RESUMO
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.
Assuntos
Estimulação Elétrica Nervosa Transcutânea , Bexiga Urinária Hiperativa , Humanos , Nervo Tibial/fisiologia , Estimulação Elétrica Nervosa Transcutânea/métodos , Resultado do Tratamento , Bexiga Urinária , Ensaios Clínicos Controlados Aleatórios como AssuntoRESUMO
BACKGROUND: Transurethral resection of the prostate (TURP) has been the gold standard of the treatment of benign prostatic hyperplasia (BPH). In recent years there has been a significant shift in the treatment of BPH and guidelines emphasize minimally invasive surgery as a new treatment option. Minimal invasive technologies (MITs), such as transurethral microwave thermotherapy (TUMT), laser ablations, transurethral needle ablation (TUNA) have emerged as an alternative to the TURP. OBJECTIVES: To assess the retreatment rates of the most commonly used minimal invasive techniques. SEARCH STRATEGY: Durability articles were selected by using defined search terms using PubMed as search engine. RESULTS: Comparing to the overall retreatment rates of MITs the results show that TUMT, holmium laser enucleation of the prostate (HoLEP) and contact laser vaporization (CLV) are among the treatments with the lowest retreatment rates. Studies show no significant differences in retreatment rates between TUMT and TURP. CONCLUSION: A review of the current literature, long term results and retreatment rates of MITs shows large variability in outcomes and retreatment rates. The true definition of a MIT remains unclear. High energy TUMT deserves reconsideration in clinical practices, due to low retreatment rates and the low need of anesthetics.