PMID- 37670742
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20231025
IS  - 2296-2360 (Print)
IS  - 2296-2360 (Electronic)
IS  - 2296-2360 (Linking)
VI  - 11
DP  - 2023
TI  - At-home use of parasacral transcutaneous electrical nerve stimulation for 
      pediatric voiding dysfunction: a randomized controlled trial to assess its safety 
      and feasibility.
PG  - 1219887
LID - 10.3389/fped.2023.1219887 [doi]
LID - 1219887
AB  - INTRODUCTION: Treating pediatric voiding dysfunction involves behavioral changes 
      that require significant time or medications that are often avoided or 
      discontinued due to side effects. Using parasacral transcutaneous electrical 
      nerve stimulation (PTENS) has shown to have reasonable efficacy, but the safety 
      and feasibility of its off-label use for pediatric voiding dysfunction are not 
      well-established. Concerns have also been raised over treatment adherence. 
      In-home therapy might improve adherence compared with office-based therapy; 
      however, no studies have evaluated in-home feasibility to date. This study aims 
      to assess the safety and feasibility of off-label use of PTENS for pediatric 
      voiding dysfunction. MATERIALS AND METHODS: A single-institution prospective, 
      randomized controlled study was conducted from March 2019 to March 2020. 
      Participants aged 6-18 years diagnosed with voiding dysfunction, overactive 
      bladder, or urinary incontinence were eligible for the study. Those with known 
      neurologic disorders, implanted electrical devices, anatomic lower urinary tract 
      abnormality, and recurrent urinary tract infections and those taking bladder 
      medications were excluded. Children with primary monosymptomatic nocturnal 
      enuresis were also excluded due to previous work suggesting a lack of efficacy. 
      Participants were randomly assigned to receive 12 weeks of urotherapy alone 
      (control) or urotherapy plus at-home PTENS treatment. Families were contacted 
      weekly to assess for adverse events (AEs) and treatment adherence. The primary 
      and secondary outcomes were safety, defined as the absence of AEs and treatment 
      adherence, respectively. RESULTS: A total of 30 eligible participants were 
      divided into two groups, with 15 participants in each arm. The median age was 9.4 
      years (interquartile range: 7.7-10.6). In total, 60% were male. Baseline 
      demographics and urotherapy compliance were similar between the two groups. With 
      PTENS use, two AEs were reported, including mild pruritus at the pad site and 
      discomfort when removing pads, while no AEs were noted in the control group. In 
      total, 60% of patients completed three 30-min sessions per week, and all 
      participants were able to complete treatment sessions for at least 10 weeks, 
      involving 30 min of PTENS treatment each time. CONCLUSION: This randomized 
      controlled study confirms that at-home use of PTENS is feasible with reasonable 
      treatment adherence and minimal AEs. Future collaborative, multi-institutional 
      studies may better determine the efficacy of this treatment modality.
CI  - (c) 2023 Malhotra, Siegal, Lange, Cervantez, White, Hannon, Schaeffer and Lau.
FAU - Malhotra, Neha R
AU  - Malhotra NR
AD  - Department of Urology, Mount Sinai Hospital, New York, NY, United States.
AD  - Department of Pediatric Urology, Primary Children's Hospital, Salt Lake City, UT, 
      United States.
FAU - Siegal, Alexandra R
AU  - Siegal AR
AD  - Department of Urology, Mount Sinai Hospital, New York, NY, United States.
FAU - Lange, Suzanne M
AU  - Lange SM
AD  - Department of Urology, University of Utah Hospital, Salt Lake City, UT, United 
      States.
FAU - Cervantez, DeeAnn
AU  - Cervantez D
AD  - Department of Pediatric Urology, Primary Children's Hospital, Salt Lake City, UT, 
      United States.
FAU - White, Heidi K
AU  - White HK
AD  - Department of Pediatric Urology, Primary Children's Hospital, Salt Lake City, UT, 
      United States.
FAU - Hannon, AnnMarie
AU  - Hannon A
AD  - Department of Pediatric Urology, Primary Children's Hospital, Salt Lake City, UT, 
      United States.
FAU - Schaeffer, Anthony J
AU  - Schaeffer AJ
AD  - Department of Pediatric Urology, Primary Children's Hospital, Salt Lake City, UT, 
      United States.
FAU - Lau, Glen A
AU  - Lau GA
AD  - Department of Pediatric Urology, Primary Children's Hospital, Salt Lake City, UT, 
      United States.
LA  - eng
GR  - K08 DK119535/DK/NIDDK NIH HHS/United States
PT  - Journal Article
DEP - 20230821
PL  - Switzerland
TA  - Front Pediatr
JT  - Frontiers in pediatrics
JID - 101615492
PMC - PMC10475593
OTO - NOTNLM
OT  - PTENS
OT  - overactive bladder
OT  - pediatric
OT  - urinary incontinence
OT  - voiding dysfunction
COIS- The authors declare that the research was conducted in the absence of any 
      commercial or financial relationships that could be construed as a potential 
      conflict of interest.
EDAT- 2023/09/06 06:42
MHDA- 2023/09/06 06:43
PMCR- 2023/08/21
CRDT- 2023/09/06 03:43
PHST- 2023/05/09 00:00 [received]
PHST- 2023/08/01 00:00 [accepted]
PHST- 2023/09/06 06:43 [medline]
PHST- 2023/09/06 06:42 [pubmed]
PHST- 2023/09/06 03:43 [entrez]
PHST- 2023/08/21 00:00 [pmc-release]
AID - 10.3389/fped.2023.1219887 [doi]
PST - epublish
SO  - Front Pediatr. 2023 Aug 21;11:1219887. doi: 10.3389/fped.2023.1219887. 
      eCollection 2023.