Materials and Methods
Continence, genitourinary infection, blood loss
THROMBOEMBOLIC DISORDER, BLOOD LOSS, PROLAPSE, GENITOURINARY INFECTION, ENDOMETRIAL HYPERPLASIA, SAID, COMPLICATIONS, PROLAPSE, HIGH-GRADE SQUAMOUS INTRAEPITHELIAL LESION, VAGINA
The present prospective and randomized trial was performed at Universidade Federal de São Paulo, Brazil, and it was approved by the Research Ethics Committee of said institution (under CAAE 0833/06; CEP 0833/06 [attached document]) and registered on Clinicaltrials.gov (NCT 01347021). The inclusion criteria were patients with apical POP in stages III or IV, aged between 50 and 90 years, who voluntarily agreed to participate and signed the informed consent form. The exclusion criteria were clinico-surgical contraindications (severe comorbidities), apical POP in stages I and II; previous pelvic radiotherapy or thromboembolic disorders; hormone therapy; endometrial hyperplasia or high-grade squamous intraepithelial lesions of the cervix, vagina, or vulva, or untreated genitourinary infection.
Standard history-taking was performed, as well as a physical examination in the supine and standing positions to stage the POP through the POP-Q according to the recommendations of the International Continence Society (ICS),

Flow diagram of the present study.

Quality of life was assessed preoperatively, 6, and 12 months after the intervention through the version validated for the Portuguese language of the Prolapse Quality of Life (P-QoL) questionnaire,

Anatomical success was evaluated by the positions of the vaginal apex, anterior and posterior compartments after 6 and 12 months of follow-up in the two groups. Data from 12 months of follow-up were used to assess both quality of life and the anatomical outcomes, because of the greater practical applicability of the outcomes. However, the authors consider the follow-up of patients to assess long-term efficacy, which was not the objective of the present study. For the assessment of cure ranges, two specific clinical criteria were used: according to the first criterion, those with the highest prolapse point lower than −1 according to the POP-Q were considered cured (stage I). Then, in the second criterion, patients were regrouped and considered cured when the point of greatest prolapse was ≤ 0, (stage II).

The duration of the surgery (time from the first incision to the completion of the suture) and blood loss (hemoglobin and hematocrit levels) were also analyzed pre- and postoperatively. Complications were described according to the terminology of the International Urogynecological Association (IUGA) and ICS.

The sample size (N) was calculated based on the primary objective of the study. According to the literature review, the authors estimated a minimum of 20 patients in each group, with a difference of 25% between them. The level of rejection of the null hypothesis was set at 0.05 or 5% (α ≤ 0,05) and the power of the sample, at 80%.
