CRD summary

The review concluded that consistent positive findings across multiple clinical trials suggested that in women with lower urinary tract symptoms (particularly those with voiding dysfunction) tamsulosin may be an effective and safe treatment option. The authors’ conclusions reflect the evidence presented but limitations in the evidence base make the reliability of the conclusions uncertain.

Authors' objectives

To evaluate the effectiveness of tamsulosin for lower urinary tract symptoms in women.

Searching

MEDLINE and EMBASE databases were searched to May 2012 for articles in English. Search terms were reported. Reference lists of retrieved articles were searched manually.

Study selection

Clinical trials that evaluated tamsulosin for the treatment of lower urinary tract symptoms in women were eligible for inclusion. Trials in patients with neurogenic bladder, structural bladder obstruction, overactive bladder or mixed incontinence were excluded. Trials that evaluated combination therapies were excluded.

Tamsulosin doses in the included studies ranged from 0.2 to 0.4 mg/day (where reported). Only two studies reported comparators: prazosin (1 to 2 mg/day) and placebo. Outcomes reported included International Prostate Symptom Score (IPSS), American Urological Association Symptom Score (AUASS), symptom improvement and sleep quality. Included patients had moderate to severe lower urinary tract symptoms (IPSS≥8), functional bladder neck obstruction, voiding symptoms and nocturia. Intervention durations ranged from two weeks to three months.

The authors did not report how many reviewers selected studies for inclusion.

Assessment of study quality

The authors did not assess study quality.

Data extraction

The authors did not report how data were extracted or how many reviewers extracted data.

Methods of synthesis

Studies were described in a narrative synthesis.

Results of the review

Seven studies (745 participants, range 18 to 296) were included in the review: two randomised controlled trials and five single group open label trials. One study was described as double-blind. Five trials were full publications and two were abstracts.

All trials showed statistically significant improvement with tamsulosin in female lower urinary tract symptoms (especially in women with predominant voiding dysfunction) as well as improvements in quality of life and sleep quality.

Adverse events, where reported, included dizziness and asthenia, stress incontinence and urgency, fatigue, drowsiness and hypotension. The prazosin group reported dizziness, orthostatic hypotension, headache and blurred vision.

Authors' conclusions

Consistent positive findings across multiple clinical trials suggested that in women with lower urinary tract symptoms (particularly those with voiding dysfunction) tamsulosin may be an effective and safe treatment option.

CRD commentary

The review question was clear and inclusion criteria were broadly defined. Outcomes were not defined. Relevant sources were searched but the limitation to studies in English meant that some data may have been missed. It was unclear whether any efforts were made to locate unpublished studies. The authors did not report whether they used methods to reduce reviewer error or bias throughout the review process. Study quality was not assessed so the reliability of the findings was unclear. Most of the included studies were single groups with no comparisons and these are liable to multiple biases. Effect sizes were not reported and this made interpretation of the results difficult. A narrative synthesis appears appropriate given the variation in the studies in terms of study design, intervention dosage, comparators, outcomes and follow-up. The findings were derived from only a few studies and sample sizes were small.

The authors’ conclusion and recommendations for practice reflect the evidence presented but the limited quality of the evidence derived from a few varied studies with small sample sizes makes the reliability of the conclusions uncertain.

Implications of the review for practice and research

Practice: The authors stated that several limitations of the present evidence must be addressed in future trials before tamsulosin should be widely used for treatment of lower urinary tract symptoms in women.

Research: The authors stated a need for a large randomised placebo-controlled trial to compare tamsulosin to placebo in female patients with voiding dysfunction. Future trials should also utilize 0.4 mg daily to minimise risk of under-dosing and to be comparable with studies that used tamsulosin for benign prostatic hyperplasia. Future studies should include longer follow-up.

Funding

Not stated.

Bibliographic details

Meyer LE, Brown JN. Tamsulosin for voiding dysfunction in women. International Urology and Nephrology 2012; 44(6): 1649-1656. [PubMed: 22983886]

Original Paper URL

http://link.springer.com/article/10.1007%2Fs11255-012-0275-0

Indexing Status

Subject indexing assigned by NLM

MeSH

Adrenergic alpha-1 Receptor Antagonists /therapeutic use; Female; Humans; Lower Urinary Tract Symptoms /drug therapy; Sulfonamides /therapeutic use; Urination Disorders /drug therapy

AccessionNumber

12013027972

Database entry date

31/10/2013

Record Status

This is a critical abstract of a systematic review that meets the criteria for inclusion on DARE. Each critical abstract contains a brief summary of the review methods, results and conclusions followed by a detailed critical assessment on the reliability of the review and the conclusions drawn.