A PROSPECTIVE RANDOMIZED STUDY OF TOLTERODINE AND DOXAZOSIN
MONOTHERAPY AS THE FIRST LINE TREATMENT OF MALE LOWER URINARY TRACT
SYMPTOMS WITH PREDOMINANT STORAGE SYMPTOMS BASED ON IPSS VOIDING TO
STORAGE SUBSCORE RATIO

Hypothesis / aims of study
Antimuscarinics appear to be an effective and safe alternative treatment for male storage lower urinary tract symptoms (LUTS).
However, whether antimuscarinics is better than alpha-blocker for men with predominant storage symptoms is still not
determined. We conducted a prospective randomized study to compare the therapeutic effect between antimuscarinics and α-
blockers monotherapy as the first-line treatment for men with predominant storage symptoms based on International Prostate
Symptom Score (IPSS) voiding to storage subscore ratio (IPSS-V/S).

Study design, materials and methods
Men aged 40 years and older with total IPSS (IPSS-T)≧8, IPSS-V/S≦1 and postvoid residual urine (PVR) less than 250 ml
were prospective enrolled from June 2011 to December 2011. Patients were randomized assigned to two treatment groups
while tolterodine 4 mg and doxazosin 4 mg were given separately. The primary endpoint was Patient Perception of Bladder
Condition (PPBC) at1 month. A PPBC change of 2 scores after treatment was considered as effective treatment. Patients who
failed the initial treatment were shifted to treatment with the other test drug.

Results
One-hundred and thirty-one patients were prospectively enrolled. The baseline parameters were similar between doxazosin and
tolterodine group (Table 1). After medical treatment for 1 month, IPSS storage subscore (IPSS-S) and quality of life (QoL)
decreased significantly in both groups. But significant increased maximal flow rate (Qmax) and decreased IPSS-T were noted
only in patients receiving doxazosin. No patient treated with tolterodine developed urinary retention, but significantly increased
PVR (from 55.5 to 83.3 ml) was noted after tolterodine monotherapy (Table 2). Four patients receiving doxazosin complained
dizziness while only 1 patient receiving tolterodine complained dysuria. Twenty-sixty of 37 patients (73%) receiving doxazosin
and 27 of 38 patients (71%) receiving tolterodine reported an improved outcome. The success rate is higher in patients
receiving tolterodine (79%) than those receiving doxazosin (45%) when patients with total prostate volume (TPV) less than 40
ml were analyzes (p=0.087) (Table 3).

Interpretation of results
Male LUTS may be due to bladder or bladder outlet disorders. Treatment of male LUTS based on IPSS V/S subscore ratio
provides an easy way for the first line monotherapy. This study show either doxazosin or tolterodine treatment can have a
success rate of >70% in overall patients with IPSS V/S≦1, suggesting that the male LUTS can be generated from different
lower urinary tract disorders. Although the data did not reach a statistical significance, we found the trend that when TPV≧40ml
more patients had a successful doxazosin treatment outcome. On the other hand, when patients had TPV<40 ml, treatment with
tolterodine provided a higher success rate. If the number of studied patients increased, the difference of success rates between
patients with large and small TPV will become more evident.

Concluding message
Both doxazosin and tolterodine can improve storage symptoms and quality of life in male patients with predominant storage
symptoms. In overall patients, there was no significant advantage of tolterodine monotherapy over doxazosin monotherapy.
However, patients received tolterodine monotherapy had higher rate of improved outcome than those received doxazosin
monotherpay when their TPV were less than 40 ml.

相关研究：托特罗定治疗残余尿＜40ml者疗效更优