Female Genital Prolapse Clinical Trial
Official title:
Single Incision Transvaginal Mesh (Elevate® Posterior) in Treatment of Posterior Vaginal Wall Prolapse Without Concurrent Surgery - National Prospective Multicenter Study
Definition: To find out complications, objective and subjective outcomes of patients with symptomatic posterior vaginal wall prolapse undergoing posterior mesh operation in nine Finnish hospitals during September 2010 and August 2013. The study hypothesis is that complications are acceptable and both objective and subjective outcomes are satisfying.
The aim of this study is to investigate the safety and efficacy of Elevate®Posterior
transvaginal mesh kit. Secondly the investigators want to evaluate the effect of this
surgical method on non-affected anterior vaginal compartment as well as patients' outcome.
This prospective multicenter national study include patients (n=111) with symptomatic
posterior vaginal wall with or without apical prolapse with stage II or more. Patients were
recruited at four university hospitals and five central hospitals in Finland between
September 2010 and August 2013. The study protocol was approved by the Ethics Committees in
participating hospitals and all attending patients gave written consent after oral and
written counseling. Baseline evaluation include standardized gynecological examination in
supine position using the POP-Q system. Detailed information on patients' characteristics
and medical history is gathered, focusing on especially gynecological issues. Patients fill
in Pelvic Floor Distress Inventory (PFDI-20) and Pelvic organ prolapse/urinary Incontinence
Sexual Questionnaire (PISQ-12).
The operations are performed by qualified surgeons (n=9) familiar with transvaginal mesh
surgery. Intraoperative data is collected and immediate postoperative problems are
registered.
The first follow-up visit take place at three months postoperatively. Gynecological
examination with POP-Q measurements are performed and complications documented. As
preoperatively, PFDI-20 and PISQ-12 questionnaires are filled in by the patients.
The second visit take place at one year postoperatively. Gynecological examination with
POP-Q measurements are performed and possible late complications documented. PFDI-20 and
PISQ-12 questionnaires are filled in again by the patients.
;
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment