Texas Children’s Pediatric and Adolescent Gynecology Division was recently awarded an NIH Small Business Innovation Research grant via Biotex Inc. to develop vaginal stents that will help vaginal reconstructive patients heal.
The most common complication after vaginal reconstruction is restenosis and scar tissue formation, which can occur in up to 73 percent of patients. As many as 50,000 girls a year and 213,000 women could benefit from postoperative treatment using newly designed vaginal stents.
There currently are no vaginal stents on the market for the pediatric population, forcing physicians to use makeshift devices fashioned from surgical gloves or other materials. “Therefore, there is a tremendous need to help these patients and their physicians with a simple device that can truly improve their quality of life beyond even the surgery,” said Texas Children’s pediatric and adolescent gynecologist Dr. Julie Hakim.
“In creating the first vaginal stent specifically designed to address the anatomic needs of the pediatric and adolescent populations, we aim to reduce early discontinuation of stent postoperatively and improve postsurgical outcomes,” she said.
Phase I testing is ongoing and submission for a grant for a Phase II clinical trial is anticipated to occur in April.