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PEDIATRIC
UROLOGY
Efficacy
of combined anticholinergic treatment and behavioral modification as a
first line treatment for nonneurogenic and nonanatomical voiding dysfunction
in children: a randomized controlled trial
Ayan S, Topsakal K, Gokce G, Gultekin EY
Department of Urology, Cumhuriyet University School of Medicine, Sivas,
Turkey.
J Urol. 2007; 177: 2325-8; discussion 2328-9
- Purpose:
This randomized blinded clinical study was designed to compare the efficacy
of tolterodine treatment combined with behavioral modification, behavioral
modification alone and behavioral modification plus placebo in children
with nonneurogenic, nonanatomical voiding dysfunction.
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Materials and Methods: A
total of 72 children meeting inclusion criteria were randomly allocated
to 1 of 3 groups. One group received tolterodine (1 mg twice daily)
along with behavioral modification, 1 received behavioral modification
only and 1 received placebo with behavioral modification. A dysfunctional
voiding scoring system questionnaire was completed for all patients
at the beginning of the study, and at 1 and 3 months of treatment.
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Results:
A total of 71 patients were evaluated. The groups did not differ with
respect to age, gender and symptom score before study enrollment (p
>0.05). Repeated calculations of symptom scores at 1 month of the
treatment revealed a significant decrease in symptoms in all 3 groups,
with a significant decrease in patients receiving tolterodine. In addition,
at month 3 the symptom score of the tolterodine group was significantly
lower compared to month 1, while scores remained steady in the behavioral
modification and behavioral modification plus placebo groups.
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Conclusions:
Tolterodine combined with behavioral modification for voiding dysfunction
in children without neurological or anatomical abnormality can be recommended
as a first line treatment before invasive evaluation.
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Editorial Comment
This is an interesting prospective randomized controlled trial, which
relied primarily on a dysfunctional voiding scoring system from Toronto
Children’s to evaluate the outcome of the treatment. 72 children
were selected with equal number of boys and girls, allocated into one
of three groups. Voiding dysfunction that qualified them for the study
was incontinence, frequency, urgency or obstructive symptoms with or
without recurrent non-febrile urinary tract infections in the absence
of obvious anatomical or neurogenic disease. Patients were between 4
and 12 years-of-age. Anatomic disease was evaluated by ultrasound and
not VCUG, and the patients were not selected by any urodynamics or uroflow
criteria. All patients were trained in behavior modification, including
timed voiding, double-voiding and relaxation of the pelvic floor during
voiding.
Group 1 patients were started on tolterodine 1 mg twice daily and were
maintained for three months. Group 2 had no medications and received
only behavior modification training. Group 3 were patients who had a
placebo administered along with behavior modification training. Dysfunctional
bowel was noted and treated in 30 of the 72 patients. The dysfunctional
voiding questionnaire was given at the beginning of the study, at end
of one month and again at the end of three months.
The results showed that initial dysfunctional voiding symptom scores
were not significantly different. All three groups showed significant
decrease after one month of treatment with a greater statistical significance
in the Tolterodine group. Interestingly, the behavior modification group
that did not receive placebo had lower symptom scores at one month and
three months. Gender adjustment did not affect statistical results of
the groups. 41 patients had a history of afebrile UTI’s and 15
patients had afebrile urinary tract infections at enrollment during
the study. Urine cultures were monitored monthly with new UTI’s
in 18 patients relatively equally spread over the three groups.
This is an interesting study because of its prospective randomized nature.
Tolterodine was tolerated in all the patients except one, with statistically
beneficial effects combined with behavior modification. The patients
chosen were patients similar to an office practice and were not particularly
well screened with urodynamics or uroflow studies, so that this represents
an “all-comers” group with very good outcomes. It will be
interesting to see if other studies use the dysfunctional voiding scoring
system and if it stands up under the test of other investigators scrutiny.
Dr.
Brent W. Snow
Division of Urology
University of Utah Health Sci Ctr
Salt Lake City, Utah, USA |