Aims of Study:
Overactive bladder
is a condition that
comprises a collection
of symptoms, namely
urinary frequency,
urgency and/or urge
incontinence. On the
basis of overall improvements
in symptomatology,
micturition diary
variables and urodynamic
parameters, tolterodine
is considered an effective
treatment for overactive
bladder. At present,
however, there is
no consensus on the
definition of cure
for this condition,
but it is generally
believed that “cure”
should not focus on
“dryness” alone but
on other symptoms
as well. In this study,
the therapeutic effect
of tolterodine on
arbitrarily defined,
but clinically relevant,
“cure” rates for the
various symptoms of
overactive bladder
was evaluated.
Methods:
This was a flexible-dose,
16‑week study
in 1380 patients (average
age 61 years;
80% women) with symptoms
of urinary urgency
and frequency, with
or without urge incontinence.
The study population
was heterogeneous,
and comprised treatment-naïve
patients and those
with previous experience
of other antimuscarinic
agents. The starting
dosage of tolterodine
was 1 mg twice
daily (BID), which
could be increased
to 2 mg BID, and subsequently
decreased to 1 mg
BID, based on the
balance of efficacy
and tolerability.
Dosage adjustment
was at the discretion
of the physician;
patients were blinded
to dosage adjustments
throughout. Micturition
diaries were collected
for 72 hours at baseline
and after 4, 8 and
16 weeks’ treatment.
Patient assessments
of urinary urgency
were also determined
at these timepoints
on a 3‑point
rating scale (not
able to hold urine;
able to hold urine
until toilet visit;
able to finish tasks
before toilet visit).
Results:
Three dosing patterns
emerged: patients
who remained on 1 mg
BID throughout (19%);
patients who escalated
to and remained on
2 mg BID (76%);
and patients who oscillated
between the two dosages
(5%). Results are
presented for all
patients combined.
The definition of “cure” for the different outcomes is shown in the Table.
“Cures” are those
patients who were
within the normal
threshold at the end
of the study.
Definition
|
Symptom
|
Baseline
|
Week 16
|
“Cure” rate (%)
|
|
Micturitions/24h
Incontinence episodes/24h
Nocturia
Pad usage/24h
|
³8
>0
>2
>0
|
<8
0
£2
0
|
22*
43*
55*
28*
|
*p<0.0001.
Figure 1 shows that
the cure rate for
incontinence increased
with treatment duration,
as did the percentage
of patients who no
longer required pad
protection. In terms
of urinary urgency,
Figure 2 shows
that the percentage
of patients not able
to hold urine at all
(upon experiencing
the need to void)
also changed with
treatment duration,
but appears to have
reached maximum effect
by 8 weeks.
Figure 1. Cure rates.
Figure 2. Urgency (percentage of patients
not able to
hold urine at all).
*p<0.0001.
Conclusions:
Using arbitrarily
defined criteria of
cure, in this study
of a heterogeneous
population typical
of that observed in
routine practice,
one quarter to one
half of patients treated
with tolterodine achieved
“cure” of various
overactive bladder
symptoms.
This study was supported by Pharmacia & Upjohn.
