None listed
Conditions
Brief summary
Transcutaneous electrical nerve stimulation (TENS) is an effective treatment method for overactive bladder and urge incontinence in children (de Gennaro et al., 2011; Barroso et al., 2011). The aim of the study is to analyse the effects of TENS on psychosocial outcomes,quality of life and lower urinary tract symptoms (LUTS) for treating overactive bladder in children by comparing changes in the strengths and difficulties questionnaire (SDQ) scores, the PinQ (paediatric incontinence quality of life) scores and lower urinary tract symptom scores (ICIQ-CLUTS – International Consultation on Incontinence Questionnaire – Pediatric Lower Urinary Tract Symptoms) before and after treatment with TENS for 3 months. The following hypotheses shall be examined: 1. Is there an improvement in psychological symptoms after three months of treatment with TENS? 2. Is there an improvement in quality of life scores after three months of treatment with TENS? 3. Is there a reduction in lower urinary tract symptoms after three months of treatment with TENS?
Interventions
TENS is based on the gate control theory of abolishing the local micturition reflex arc. The sticky electrodes are applied on the lower back, on the bladder dermatome S2, S3 and S4. The child is encouraged to wear the TENS for 1 hour every day for three months. The TENS is set at a frequency 10 Hz with the current density set as has as tolerated by the child. Children attending the urinary incontinence clinics at The Children's Hospital at Westmead and John Hunter Children’s Hospital in Newcastl
TENS is based on the gate control theory of abolishing the local micturition reflex arc. The sticky electrodes are applied on the lower back, on the bladder dermatome S2, S3 and S4. The child is encouraged to wear the TENS for 1 hour every day for three months. The TENS is set at a frequency 10 Hz with the current density set as has as tolerated by the child. Children attending the urinary incontinence clinics at The Children's Hospital at Westmead and John Hunter Children’s Hospital in Newcastle, who are diagnosed with overactive bladder who require additional treatment for their overactive bladder after at least one month of urotherapy will be invited to participate in the study. Children are referred by their general practitioners or specialists to the clinics. Parents will be informed that parasacral TENS is an alternative to the pharmacological treatment with anticholinergics. Those wishing to participate in the study and have provided informed consent will be provided with a TENS machine for three months. Children and their parents will be instructed on how to use the TENS, which will be used in their homes at times convenient to them. the child will be asked to wear the TENS (set at 10 Hz) for 60 minutes per day for 3 months. The study coordinator will contact study participants every 4 weeks to provide additional support and to evaluate their progress. Participants will be asked to complete 3 baseline questionnaires at enrolment and after 3 months of TENS use. As this study forms part of an international collaboration, data from the Australian sites will be also be compared with data from Germany and Brazil.
Sponsors
Assoc Prof Patrina Caldwell
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
4 Years to 17 Years
Healthy volunteers
No
Inclusion criteria
All children who present to the outpatient incontinence clinics at the Children’s Hospital at Westmead and John Hunter Children’s Hospital with overactive bladder who have had at least one month of urotherapy, for which treatment with TENS is indicated, where parents chose to use TENS instead of anticholinergic medications as first line therapy
Exclusion criteria
Children who have previously used or are currently using anticholinergics for overactive bladder syndrome. Also patients with concomitant faecal incontinence.
Outcome results
None listed