Pelvic organ prolapse: comparison of two surgical techniques for the treatment of uterine prolapse

Not Applicable

Recruiting

• Conditions: N81.3; terine prolapse.Quality of life; I01.800

• Registration Number: RBR-7t6rg2
• Lead Sponsor: Hospital da Mulher Prof. Dr. José Aristodemo Pinotti - CAISM

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-04-08
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: Female
• Target Recruitment: Not specified

Inclusion Criteria

Women with stage uterine prolapse 3 and 4. Women menopausal between 55-75 years. Are only included postmenopausal women because the genital prolapse is a condition more prevalent in this age group and has developed differently when it occurs in premenopausal women. To homogenize the group, we will select only postmenopausal women. Sample size target will be 90 women with uterine prolapse stage three and four.

Exclusion Criteria

Women who do not wish to participate in the study. Women with cognitive impairment and illiterate and unable to understand the questionnaires. Women who have or have had gynecological cancer. Women with pelvic floor surgery antecedent.

Study & Design

• Study Type: Intervention
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Women undergoing colpofixation the sacrospinous ligament with screen placement on the anterior wall will have objective and subjective cure rates of apical vaginal prolapse lower than women who underwent abdominal technique colpopromontofixação at the end of the study.<br>We will use to objectively evaluate healing the classification of POP-Q, as recommended by the International Continence Society.<br>For subjective evaluation, we will use a questionnaire about quality of life in genital prolapses, validated for the Portuguese.<br>Because it is a randomized clinical trial, because of risks with respective 95% confidence interval for the same will be calculated. The homogeneity between the groups, the chi-square statistic is calculated and to assess objective cure according to the classification of POP-Q will be performed analysis of variance with repeated measures.<br><br><br><br><br><br>

Secondary Outcome Measures

Name	Time	Method
The colpopromontofixação present higher morbidity with increased operative time, blood loss and immediate complicaçãos than colpofixation the sacrospinous ligament with mesh placement in the anterior wall, but this útlima present higher rates of late complications such as vaginal mucosa erosion, screen display and dyspareunia.<br>Because it is a randomized clinical trial, the risk ratio with respective 95% confidence interval for the same will be calculated. The homogeneity between the groups, the chi-square statistic is calculated and to assess the outcomes will be performed analysis of variance with repeated measures.