Safety and Efficacy of a Transvaginal Suture Capturing Mesh Device (NCT01823055) | Clinical Trial Compass
CompletedNot Applicable
Safety and Efficacy of a Transvaginal Suture Capturing Mesh Device
214 participantsStarted 2012-01
Plain-language summary
To perform a clinical safety and efficacy assessment of the Uphold LITE system for pelvic organ prolapse in a prospective multicenter, single cohort study.
Who can participate
Age range18 Years
SexFEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 18 years of age or older and present with primary or recurrent prolapse of the middle vaginal compartment corresponding to stage 2 or higher (according to the Pelvic Organ Prolapse Quantification \[POP-Q\] system)9,
* with or without anterior vaginal wall prolapse, and
* experiences symptoms of vaginal bulging with or without a previous hysterectomy
* being able to provide oral and written informed consent before entering the study.
Exclusion Criteria:
* previous cancer of any pelvic organ,
* systemic glucocorticoid treatment,
* insulin-treated diabetes,
* an inability to participate in study follow-up or to provide informed consent, or
* the need for any concomitant pelvic surgery.
What they're measuring
1
Immediate and delayed complications related to the surgical procedure