Pelvic Organ Prolapse
Conditions
Brief summary
This randomized controlled study is designed to test the non inferiority of no attachment of posterior mesh compared to fixation of posterior mesh to the vagina in laparoscopic sacral colpopexy in terms of anatomical correction of the prolapse, post-operative and long term morbidity and rate of recurrence.
Interventions
PROCEDURElaparoscopic sacral colpopexy with posterior mesh no attachment
pelvic organ prolapse correction with laparoscopic sacralcolpopexy with no attachement of posterior mesh
PROCEDURElaparoscopic sacral colpopexy with posterior mesh attachment
pelvic organ prolapse correction with laparoscopic sacralcolpopexy with the attachement of posterior mesh to vagina
Sponsors
Miulli General Hospital
Catholic University of the Sacred Heart
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
FEMALE
Age
No minimum to 75 Years
Healthy volunteers
No
Inclusion criteria
-patients who required surgical treatment for symptomatic pelvic organ prolapse stage ≥ 2 with or without stress urinary incontinence
Exclusion criteria
* Age \> 75 years * Severe cardiovascular or respiratory disease * Pregnancy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| correction of pelvic organ prolapse | 1 year | number of women with correction of prolapse mesured in S POP-Q stage during FU visit |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| rate of recurrence | 1 year | number of women with de novo anterior or posterior or central prolapse |
| long term outcomes | 1 year | number of women with nicturia, dysuria, obstructed defecation , urinary incontinence, pelvic pain |
Countries
Italy
Contacts
Primary ContactMaurizio Guido
Outcome results
None listed