The main objective of this study will be to assess whether an additive stimulation of the posterior tibial nerve (PTNS) in combination with bladder training has a significant reduction in frequency of micturition in patients with overactive bladder…
ID
Source
Brief title
Condition
- Bladder and bladder neck disorders (excl calculi)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
* The primary outcome is the percentage of patients with a 70% improvement
in the ICIQ-Sf total score.
Secondary outcome
* Secondary outcomes to be measured:
* Micturition frequency at 6-12 wks/ daytime/nightime
* Reduction in UUI (Urge Urinary Incontinence) episodes/pwk
Background summary
Overactive Bladder is a disabling condition with a great impact on Quality of
Life. With an overall prevalence rate of 11,8% it affects millions of people
around the world. In addition to the non-invasive conservative treatment
options like medication, bladder training and/or pelvic muscle floor training a
newly intervention is explored in recent years. This peripheral neuromodulation
technique is developed from old Chinese acupuncture knowledge, whereas the
posterior tibial nerve is stimulated at a location of an acupuncture point
three fingerbreadths above the inner ankle. The main group of patients
receiving this intervention are those who are refractory to conservative
treatment. In this study we*re trying to investigate whether it is clinically
relevant to bring it forward in the decision tree. The main objective of this
study will be to assess whether an additive stimulation of the posterior tibial
nerve (PTNS) in combination with bladder training has a significant reduction
in frequency of micturition, urge urinary incontinence episodes and quality of
life, measured by the ICIQ-sf in patients with overactive bladder than bladder
training alone
Study objective
The main objective of this study will be to assess whether an additive
stimulation of the posterior tibial nerve (PTNS) in combination with bladder
training has a significant reduction in frequency of micturition in patients
with overactive bladder than bladder training alone.
Study design
A prospective Randomized Clinical Trial
two arms:
Bladder training
Bladder training and PTNS
Intervention
Bladder training and PTNS
Study burden and risks
The burden could be the extra time to be invested.
Risks are minimal: there is a little possibility of minor bleedings.
atalantahof 16
3544VD utrecht
Nederland
atalantahof 16
3544VD utrecht
Nederland
Listed location countries
Age
Inclusion criteria
All patients diagnosed with OAB syndrome will be included.
Criteria for diagnosis are as follow:
* Urgency and frequency: more than 8 voids per 24 hours and the sudden urge to void can hardly be suppressed.
* Urge incontinence: urgency leading to urinary leakage occurring at least three times weekly
* willingness to fill up a daily bladder diary.
* age > 18yrs
Exclusion criteria
* Symptoms existing for less than 6 months
* Pregnancy.
* Active urinary tract or recurrent urinary tract infection
* Severe cardiopulmonary disease
* Diabetes with peripheral nerve involvement
* Neurological disorders
* flowmetrie < 15mm/sec
Design
Recruitment
metc-ldd@lumc.nl
metc-ldd@lumc.nl
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 | NL26931.098.09 |