Pelvic organ prolapse
Conditions
Interventions
Control group: 50 patients with moderate or severe genital prolapse who will be treated with the single Richter traditional sacrospinous fixation surgery and followed for 12 months
Case group: 50 pat
Device
Procedure/surgery
Sponsors
Universidade Federal de São Paulo
Universidade Federal de São Paulo
Eligibility
Sex/Gender
Female
Age
50 Years to 80 Years
Inclusion criteria
Inclusion criteria: Women; age between 50 and 80 years; symptomatic cervical or vaginal prolapse greater than stage II; primary or secondary prolapse; with or without associated urinary incontinence
Exclusion criteria
Exclusion criteria: Genitourinary malignant neoplasia; pelvic radiotherapy; clinical diseases that made the surgical procedure unfeasible; collagen diseases; acute infectious disease
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Expected outcome 1: objective cure of surgical techniques characterized by descent of the vagina apex less than one third of the total vaginal length; we expect to confirm that the use of Splentis anchoring system for sacrospinal fixation is not inferior to the traditional technique using a 15% margin ;Observed outcome 1: Objective cure of genital prolapse was obtained in 80% of women who received Splentis and 73% of those who received the traditional technique, confirming the non-inferiority of the experimental technique | — |
Secondary
| Measure | Time frame |
|---|---|
| Expected outcome 2: objective cure of surgical techniques characterized by composite criteria of descent of the vagina apex less than one third of the total vaginal length and no descent of the anterior and posterior vaginal wall up to the vaginal beyond the hymen 12 months after surgeries ;Observed outcome 2: objective cure by composite criteria was observed in 69% of women who received Splentis and 70% of women who received the traditional technique ;Expected outcome 3: improvement in quality of life and sexual function of women assessed through the scores of the P-Qol and PISQ-12 questionnaires 12 months after surgery is expected;Observed outcome 3: both surgical techniques equally improved women's quality of life and sexual function scores after 12 months of follow-up;Expected outcome 4: it is expected to compare surgical techniques with respect to peri and postoperative complications; surgical time; blood loss; urinary dysfunction; dyspareunia; pain; urinary infection; time to return to routine activities ;Outcome 4: We detected significantly shorter intraoperative time to dissect and reach the sacral spinal ligament (15 versus 22 min), shorter hospitalization time (24 versus 48 hs), lower urinary tract infection rates (11% versus 27%), and lower visual analog scale pain scores in the first 30 days postoperatively in patients who received Splentis compared to those who had traditional technique; no differences between surgeries related to other parameters | — |
Countries
Argentina, Brazil, Mexico
Contacts
Public ContactRodrigo Castro
Universidade Federal de São Paulo
Outcome results
None listed