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Study of Pessary Washing frequencies in the treatment of Genital Prolapse

Periodicity assessment for Cleaning the Vaginal Pessary in the treatment of the Pelvic Organ Prolapse: randomized controlled trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-6hn82h4
Enrollment
Unknown
Registered
2023-05-30
Start date
2021-07-01
Completion date
Unknown
Last updated
2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Female genital prolapse

Interventions

72 women will be selected, who opt for conservative treatment with the use of a pessary, after acceptance the participants will be randomized into 2 groups: "Group 3m" with a return period every 3 mon
E07.858.499

Sponsors

Suelene Costa de Albuquerque Coelho
Lead Sponsor
Uiversidade Estadual de Campinas (Unicamp)
Collaborator

Eligibility

Sex/Gender
Female
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Stage 3 or 4 genital prolapse by POP-Q; Option for vaginal pessary treatment

Exclusion criteria

Exclusion criteria: Women with prolapse not assessed by POP-Q; Women with non-ring model pessaries; Women with cognitive impairment to answer forms and questionnaires

Design outcomes

Primary

MeasureTime frame
It is expected that there is no difference in the presence of vaginal ulcers, observed through the gynecological examination, in women who underwent hygiene in the period of 3 or 6 months. The variable ulcers will be presented as absent, epithelial erythema, granulation tissue, epithelial rupture or erosion (less than 1 cm) or ulcer (epithelial rupture or erosion greater than 1 cm)—

Secondary

MeasureTime frame
It is expected that there will be no difference in the report of vaginal and urinary symptoms and quality of life (assessed by questionnaires validated for Brazilian Portuguese) between the women in the 2 groups. The results will be presented in numbers (total of the questionnaires and each domain) and will be presented in mean and standard deviation.;It is expected that there is no difference in the presence of complications related to alteration of the vaginal flora, obtained through the woman's report and physical examination, and presented in the form of presence or absence of vaginal discharge, complaint of pruritus, alterations in the vaginal flora, presence of bacterial vaginosis, vaginal candidiasis and leukocytes.—

Countries

Brazil

Contacts

Public ContactCássia Juliato

Uiversidade Estadual de Campinas (Unicamp)

cassia.raquel@gmail.com+55 019 3521-9306

Outcome results

None listed

Source: REBEC (via WHO ICTRP)