Uterine prolapse
Conditions
Interventions
This is an open protocol randomized clinical trial. Experimental Group: 12 women with grade III or IV uterine prolapse will undergo vaginal hysterectomy with vaginal apex fixation using Splentis TM. C
and application of the Prolapse Quality of life Questionnaire (P-QoL) and Genital Self-Image Scale (GSIS-20) at the following times: preoperative, 6 and 12 months. All surgeries will be performed by u
E04.950.300.399.380
Sponsors
Faculdade de Medicina do ABC
Faculdade de Medicina do ABC
Eligibility
Sex/Gender
Female
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Women at least 18 years old; with uterine prolapse grades III or IV; women wanting hysterectomy
Exclusion criteria
Exclusion criteria: History of thrombosis or thromboembolic disorders; chronic kidney or liver disease; cerebrovascular accident or transient ischemic attack; endometrial hyperplasia; rheumatological diseases; low- or high-grade squamous intraepithelial lesions of the cervix, vagina, or vulva; untreated genitourinary infection
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Expected outcome 1: we hope to find anatomical correction of point C in 12 months, which will be defined as any measurement above the hymenial caruncle 12 months post-operatively.;Found Outcome 1: Evaluation of point C showed a statistically significant difference in prolapse between times 0 and 6 months (p<0.001), and 0 and 12 months (p<;0.001), but no statistically significant difference between the mesh and no mesh groups at any of the times studied. | — |
Secondary
| Measure | Time frame |
|---|---|
| Expected outcome 2: improvement in the P-QoL questionnaire score after 6 and 12 months, which will be quantified as any decrease in the score from 0 to 100 at 6 and 12 months postoperatively compared to the preoperative score;Found Outcome 2: P-QOL assessment: statistically significant improvement according to the statistical method used only in the items "sexual health"; "limitation of function"; "physical limitation" and "social limitation". There was also a reduction in the post-operative values for the other items, but the method was unable to identify the statistical difference.;Expected outcome 3: improvement in the GSIS-20 questionnaire score after 6 and 12 months, which will be quantified as any increase in the score from 0 to 40 at 6 and 12 months postoperatively compared to the preoperative score.;Found Outcome 3: GSIS assessment: increased scores when comparing 0 and 6 months, and 0 and 12 months (p<;0.001), with no difference between the screened and non-screened groups at the three time points: 0, 6 and 12 months (p=0.654). ;Expected outcome 4: Description of postoperative complications, at 7 days, and1, 6 and 12 months.;Found Outcome 4: Postoperative (PO) 7 days: 1 patient required a blood transfusion of 2 red blood cell concentrates, 1 patient complained of urgeincontinence, which had already been reported preoperatively, and 1 patient required admission to the intensive care unit (ICU) due to hypertensive peaks, all from the no mesh group. PO 30 days: 1 death from bronchopneumonia in a 78-year-old patient who was on no mesh group and had no surgical complications. PO 6 months: 4 vaginal mesh extrusions in the HV group with SPLENTIS™ (33%); 2 prolapse recurrences in the group without mesh. PO12 months 1 recurrence in the no mesh group | — |
Countries
Brazil
Contacts
Public ContactHeloá Rondinelli
Faculdade de Medicina do ABC
Outcome results
None listed