The assessment of a novel electrical stimulation waveform recently introduced for the treatment of overactive bladder.

Transdermal amplitude modulated signal (TAMS) is a novel electrical stimulus which has been recently introduced for the treatment of overactive bladder (OAB) syndrome. It has been suggested that it has advantages over conventional waveforms by providing more effective penetration of the skin to enhance the efficacy of therapy. As there is no literature which supports this, we performed this study to evaluate potential advantages of the TAMS signal for electrical stimulation of subcutaneous nerves as compared to conventional stimuli. The stimuli were applied on forearms of ten healthy volunteers and electrical parameters of stimuli and sensation measurements were recorded. None of the recorded electrical parameters showed significant differences (paired t-test p ≥ 0.250) between the TAMS and conventional waveforms. Similarly, the mean sensation recorded at motor threshold level and at 50% of maximal motor response level showed no differences (paired t-test p = 0.242 and p = 0.687 respectively). It is unlikely, based on the results of this study, that TAMS provides any enhancement of the efficacy of conventional stimuli. We would recommend that further studies are carried out to clearly demonstrate in man what, if any, advantages the TAMS waveform has over conventional stimulation before it is widely deployed into clinical practice.

Medical consumption and costs during a one-year follow-up of patients with LUTS suggestive of BPH in six european countries: report of the TRIUMPH study.

OBJECTIVE: To determine the medical consumption and associated treatment costs of patients with LUTS suggestive of BPH. METHODS: A prospective, cross-sectional, observational survey in six European countries: France, Germany, Italy, Poland, Spain and the United Kingdom, with a one-year follow-up of incident and prevalent patients. RESULTS: Treatment costs were estimated for 5,057 patients with a mean age of 66 years and a mean IPSS score at inclusion of 11.5. In 30% of patients watchful waiting was the therapy of choice for the full follow-up period, 57% were prescribed alpha-lockers, 11% finasteride and 10% phytotherapy at any moment during the follow-up (including switches and combination of treatment). Surgery rate was 4.9%. Mean one-year treatment costs were 858 per patient, three quarters of which concerned medication costs. Multivariate regression analysis showed that medication choice, complications and undergoing surgery were associated with higher costs. CONCLUSIONS: Treatment costs for patients with LUTS suggestive of BPH were moderate and largely consisted of medication costs. Daily practice and associated costs varied considerably across the six countries.

Comparison of darifenacin and oxybutynin in patients with overactive bladder: assessment of ambulatory urodynamics and impact on salivary flow.

OBJECTIVES: To evaluate the effects of darifenacin, an M3 selective receptor antagonist, compared with oxybutynin, on ambulatory urodynamics, salivary flow, heart rate and visual nearpoint in patients with overactive bladder (OAB). METHODS: A double-blind, randomized, crossover study (n=65) with three treatment cohorts: darifenacin immediate release (IR) 2.5 mg three times a day (t.i.d.) or oxybutynin 2.5 mg t.i.d.; darifenacin controlled release (CR) 15 mg once daily (q.d.) or oxybutynin 5 mg t.i.d.; darifenacin CR 30 mg q.d. or oxybutynin 5 mg t.i.d. Within cohorts, patients received 7 days' treatment with each agent separated by 14 days' washout. RESULTS: All active treatments improved urodynamic parameters. Both darifenacin CR doses had significantly less effect on salivary flow than oxybutynin. Effects on urodynamic parameters, heart rate and visual nearpoint were comparable. CONCLUSION: Ambulatory urodynamics appears to be an innovative and potentially useful investigative tool in the evaluation of the efficacy of new therapeutic agents. Darifenacin CR is an efficacious therapy for OAB with comparable effects on urodynamic parameters but producing significantly less dry mouth than oxybutynin.

Frequency volume charts in the assessment and evaluation of treatment: how should we use them?

Frequency volume charts are an essential adjunct to both the assessment of patients at presentation and the evaluation of new treatments for filling and voiding dysfunction. Since 24 hour frequency can be altered significantly by fluid intake and insensible fluid loss. We critically evaluated the usefulness of the different parameters measured on a frequency/volume chart (FVC) to determine which provided the most reliable information. Sixty-three patients were asked to complete 2 FVCs over 3 or more days with at least one week between the two measurements. Fifty-one patients completed the diaries and the changes in mean voided volume and urinary frequency were analyzed. Eight patients had significant differences in their mean voided volume or their 24 hour frequency, 2 patients had a significant difference in both mean voided volume and 24 hour frequency. There was an excellent correlation for both the mean voided volume (r = 0.86) and the 24 hour frequency (r = 0.9). The individual variation, using repeated measures analysis, was greater for the 24 hour frequency. There is natural variation of 24 hour frequency between diaries that may invalidate apparently successful treatment outcomes. We recommend the use of the mean voided volume as part of the evaluation of new treatments in chronic voiding dysfunction and urinary incontinence.

Urodynamic assessment of the bashful bladder.

PURPOSE: We prospectively studied the potential contribution of ambulatory urodynamic monitoring in men with urinary symptoms unable to initiate a void on conventional video cystometrography. MATERIALS AND METHODS: A total of 40 consecutive symptomatic men with a median International Prostate Symptom Score of 19 (range 1 to 29) and median age of 51.9 years (range 30 to 75) who were unable to void during video cystometrography underwent ambulatory urodynamic monitoring. Solid-state transducers mounted on silicone coated catheters were inserted urethrally and rectally, and connected to a portable recorder. Subjects voided in private into a specially designed flow meter, which they connected to the recording device. RESULTS: Of the patients 2 (5%) failed to attend ambulatory urodynamic monitoring, despite multiple reminders, and in 1 (2.5%) the trace was uninterpretable. Pressure flow data were available for the remaining 37 patients with mean plus or minus standard deviation 2.72+/-0.1 storage void cycles recorded per patient. All 6 patients (15%) with obstruction were older than 40 years. In 6 cases (15%) obstruction was equivocal and the remainder were unobstructed. Transurethral prostatic resection in 2 and urethrotomy in 1 of 6 patients with obstruction resulted in subjective and objective improvement. CONCLUSIONS: The bashful bladder syndrome was not associated with any specific urodynamic diagnosis. Ambulatory urodynamic monitoring will yield a urodynamic diagnosis in more than 90% of cases after failure to record void data on video cystometrography. A surgically correctable cause of symptoms can be found in about 20% of men older than 40 years. The contribution of ambulatory urodynamic monitoring compared to more conventional evaluation in men younger than 40 years is negligible.

A pilot study for a randomized controlled trial comparing the efficacy, safety and cost-effectiveness of surgical treatments of the prostate.

OBJECTIVE: To assess the numbers of men in outpatients and subsequently undergoing transurethral resection of the prostate (TURP) who were referred during 1993-94 and 1996-97, thereby assessing the feasibility of a subsequent study of treatment efficacy in men with bladder outlet obstruction secondary to benign prostatic hyperplasia, prospectively randomized to the surgical treatment options, i.e. TURP, laser ablation of the prostate, transurethral needle ablation and T3 thermotherapy, to investigate treatment outcome, cost-efficacy and cost-benefit. PATIENTS AND METHODS: All patients considered and consenting for prostate surgery were reviewed prospectively with a view to inclusion in the proposed trial. The diagnosis was based on two estimates of flow rate from voids of >150 mL and from symptoms assessed using the International Prostate Symptom Score. All patients had TURP explained by a urological surgeon and nursing staff, and subsequently had further consultation with research staff. RESULTS: Patients seen in clinic as new referrals increased by 11% between the periods assessed, although the numbers undergoing TURP decreased by 19%. Of the 383 patients screened, who were on the waiting list for TURP, only 13 elected to enter the trial. Of the 383 men, 267 (67%) ultimately had prostate surgery, with 39 (10%) electing to continue with watchful waiting and 34 (9%) continuing with pharmacotherapy. CONCLUSION: Although more men with benign prostatic disease and lower urinary tract symptoms are being seen in clinics, the reduced proportion of patients continuing to surgical intervention will lead to increasing difficulty in carrying out randomized controlled clinical trials assessing surgical options. With ever more therapeutic options available, patients find it difficult to make decisions in both the clinical situation and when asked to enter a trial. Fully informed decisions by both the surgeon and the patient will only be possible when objective data are available from trials that investigate outcome, cost-efficacy and cost-benefit. This study suggests that when presented with more information and counselling, fewer men decide to undergo prostate surgery for symptomatic BPH.

The importance of accurate assessment and conservative management of the open bladder neck in patients with post-pelvic fracture membranous urethral distraction defects.

OBJECTIVE: To review the pre-operative assessment of bladder neck competence and assess the success of non-operative management of the bladder neck in patients with pelvic fracture membranous urethral distraction defects. PATIENTS AND METHODS: A series of four patients with long-standing post-pelvic fracture urethral distraction defects and open bladder necks demonstrated on pre-operative investigation are presented. RESULTS: All four patients were managed by perineal urethroplasty without surgery to the bladder neck. All patients were continent post-operatively despite the injury having ablated the distal sphincter mechanism. CONCLUSION: We believe that the majority of patients can be managed successfully by a non-operative approach to the bladder neck, sparing them the unnecessary operative morbidity of an abdomino-perineal repair, which should be reserved for those with obviously scarred or distorted bladder necks.

Is urethral pressure profilometry useful in the preoperative assessment of benign prostatic hyperplasia?

The principal aim of this study was to provide an objective assessment of the potential role of urethral pressure profilometry as a technique for assessing prostatic size by direct comparison with endoscopic assessment of prostatic length and computed tomographic measurement of prostatic volume and length. There was a poor correlation between pre-operative prostatic length and amount resected in the operating theatre. The results obtained with urethral pressure profilometry correlated poorly with those obtained using the other techniques, and cannot therefore be relied upon in routine clinical practice. Although there was good correlation between the length of the prostate and prostatic size, assessed by pre-operative computed tomography, this correlated poorly with the amount of tissue resected at operation. Further studies need to be conducted to compare objectively the completeness of prostatic resection with the outcome following prostatectomy.

Contemporary flow meters: an assessment of their accuracy and reliability.

The accuracy, reliability and cost effectiveness of 5 currently marketed flow meters have been assessed. The mechanics of each meter is briefly described in relation to its accuracy and robustness. The merits and faults of the meters are discussed and the important features of flow measurements that need to be taken into account when making diagnostic interpretations are emphasised.