bTUNED: transcutaneous tibial nerve stimulation for neurogenic lower urinary tract dysfunction.
BJU Int
; 132(3): 343-352, 2023 09.
Article
en En
| MEDLINE
| ID: mdl-37204144
ABSTRACT
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 ANDRESULTS:
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 11 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.Palabras clave
Texto completo:
1
Ejes tematicos:
Pesquisa_clinica
Banco de datos:
MEDLINE
Asunto principal:
Estimulación Eléctrica Transcutánea del Nervio
/
Vejiga Urinaria Hiperactiva
Tipo de estudio:
Clinical_trials
/
Guideline
Límite:
Humans
Idioma:
En
Año:
2023
Tipo del documento:
Article