Women with stress urinary incontinence reported more satisfaction with long-term outcomes when treated with a tension-free vaginal tape (TVT) procedure than bulking therapy with transurethral polyacrylamide hydrogel (PAHG) injection, according to extended follow-up from a randomized trial.

At 5 years, the median satisfaction score was a near-perfect 98 in the TVT group and 90 in the PAHG group on the 100-point visual analog scale, with 92.7% and 74.7%, respectively, having patient satisfaction scores of 80 or more — a difference of 18.0 percentage points (95% CI 7.7-28.0).

“Thus, PAHG did not reach the noninferiority criteria set in our randomized trial,” Tomi Mikkola, MD, of the Helsinki University Hospital in Finland, and colleagues wrote in NEJM Evidence. However, “the VAS satisfaction median in both treatment groups was high, indicating that both treatments provided high long-term patient satisfaction.”

Moreover, although PAHG was not objectively as effective as TVT, “most women treated with PAHG considered themselves cured or improved and did not request further invasive treatment,” the researchers observed.

Specifically, an objective cure as measured by a negative cough stress and pad stress test occurred in 65.6% of the TVT group and 47.5% of the PAHG group. Subjectively, 96.9% and 85.9%, respectively, considered themselves cured or improved.

“The long-term efficacy of the tension-free vaginal tape procedure has been widely documented, and our current data support this,” the authors wrote. “For PAHG and other bulking agents, the common perception is that the effect deteriorates over time, resulting in inadequate cure and subjective satisfaction. In our trial, however, the high subjective cure rate with PAHG was sustained, as 86% of women still considered themselves cured or improved at 5 years compared with 92% at 1 year and 89% at 3 years.”

In explaining the rationale behind the trial, Mikkola and colleagues pointed out that while midurethral sling surgery with retropubic TVT has been a common surgical procedure for stress urinary incontinence, there have been long-term safety concerns. On the other hand, they noted that bulking agents like PAHG are a minimally invasive alternative but with efficacy believed to decrease over time, resulting in unknown long-term patient satisfaction, safety, and efficacy.

Their study included 195 women who attended the follow-up visit at 5 years out of the 223 originally randomized to treatment in the noninferiority trial. Both the PAHG or TVT procedures were performed in an outpatient setting. Women were eligible if they had stress urinary incontinence not responding to conservative treatment with pelvic floor muscle therapy, a positive cough stress test without urge-type leakage, post-void residual volume of less than 100 mL, and a bladder capacity over 300 mL. They could not have had a previous procedure for incontinence.

As a part of the protocol after the initial PAHG treatment, women were offered an additional “top-up” PAHG injection, which was carried out at the 3-month visit for patients who described persisting stress urinary incontinence symptoms. Patients with persisting stress urinary incontinence who were not satisfied with the given treatment could choose the alternative treatment at any of the follow-up visits.

In a per protocol analysis, the median satisfaction score was 99 in the TVT group and 88 in the PAHG group, with 92.4% and 71% of women having a visual analog scale patient satisfaction score of 80 or more, respectively. Most women (96.7% treated with TVT and 87.1% with PAHG) considered themselves subjectively cured or improved, while objective cure as measured by a negative cough stress and pad test was reached in 67.4% and 40.3% of the two groups, respectively.

Regarding safety, perioperative or postoperative complication rates within the 5-year follow-up period were 43.8% in the TVT group and 22.2% in the PAHG group before crossovers.

While the trial included only white women, the researchers noted that the “trial population represents a nonselected group of women who did not achieve success with conservative treatment by general practitioners in primary healthcare.”

Please enable JavaScript to view the

comments powered by Disqus.