Female Genital Prolapse
Conditions
Keywords
Female, Prolapse surgery with transvaginal mesh, Subjective outcome
Brief summary
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.
Detailed description
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.
Interventions
DEVICETransvaginal posterior mesh
A trocar-free fixation system with low-weight mesh
Sponsors
Oulu University Hospital
Helsinki University Central Hospital
Tampere University Hospital
Turku University Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
30 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
* patients with symptomatic posterior vaginal wall with or without apical prolapse with stage II or more
Exclusion criteria
* concomitant surgery, immunosuppressive treatment of any kind, previous or forthcoming bowel operation with low anastomosis creation and previous vaginal radiation therapy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of participants with adverse events as a measure of safety and tolerability | up to 1 year |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| POP-Q measurement | preoperatively, 3 months and 1 year | Objective results of the operation (vaginal anatomy) |
| Pelvic floor distress inventory (PFDI-20) | preoperatively, 3 months and 1 year | Subjective outcome of the operation on pelvic floor symptoms |
| Pelvic organ prolapse/urinary incontinence sexual questionnaire (PISQ-12) | preoperatively, 3 months and 1 year | Subjective outcome of the operation on sexual functioning |
Countries
Finland
Outcome results
None listed