Nitesh Patidar1, Varun Mittal1, Manoj Kumar1, Sanjoy Kumar Sureka1, Sohrab Arora1, Mohd Sualeh Ansari2. 1. Department of Urology and Renal Transplant, Sanjay Gandhi Postgraduate, Institute of Medical Sciences, Lucknow, India. 2. Department of Urology and Renal Transplant, Sanjay Gandhi Postgraduate, Institute of Medical Sciences, Lucknow, India. Electronic address: ansarimsa@hotmail.com.
Abstract
BACKGROUND: Non-neurogenic overactive bladder (OAB) is a common problem in children that may affect their quality of life. Various methods of neuromodulation have been reported to treat refractory lower urinary tract dysfunction. Since most of these techniques are invasive, they are less applicable in children. OBJECTIVE: To evaluate the efficacy of transcutaneous PTNS in treatment of OAB in children, in a randomized clinical setting. STUDY DESIGN: This study was single-blinded, prospective, sham controlled randomized trial. 40 children with non-neurogenic OAB refractory to behavioural and anticholinergic therapy were randomized either to test group or sham group. Neuromodulation was performed using two self-adhesive electrodes cephalad to medial malleolus. In test group the stimulation was given with voltage pulse intensity of 0 to 10 mA, pulse width of 200 μs and frequency of 20 Hz. In sham group patch electrodes were applied to simulate the test group but no stimulation was given. In both groups, weekly session of 30 min was given for a period of 12 weeks. The OAB symptoms, severity of incontinence, number of voids daily (NV), average voided volume (AVV) and maximum voided volume (MVV) were evaluated before and after treatment. RESULTS: On assessment of subjective improvement of OAB symptoms, 66.66% patients reported cure and 23.81% patients reported significant improvement of symptoms in test group whereas in sham group only 6.25% patients reported significant improvement. In test group 71.42% patients reported complete improvement in incontinence whereas in sham group only 12.5% patient reported complete improvement. The AVV, MVV and NV improved significantly in test group (p <0.001) as compared to sham group (Table). DISCUSSION: The present study is unique as none of the earlier studies in children were sham controlled. It is also first PTNS study in which patch electrodes were used; therefore it is completely noninvasive. This technique provides better patient acceptability and compliance. This study proved that, there is a definite effect of PTNS as compared to placebo because when patients from sham group were treated actively, they responded well. The present study has few limitations as it has relatively short follow-up period of 12 weeks. Relapse of OAB symptoms and maintenance schedule of PTNS need to be assessed further. CONCLUSION:Transcutaneous PTNS is superior to placebo in treatment of non-neurogenic overactive bladder in children. In view of its effectiveness and acceptability we believe that transcutaneous PTNS should be part of pediatric urology armamentarium for treatment of OAB.
RCT Entities:
BACKGROUND:Non-neurogenic overactive bladder (OAB) is a common problem in children that may affect their quality of life. Various methods of neuromodulation have been reported to treat refractory lower urinary tract dysfunction. Since most of these techniques are invasive, they are less applicable in children. OBJECTIVE: To evaluate the efficacy of transcutaneous PTNS in treatment of OAB in children, in a randomized clinical setting. STUDY DESIGN: This study was single-blinded, prospective, sham controlled randomized trial. 40 children with non-neurogenic OAB refractory to behavioural and anticholinergic therapy were randomized either to test group or sham group. Neuromodulation was performed using two self-adhesive electrodes cephalad to medial malleolus. In test group the stimulation was given with voltage pulse intensity of 0 to 10 mA, pulse width of 200 μs and frequency of 20 Hz. In sham group patch electrodes were applied to simulate the test group but no stimulation was given. In both groups, weekly session of 30 min was given for a period of 12 weeks. The OAB symptoms, severity of incontinence, number of voids daily (NV), average voided volume (AVV) and maximum voided volume (MVV) were evaluated before and after treatment. RESULTS: On assessment of subjective improvement of OAB symptoms, 66.66% patients reported cure and 23.81% patients reported significant improvement of symptoms in test group whereas in sham group only 6.25% patients reported significant improvement. In test group 71.42% patients reported complete improvement in incontinence whereas in sham group only 12.5% patient reported complete improvement. The AVV, MVV and NV improved significantly in test group (p <0.001) as compared to sham group (Table). DISCUSSION: The present study is unique as none of the earlier studies in children were sham controlled. It is also first PTNS study in which patch electrodes were used; therefore it is completely noninvasive. This technique provides better patient acceptability and compliance. This study proved that, there is a definite effect of PTNS as compared to placebo because when patients from sham group were treated actively, they responded well. The present study has few limitations as it has relatively short follow-up period of 12 weeks. Relapse of OAB symptoms and maintenance schedule of PTNS need to be assessed further. CONCLUSION: Transcutaneous PTNS is superior to placebo in treatment of non-neurogenic overactive bladder in children. In view of its effectiveness and acceptability we believe that transcutaneous PTNS should be part of pediatric urology armamentarium for treatment of OAB.
Authors: Mana H Vriesman; Ilan J N Koppen; Michael Camilleri; Carlo Di Lorenzo; Marc A Benninga Journal: Nat Rev Gastroenterol Hepatol Date: 2019-11-05 Impact factor: 46.802
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