Randomized Study Comparing Surgical Treatments for Vulvovaginal Gaping Plication of Puborectalis Muscles Versus Perineorrhaphy ± Transverse Myorrhaphy

What this Trial Is About

Researchers are studying vulvovaginal incompetence, a condition often linked with prolapse that leads to issues like vesicourethral and rectoanal dysfunction, as well as sexual discomfort due to physical and psychological trauma. This trial compares two surgical methods to reconstruct vulvovaginal anatomy and address symptoms such as vaginal laxity and loss of sensitivity. The study aims to evaluate the effectiveness of these approaches over a 12-month period. The trial compares two surgical treatments: anatomical reconstruction through sagittal plication of the puborectalis muscles and reconstruction by perineorrhaphy with or without transverse myorrhaphy of the puborectalis muscles. These procedures aim to restore normal anatomy and improve symptoms of vulvovaginal incompetence. Both approaches are being assessed to determine which better restores vaginal structure and function. Participants will undergo surgical treatment and be monitored over 12 months to assess outcomes. Researchers will use MRI scans to examine the genital hiatus and questionnaires to evaluate sexual quality of life, anal incontinence, and constipation. The main measure is the anatomical effectiveness of the vulvovaginal reconstruction at 12 months. The study involves regular assessments to track anatomical and functional improvements and any related symptoms.

Randomized Study Evaluating the Treatment of Vulvovaginal Gaping by Plication of the Puborectalis Muscles Versus Perineorrhaphy ± Transverse Myorrhaphy of the Puborectalis Muscles at 12 Months. (HERA)