The cost of feedback microwave thermotherapy compared with transurethral resection of the prostate for treating benign prostatic hyperplasia.

OBJECTIVE: To compare the efficacy of a new microwave thermotherapy for treating benign prostatic hyperplasia (BPH), the ProstaLund Feedback Treatment (PLFT, ProstaLund Operations AB, Lund, Sweden) and transurethral resection of the prostate (TURP) in a clinical trial to their effectiveness in clinical practice over 1 year, to estimate their cost over 1 year, and to evaluate the cost of re-interventions over a longer period (2-3 years). PATIENTS AND METHODS: In a large randomized international 1-year clinical trial PLFT was as effective as TURP in improving symptoms of BPH and urinary flow. Because PLFT is an outpatient procedure it was less costly than TURP. However, the cost-effectiveness of the new procedure depends on its long-term effectiveness in clinical practice. All 146 patients in the randomized clinical trial were included in the present analysis. The outcome was based on the International Prostate Symptom Score (IPSS) and the bother score, and costs were estimated from treatment-related adverse events and hospitalization. To validate the estimates based on the clinical trial 1-year data on effectiveness and complete resource use in clinical practice were collected in a retrospective observational study from hospital charts and patient questionnaires of 88 patients who had undergone either TURP or PLFT. To assess the number of re-interventions after TURP after the first year information was obtained from hospital and surgical procedure data in the Swedish inpatient registry. The 3-year data for a total of 52,010 patients who had an index hospitalization for TURP between 1990 and 1995 were available for the analysis. The estimate of long-term consequences of PLFT was based on complication and re-intervention data for 87 patients who had undergone PLFT between 1997 and 1999. RESULTS: The mean 1-year costs in the clinical trial were estimated at [symbol: see text] 1763 for PLFT and [symbol: see text] 3209 for TURP. When all treatment-related resource use in clinical practice for 88 patients was included the costs were estimated at [symbol: see text] 1924 and [symbol: see text] 3264 for PLFT and TURP, respectively. The IPSS and bother scores were not significantly different between the groups in both datasets. Using the registry data the cost of TURP including re-interventions (TURP and bladder neck incisions) was estimated at [symbol: see text] 3159 over 2 years and [symbol: see text] 3185 over 3 years; the respective costs for PLFT were [symbol: see text] 2121 and at [symbol: see text] 2151. CONCLUSIONS: In the 1-year clinical trial PLFT was as effective but less costly than TURP, but long-term data are still lacking. However, the preliminary analysis over 3 years indicates that the average cost of the procedure remains lower than the total cost of TURP for the same period.

A vegan diet free of gluten improves the signs and symptoms of rheumatoid arthritis: the effects on arthritis correlate with a reduction in antibodies to food antigens.

OBJECTIVE: Whether food intake can modify the course of rheumatoid arthritis (RA) is an issue of continued scientific and public interest. However, data from controlled clinical trials are sparse. We thus decided to study the clinical effects of a vegan diet free of gluten in RA and to quantify the levels of antibodies to key food antigens not present in the vegan diet. METHODS: Sixty-six patients with active RA were randomized to either a vegan diet free of gluten (38 patients) or a well-balanced non-vegan diet (28 patients) for 1 yr. All patients were instructed and followed-up in the same manner. They were analysed at baseline and after 3, 6 and 12 months, according to the response criteria of the American College of Rheumatology (ACR). Furthermore, levels of antibodies against gliadin and beta-lactoglobulin were assessed and radiographs of the hands and feet were performed. RESULTS: Twenty-two patients in the vegan group and 25 patients in the non-vegan diet group completed 9 months or more on the diet regimens. Of these diet completers, 40.5% (nine patients) in the vegan group fulfilled the ACR20 improvement criteria compared with 4% (one patient) in the non-vegan group. Corresponding figures for the intention to treat populations were 34.3 and 3.8%, respectively. The immunoglobulin G (IgG) antibody levels against gliadin and beta-lactoglobulin decreased in the responder subgroup in the vegan diet-treated patients, but not in the other analysed groups. No retardation of radiological destruction was apparent in any of the groups. CONCLUSION: The data provide evidence that dietary modification may be of clinical benefit for certain RA patients, and that this benefit may be related to a reduction in immunoreactivity to food antigens eliminated by the change in diet.

Prospective evaluation of hot flashes during treatment with parenteral estrogen or complete androgen ablation for metastatic carcinoma of the prostate.

PURPOSE: We evaluated the incidence and frequency of, and distress due to hot flashes after castration therapy with polyestradiol phosphate and complete androgen ablation. MATERIALS AND METHODS: A total of 915 men with metastatic prostate carcinoma enrolled in the Scandinavian Prostatic Cancer Group-5 trial study were randomized to intramuscular injections of 240 mg. Polyestradiol phosphate every 2 weeks for 8 weeks followed by monthly subcutaneous injections or complete androgen ablation, that is bilateral orchiectomy or 3.75 mg. of the gonadotropin-releasing hormone analog triptorelin monthly combined with 250 mg. of the antiandrogen flutamide 3 times daily. The incidence and frequency of, and distress due to hot flashes were recorded at regular intervals using a questionnaire. RESULTS: Of the 915 men 901 were evaluated at a median followup of 18.5 months. The incidence of hot flashes was 30.1% and 74.3% in the polyestradiol phosphate and complete androgen ablation groups, respectively (p <0.001). In the polyestradiol phosphate group the frequency of and distress due to hot flashes were significantly lower than in the androgen ablation group. There was complete relief from hot flashes in 50% of the men on polyestradiol phosphate during followup compared with none on androgen ablation. The incidence of hot flashes did not differ in men with and without tumor progression. CONCLUSIONS: Endocrine treatment with polyestradiol phosphate induced fewer and less distressing hot flashes than complete androgen ablation. Flashes also disappeared to a greater extent during polyestradiol phosphate than during androgen ablation. The data in this study enable us to provide thorough individual information to patients on the risk and grade of expected distress and duration of hot flashes during polyestradiol phosphate or complete androgen ablation treatment.

Tamsulosin 0.4 mg once daily: tolerability in older and younger patients with lower urinary tract symptoms suggestive of benign prostatic obstruction (symptomatic BPH). The European Tamsulosin Study Group.

OBJECTIVES: To compare the safety and tolerability of tamsulosin 0.4 mg once daily in younger (< 65 years) and older (> or = 65 years) patients with lower urinary tract symptoms (LUTS) suggestive of benign prostatic obstruction (BPO). METHODS: In a retrospective analysis of two European double-blind, randomized, placebo-controlled trials, safety was assessed in 574 younger or older patients treated with tamsulosin or placebo for 12 weeks. RESULTS: The incidence of adverse events, drug-related adverse events, serious adverse events and discontinuations due to adverse events was similar in older and younger tamsulosin-treated patients and was not significantly different from placebo. Although abnormal ejaculation was slightly more common in younger than older men receiving tamsulosin, the difference was not statistically significant from the placebo groups in both age groups. The incidence of adverse events possibly associated with vasodilation in tamsulosin-treated younger and older patients was 8.4 and 4.2%, respectively; these were comparable with the values for placebo-treated patients: 7.5 and 6%, respectively. Baseline systolic blood pressure was higher in older than younger patients, but there were minimal changes in blood pressure or pulse rate in tamsulosin- or placebo-treated patients in either age group. CONCLUSIONS: Tamsulosin is well tolerated and suitable for use in older and younger patients with LUTS suggestive of BPO (symptomatic BPH).

Obstructive effect of a closed 12F urethral catheter during the emptying phase of cystometry in patients with a spinal reflex bladder.

In spinal cord injured patients with a reflex urinary bladder urodynamic evaluation of the detrusor pressure during the emptying phase is important, but the methods are not yet standardised. The aim of this study was to examine whether the detrusor pressure is significantly affected by the presence of a catheter in the urethra. In seven patients with a spinal reflex bladder, the maximum detrusor pressure and the duration of detrusor contractions in cystometry with a suprapubic technique were compared with the corresponding measurements when a closed 12F catheter was added to mimic a transurethral cystometric technique. Four cystometries were performed with about 10 min intervals and the mean values from two cytometries without the urethral catheter were compared with the mean values from two cystometries with the catheter. After addition of the urethral catheter there was an increase of the mean maximum detrusor pressure form 8.4 to 10.5 kPa (P = 0.009). The mean duration of the detrusor contraction increased from 122 to 191 s (P = 0.031) and the mean time during which the detrusor pressure exceeded 4 kPa, in each contraction, increased from 60 to 150 s (P = 0.009). The average flow rate, calculated as the voided volume divided by the duration of a contraction, decreased from 1.4 to 0.6 ml s-1 (P = 0.009).(ABSTRACT TRUNCATED AT 250 WORDS)

New method to quantify the urodynamic improvement when treating bladder outlet obstruction: the efficacy of transurethral resection in benign prostatic hypertrophy.

A method to measure the urodynamic improvement when treating urethral obstruction is introduced and applied to patients with benign prostatic hypertrophy. The patients performed pressure-flow studies before and 3-6 months after TUR-p. The urethral resistance relation was estimated by curve fitting in the pressure flow plot. The new method quantifies the improvement in urethral resistance as the distance between the urethral resistance relation before and after treatment expressed in pressure units. The distance is measured at the flow rate equal to 75% of the maximum flow rate for the micturition with the lowest maximum flow rate and this distance is called delta-URA. The median improvement after TUR-p was 71 cm H2O (range 2-119). The improvement was strongly correlated to the resistance before treatment and the regression line indicates that the operation normalizes the resistance irrespective of its preoperative value. On the average a lowering of the urethral resistance relation with 8 cm H2O improved the maximum flow rate with 1 ml/s. The greatest advantage with the new method is that it has a high validity and is almost completely insensitive to changes in contractility.

Estimation of urethral resistance by curve fitting in the pressure-flow plot. Theory and experience in normal men and men with benign prostatic hypertrophy.

The curvature of the urethral resistance relation was estimated in 21 normal men, in 32 prostatism patients, in 60 men with a diagnosis of benign prostatic hypertrophy (BPH) and obstruction, and in 55 men after treatment of BPH. The curvature was determined by curve fitting in the pressure-flow plot using the method of least squares. In all, 58% of the normal men and prostatism patients had a urethral resistance relation with the convexity directed upward, demonstrating a low-compliant type of distensibility. After transurethral resection (TUR), significantly more men had the convexity of the urethral resistance relation directed downward, showing that the distensibility was more of a constrictive type. This change in the elastic properties of the flow-controlling zone can be assessed only by using several curvatures to estimate the urethral resistance relation. Another advantage for the method of using different curvatures is that the effects of bladder contractility are minimized. However, should one use only one form of the urethral resistance relation, it is recommended that a linear relation be chosen.

Prostatism symptoms in a randomly selected population: introduction of a patient administered population based symptom evaluation score.

A questionnaire concerning micturition symptoms and bother was answered by 2559 (66%) randomly selected males. Voiding problems increased with age from about 4 to 40%. The symptoms were weakly but significantly correlated to each other (rs < 0.55). The ability of a particular symptom question to predict whether a subject actually would seek a doctor was generally low. A score system with a maximum score of 33 points was constructed. If prostatism was defined as a certain score or higher, a change in the definition in the score interval 4-10 would change the number of subjects with this syndrome with approximately 10%/score point. As a consequence of the results, the use of a symptom score as a criterion for the decision to treat patients suffering from prostatism is challenged. A patient administered symptom evaluation from is strongly recommended to obtain a more objective symptom registration.

Flow rate nomograms in 7- to 16-year-old healthy children.

To construct flow rate nomograms for children, 180 healthy boys and girls aged 7-16 years were examined with a new kind of flowmeter. Each child presented at least two registrations. The flow rate was significantly higher at the second examination and these micturitions were used to construct the nomograms. The relation between flow rate and volume may be described by the function flow = b volume(c), where b and c describe the slope and curvature, respectively. The advantages of using this relation are that non-parametric statistics can be employed, the variation around the median increases with increasing volume, and it is easy to calculate volume corrected flow rates. The exponent 0.5, often used earlier, was found to overestimate flow rates obtained at low volumes. In the constructed nomograms, the exponent varied between 0.29 and 0.42. The volume corrected maximum flow rate was about 2 ml/s higher in girls than in boys. This difference was significant. The difference of about 1.5 ml/s in average flow rate was not significant. The flow rate increased significantly with age. For volume corrected flow rates, there was, however, no significant change with age. Thus, the increase in flow rate with age is secondary to an increase in voided volume. As a result of these analyses, four nomograms were constructed showing the maximum and average flow rates for boys and girls separately. The flow rates of the new nomograms are on a level with or somewhat higher than the flow rates in previously presented nomograms for both children and young adults.

Urinary flow in healthy schoolchildren.

The urinary free flow in 180 healthy schoolchildren aged 7-16 years was examined with a new kind of uroflowmeter. The examinations were performed at ordinary school toilets and each child presented at least two registrations. Besides the shape of the flow curve, the urinary flow was evaluated by the parameters voided volume, maximum flow rate, average flow rate, flow at 1 second and at 0.5 seconds, time to maximum flow, and voiding time. All parameters were related to sex, age, and body parameters. Two recorded micturitions are considered a minimum to obtain a reliable assessment of the urinary flow curve of a child and the shape of the curve is the most important factor to analyse. The normal flow curve is "bell-shaped" regardless of sex, age, and voided volume, and the urine is emptied in one portion. At the first micturition, more curves are irregular and flow rates are significantly lower than at the second one. Voided volume, maximum flow rate, average flow rate, time to maximum flow, and voiding time increase weakly but significantly with age and body parameters. Maximum flow rate, average flow rate, and the flow at 1 second are significantly higher for girls and are correlated to each other. All examined flow parameters except the flow at 0.5 seconds are significantly correlated to voided volume. The results differ from previous studies of children by larger voided volumes, shorter voiding time and time to maximum flow and by higher values for maximum flow rate, average flow rate, and flow at 1 second.

Detrusor pressure in cystometry compared to physiological filling in patients with a reflex urinary bladder after spinal cord injury.

The maximum detrusor pressure and the duration of detrusor contractions in 10-50 ml/min fill cystometry were compared to the corresponding measurements during 12 hours of physiological filling, in 18 patients with a reflex urinary bladder after spinal cord injury. In four consecutive cystometries with 10 min intervals the intraindividual variation of the maximum detrusor pressure and the duration of detrusor contractions were similar to the variation during physiological filling. The mean pressure values in cystometries of each patient correlated well with the mean values in registration during physiological filling. In cystometry, there was no significant difference between mean values in 50 ml/min filling compared to 10 ml/min filling nor between mean values in first and second cystometries compared to third and fourth cystometries. Thus, mean values from a series of 10 ml/min or 50 ml/min fill cystometries appear to be as useful as registrations during physiological filling to describe the mean maximum detrusor pressure and the mean duration of contractions in a patient with a spinal reflex bladder.

Estimation of elastic properties in the urethral flow controlling zone by signal analysis of urodynamic pressure/flow data.

When urethral flow is treated as a lossless flow through an elastic tube, the relationship between the detrusor pressure and the urinary flow can be related to the elasticity of the flow-controlling zone of the urethra. A recent analytical method of describing urethral elasticity is implemented on a computer. The function p(Q) = pmo + LmQm is fitted to the recorded pressure/flow data. p(Q) is the detrusor pressure, Q the flow and pmo, m and Lm parameters. The elastic properties are then obtained as p(A) = pmo + KnAn, where p(A) is the static pressure, A the cross-sectional area of the flow-controlling zone and n and Kn calculated parameters. The urodynamic methods used and the computer implementation of the analytical method are described. In obstructed and unobstructed men without neurological symptoms, the elastic properties could be estimated in 94 per cent of the micturitions. The method makes it possible to describe urethral flow properties with Griffiths' model in a standardised way and compare results obtained by different investigators. It is recommended for quantification of urethral obstruction in research and for assessment of borderline cases of obstruction in clinical practice.

Continuous monitoring of detrusor pressure in patients with a reflex urinary bladder after spinal cord injury.

In spinal cord injury, the detrusor pressure, as a parameter of urinary bladder dysfunction, is related to incontinence and renal complications. In order to determine the intraindividual variation of maximum pressure and duration of detrusor contractions, in patients with a spinal reflex bladder, the detrusor pressure was registered during 24 hours of physiological filling in 16 patients. Between the bladder contractions the detrusor pressure was low in all patients, indicating high bladder complicance. During contractions the maximum detrusor pressure and its duration varied both inter- and intraindividually. In individual patients, however, mean values during the initial 12 hours correlated with mean values during the final 12 hours. Thus, mean values of a series of contractions appear to be characteristic of each patient and useful in describing the voiding pressure in spinal reflex bladder.