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.

Phamacological treatment of persistant lower urinary tract symptoms after a transurethral resection of the prostate is predictive of a new surgical treatment: 10 years follow-up study.

AIM: To evaluate possible risk factors of re intervention in patients with benign prostatic enlargement (BPE) undergoing transurethral resection of the prostate (TURP). MATERIALS AND METHODS: A consecutive series of patients with LUTS and BPE underwent TURP in our center in 2004 and 2005 and they were then followed up to September 2016. Patients were assessed at baseline, 3-, 6-month postoperatively and yearly thereafter with medical history, international prostate symptom score, prostate specific antigen, maximal urinary flow rate, post void residual urine. Reoperation was defined as the requirement of a new TURP to relieve bothersome LUTS. Cox regression was used to determine covariates associated with reoperation rate and the Kaplan-Meier curve assessed the time to reoperation. RESULTS: Overall, 92 patients were enrolled. Median follow up was 142 months. 13 patients underwent a second TURP during the follow-up period (reoperation rate was 14%); out of them 9/13 (69%) received medical treatment for persistent LUTS (p = .001). The need of LUTS/BPE pharmacological treatment after TURP is an independent risk factor for a second surgical procedure (odds ratio 9,3; p = .001). Out of the 13 patients treated with a re-TURP, 12 (92%) underwent surgery within 5 years of follow-up. CONCLUSION: In our single center study, the need of LUTS/BPE pharmacological treatment was a predictive factor of a re-TURP. Considering that more than 90% of re-TURP were performed during the first 5 years of follow-up, it is assumable that a follow-up longer than 5 years is not needed in these patients.