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Biomedical subjects

Frans M J Debruyne

Publications and source records attributed to Frans M J Debruyne.

17 recordsLinked to original sources

PSA velocity in conservatively managed BPH: can it predict the need for BPH-related invasive therapy?

OBJECTIVE: To study the value of PSA velocity (PSAV) to predict benign prostatic hyperplasia (BPH) progression in patients managed with alpha(1)-blockers or watchful waiting (WW). METHODS: Nine hundred and forty two BPH patients treated with alpha(1)-blocker or WW were reviewed. PSAV was defined as: (PSA(t)-PSA(b))/(t/12); where PSA(t) = PSA at time of follow-up (t, in months), PSA(b) = PSA at baseline. PSA(t) was taken from the 1 year follow-up visit or, if not present, from the next available visit with a maximum of 24 months. RESULTS: Five hundred and ninety five patients (234 alpha(1)-blocker, 361 WW) were included in the analyses. PSAV range was -5.24 to 43.06 ng/ml/year in alpha(1)-blocker patients and -6.11 to 19.55 ng/ml/year in WW patients (median: 0.01 ng/ml/year). PSAV was stratified into tertiles (Stable/Decrease/Increase). There were no significant differences in retreatment-free survival and the risk of BPH-related invasive therapy between the tertiles in both treatment groups. CONCLUSIONS: PSAV did not predict BPH progression in either alpha(1)-blocker treated patients or WW group.

Adrenergic alpha-Antagonists↗

Correlation between quality of life and voiding variables in patients treated with percutaneous tibial nerve stimulation.

OBJECTIVE: To investigate the relationship between quality of life (QoL) and voiding variables in patients with lower urinary tract dysfunction treated with percutaneous tibial nerve stimulation (PTNS), as it is assumed that improvements in voiding will lead to a better QoL in such patients. PATIENTS AND METHODS: The study included 30 patients with urge urinary incontinence who were treated with PTNS; 24-h bladder diaries and QoL questionnaires (Short Form, SF-36, and incontinence-specific QoL) were completed at baseline and after PTNS. RESULTS: There was a significant correlation (P < 0.05) between the number of pads used and the SF-36 domains of physical and vitality, between the number of incontinence episodes and the SF-36 domains of physical and role physical, between nocturia and the SF-36 domains of general and mental health, between the mean voided volume and the SF-36 domains of role physical and final, and between the mean voided volume and the incontinence-specific QoL score. CONCLUSIONS: PTNS is useful for treating refractory urge incontinence and should at least be considered as a therapeutic alternative before resorting to aggressive surgery, as voiding and QoL variables significantly and quantifiably correlate in patients with refractory urge urinary incontinence who are treated with PTNS. Patients must have a reduction of >or = two pads/day before their QoL improves, and this might be the best definition of successful therapy for patients with urge urinary incontinence.

Adult↗

Percutaneous tibial nerve stimulation in the treatment of refractory overactive bladder syndrome: is maintenance treatment necessary?

OBJECTIVE: To determine the effect of a pause in percutaneous tibial nerve stimulation (PTNS) in successfully treated patients with an overactive bladder (OAB), and the reproducibility of successful treatment when restored. PATIENTS AND METHODS: Eleven patients (mean age 51 years) with refractory OAB (more than seven voids and/or three or more urge incontinence episodes per day) were successfully treated with PTNS, and then discontinued treatment. Patients completed bladder diaries and quality-of-life (QoL) questionnaires (Short Form-36 and I-QoL) before (T1) and after a 6-week pause (T2) of maintenance PTNS, and again after re-treatment (T3). The first objective was defined as a > or = 50% increase in the incontinence episodes and/or voiding frequency in the bladder diary after T2. The second objective was defined as > or = 50% fewer incontinence episodes and/or voiding frequency in bladder diary after T3. RESULTS: At T2, seven of the 11 patients had a > or = 50% increase in incontinence episodes and/or voiding frequency in the bladder diary. The mean voided volume, nocturia, number of incontinence episodes and incontinence severity deteriorated significantly (P < 0.05). At T3, nine patients had > or = 50% fewer incontinence episodes and/or voiding frequency in the bladder diary. Nocturia, the number of incontinence episodes, incontinence severity, mean voided volume and quality of life improved significantly (P < 0.05). CONCLUSIONS: Continuous therapy is necessary in patients with OAB treated successfully by PTNS. The efficacy of PTNS can be reproduced in patients formerly treated successfully.

Adult↗

Holmium:YAG laser for treatment of strictures of vesicourethral anastomosis after radical prostatectomy.

BACKGROUND AND PURPOSE: Strictures of the vesicourethral anastomosis (VUA) following radical prostatectomy tend to recur. We used the holmium:YAG laser for treatment of recurrent stricture of the VUA. We evaluated the technique and its efficacy. PATIENTS AND METHODS: In 10 patients, the Ho:YAG laser was used with a 365-mum fiber at a setting of 2 J and frequency 10 to 20 Hz, creating a deep incision of the scar tissue at the 6 o'clock position. This was followed by a vaporizing resection of the remaining scar tissue between 3 and 9 o'clock. We aimed to vaporize up to well-vascularized surrounding tissue. Retrospectively, the charts were reviewed for hospital stay, voiding complaints, recurrence of stenosis, complications, and flow rates. The mean follow-up was 18 months. RESULTS: There were no operative complications. After removal of the catheter, all patients could void without difficulty. No re-treatment was needed for recurrent stenosis. Any existing irritative voiding complaints or incontinence did not change after treatment. In all patients, the flow pattern improved: the mean maximum flow rate increased, and the mean postvoiding residual volume decreased. CONCLUSION: The Ho:YAG laser seems to be a safe and effective treatment for first or recurrent strictures of the VUA after radical prostatectomy.

Aged↗

Design of clinical trials in advanced prostate cancer: avoiding the dead ends.

Despite more than 30 years of clinical trials, investigations in prostate cancer have not succeeded in making advances comparable to those in other branches of research, such as breast cancer. Indeed, prostate cancer trials have repeatedly run into a series of "dead ends", as investigators face the problems of inadequate funding for research, treatments that result in only minimal improvements in survival, and lack of treatment options that have sufficient prospects for success. This article briefly reviews the strategies behind clinical investigations into prostate cancer over the last three decades, evaluates the pitfalls that have hindered research, and makes suggestions for the appropriate design of clinical trials that are safe and beneficial to patients while maintaining cost-effectiveness and accountability to patients and society.

Clinical Trials as Topic↗

Posterior tibial nerve stimulation in the treatment of voiding dysfunction: urodynamic data.

OBJECTIVES: To determine urodynamic changes and predictive factors in patients with voiding dysfunction who underwent 12 percutaneous tibial nerve stimulations. METHODS: Thirty nine patients with chronic voiding dysfunction were enrolled in a prospective multicenter trial in the Netherlands (n = 19) and in Italy (n = 20). A 50% reduction in total catheterised volume per 24 hr was taken as a primary objective outcome measure. Patients' request for continuation of treatment was regarded as subjective success. Objective urodynamic parameters and bladder indices were determined. Odds ratios and their 95% confidence interval were computed as a measure for predictive power in order to reveal predictive factors (Pdet at Qmax, Qmax, BVE, and BCI). RESULTS: Primary outcome measure was obtained in 41%, an additional 26% reduced their 24 hr residuals with more than 25%. Fifty nine percent of patients chose to continue treatment. Detrusor pressure at maximal flow, cystometric residuals, and bladder indices improved significantly for all patients (P < 0.05). Patients with minor voiding dysfunction were more prone to notice success (Odds ratio: 0.73; 95% CI: 0.51-0.94). CONCLUSIONS: PTNS is a young treatment modality, minimally invasive, and easily accessible. It might be an attractive first line option for patients with (minor) voiding dysfunction.

Adult↗

Posterior tibial nerve stimulation in the treatment of urge incontinence.

AIMS: The objective of this study was to evaluate the effect of posterior tibial nerve stimulation (PTNS) for treatment of urge incontinence. METHODS: In a prospective multicentre study, 35 patients with complaints of urge incontinence underwent 12 weekly sessions of PTNS at one of five sites in the Netherlands and one site in Italy. Frequency/volume charts and I-QoL and SF-36 questionnaires were completed at 0 and 12 weeks. Success was analysed by using subjective and objective criteria. Overall subjective success was defined as the willingness to continue treatment, whereas objective success was defined as a significant decrease (to<50%) in total number of leakage episodes. RESULTS: Twenty-two patients (63%) reported a subjective success. Twenty-four patients (70%) showed a 50% or greater reduction in total number of leakage episodes. Sixteen (46%) of these-patients were completely cured (i.e., no leakage episodes) after 12 sessions. Quality of life parameters improved significantly. CONCLUSIONS: We conclude that posterior tibial nerve stimulation is an effective, minimally invasive option for treatment of patients with complaints of urge incontinence, as improvement was seen in subjective as well as objective parameters.

Adult↗

Percutaneous tibial nerve stimulation in the treatment of overactive bladder: urodynamic data.

AIM: The aim of this study was to evaluate urodynamic changes after percutaneous tibial nerve stimulation (PTNS) for the treatment of complaints related to overactive bladder syndrome and to search for urodynamic-based predictive factors. METHODS: Ninety consecutive patients with symptoms related to overactive bladder syndrome were enrolled in this study. Patients underwent 12 PTNS sessions. For evaluating objective success, the primary outcome measure was a reduction in number of urinary leakage episodes of 50% or more per 24 hours. Patients' request for continuation of therapy was considered subjective success. This study focussed on urodynamic features at baseline and on changes found after 12 PTNS treatments. RESULTS: The objective success rate was 56% (leakages/24 hours). Subjective success rate was 64%. Frequency/volume chart data and quality of life scores improved significantly (P < 0.01). Pre- and posturodynamic data were available from 46 participants. Detrusor instabilities (DI) could be abolished in a few cases only. Increments in cystometric bladder capacity and in volume at DI were significant (P = 0.043 and 0.012, respectively). Subjects without detrusor instabilities at baseline were 1.7 times more prone to respond to PTNS (odds ratio, 1.75; 95% confidence interval [CI], 0.67-4.6). The more the bladder overactivity was pronounced, the less these patients were found to respond to PTNS, the area under the receiver operating curve was 0.644 (95% CI, 0.48-0.804). CONCLUSION: PTNS could not abolish DI. PTNS increased cystometric capacity and delayed the onset of DI. Cystometry seemed useful to select good candidates: patients without DI or with late DI onset proved to be the best candidates for PTNS.

Adult↗

Posterior tibial nerve stimulation in the treatment of idiopathic nonobstructive voiding dysfunction.

OBJECTIVES: To evaluate the effect of stimulation of the posterior tibial nerve in the treatment of voiding dysfunction. METHODS: Thirty-nine patients with chronic voiding dysfunction necessitating clean intermittent catheterization were enrolled in a prospective multicenter trial in the Netherlands (n = 19) and Italy (n = 20). They underwent 12 weekly sessions of posterior tibial nerve stimulation. Frequency/volume charts, an incontinence quality-of-life instrument, and the MOS 36-item Short-Form Health Survey were completed at 0 and 12 weeks. Subjective success was defined by the patient's positive response resulting in a request to continue treatment. Efficacy was based on analysis of the frequency/volume charts comparing the baseline values with the data at 12 weeks. A reduction of 50% or more in total catheterized volume was considered as an objective success (primary outcome measurement). RESULTS: Of the 39 patients, 23 (59%) chose to continue treatment. The frequency/volume charts showed a 50% decrease in total catheterized volume in 16 (41%) of 39 patients. Additionally, 10 patients (26%) noted a reduction of 25% to 50% in their total catheterized volume. For all patients, the total catheterized volume decreased by a mean of -228 mL (range -49 to -528). The incontinence quality-of-life instrument and Short-Form Health Survey parameters improved significantly. CONCLUSIONS: Percutaneous stimulation of the posterior tibial nerve seems to be an effective, minimally invasive option worth trying in patients with idiopathic voiding dysfunction. Improvement was seen in objective micturition parameters, as well as in subjective quality-of-life data.

Adult↗

Percutaneous tibial nerve stimulation as neuromodulative treatment of chronic pelvic pain.

PURPOSE: Neuromodulative therapies have been used with moderate success in patients with chronic pelvic pain. Intermittent Percutaneous Tibial Nerve Stimulation (PTNS) is a new, minimally invasive treatment option, which has shown to significantly decrease accompanying pain complaints in patients with lower urinary tract dysfunction, such as urge incontinence or urgency/frequency. In our study, we evaluate the objective results of PTNS in patients with chronic pelvic pain as their main complaint. MATERIALS AND METHODS: In a prospective multicentre trial PTNS was evaluated in 33 patients with chronic pelvic pain. Effects were recorded by Visual Analogue Scale (VAS) for pain diaries, the McGill pain questionnaire and the SF-36 general quality of life questionnaire at baseline and after 12 weeks of treatment. Subjective (patients' request to continue chronic treatment to keep the obtained success) and objective responses (decrease in mean VAS >50% and VAS <3 after treatment) were evaluated. RESULTS: A subjective response was seen in 42% of all patients. In seven patients (21%) mean VAS decreased >50%, in six cases (18%) the decrease was >25%. After 12 weeks of treatment, seven patients (21%) ended up with a mean VAS <3. In all patients quality of life (SF-36) significantly improved, as did the total pain rate intensity (McGill). CONCLUSIONS: Despite very modest overall success rates and the need for placebo-controlled studies, PTNS may have a place in the treatment of patients with chronic pelvic pain who have already tried many other therapies and are left with no further option.

Adult↗

Long-term results of ileum interposition for ureteral obstruction.

OBJECTIVE: To present the long-term results of ileum interposition in the ureter for uni- or bilateral ureteral obstruction. PATIENTS AND METHODS: Between 1981 and 2000, a total of 22 patients received an ileal segment interposition as a substitution for the ureter, of whom 18 were available for analysis. The mean age was 54 years (range 29-73). Patients were followed for a mean period of 65 months (range 2-196). Assessment included clinical examination, serum creatinine levels, renal ultrasonography, intravenous pyelography and isotopic renography. In eight patients, the ileal-ureteral substitution was the first reconstructive procedure. The other patients underwent up to four previous reconstructions of different types. Fourteen patients were treated for unilateral ureteral obstruction, four of whom had a functional or anatomical solitary kidney, the other four patients had bilateral obstruction. RESULTS: In 16 patients renal function improved after ileal-ureteral substitution. One patient underwent a nephrectomy because of a decreased renal function due to an obstruction at the level of the uretero-ileal anastomosis. One patient had a nephrectomy because of recurrent macroscopic hematuria caused by multiple arterio-venous malformations. Overall, 15 patients (83%) had a good functioning kidney after a mean period of 65 months. In three patients an early reintervention was necessary because of bleeding, small bowel obstruction and urinary leakage from a pyelo-ileal anastomosis. Six patients required a reintervention in the long-term: two had a nephrectomy, three had a re-anastomosis between the renal pelvis and the proximal ileal segment, while the sixth patient underwent a PNL for a kidney stone. Recurrent urinary tract infections were seen in six patients, of whom three had to undergo a reintervention. Metabolic acidosis was detected in two patients and was treated with sodium bicarbonate substitution. CONCLUSION: Ileal-ureteral substitution is a valuable procedure with good long-term results and an acceptable rate of secondary interventions in patients for whom other alternatives are not feasible.

Adult↗

Recent developments in guidelines on benign prostatic hyperplasia.

Guidelines within the healthcare system aim to rationalize the diagnosis, treatment and follow-up of a particular disease and can be applicable on an international scale or may be country specific. Specialists, who determine the clinical evidence for individual practices, prepare these guidelines, and the strength of these recommendations depends on available evidence. The assessment of patients includes a minimal number of non-invasive tests. Only in cases of abnormalities are additional (more invasive) tests recommended. Treatment decisions should be evidence-based but, despite guidelines, the choice of treatment is often highly dependent on the personal preference of the urologist. Patients' awareness of different treatment options and their involvement in choosing a treatment is also increasing. Economical aspects are becoming more and more important in making healthcare decisions. Data on durability of treatments, however, are limited and deserve special attention in order to provide the most cost-effective care for different patient groups.

Evidence-Based Medicine↗

Important factors in the diagnosis and primary staging of testicular tumours.

PURPOSE OF REVIEW: In the present review we outline the use of different staging methods and highlight future possibilities in the management of testicular germ cell cancer. RECENT FINDINGS: The 5-year survival for testicular cancer has improved dramatically over the past 30 years, with cure rates approaching 95%. This success is attributed to the appropriate integration of effective treatments and staging modalities. Staging currently represents the cornerstone on which treatment is based. Because most patients will be cured, attention has shifted toward reducing morbidity of treatment while maintaining high cure rates. This implies that staging must be accurate before any change to the treatment regimen can be instituted. SUMMARY: Effective management of testicular germ cell cancer continues to pose a major challenge. Early and accurate diagnosis is very important because it will influence the choice of treatment and thus may impact on prognosis.

Germinoma↗

Baseline prostatic specific antigen does not predict the outcome of high energy transurethral microwave thermotherapy.

PURPOSE: We assessed the prognostic value of baseline prostate specific antigen (PSA) for outcome after high energy transurethral thermotherapy in patients with lower urinary tract symptoms. MATERIAL AND METHODS: Data were collected prospectively in 404 consecutive patients treated with high energy transurethral thermotherapy with the Prostatron device (EDAP-Technomed, Lyon, France). Patients were followed a minimum of 1 year. At baseline certain criteria were assessed, including pretreatment PSA, uroflowmetry, ultrasound measurement of prostatic volume, voided and post-void residual urine volume, and International Prostate Symptom Score (I-PSS) and quality of life scores. Outcome assessment included I-PSS, quality of life score and uroflowmetry of peak urine flow. Linear regression analyses were performed to correlate baseline PSA with improved clinical parameters at 12 months of followup. Logistic regression analyses and receiver operating characteristics curves characterized the ability of baseline PSA to discriminate patients with a more or less favorable outcome. RESULTS: An evident linear association was identified for prostate size at baseline and PSA. After 1 year 36 patients were treated again due to transurethral thermotherapy failure and 16 had died, which was not related to lower urinary tract symptoms or treatment for lower urinary tract symptoms. To include re-treated patients in the analyses we considered that their I-PSS, quality of life and peak urine flow values at 1 year were unchanged compared with baseline. Of the 388 evaluable patients an improvement of 50% or more in I-PSS, quality of life and peak urine flow was observed in 57%, 62% and 44%, respectively. Absolute mean changes at 1 year were -9.7, -2 and 5.2 ml. per second for I-PSS, quality of life and peak urine flow, respectively. Neither linear nor logistic regression analysis showed any clinically relevant correlation between baseline PSA and changes in I-PSS (r = -0.004), quality of life (r = -0.135) or peak urine flow (r = 0.105) at 1 year. Receiver operating characteristics curves failed to distinguish more or less favorable outcomes in all evaluated parameters. CONCLUSIONS: Pretreatment PSA cannot predict the clinical outcome after high energy transurethral thermotherapy.

Diathermy↗

Vaccination of patients with metastatic renal cell carcinoma with autologous dendritic cells pulsed with autologous tumor antigens in combination with interleukin-2: a phase 1 study.

Dendritic cells (DC) have been recognized as the most potent antigen presenting cells (APC) of the immune system. We performed a phase 1 study in twelve patients with metastatic renal cell carcinoma (RCC) using autologous immature DC loaded with autologous tumorlysate (TuLy) as a vaccine based on our earlier in vitro observations that such DC can activate tumor-specific cytotoxic T-lymphocytes. The treatment was combined with low-dose interleukin (IL)-2, as this has shown benefit in DC-based therapies. Patients received three intradermal vaccinations at two weekly intervals, and, after each vaccination, IL-2 was administered for 5 consecutive days. In six patients, keyhole-limpet hemocyanin (KLH) was added to the DC culture for immunologic monitoring purposes. In general, DC phenotype was CD14(low), CD86(high), CD40(high), CD80(low), and CD83(low). We noticed that the number of CD14+ cultured DC increased during treatment. Nevertheless, ovalbumin uptake remained high, underlining that these cells were still functional immature DC. The vaccine was able to elicit cellular anti-KLH responses, emphasizing the ability of the injected DC to mount an immunologic response. However, proliferative responses against TuLy were not detected, and humoral responses against TuLy or KLH were absent. Objective clinical responses were not observed, but extended stable disease was noted. The absence of cellular, humoral, or clinical antitumor responses suggests that the vaccination strategy with immature DC has little benefit for patients with advanced RCC. Nevertheless, this study shows the feasibility of a completely autologous DC and tissue culture methodology for the generation of TuLy pulsed DC.

Adjuvants, Immunologic↗