A prospective randomized trial comparing the 1-stage with the 2-stage implantation of a pulse generator in patients with pelvic floor dysfunction selected for sacral nerve stimulation.
Eur Urol
; 45(5): 649-54, 2004 May.
Article
em En
| MEDLINE
| ID: mdl-15082209
ABSTRACT
OBJECTIVE:
The aim of this study was to evaluate in a prospective, randomized setting if the 2-stage implant, compared to a 1-stage implant, leads to a superior subjective or objective outcome of sacral nerve stimulation after implantation of the pulse generator in patients with lower urinary tract symptoms. PATIENTS ANDMETHODS:
We implanted a sacral (S3) foramen lead and a pulse generator (model 3023, Medtronic Inc, Minneapolis, MN, USA) in 42 patients. They were randomized in a 1-stage or a 2-stage implant if a more than 50% improvement in voided volume or reduction of residual urine was seen during the test stimulation phase as compared to baseline.RESULTS:
At 24 months follow-up, subjective (visual analogue scale) and objective (voided volume or residual urine) assessment were significantly better in the 2-stage group. Ten patients (24%) failed therapy, 7 in the 1-stage implant and 3 in the 2-stage group. Two patients were lost to follow-up. Logistic regression analysis revealed that failure was positively related to the 1-stage implant and negatively to the age of the patients. 76% of the treated patients had sustained clinical benefit with 23 revisions performed. The mean cost is respectively for the PNE (2006 Euro), for the 2-stage implant (10826 Euro) and for the 1 stage implant (8505 Euro).CONCLUSION:
With this study, we demonstrated that the 2-stage implantation technique of the sacral neuromodulation therapy performed as a longer test stimulation phase has a higher success rate.
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Coleções:
01-internacional
Contexto em Saúde:
1_ASSA2030
Base de dados:
MEDLINE
Assunto principal:
Transtornos Urinários
/
Terapia por Estimulação Elétrica
Tipo de estudo:
Clinical_trials
/
Etiology_studies
/
Health_economic_evaluation
/
Observational_studies
/
Prognostic_studies
Limite:
Humans
/
Middle aged
Idioma:
En
Revista:
Eur Urol
Ano de publicação:
2004
Tipo de documento:
Article