Uterine Prolapse
Conditions
Interventions
This is a 1:1 randomized parallel study with 40 women with pelvic organ prolapse using two types of pessaries: internal and external. After signing the consent form, the recruited women were referred
Use of external pessary. Quality of life questionnaires were applied before and after 3 months of the intervention.
Sponsors
University of São Paulo
University of São Paulo
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: Women with stage II pelvic organ prolapse (with point of greatest prolapse greater than 0) and III according to Pelvic Organ Prolapse Quantification System who agreed to participate in the study.
Exclusion criteria
Exclusion criteria: Cancer of the genitourinary tract;Post-menopausal genital bleeding;repeated urinary tract infection; short vagina; Recurrent genital infection; Impossibility of proper monitoring and maintenance of the pessary ;Contraindication to the use of estriol
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Expected Outcome 1. Evaluate the effectiveness of using the internal and external pessary; through a quality of life questionnaire;Outcome found 1 It is concluded that the internal pessary and the external pessary improve the quality of life of women with pelvic organ prolapse, the internal pessary is more effective in the treatment of women with pelvic organ prolapse than the external pessary. Regarding subjective healing, 75% of women in the internal pessary group were cured compared to 15% in the external pessary group;Expected Outcome 2. Comparing complications between the use of internal and external pessaries; through statistical analysis;Outcome 2 Complications were higher in women who received the internal pessary, but all complications were mild. Statistically significant differences were observed between the two groups when the presence of complications was compared, being greater in the group that received the internal pessary. 35% of women in the internal pessary group had complications compared to 5% in the external pessary group ;Expected outcome 3. Assess whether there is any change in pelvic organ prolapse staging using the “pelvic organ prolapse quantification” before and after treatment with the internal and external pessary, after removing the device;Outcome found 3 The internal pessary changed pelvic organ prolapse quantification staging related to anterior and apical vaginal wall prolapse in women with pelvic organ prolapse, which did not happen with the external pessary | — |
Countries
Brazil
Contacts
Public ContactRenato Hosoume
University of São Paulo
Outcome results
None listed