Background and Objectives: Overactive bladder (OAB) is frequently associated with impaired quality of life and sleep disturbances, particularly in women with refractory symptoms. Non-invasive neuromodulation targeting autonomic regulation has emerged as a potential therapeutic approach. The purpose of this pilot trial is to assess the efficacy and safety of NESA non-invasive neuromodulation in the treatment of patients with overactive bladder. Materials and Methods: Triple-blind, randomized, sham-controlled pilot trial. Women ≥ 18 years with refractory OAB were randomized to active NESA or sham using an identical protocol (10 sessions, 60 min, twice weekly). Outcomes were collected at baseline, after session 5, and after session 10. The primary outcome was mean daily micturitions, assessed using a 3-day voiding diary. Secondary outcomes included other diary variables, urinary questionnaires (ICIQ-UI SF, ICIQ-QoL, B-SAQ), and sleep measures (PSQI, ISI). Results: Per-protocol analysis included 43 women (NESA n = 24; sham n = 19). At session 10, mean daily micturitions decreased from 9.19 to 8.07 with NESA and increased from 10.56 to 11.03 with sham (between-group p = 0.043; d = -0.97). Sleep improved with NESA versus sham (PSQI p = 0.001; d = -0.63; ISI p = 0.001; d = -0.59). Between-group differences in urinary symptom questionnaires were not significant. No device-related adverse events occurred. Conclusions: In this pilot trial, NESA neuromodulation was safe and showed preliminary signals of benefit, particularly for mean daily frequency and sleep outcomes. However, given the exploratory design, small sample size, and per-protocol analysis, these findings should be interpreted cautiously and confirmed in larger adequately powered trials before clinical implementation.
Medicina (Kaunas, Lithuania). 2026 May 11*** epublish ***
Guillermo Conde-Santos, Alicia Martín-Martínez, Sonia Carballo-Rastrilla, Abián Fernández-Mederos, Aníbal Báez-Suárez, Andrea Hernández-Pérez, María P Quintana-Montesdeoca, Raquel Medina-Ramírez
Hospital Quiron Salud Tenerife, 38006 Santa Cruz de Tenerife, Spain., Maternal and Child Hospital of Las Palmas de Gran Canaria, 35016 Las Palmas, Spain., Faculty of Health Sciences, University of Las Palmas de Gran Canaria, 35016 Las Palmas, Spain., Faculty of Health Sciences, University of La Laguna, 28200 Santa Cruz de Tenerife, Spain.