OBJECTIVES: To report the clinical outcomes of the VictoTM (Promedon, Cordoba, Argentina) adjustable artificial urinary sphincter (AUS) implantation in a cohort of patients with severe urinary incontinence (UI) after prostate surgery. PATIENTS AND METHODS: This study enrolled patients with UI following prostate surgery who underwent a Victo implantation between May 2018 and December 2023. Patients were prospectively evaluated at baseline, and at 3 and 12 months after device activation, and thereafter annually. The 24-h pad-weight test (24hPWT) was used to assess severity of UI, while the Patient Global Impression of Improvement (PGI-I) and patient satisfaction according to a Likert scale were used to measure patient-reported outcomes. RESULTS: A total of 96 patients with a median (interquartile range [IQR]) age of 68 (65-72) years were included in the final analysis. The median (IQR) follow-up was 3 (1-4) years. In all, 10 patients completed the 5-year follow-up. After the treatment, we observed a significant reduction in 24hPWT by the median of 83% (P < 0.001) at 3 months and by a median of 79% (P < 0.001) at 3 years. According to the PGI-I, a total of 87%, 92%, 87%, 81%, 83%, and 50% (five of 10) of patients rated their condition/incontinence as 'very much improved', 'much improved' or 'little improved' at 3 months, 1-, 2-, 3-, 4-, and 5-year follow-up visits, respectively. The proportion of patients, who were 'very satisfied' or 'satisfied' with the treatment outcome was 79%, 80%, 75%, 69%, 80%, and 60% (six of 10) at 3 months, 1-, 2-, 3-, 4-, and 5-years, respectively. There were a total of 13 (14%) device failures during the follow-up period. CONCLUSION: In conclusion, our data suggest that Victo AUS significantly reduces the severity of UI after prostate surgery and provides a reasonably high patient-reported satisfaction with treatment outcomes at mid-term follow-up.
- MeSH
- inkontinence moči * chirurgie terapie MeSH
- lidé středního věku MeSH
- lidé MeSH
- pooperační komplikace MeSH
- prospektivní studie MeSH
- prostatektomie * škodlivé účinky MeSH
- senioři MeSH
- spokojenost pacientů MeSH
- umělý močový svěrač * MeSH
- výsledek terapie MeSH
- Check Tag
- lidé středního věku MeSH
- lidé MeSH
- mužské pohlaví MeSH
- senioři MeSH
- Publikační typ
- časopisecké články MeSH
PURPOSE: To estimate the timepoint of onset of the lower urinary tract symptoms (LUTS) over the course of multiple sclerosis (MS), determine which of the LUTS typically appears first, and identify risk factors for early development of LUTS in patients with MS (PwMS). METHODS: This observational study included 1167 PwMS. The participants were predominantly women (72%), median age was 45 (IQR 36;53) years, and median disease duration was 11 (IQR 6;16) years. Inclusion criteria were age over 18 years, proven MS diagnosis according to McDonald ́s criteria (2017), and complete medical records since establishment of MS diagnosis. A structured in-person interview addressing the study objectives was performed during routine follow-up visit. The data were cross-checked with the medical records. RESULTS: Median LUTS-free survival time after MS diagnosis has been made, was 8 (IQR 7;10) years. Storage, voiding and postmicturition symptoms were identified as a first LUTS in 549/709 (77%), 130/709 (18%), and 30/709 (4.2%) PwMS, respectively. Most frequently reported first LUTS was urgency 360 (51%). Using multivariate analysis, higher age, higher degree of disability, and presence of cerebellar and/or pyramidal symptoms at the time of MS diagnosis were significantly associated with shorter LUTS-free survival. No significant relationship between LUTS-free survival and sex or type of MS was found. CONCLUSIONS: Our data show, that LUTS occur after median time of 8 years after MS diagnosis, with urgency being the most frequently reported first LUTS.
- MeSH
- časové faktory MeSH
- dospělí MeSH
- lidé středního věku MeSH
- lidé MeSH
- rizikové faktory MeSH
- roztroušená skleróza * komplikace MeSH
- symptomy dolních močových cest * etiologie epidemiologie MeSH
- Check Tag
- dospělí MeSH
- lidé středního věku MeSH
- lidé MeSH
- mužské pohlaví MeSH
- ženské pohlaví MeSH
- Publikační typ
- časopisecké články MeSH
- pozorovací studie MeSH
AIMS: We present results of a two-arm pilot study assessing the feasibility of conducting a double-blind randomized controlled trial (RCT) to evaluate the efficacy of sacral neuromodulation (SNM) in patients with multiple sclerosis (MS) suffering from neurogenic lower urinary tract dysfunction (NLUTD). METHODS: Eligible subjects with refractory NLUTD and EDSS < 5 underwent SNM test phase. Those showing more than a 50% improvement of bladder variables, received implantable pulse generators (IPG) and were randomized to either treatment group (IPG ON) or to sham group (IPG OFF) for 1 month. During second month, all patients had the IPG ON until the end of the trial. The primary endpoints were trial feasibility, recruitment potential, and response rate at the end of SNM test phase. Secondary endpoint was safety. Changes in key bladder diary-derived variables and patient reported outcomes were recorded as well. RESULTS: Thirty-two patients were screened, 17 were eligible and 13 were included in the SNM test phase. Eleven were considered responders and were implanted with IPG. Subsequently, six patients were randomized to the treatment group and five to the sham group. No serious adverse events were reported. In the intervention phase, both objective and subjective improvements were seen in the treatment group, while the symptoms in the sham group remained mostly unchanged. At study completion, six patients reported being completely satisfied, three were mostly satisfied, and two were indifferent to the treatment. CONCLUSIONS: This pilot trial demonstrated feasibility of double-blind RCT assessing safety and efficacy of SNM in MS patients. TRIAL REGISTRATION: ClinicalTrials.gov NCT05380856.
- MeSH
- dospělí MeSH
- dvojitá slepá metoda MeSH
- elektrostimulační terapie * metody škodlivé účinky MeSH
- lidé středního věku MeSH
- lidé MeSH
- neurogenní močový měchýř * terapie etiologie patofyziologie MeSH
- pilotní projekty MeSH
- plexus lumbosacralis MeSH
- roztroušená skleróza * komplikace MeSH
- sexuální dysfunkce fyziologická * terapie etiologie patofyziologie MeSH
- studie proveditelnosti MeSH
- symptomy dolních močových cest * terapie etiologie patofyziologie MeSH
- výsledek terapie MeSH
- Check Tag
- dospělí MeSH
- lidé středního věku MeSH
- lidé MeSH
- mužské pohlaví MeSH
- ženské pohlaví MeSH
- Publikační typ
- časopisecké články MeSH
- randomizované kontrolované studie MeSH
INTRODUCTION: Currently, there is no causal cure for Parkinson's disease (PD), and medications and other therapeutic procedures only allow for the reduction of symptoms. Noninvasive neuromodulation is among the potentially promising treatments for PD patients. The present pilot study aimed to evaluate the safety and efficacy of peroneal electrical Transcutaneous NeuroModulation (peroneal eTNM®) in the treatment of PD symptoms with a particular emphasis on disease-related quality of life. METHODS: Twelve patients with clinically established Parkinsońs disease (8 males; mean age 59.5 ± 11.6 years) were enrolled. In addition to state-of-the-art background pharmacotherapy for PD, patients were treated with peroneal eTNM® daily for 30 min for 6 weeks followed by 6 weeks of follow-up without stimulation. The primary endpoint was safety and tolerability, the secondary endpoint was the response of the condition on the 'add-on' peroneal eTNM®. RESULTS: Peroneal eTNM® proved to be feasible for home treatment in the PD population. Treatment-related adverse events were not reported throughout the study. Along with an excellent safety profile, peroneal eTNM® showed considerable positive trends in terms of improvement in quality of life as measured by EQ-5D-5L questionnaire. There was a definitive trend toward a reduction in Section III of the Unified Parkinson's Disease Rating Scale showing positive changes in tremor-related items. At the end of the study, 50 % of the patients were considered clinical responders. CONCLUSIONS: Larger and more rigorously designed studies are needed to validate the utility and position of peroneal eTNM® in the treatment of patients with PD.
- Publikační typ
- časopisecké články MeSH
Nežádoucí účinky anticholinergik užívaných v léčbě hyperaktivního močového měchýře na centrální nervový systém. Podávání anticholinergik je základem terapie hyperaktivního močového měchýře. Jejich efektivita byla prokázána v řadě velkých randomizo- vaných studií. V poslední době je věnována velká pozornost nežádoucím účinkům anticholinergik užívaných v léčbě hyperaktivního močového měchýře na centrální nervový systém. Současná literární evidence ukazuje na sice nízké, ale reálné riziko zhoršení kognitivních funkcí a rozvoje demence při dlouhodobém užívání anticholinergik, zejména oxybutininu a tolterodinu. Před zahájením léčby anticholinergiky by měl být zvažován benefit a potenciální riziko u každého individuálního pacienta. Zvýšené opatrnosti je třeba zejména u pacientů s preexistujícím kognitivním deficitem. Při selhání léčby anticholinergiky nebo při výskytu nežádoucích účinků je třeba časně zvažovat nasazení léčby z dalších linií léčby.
Administration of anticholinergics represents the mainstay of overactive bladder therapy. Their efficacy has been proven in a number of large randomized trials. Recently, much attention has been paid to the adverse effects of anticholinergics used in the treatment of overactive bladder on the central nervous system. Current literature evidence shows a low but real risk of cognitive impairment and the development of dementia with long-term use of anticholinergics, particularly oxybutynin and tolterodine. Before starting anticholinergic therapy, the benefits and potential risk should be carefully considered for each individual patient. Particular caution is required in patients with pre-existing cognitive impairment. If anticholinergic treatment fails or side effects occur, alternative treatment options should be considered early.
- Klíčová slova
- Oxybutynin,
- MeSH
- cholinergní antagonisté * farmakologie škodlivé účinky terapeutické užití MeSH
- demence chemicky indukované etiologie MeSH
- hyperaktivní močový měchýř * farmakoterapie komplikace MeSH
- kognitivní dysfunkce * chemicky indukované etiologie patofyziologie MeSH
- kyseliny mandlové farmakologie škodlivé účinky terapeutické užití MeSH
- lidé MeSH
- receptory muskarinové fyziologie účinky léků MeSH
- Check Tag
- lidé MeSH
- MeSH
- dospělí MeSH
- fekální inkontinence * etiologie MeSH
- Hirschsprungova nemoc * komplikace MeSH
- lidé MeSH
- poporodní období MeSH
- těhotenství MeSH
- Check Tag
- dospělí MeSH
- lidé MeSH
- těhotenství MeSH
- ženské pohlaví MeSH
- Publikační typ
- časopisecké články MeSH
- kazuistiky MeSH
INTRODUCTION: Our objective was to conduct an individual patient data meta-analysis (IPDMA) of the two published randomized placebo-controlled trials of mirabegron in people with neurogenic lower urinary tract dysfunction (NLUTD) due to spinal cord injury (SCI) or multiple sclerosis (MS). METHODS: We identified two randomized, placebo-controlled trials. We extracted individual patient data from the trials and evaluated two primary outcomes: change in maximum cystometric capacity and change in the patient perception of bladder condition (PPBC). We also evaluated several secondary outcomes related to urodynamic function and quality of life. We conducted three exploratory analyses to test hypotheses based on our clinical experiences with mirabegron in NLUTD. Analysis of covariance with adjustment for baseline values was used for the statistical analysis. RESULTS: Our IPDMA included 98 patients from the two trials. The results showed that mirabegron was associated with a significant improvement in maximum cystometric capacity (+41 mL, p = 0.04) and in the PPBC (-0.8, p < 0.01) compared to placebo. Secondary outcomes including peak neurogenic detrusor overactivity pressure (-20 cm H2O, p < 0.01), incontinence-QOL score (+12, p < 0.01), and 24 h pad weights (-79 g, p = 0.04) also improved significantly compared to placebo. Exploratory analyses found similar improvements in people with MS and SCI; some outcomes improved to a greater degree among people with incomplete SCI, or SCIs that were below T7. CONCLUSIONS: Our IPDMA provides evidence supporting the use of mirabegron in patients with NLUTD due to SCI or MS. Further work evaluating differential responses in people with different SCI lesion characteristics may be warranted.
- MeSH
- acetanilidy * MeSH
- hyperaktivní močový měchýř * MeSH
- kvalita života MeSH
- lidé MeSH
- neurogenní močový měchýř * MeSH
- poranění míchy * komplikace MeSH
- roztroušená skleróza * komplikace MeSH
- thiazoly * MeSH
- urodynamika fyziologie MeSH
- výsledek terapie MeSH
- Check Tag
- lidé MeSH
- Publikační typ
- časopisecké články MeSH
- metaanalýza MeSH
OBJECTIVES: In this study, we aimed to investigate whether peroneal electrical Transcutaneous Neuromodulation invented for overactive bladder (OAB) treatment elicits activation in brain regions involved in neural regulation of the lower urinary tract. MATERIALS AND METHODS: Among 22 enrolled healthy female volunteers, 13 were eligible for the final analysis. Functional magnetic resonance imaging (fMRI) (Siemens VIDA 3T; Erlangen, Germany) was used to compare the brain region activation elicited by peroneal electrical Transcutaneous Neuromodulation with the activation elicited by sham stimulation. Each subject underwent brain fMRI recording during eight 30-second periods of rest, alternating with 30-second periods of passive feet movement using the sham device, mimicking the motor response to peroneal nerve stimulation. Subsequently, fMRI recording was performed during the analogic "off-on" stimulation paradigm using peroneal electrical transcutaneous neuromodulation. Magnetic resonance imaging data acquired during both paradigms were compared using individual and group statistics. RESULTS: During both peroneal electrical Transcutaneous Neuromodulation and sham feet movements, we observed activation of the primary motor cortex and supplementary motor area, corresponding to the cortical projection of lower limb movement. During peroneal electrical Transcutaneous Neuromodulation, we observed significant activations in the brain stem, cerebellum, cingulate gyrus, putamen, operculum, and anterior insula, which were not observed during the sham feet movement. CONCLUSIONS: Our study provides evidence that peroneal electrical Transcutaneous Neuromodulation elicits activation of brain structures that have been previously implicated in the perception of bladder fullness and that play a role in the ability to cope with urinary urgency. Our data suggest that neuromodulation at the level of supraspinal control of the lower urinary tract may contribute to the treatment effect of peroneal electrical Transcutaneous Neuromodulation in patients with OAB.
PURPOSE: We investigated the safety and efficacy of peroneal electrical transcutaneous neuromodulation using the URIS neuromodulation system in a home-based setting in comparison with standard treatment using solifenacin in treatment-naïve female patients with overactive bladder. MATERIALS AND METHODS: A total of 120 patients were screened, of whom 77 were randomized in a 2:1 ratio to 12 weeks of treatment with daily peroneal electrical transcutaneous neuromodulation or solifenacin 5 mg. The primary endpoint was safety; efficacy assessments included proportion of responders, defined as subjects with ≥50% reduction in bladder diary-derived variables; Overactive Bladder-Validated 8-question Screener, and European Quality of Life-5 Dimensions questionnaire; and treatment satisfaction after 12 weeks of therapy. RESULTS: Seventy-one out of 77 randomized patients completed the study. In the peroneal electrical transcutaneous neuromodulation group 6/51 (12%) patients reported a treatment-related adverse event vs 12/25 (48%) in the solifenacin group (P < .001). No clinically significant changes were observed in any other safety endpoint. The proportions of responders in the peroneal electrical transcutaneous neuromodulation group vs the solifenacin group were 87% vs 74% with respect to Patient Perception of Intensity of Urgency Scale grade 3 urgency episodes, 87% vs 75% with respect to grade 3+4 urgency episodes, and 90% vs 94% with respect to urgency incontinence episodes. In post hoc analyses we observed significant improvement over time in multiple efficacy variables in both treatment arms. CONCLUSIONS: Peroneal electrical transcutaneous neuromodulation is a safe and effective method for overactive bladder treatment associated with a significantly lower incidence of treatment-related adverse events compared to solifenacin and a considerably better benefit-risk profile.
- MeSH
- antagonisté muskarinových receptorů MeSH
- hyperaktivní močový měchýř * farmakoterapie MeSH
- kvalita života MeSH
- lidé MeSH
- prospektivní studie MeSH
- solifenacin sukcinát * terapeutické užití MeSH
- výsledek terapie MeSH
- Check Tag
- lidé MeSH
- ženské pohlaví MeSH
- Publikační typ
- časopisecké články MeSH
- multicentrická studie MeSH
- randomizované kontrolované studie MeSH
BACKGROUND: Acquired haemophilia (AH) is a serious autoimmune haematological disease caused by the production of auto-antibodies against coagulation factor VIII. In some patients, AH is associated with a concomitant malignancy. In case of surgical intervention, AH poses a high risk of life-threatening bleeding. CASE SUMMARY: A 60-year-old female patient with multiple recurrences of non-muscle invasive bladder cancer underwent transurethral tumour resection. A severe haematuria developed postoperatively warranting two endoscopic revisions; however, no clear source of bleeding was identified in the bladder. Subsequent haematological examination established a diagnosis of AH. Treatment with factor VIII inhibitor bypass activity and immunosuppressive therapy was initiated immediately. The patient responded well to the therapy and was discharged from the hospital 21 d after the primary surgery. At the 38-mo follow-up, both AH and bladder cancer remained in complete remission. CONCLUSION: AH is a rare, life-threatening haematological disease. AH should be considered in patients with persistent severe haematuria or other bleeding symptoms, especially if combined with isolated activated partial thromboplastin time prolongation.
- Publikační typ
- kazuistiky MeSH