bTUNED: transcutaneous tibial nerve stimulation for neurogenic lower urinary tract dysfunction

OBJECTIVE To present the protocol for a randomized controlled trial (RCT) evaluating the efficacy and safety of transcutaneous tibial nerve stimulation (TTNS) for refractory neurogenic lower urinary tract dysfunction (NLUTD). STUDY DESIGN AND RESULTS bTUNED (bladder and TranscUtaneous tibial Nerve stimulation for nEurogenic lower urinary tract Dysfunction) is an international multicentre, sham-controlled, double-blind RCT investigating the efficacy and safety of TTNS. The primary outcome is success of TTNS, defined as improvements in key bladder diary variables at study end compared to baseline values. The focus of the treatment is defined by the Self-Assessment Goal Achievement (SAGA) questionnaire. Secondary outcomes are the effect of TTNS on urodynamic, neurophysiological, and bowel function outcome measures, as well as the safety of TTNS. CONCLUSIONS A total of 240 patients with refractory NLUTD will be included and randomized 1:1 into the verum or sham TTNS group from March 2020 until August 2026. TTNS will be performed twice a week for 30 min during 6 weeks. The patients will attend baseline assessments, 12 treatment visits and follow-up assessments at the study end

Comparison of prostatic artery embolisation (PAE) versus transurethral resection of the prostate (TURP) for benign prostatic hyperplasia: randomised, open label, non-inferiority trial

OBJECTIVE To compare prostatic artery embolisation (PAE) with transurethral resection of the prostate (TURP) in the treatment of lower urinary tract symptoms secondary to benign prostatic hyperplasia in terms of patient reported and functional outcomes. DESIGN Randomised, open label, non-inferiority trial. SETTING Urology and radiology departments of a Swiss tertiary care centre. PARTICIPANTS 103 patients aged ≥40 years with refractory lower urinary tract symptoms secondary to benign prostatic hyperplasia were randomised between 11 February 2014 and 24 May 2017; 48 and 51 patients reached the primary endpoint 12 weeks after PAE and TURP, respectively. INTERVENTIONS PAE performed with 250-400 μm microspheres under local anaesthesia versus monopolar TURP performed under spinal or general anaesthesia. MAIN OUTCOMES AND MEASURES Primary outcome was change in international prostate symptoms score (IPSS) from baseline to 12 weeks after surgery; a difference of less than 3 points between treatments was defined as non-inferiority for PAE and tested with a one sided test. Secondary outcomes included further questionnaires, functional measures, magnetic resonance imaging findings, and adverse events; changes from baseline to 12 weeks were compared between treatments with two sided tests for superiority. RESULTS Mean reduction in IPSS from baseline to 12 weeks was -9.23 points after PAE and -10.77 points after TURP. Although the difference was less than 3 points (1.54 points in favour of TURP (95% confidence interval -1.45 to 4.52)), non-inferiority of PAE could not be shown (P=0.17). None of the patient reported secondary outcomes differed significantly between treatments when tested for superiority; IPSS also did not differ significantly (P=0.31). At 12 weeks, PAE was less effective than TURP regarding changes in maximum rate of urinary flow (5.19 15.34 mL/s; difference 10.15 (95% confidence interval -14.67 to -5.63); P<0.001), postvoid residual urine (-86.36 -199.98 mL; 113.62 (39.25 to 187.98); P=0.003), prostate volume (-12.17 -30.27 mL; 18.11 (10.11 to 26.10); P<0.001), and desobstructive effectiveness according to pressure flow studies (56% 93% shift towards less obstructive category; P=0.003). Fewer adverse events occurred after PAE than after TURP (36 70 events; P=0.003). CONCLUSIONS The improvement in lower urinary tract symptoms secondary to benign prostatic hyperplasia seen 12 weeks after PAE is close to that after TURP. PAE is associated with fewer complications than TURP but has disadvantages regarding functional outcomes, which should be considered when selecting patients. Further comparative study findings, including longer follow-up, should be evaluated before PAE can be considered as a routine treatment. TRIAL REGISTRATION Clinicaltrials.gov NCT02054013

Prostatic artery embolization versus conventional TUR-P in the treatment of benign prostatic hyperplasia: protocol for a prospective randomized non-inferiority trial

BACKGROUND Benign prostatic hyperplasia (BPH) is a prevalent entity in elderly men and transurethral resection of the prostate (TURP) still represents the gold standard of surgical treatment despite its considerable perioperative morbidity. Recently, prostatic artery embolization (PAE) was described as a novel effective and less invasive treatment alternative. Despite promising first results, PAE still has to be considered experimental due to a lack of good quality studies. Prospective randomized controlled trials comparing PAE with TUR-P are highly warranted. METHODS/DESIGN This is a single-centre, prospective, randomized, non-inferiority trial comparing treatment effects and adverse events of PAE and TURP in a tertiary referral centre. One hundred patients who are electable for both treatment options are randomized to either PAE or TURP. Changes of the International Prostate Symptom Score (IPSS) after 3 months are defined as primary endpoint. Changes in bladder diaries, laboratory analyses, urodynamic investigations and standardised questionnaires are assessed as secondary outcome measures. In addition contrast-enhanced magnetic resonance imaging of the pelvis before and after the interventions will provide crucial information regarding morphological changes and vascularisation of the prostate. Adverse events will be assessed on every follow-up visit in both treatment arms according to the National Cancer Institute Common Terminology Criteria for Adverse events and the Clavien classification. DISCUSSION The aim of this study is to assess whether PAE represents a valid treatment alternative to TURP in patients suffering from BPH in terms of efficacy and safety. TRIAL REGISTRATION ClinicalTrials.gov NCT02054013

Aquablation versus holmium laser enucleation of the prostate in the treatment of benign prostatic hyperplasia in medium-to-large-sized prostates (ATHLETE): protocol of a prospective randomised trial

Introduction A novel method for the surgical treatment of benign prostatic hyperplasia (BPH) called Aquablation has become commercially available. Previous studies have been able to show similar functional results when compared with transurethral resection of the prostate and a high efficacy has been demonstrated when this approach is applied to patients with a prostate size of 80–150 cm3.Holmium laser enucleation of the prostate (HoLEP) is a well-established procedure in the surgical treatment of BPH in prostate glands larger than 30 mL and a first-line therapy in glands over 80 mL. To date, no data are available whether Aquablation is non-inferior compared with HoLEP in the treatment of patients with medium-to-large-sized prostates regarding safety and efficacy.Methods and analysis This is a prospective, randomised, open-label, non-inferiority clinical trial conducted at a Swiss centre of tertiary care. The primary outcome is assessment of non-inferiority of Aquablation compared with HoLEP in reducing lower urinary tract symptoms due to benign prostatic obstruction measured by the International Prostate Symptom Score (IPSS). Randomisation will be performed using secuTrial, stratifying on age (&lt;70 years, 70+ years) and prostate volume (&lt;100 mL, 100+ mL). Both interventions are performed in an inpatient setting and regular follow-up controls starting 8 weeks after intervention and continuing up to 5 years will be performed. The primary outcome (change in IPSS from baseline to 6 months) will be tested for non-inferiority with a one-sided t-test. Secondary outcomes, such as efficacy parameters, several patient-reported outcome measures, and periprocedural and safety parameters will be described by calculating means or relative frequencies for each treatment group and testing differences with two-sided standard superiority tests.Ethics and dissemination The study was approved by the local ethics committee (EKOS 2020-02353). Results of the primary endpoint and each of the secondary endpoints will be published in an international peer-reviewed journal.Trial registration number ClinicalTrials.gov Registry (NCT04560907)

The 2013 EAU Guidelines on Chronic Pelvic Pain:Is Management of Chronic Pelvic Pain a Habit, a Philosophy, or a Science? 10 Years of Development

<p>Context: Progress in the science of pain has led pain specialists to move away from an organ-centred understanding of pain located in the pelvis to an understanding based on the mechanism of pain and integrating, as far as possible, psychological, social, and sexual dimensions of the problem. This change is reflected in all areas, from taxonomy through treatment. However, deciding what is adequate investigation to rule out treatable disease before moving to this way of engaging with the patient experiencing pain is a complex process, informed by pain expertise as much as by organ-based medical knowledge.</p><p>Objective: To summarise the evolving changes in the management of patients with chronic pelvic pain by referring to the 2012 version of the European Association of Urology (EAU) guidelines on chronic pelvic pain.</p><p>Evidence acquisition: The working panel highlights some of the most important aspects of the management of patients with chronic pelvic pain emerging in recent years in the context of the EAU guidelines on chronic pelvic pain. The guidelines were completely updated in 2012 based on a systematic review of the literature from online databases from 1995 to 2011. According to this review, levels of evidence and grades of recommendation were added to the text. A full version of the guidelines is available at the EAU office or Web site (www.uroweb.org).</p><p>Evidence synthesis: The previously mentioned issues are explored in this paper, which refers throughout to dilemmas for the physician and treatment team as well as to the need to inform and engage the patient in a collaborative empirical approach to pain relief and rehabilitation. These issues are exemplified in two case histories.</p><p>Conclusions: Chronic pelvic pain persisting after appropriate treatment requires a different approach focussing on pain. This approach integrates the medical, psychosocial, and sexual elements of care to engage the patient in a collaborative journey towards self-management. (C) 2013 European Association of Urology. Published by Elsevier B. V. All rights reserved.</p>

Life-Threatening Bleeding from Peristomal Varices after Cystoprostatectomy: Multimodal Approach in a Cirrhotic, Encephalopathic Patient with Severe Portal Hypertension

The bleeding of peristomal varices due to a portosystemic shunt is rare but potentially life-threatening in cirrhotic patients with portal hypertension. The scarce case reports in the literature recommend transjugular intrahepatic portosystemic shunt (TIPS) to prevent further bleeding. We report on a 72-year-old man who was referred to our hospital because of life-threatening bleeding from peristomal varices, three years after radical cystoprostatectomy for invasive bladder cancer. CT imaging showed liver cirrhosis with a prominent portosystemic shunt leading to massively enlarged peristomal varices. TIPS was taken into consideration, but not possible due to hepatic encephalopathy (HE). Medical therapy with lactulose and the nonselective beta-blocker carvedilol was initiated to treat HE and portal hypertension. In a second step, the portosystemic shunt was percutaneously embolized. Here, we present a multimodal approach to treat intractable bleeding from peristomal varices in a patient with ileal conduit urinary diversion, not suitable for TIPS

In-hospital cost analysis of prostatic artery embolization compared to transurethral resection of the prostate: Post hoc analysis of a randomized controlled trial

OBJECTIVES To perform a post-hoc analysis of in-hospital costs incurred in a randomized controlled trial comparing prostatic artery embolization (PAE) and transurethral resection of the prostate (TURP). PATIENTS AND METHODS In-hospital costs arising from PAE and TURP were calculated using detailed expenditure reports provided by the hospital accounts department. Total costs including those arising from surgical and interventional procedures, consumables, personnel, and accommodation were analysed for all of the study participants and compared between PAE and TURP using descriptive analysis and two-sided t-tests adjusted for unequal variance within groups (Welch t-test). RESULTS Mean total costs per patient (± SD) were higher for TURP at €9,137 ± 3,301 than for PAE at €8,185 ± 1,630. The mean difference (md) of €952 was not statistically significant (p=0.07). While the mean procedural costs were significantly higher for PAE (md €623 (p=0.009)), costs apart from the procedure were significantly lower for PAE with an md of €1,627 (p< 0.001). Procedural costs of €1,433 ± 552 for TURP were mainly incurred by anaesthesia, whereas €2,590 ± 628 for medical supplies were the main cost factor for PAE. CONCLUSIONS Since in-hospital costs are similar but PAE and TURP have different efficacy and safety profiles, the patient's clinical condition and expectations - rather than finances - should be taken into account when deciding between PAE and TURP. This article is protected by copyright. All rights reserved

Sacral neuromodulation for neurogenic lower urinary tract dysfunction: systematic review and meta-analysis

Context Treatment of neurogenic lower urinary tract dysfunction (LUTD) is a challenge, because conventional therapies often fail. Sacral neuromodulation (SNM) has become a well-established therapy for refractory non-neurogenic LUTD, but its value in patients with a neurologic cause is unclear. Objective To assess the efficacy and safety of SNM for neurogenic LUTD. Evidence acquisition Studies were identified by electronic search of PubMed, EMBASE, and ScienceDirect (on 15 April 2010) and hand search of reference lists and review articles. SNM articles were included if they reported on efficacy and/or safety of tested and/or permanently implanted patients suffering from neurogenic LUTD. Two reviewers independently selected studies and extracted data. Study estimates were pooled using Bayesian random-effects meta-analysis. Evidence synthesis Of the 26 independent studies (357 patients) included, the evidence level ranged from 2b to 4 according to the Oxford Centre for Evidence-Based Medicine. Half (n = 13) of the included studies reported data on both test phase and permanent SNM; the remaining studies were confined to test phase (n = 4) or permanent SNM (n = 9). The pooled success rate was 68% for the test phase (95% credibility interval [CrI], 50–87) and 92% (95% CrI, 81–98%) for permanent SNM, with a mean follow-up of 26 mo. The pooled adverse event rate was 0% (95% CrI, 0–2%) for the test phase and 24% (95% CrI, 6–48%) for permanent SNM. Conclusions There is evidence indicating that SNM may be effective and safe for the treatment of patients with neurogenic LUTD. However, the number of investigated patients is low with high between-study heterogeneity, and there is a lack of randomised, controlled trials. Thus, well-designed, adequately powered studies are urgently needed before more widespread use of SNM for neurogenic LUTD can be recommended