TVT Sling or Hydrogel Injections: Four Five-Year Trial Checks

The Helsinki trial compared TVT-Exact, a tension-free vaginal tape mesh sling, with Bulkamid, hydrogel injected around the urethra. Both were outpatient procedures under local anesthesia.¹

Our bulking procedure guide explains what an injection appointment involves.

Which women were followed?

This unblinded trial randomized 223 women with primary stress incontinence; 212 received their assigned treatment. Clinically significant prolapse and severe obesity were excluded.¹

195 women attended five-year follow-up. The report was published in 2025.²

What did the satisfaction result mean?

At five years, satisfaction reached at least 80 out of 100 in 89 of 96 TVT participants and 74 of 99 hydrogel participants. This measured satisfaction, not cure.²

Hydrogel’s satisfaction rate was 18 percentage points lower (95% confidence interval 7.7–28). The trial could not establish that hydrogel was no more than 20 percentage points worse, its prespecified noninferiority margin.²

For a consultation, ask what result matters to you: no leaks during a cough test, fewer pads, or being satisfied with improvement despite occasional leakage.

Did the pathway include another procedure?

By three years, of 96 participants originally assigned hydrogel who attended follow-up, 31 had received only one injection without later TVT; 30 had crossed over to TVT. The protocol allowed additional treatment, and the main analysis retained original treatment groups despite crossover. These are three-year treatment paths, not five-year repeat-treatment rates.¹

Ask whether a quoted success rate includes additional injections or later surgery.

What counted as a complication?

Before crossover, complications over five years were recorded in 42 of 96 TVT participants versus 22 of 99 hydrogel participants. These totals are not rates of serious complications or mesh removal.²

The three-year report counted infections, urinary retention and complications requiring reoperation. Its funders were Helsinki University Hospital and Contura, the hydrogel manufacturer, with no influence on the research or report declared.¹

Discuss permanence and the follow-up plan

NICE³ guidance for England, published in 2019, says bulking materials are permanent, repeat injections may be needed and effects can wear off. A retropubic mesh sling is also permanent, and complete removal may not be possible. It recommends discussing other surgical choices and giving written implant or injection details.³

Ask: “What would you offer if this does not control my leaks, and how would that change my recovery and costs?” Our bulking follow-up questions help prepare that conversation.

The Surgery for leaks with effort section of Laugh, Sneeze, Jump explains sling approaches and bulking alternatives to discuss with a specialist.