A Pilot Study to Investigate the Use of tamsulosin in women with Lower Urinary Tract Symptoms (LUTS)

Anurag K. Das, M.D.1, John McKay2, Caroline Doyle, Ph.D.2, Paul Gagnier, M.D., Ph.D.2.
1Beth Israel Deaconess Medical Center, Boston, MA, USA, 2Boehringer Ingelheim, Ridgefield, CT, USA.

Introduction and Objective: Lower urinary tract symptoms (LUTS) are common in women. Although many women have primarily storage (irritative) symptoms, others have a combination of storage and voiding (obstructive) symptoms without having a defined mechanical obstruction. Anti-muscarinic drugs are commonly used to treat women with LUTS whether they have primarily storage or storage and voiding symptoms. It is doubtful that anti-muscarinics improve voiding symptoms, and may actually worsen such symptoms. Alpha-blockers may help in women with LUTS if the predominant symptoms are voiding related. This may be due to bladder neck relaxation as has been shown in children or due to other not yet well-defined mechanisms. Tamsulosin, an alpha 1 a,d subtype selective alpha blocker with minimal side-effects and an excellent safety profile, has anecdotally been noted to improve such symptoms in women. At the time of this study, no validated female LUTS questionnaires were available, and thus the American Urological Association symptom index was used as it best divided symptoms between storage and voiding. This randomized, double-blinded, placebo-controlled study compared the symptomatic improvement afforded by tamsulosin vs. placebo in female LUTS with a significant component of voiding symptoms.
Methods: Women with an AUA total symptom score > 13, AUA Obstructive score > 5, were randomized into a double blind, placebo- controlled trial of eight weeks duration. Patients were randomized to tamsulosin 0.4mg or placebo once daily. The AUA symptom index was the primary measure of efficacy. The Incontinence Impact Questionnaire and Urinary Distress Inventory Questionnaire were secondary endpoints.
Results

Total AUA Symptom Score and Change From Baseline
AUA symptom scorePlaceboTamsulosin 0.4 mgAUA symptom scorePlaceboTamsulosin 0.4 mg
All Patients (13-35)N=33N=37Severe (20-35)N=15N=21
Baseline19.920.4Baseline24.024.6
Change From Baseline-4.0-5.2Change From Baseline-2.8-8.7*
*P=0.017 (tamsulosin 0.4mg versus placebo)

Tamsulosin was well tolerated.
Conclusions: Evaluating all patients, the change from baseline in AUA score was in favor of tamsulosin but did not reach statistical significance compared to placebo. However, the subset of patients with a total AUA score > 20 showed a statistically significant improvement from tamsulosin treatment. Considering the relatively small number of patients, the improvement appears clinically significant. However, these results must be confirmed in a trial designed to specifically look at this patient population as the primary prespecified analysis.
Allowed Count: 2,280
Current Count: 1,965

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