Stress urinary incontinence surgery outcomes accurately assessed by questionnaire
Single-item survey is easy to administer, correlates with other measures
San Francisco—A simple, one-item questionnaire is easy to administer, correlates with other widely used subjective and objective measures, and can be used as an outcome measure to evaluate surgery for stress urinary incontinence (SUI), researchers suggested at the AUA annual meeting here.
The Patient Global Impression of Improvement (PGI-I) can be reasonably used as a universal questionnaire to assess success and failure of SUI surgical procedures, said first author Sagar Shah, MD, a fellow in female pelvic medicine and reconstructive surgery at New York University, working with Victor Nitti, MD, and colleagues.
Dr. Shah and colleagues feel the PGI-I can provide some uniformity in reporting outcomes of different treatment modalities.
"To date, there really is no standardization in the reporting of outcomes of SUI surgery," Dr. Shah said. "Many studies report various objective measures and some report subjective measures. But right now, there are no universally utilized or accepted criteria. This makes comparing outcomes among treatments very difficult."
The PGI-I asks patients to rate their impression of their condition following treatment. Possible answers are "very much better," "much better," "a little better," "no change," "a little worse," "much worse," and "very much worse." Numerical scoring ranges from 1 for "very much better" to 7 for "very much worse."
"PGI-I has already been shown to correlate with objective measures of outcome for SUI surgery such as the 24-hour pad test, and with other questionnaires like the Incontinence Questionnaire–Short Form (ICIQ-SF) in studies evaluating it with duloxetine and the male perineal sling," said Dr. Shah. "But to date, it had not been examined in surgical treatment of female SUI."
Dr. Shah's team prospectively evaluated a group of women undergoing SUI surgery with a TVT-O sling without any other concomitant surgery. Patients were asked to complete these validated questionnaires both preoperatively and at least 3 months postoperatively:
Patients also completed the PGI-I postoperatively. Their subjective assessment of success and objective assessment from physical exam were recorded and compared. They were then separated into groups based on success or failure, and their PGI-I scores were compared.
After excluding those patients with missing preoperative or postoperative data, the researchers had a cohort of 72 women (mean age, 58.43±12.8 years). Mean follow-up was 10.42 months (range, 3 to 38 months). Overall rates of subjective and objective cure were 77.8% and 93.1%, respectively.
Score differs in those with subjective cure
PGI-I score was found to be significantly different in those with subjective cure (1.46±.114) compared with those with residual subjective SUI (2.63±.272, p=.001). It approached statistical significance in those women with (1.63±.114) and without (2.67±.667) objective cure (p=.0666).
"If objective cure alone equated with success, then a significant difference in PGI-I should have been seen in the objectively 'cured' versus those not cured," the authors wrote. "But this was not the case."
About 15% (10 of 67) of objectively "cured" patients had a PGI-I score >2, which equates to failure. Of those 10, seven reported urge incontinence and three did not mention any subjective SUI, though the latter group had urgency or what the authors termed "unaware" or "insensible" incontinence.
Dr. Shah said he and his colleagues chose the TVT-O procedure for their analysis simply because it's the most common surgery they perform for SUI.
"We would anticipate results to be similar in other types of SUI surgery, since PGI-I has already been evaluated previously with medical SUI treatment in women and in males undergoing surgical SUI treatment with a sling," Dr. Shah said.
Dr. Nitti is a consultant/adviser for Ethicon Women's Health & Urology.