitted to the GPSS ward of nursing home Maartenshof in Groningen, the Netherlands, for six weeks. The primary outcome measure was the number of patients who were able to live independently at home after discharge. The secondary outcome measures were changes in medication, change in cognitive performance and the duration of being able to live independently at home. RESULTS: After treatment on the GPSS ward, 49 patients could return home. Patients with a Mini-Mental State Examination (MMSE) score < 26 showed a significant increase of 2.5 points (14%, p = 0.003) after treatment. The frontal lobe functions, measured with the Frontal Assessment Battery, showed a significant increase of 1.3 points (11%, p = 0.024). In 31 (76%) patients, the dopaminergic medication was underdosed; after increasing the dosage, the clinical symptoms improved. In 10 (53%) psychotic patients, the dosage of atypical antipsychotics was increased. After an average follow-up period of 16.5 months (range: 10.0-24.5), 38 patients (63%) were still living at home. CONCLUSION: Treatment at the GPSS ward postpones a definitive nursing home placement. An important factor in this is the optimisation of medication for motor, behavioural and cognitive functioning. This treatment should be used more widely for patients in the end stages of Parkinson's disease.

The Glasgow Aneurysm Score as a tool to predict 30-day and 2-year mortality in the patients from the Dutch Randomized Endovascular Aneurysm Management trial.

OBJECTIVE: Randomized trials have shown that endovascular repair (EVAR) of an abdominal aortic aneurysm (AAA) has a lower perioperative mortality than conventional open repair (OR). However, this initial survival advantage disappears after 1 year. To make EVAR cost-effective, patient selection should be improved. The Glasgow Aneurysm Score (GAS) estimates preoperative risk profiles that predict perioperative outcomes after OR. It was recently shown to predict perioperative and long-term mortality after EVAR as well. Here, we applied the GAS to patients from the Dutch Randomized Endovascular Aneurysm Repair (DREAM) trial and compared the applicability of the GAS between open repair and EVAR. METHODS: A multicenter, randomized trial was conducted to compare OR with EVAR in 345 AAA patients. The GAS was calculated (age + [7 points for myocardial disease] + [10 points for cerebrovascular disease] + [14 points for renal disease]). Optimal cutoff values were determined, and test characteristics for 30-day and 2-year mortality were computed. RESULTS: The mean GAS was 74.7 +/- 9.3 for OR patients and 75.9 +/- 9.7 for EVAR patients. Two EVAR patients and eight OR patients died < or =30 days postoperatively. The area under the receiver-operator characteristic curve (AUC) was 0.79 for OR patients and 0.87 for EVAR patients. The optimal GAS cutoff value was 75.5 for OR and 86.5 for EVAR. By 2 years postoperatively, 18 patients had died in both the EVAR and the OR patient groups. The AUC was 0.74 for OR patients and 0.78 for EVAR patients. The optimal GAS cutoff value was 74.5 for OR and 77.5 for EVAR. CONCLUSION: This is the first evaluation of the GAS in a randomized trial comparing AAA patients treated with OR and EVAR. The GAS can be used for prediction of 30-day and 2-year mortality in both OR and EVAR, but in patients that are suitable for both procedures, it is a better predictor for EVAR than for OR patients. In this study, the GAS was most valuable in identifying low-risk patients but not very useful for the identification of the small number of high-risk patients.