Cystocele, Enterocele, Rectocele, Uterine Prolapse, Vaginal Vault Prolapse
Conditions
Keywords
sacrocolpopexy, meshes, sacrospinous ligament
Brief summary
Pelvic prolapse is one of the most frequent pathology in Gynecology. Recurrency of the prolapse after primary surgery is relatively high, 15-30%. Sacrocolpopexy has showed to be effective but it requires a long learning curves and is more aggressive. New meshes techniques seem to be effective, as well, with less learning curve but they are expensive and there are no randomize studies published. The investigators aim is to compare both techniques in terms of: anatomical and functional efficacy, cost, operating time and complications.
Interventions
DEVICEElevate mesh
The correction of the prolapse can be made by this new technique.
DEVICESacrocolpopexy
Attach a mesh between the vagina and the promontorium.
Sponsors
American Medical Systems
Francisco Carmona
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
21 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Subject has been diagnosed with one or more clinically significant anterior, apical, or posterior genital prolapse disorder(s)(symptomatic POP-Q stage II or higher) requiring surgical repair.
Exclusion criteria
* Investigator determines subject is not a candidate for surgical repair of her genital prolapse. * Subject has had a prior prolapse procedure involving graft placement (synthetic or biologic) * Subject has active or latent systemic infection or signs of tissue necrosis. * Subject has restricted leg motion (inability to abduct or adduct leg positioning in the lithotomy position) with or without a hip replacement / prosthesis. * Subject is currently pregnant or intends to become pregnant during the study period. * Subject has had radiation therapy to the pelvic area. * Subject has pelvic cancer, has had pelvic cancer within the past 12 months or has been on cytostatic medication within the past 12 months. * Subject has uncontrolled diabetes. * Subject is on any medication with could result in compromised immune response, such as immune modulators. * Subject has undergone previous pelvic surgery \< 6 months prior to enrollment in this study. * Subject is unwilling or unable to give valid informed consent. * Subject is unwilling or unable to comply with the requirements of the protocol, complete all quality of Life questionnaires and return for all follow-up visits. * Subject with contraindications for laparoscopy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Functional and anatomical efficacy | 1 year |
Secondary
| Measure | Time frame |
|---|---|
| operating time, cost and complications of both techniques | 6 months |
Countries
Spain
Outcome results
None listed