OBJECTIVE: To assess the objective efficacy of transcutaneous posterior tibial nerve stimulation in children presenting with overactive bladder resistant to well conducted treatment. MATERIAL AND METHOD: This was a randomized, double-blind, controlled study on 20 children with OAB. All patients were previously treated with anticholinergic drugs associated with detrusor rehabilitation, diet advice, bladder-voiding hygiene and constipation treatment, with poor clinical results. Patients were randomized into two groups: -Group A: treatment with PTNS (n = 11). -GroupB: sham treatment (n = 9). The program lasted 12 consecutive weeks with two 30-minutes sessions a week. Each patient underwent pre-stimulation urodynamic testing to validate bladder overactivity followed by a post-stimulation testing. Pre- and post-stimulation urodynamic parameters were compared in order to objectively evaluate the treatment's efficacy. The patients noted their incontinence episodes for 7 consecutive days in a diary before the beginning of the program, in the middle and at the end of it: this led to computing an incontinence score (score ranged from 0 to 13, from good to poor). The difference between the pre-stimulation and post-stimulation score enabled to express clinical results in terms of poor (less than a 3-point decrease), medium (a 3 to 5-point decrease), good (6 to 8-point decrease), very good (final score ranged between 0 and 3). Children were questioned regarding their impression of being stimulated or not. RESULTS: In Group A, there were five very good clinical results (45%), one medium (10%) and five poor results (45%). In groupB, nine very good results (66%) and three poor results (33%) were noted. Regarding urodynamic testing, volume voided during urgency (184 mL to 265 mL), maximal cystomanometry volume (215 mL to 274 mL) and volume at the onset of the first overactive detrusor contraction (ODC) (48 mL to 174 mL) were significantly increased in Group A (p = 0.002, p = 0.024 and p = 0.001) and maximal bladder pressure during ODC had decreased (61 to 46) (p = 0.042). 85% children in group A thought they were being stimulated vs. 70% in groupB. CONCLUSION: Even though we noticed urodynamics improvements in group A, which objectively supports the efficacy of TCTPNS, clinical results remained the same between the two groups. In spite of the small size of our sample, this underlines the placebo effect of any type management in this pediatric population. Studying precisely the maximal useful voltage and duration of stimulation should then be relevant in order to yield maximal benefits from this easy-to-use procedure.
RCT Entities:
OBJECTIVE: To assess the objective efficacy of transcutaneous posterior tibial nerve stimulation in children presenting with overactive bladder resistant to well conducted treatment. MATERIAL AND METHOD: This was a randomized, double-blind, controlled study on 20 children with OAB. All patients were previously treated with anticholinergic drugs associated with detrusor rehabilitation, diet advice, bladder-voiding hygiene and constipation treatment, with poor clinical results. Patients were randomized into two groups: -Group A: treatment with PTNS (n = 11). -Group B: sham treatment (n = 9). The program lasted 12 consecutive weeks with two 30-minutes sessions a week. Each patient underwent pre-stimulation urodynamic testing to validate bladder overactivity followed by a post-stimulation testing. Pre- and post-stimulation urodynamic parameters were compared in order to objectively evaluate the treatment's efficacy. The patients noted their incontinence episodes for 7 consecutive days in a diary before the beginning of the program, in the middle and at the end of it: this led to computing an incontinence score (score ranged from 0 to 13, from good to poor). The difference between the pre-stimulation and post-stimulation score enabled to express clinical results in terms of poor (less than a 3-point decrease), medium (a 3 to 5-point decrease), good (6 to 8-point decrease), very good (final score ranged between 0 and 3). Children were questioned regarding their impression of being stimulated or not. RESULTS: In Group A, there were five very good clinical results (45%), one medium (10%) and five poor results (45%). In group B, nine very good results (66%) and three poor results (33%) were noted. Regarding urodynamic testing, volume voided during urgency (184 mL to 265 mL), maximal cystomanometry volume (215 mL to 274 mL) and volume at the onset of the first overactive detrusor contraction (ODC) (48 mL to 174 mL) were significantly increased in Group A (p = 0.002, p = 0.024 and p = 0.001) and maximal bladder pressure during ODC had decreased (61 to 46) (p = 0.042). 85% children in group A thought they were being stimulated vs. 70% in group B. CONCLUSION: Even though we noticed urodynamics improvements in group A, which objectively supports the efficacy of TCTPNS, clinical results remained the same between the two groups. In spite of the small size of our sample, this underlines the placebo effect of any type management in this pediatric population. Studying precisely the maximal useful voltage and duration of stimulation should then be relevant in order to yield maximal benefits from this easy-to-use procedure.
Authors: Liesbeth L De Wall; Anna P Bekker; Loes Oomen; Vera A C T Janssen; Barbara B M Kortmann; John P F A Heesakkers; Anke J M Oerlemans Journal: Int J Environ Res Public Health Date: 2022-07-25 Impact factor: 4.614