Pelvic Organ Prolapse
Conditions
Brief summary
This randomized controlled study is designed to test absorbable suture compared to non absorbable suture in laparoscopic sacral colpopexy in terms of anatomical correction of the prolapse, post-operative and long term morbidity, rate of recurrence, subjective satisfaction of the patient and rate of mesh erosion.
Interventions
PROCEDURElaparoscopic sacral colpopexy with absorbable suture
laparoscopic sacral colpopexy to correct pelvic organ prolapse with anterior and posterior meshes with absorbable suture
PROCEDURElaparoscopic sacral colpopexy with non absorbable suture
laparoscopic sacral colpopexy to correct pelvic organ prolapse with anterior and posterior meshes with non absorbable suture
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
40 Years 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 |
|---|---|---|
| Number of patients with anatomical correction of the prolapse | 1 year | Anatomical correction of the prolapse evaluated by gynecological visit |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| rate mesh erosion | 1 year | — |
| long term outcomes | 1 year | development of nicturia, dysuria, obstructed defecation , urinary incontinence |
| Rate of recurrence | 1 year | de novo anterior or central or posterior compartment prolapse |
Countries
Italy
Outcome results
None listed