The objective is to find out whether injection of Botulinum toxin A into the wall of the bladder has, besides effects on bladder capacity and urgency symptoms, any influence on the contractility of the detrusor muscle.
ID
Source
Brief title
Condition
- Urinary tract signs and symptoms
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main endpoint is the change in detrusor contractility after Botulinum toxin
A treatment.
Secondary outcome
The secondary endpoint is the change in post void residual volume in relation
to the detrusor contractility.
Background summary
Botulinum toxin A (BT-A) causes muscle relaxation when injected intramuscular.
The protein works peripherally and does not cross the blood-brain barrier. In
patients with overactive bladder (OAB) injection with Botulinum toxin A into
the bladder wall has shown to reduce complaints of urgency, frequency and
urge-incontinence. The working mechanism of BT-A in the peripheral tissue, the
muscle itself, is known to some extent. BT-A is believed to act on both the
afferent and the efferent branch of the micturition regulation circuitry. The
effect of the BT-A treatment on the contractility of the detrusor has never
been investigated. This is remarkable, since this factor could provide
information about both the wordking mechanism of BT-A and the predisposing
factors for the need for intermittent catheterisation after the treatment.
Study objective
The objective is to find out whether injection of Botulinum toxin A into the
wall of the bladder has, besides effects on bladder capacity and urgency
symptoms, any influence on the contractility of the detrusor muscle.
Study design
This is a prospective pilot study in which patients with OAB will fill out a
micturition diary and Quality of Life-questionnaire and undergo an urodynamic
investigation before and six weeks after their treatment with BT-A injections.
Intervention
Before the treatment patients undergo urodynamic measurements to establish the
baseline value of detrusor contractility. Then the Botulinum toxin A is
injected into the detrusor muscle during an endoscopic procedure. Six weeks
after the injection, a second urodynamic investigation is carried out to
establish any changes in the detrusor contractility. Also patients will fill
out a micturition diary Quality of Life-questionnaire before and after the
treatment, to objectify the effect of the treatment on the patients symptoms.
Study burden and risks
The study is performed in patients who are already planned for the procedure of
Botulinum toxin A injections. Urodynamics before injection of BT-A is part of
the standard procedure. In the case of this research one extra test, a so
called isovolumetric contraction test, is carried out as a part of the
urodynamics. Six weeks after the treatment patients will undergo another
urodynamic investigation.
Before and six weeks after the treatment patients will fill out two
questionnaires, taking 10-15 minutes of their time. After the post-operative
urodynamics, patients will continue in the regular follow-up. The patients will
not directly benefit from this study. However, for the patient group this study
may provide information that predicts the need to start intermittent
catheterisation after treatment with Botulinum toxin A.
Postbus 30001
9700 RB Groningen
NL
Postbus 30001
9700 RB Groningen
NL
Listed location countries
Age
Inclusion criteria
Male and female patients 20 - 70 years of age
Symptoms of overactive bladder for more than 6 months
Micturition frequency > 7 times/day
Incontinence episodes > 6/week
Capable of filling out a micturition diary
Exclusion criteria
Treatment with Botulinum toxin A in the last 9 months
Treatment with anticholinergic drugs during the last 2 weeks
Active or repeated urinary tract infection
Peripheral neuropathy (i.e. Diabetic neuropathy)
Having an indwelling catheter
Malignancy in the area of the pelvis
Pelvic surgery less than 6 months ago
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 |
---|---|
EudraCT | EUCTR2007-004650-93-NL |
CCMO | NL19281.042.07 |