By Crystal Phend, Senior Staff Writer, MedPage Today
Published: May 02, 2012
Reviewed by Robert Jasmer, MD; Associate Clinical Professor of Medicine, University of California, San Francisco.Take Posttest
For uncomplicated stress urinary incontinence, preoperative urodynamic testing doesn’t add much to the basic office evaluation, a clinical trial determined.
The specific dysfunctions diagnosed changed somewhat with further physiologic testing, but those changes didn’t significantly alter treatment selection or outcomes, Charles W. Nager, MD, of the the University of California San Diego, and colleagues found.
Surgical treatment wasn’t any less successful after clinical exam diagnosis alone than with urodynamic testing, with success rates of 77.2% versus 76.9%, the group reported online in the New England Journal of Medicine.
“Our findings suggest that for women with uncomplicated stress urinary incontinence, a basic office evaluation as described in this report (i.e., a positive result on a provocative stress test, a normal postvoiding residual volume, an assessment of urethral mobility, and confirmation of the absence of bladder infection) is a sufficient preoperative workup,” they wrote.
That’s good news for women, because the preoperative urodynamic assessment is uncomfortable, expensive (more than $500 for the three-part study under Medicare), and raises the risk of urinary tract infection, the group pointed out.
Some professional organizations already recommend against routine urodynamic testing before surgery for clear clinical diagnoses of pure stress urinary incontinence, although that represents only a fraction of women typically seen in clinical practice.
The trial results expand this recommendation more broadly to women with mixed urinary incontinence symptoms as long as stress symptoms predominate over urgency symptoms, Nager’s group pointed out.
Their multicenter Value of Urodynamic Evaluation (VALUE) trial included 630 women with predominantly stress urinary incontinence based on questionnaire responses, clinical assessment, and loss of urine observed with a cough or Valsalva maneuver at any bladder volume.
They were randomized to that standardized office evaluation alone or additional urodynamic testing before their planned surgery.
The additional testing with noninstrumented uroflowmetry, filling cystometry with Valsalva leak-point pressures, and a pressure-flow study confirmed the office exam-based diagnosis for 97% of women.
Women who had urodynamic testing done were more likely to be diagnosed with voiding phase dysfunction and less likely to get a diagnosis of overactive bladder or suspected intrinsic sphincter deficiency than women in the office evaluation-only group.
But these changes in preoperative diagnosis didn’t change the distribution of surgical treatments performed compared with no urodynamic testing:
- Retropubic midurethral sling (64.7% and 64.6%)
- Transobturator midurethral sling (29.0% and 28.1%)
- Mini-sling (2.0% and 1.4%)
- Traditional sling (3.4% and 4.9%)
- Retropubic urethropexy (0.0% and 0.7%)
- Urethral-bulking injection (1.0% and 0.4%)
For some women treated with a midurethral sling urodynamic testing resulted in a change in plans from the retropubic version of the surgery to the transobturator version or vice versa (12 and 6 cases, respectively).
But, the researchers noted, “there were no other major changes in decision making.”
For the primary outcome measure, the difference in the proportion of women achieving treatment success — at least a 70% drop in the Urogenital Distress Inventory score and “much” or “very much” better rating on the Patient Global Impression of Improvement at 12 months — was only 0.3% between groups and met noninferiority criteria.
Nor were there any significant differences between evaluation strategies for secondary endpoints:
- Incontinence Severity Index scores
- Patient Global Impression of Severity scores
- Condition-specific quality of life
- Global quality of life
- Positive provocative stress tests at 12 months
- Patient satisfaction at 12 months
Adverse events likewise didn’t differ with or without urodynamic testing (21.3% versus 19.4%, P=0.55).
The study couldn’t address more complex urinary incontinence cases, such as urge-predominant incontinence, patients with prior surgeries to treat incontinence, neurologic disease, or planned concomitant surgery for pelvic-organ prolapse, Nager’s group cautioned.
Generalizability may have been limited by the greater experience of the treating surgeons, among whom more than 90% were fellowship-trained.
The study was funded by the National Institute of Diabetes and Digestive and Kidney Diseases and the Eunice Kennedy Shriver National Institute of Child Health and Human Development.
Nager reported funds to his institution from the National Institute of Diabetes and Digestive and Kidney Diseases.
Primary source: New England Journal of Medicine
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Article source: http://www.medpagetoday.com/Urology/UrinaryIncontinence/32474