Intrauterine Stent for Uterine Abnormalities

This trial aims to find the best way to prevent scar tissue inside the uterus after surgery to repair a uterine septum (a wall of tissue that divides the uterus). Researchers are testing whether placing a small balloon inside the uterus after surgery can prevent scar tissue formation. Participants will either have the balloon placed or not after their surgery. Women scheduled for a specific type of uterine surgery to remove a septum, with at least half of their uterus affected, might be suitable for this trial. As an unphased trial, this study allows participants to contribute to innovative research that could enhance surgical outcomes for future patients.

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Research has shown that intrauterine stents, like the one being studied, are generally safe. For instance, one study found that a similar device, the Jada device, successfully controlled bleeding in 94% of cases, indicating it is well-tolerated. Another study examined an intrauterine balloon stent and found it to be safe, although some participants experienced infections. About one-third of the balloon stent group had positive microorganism cultures, meaning some bacteria were found, but they were not necessarily harmful.

Researchers are excited about the intrauterine stent technique for uterine abnormalities because it offers a novel approach compared to standard treatments like hormonal therapy and surgical interventions. Unlike existing options, this method involves the placement of an inflated intrauterine pediatric Foley catheter, which stays in place for 7-10 days post-surgery. This mechanical approach may provide physical support and potentially improve surgical outcomes without relying solely on hormone-based therapies. By providing a new delivery method, this technique could offer a quicker and more localized solution, reducing the reliance on systemic treatments.

Research has shown that using an intrauterine stent, similar to a small tube, can help prevent internal scar tissue after surgery. In this trial, one group of participants will receive an intraoperative placement of an inflated intrauterine pediatric Foley catheter, a type of stent, which will remain in place for 7-10 days post-surgery. Studies indicate that placing a stent can effectively reduce the risk of scar tissue recurrence and help restore the uterus's shape. One study found that the chances of ongoing pregnancy were similar between those using a balloon and those using an intrauterine device (IUD), suggesting the balloon is as effective as other methods. Another study found that using a stent is effective and easy for treating mild-to-moderate internal scar tissue. Overall, these findings suggest that intrauterine stents may help reduce scar tissue after surgery.²⁶⁷⁸⁹