Related Experiment Video
Updated: Jul 2, 2026
Transvaginal Mesh Insertion in the Ovine Model
Published on: July 27, 2017
Device for occlusion of rectovaginal fistula: clinical trials
Purpose:
To evaluate a device designed for occlusion of rectovaginal fistula in patients with acquired rectovaginal fistula.
Materials And Methods:
The device consisted of a disk portion, an anchoring portion, and a shaft that connected each portion. The device was framed with a nitinol wire. The disk portion was framed in a four-leaf clover configuration, and the anchoring portion had two ellipsoid arms. The disk and anchoring portions were mounted with a nylon patch and coated with silicone. The device was designed for transrectal insertion and was placed in seven women with rectovaginal fistula caused by pelvic irradiation or pelvic surgery.
Results:
All devices were placed successfully, and all fistulas were completely occluded after placement of the device. No procedural complications were encountered. The follow-up period was 1-26 months. One patient died of distant metastasis 5 months after placement of the device. None of the patients reported leakage from the rectovaginal fistula during the follow-up period.
Conclusion:
The occlusion device may be promising and beneficial for use in occlusion of rectovaginal fistula that results from pelvic irradiation or pelvic surgery.
