The goal of this study is to analyse the effect and safety of PTNS in 20 children with persistent overactive bladder complaints refractory to standard treatment
ID
Source
Brief title
Condition
- Urinary tract signs and symptoms
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Outcome and differences in parameters measured on Frequency-volume charts:
urgency, average bladder capacity, diaper weight, micturation frequency
day/night, severity of incontinence. All parameters are measured at basline,
after 12 weeks and after 16 weeks and compared
Secondary outcome
Outcome and differences in quality of life scores at baseline, 12 weeks and 16
weeks
Background summary
Introduction
Approximately 6-9% of school-aged childrengirls suffer from overactive bladder
with or without urinary incontinencetimes From the age of 6-7 years old other
treatments can be started besides conservative methods like urotherapy, pelvic
floor training and or medical/psychological treatment (Austin, Bauer et al.
2014).
For many children, these are successful treatments (Mulders,
Cobussen-Boekhorststraat et al 2011;. Vijverberg, Stortelder et al 2011;.. Van
Gool, de Jong et al 2013). For the group of children in which this therapy is
not successful (20%), more experimental treatments can be considered, like for
example botulinum toxin treatment (Blackburn, Jones et al. 2013). This
treatment requires anesthesia. the effect of Botuline toxine is approximately
6-9 months after which symtoms frequently recur
Percutaneous Tibial Nerve Stimulation (PTNS) or stimulation of the posterior
tibial nerve through a needle in the skin, is for some years now a successful
treatment in adults with overactive bladder syndrome (OAB) (Biemans and van
Balken 2013 Gaziev, Topazio et al. 2013). There is recent literature showing
that this treatment in children with OAB symptoms is successful and can be used
safely (Hoebeke, Renson et al 2002;. Capitanucci, Camanni et al. 2009).
Study objective
The goal of this study is to analyse the effect and safety of PTNS in 20
children with persistent overactive bladder complaints refractory to standard
treatment
Study design
Material and Method
PTNS treatment is a minimally invasive treatment, and can be applied in
children with OAB symptoms.
During the treatment, which is given by a nurse specialist, stimulation finds
place of the tibial nerve by means of a needle into the skin. Here, the wrong
or undesirable sensations from the pelvis can be blocked by providing an
electrical signal to a nerve branch at the ankle. This nerve branch is closely
connected with the nerves of the organs in the pelvis, such as bladder, rectum
and sphincter. By stimulating the tibial nerve, the behavior of the nerves that
run to the pelvic organs, affects positive.
The treatment consists of a stimulation of half an hour, for 12 weeks in the
outpatient department of urology.
For this effectiveness study 20 children from two centers will be treated,
Radboud University Nijmegen Medical Centre, outpatient pediatric urology,
Nijmegen and Noorderboog hospital, drying bed and pelvis center, Meppel
Intervention
during 12 weeks , participants come for 30 minutes for the nerve tiblialis
stimulation.
Study burden and risks
-12 weeks for 1/2 hour to the hospital can be a burden for children and parents
- when puncturing a needles hurts, this can be stressfull for the child
Geert Groote plein 10
Nijmegen 6500 HB
NL
Geert Groote plein 10
Nijmegen 6500 HB
NL
Listed location countries
Age
Inclusion criteria
* age >8 en <16 year
* complaints of bladder overactivity
* patients with functional bladder capacity < 65 % of estimated bladder capacity for age (Austin, Bauer et al. 2014) .
* previous unsuccesfull treatments for overactive bladder: urotherapy, pelvic floor therapy, medical / psychological treatment:
* clean urine sediment
* signed informed consent
Under the age of 12 both parents, Above the age of 12 both parents and patient
Exclusion criteria
- congenitale urological anomalies, except for mild urethral valves and meatus operation (asessed by pediatric urologist)
-voiding problems due to neurogenic case
-continuing of anticholinergics
- untreated or inadequatly treated obstipation
-pacemaker or implanted defibrillator
-Prone to excessive bleeding
-Pregnancy
-previous PTNS treatment
-previous botuline toxine intravesical treatment for overactive bladder within 6 months of the start of the study
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
CCMO | NL55958.091.15 |