Research question: is primary aggressive treatment of constipation with rectal wash-out in girls with NNBSD at least equally effective as usual care?
ID
Source
Brief title
Condition
- Bacterial infectious disorders
- Urinary tract signs and symptoms
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Cure of UTIs, 6 months after stop of chemoprophylaxis, will be the primary goal
of treatment.
Secondary outcome
Cure of urinary incontinence, when relevant, is the second goal of treatment,
recovery of normal rectal function and relief of constipation is the third.
Background summary
Girls with non-neurogenic bladder/sphincter dysfunction (NNBSD) have impaired
relaxation of the pelvic floor during voiding and defecation. This results
mandatorily into residual urine after voiding with subsequent urinary tract
infections (UTIs), urinary incontinence, constipation and fecal soiling.
Patients also suffer from an impaired feeling of the filling state of both the
bladder and the rectum which leads to rectal overdistension without urge to
defecate. NNBSD is socially important as 7-10% of all girls have complaints in
this field and 40% of these have vesico-ureteric reflux as well that can lead
to complicated UTIs with renal scarring. Untreated, the girls are at risk for
chronic renal failure and for life-long pelvic floor problems. When treated
properly renal function is secured and pelvic floor dysfunction at later age is
prevented.
Over the years, treatment has been focussed on the learning of proper bladder
emptying combined with standard oral treatment of constipation. In the group of
children that failed to be cured from UTIs it has become a plausible suggestion
that the persistent rectal distension with fecal compaction is the major cause
for treatment failure and that only active treatment of the distended rectum
can control the disease. Temporary retrograde rectal wash-out with water is
expected to restore proper feeling of rectal filling and proper emptying of the
distended rectum with subsequent relief of the lower urinary tract problems.
Literature provides sufficient clues to support this suggestion.
Study objective
Research question: is primary aggressive treatment of constipation with rectal
wash-out in girls with NNBSD at least equally effective as usual care?
Study design
Girls aged 6 to 12 years with NNBSD, afdter 3 months of standard outpatient
treatment, will be randomly allocated to receive either standard outpatient
cognitive bladder training by a urotherapist combined with antibiotic
prophylaxis and oral laxatives, or to the standard medical outpatient treatment
combined with a 3 months episode of rectal wash-outs with water at home. The
study will take 24 months for completion. The ultimate goal is to derive at an
alternative treatment for NNBSD that can be applied at a younger age and is
probably cheaper than usual care.
Intervention
3 months standard outpatient treatment
3 months study intervention 1 or 2 with continuation of medication.
After 6 months chemoprophylaxis is stopped.
Study burden and risks
Burden is comparable with the current treament of the condition.
Postbus 85090
3508AB Utrecht
Nederland
Postbus 85090
3508AB Utrecht
Nederland
Listed location countries
Age
Inclusion criteria
recurrent urinary tract infections, NNBSD, residual urine after voiding >10% of expected bladder capacity for age, possibly urinary incontinence, persistent rectal constipation after at least 3 months oral laxative therapy. School maturity.
Exclusion criteria
congenital malformations of the urinary tract other then vesico-ureteral reflux, earlier surgery on the lower urinary tract other then surgery for reflux or meatal stenosis, impossible communication in Dutch or English.
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 | NL13337.041.06 |