Fitostimoline Vaginal Pessaries in Women With Hysterectomy. Randomized, Perspective, Monoscentric Study.

University of Milan

Status: Unknown

Conditions: Vaginal Bleeding

Treatments: Other: standard of care; Drug: fitostimoline vaginal pessaries

Study type: Observational

Funder types: Other

Identifiers

NCT04612881

Fitostimoline pessaries

Details and patient eligibility

About

Clinical evaluation of Fitostimoline vaginal pessaries in the treatment of hysterectomy. An observational, randomized, perspective study performed on 60 women where 30 women are treated with fitostimoline pessaries and 30 women are treated with the standard of care.

Enrollment: 60 estimated patients

Sex: Female

Ages: 30 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• patient aged between 35 and 80 years
• patient undergoing hysterectomy
• Willingness to understand the procedures and aims of the study

Exclusion criteria

• Anamnestic or clinical data of metabolic or endocrine diseases (such as uncontrolled diabetes mellitus) or any other local and / or systemic pathology potentially able to interfere with the study parameters;
• Concomitant treatment with antibiotics / antiseptics, NSAIDs, analgesics (excl. Paracetamol)
• Non-therapeutic use of psychoactive substances;
• Abuse of drugs and / or alcohol / smoking;
• Neurological disorders or psychiatric conditions potentially capable of affecting the validity of the consent and / or compromising the patient's adherence to the study procedures;
• Known allergy, hypersensitivity or intolerance to the constituents of the preparations under study;
• Any condition, medical or otherwise, that could significantly reduce the possibility of obtaining reliable data, achieving the objectives of the study, perfecting its completion;
• Presumption of poor reliability or collaboration;
• Treatment with any preparation in the last 30 days prior to the start of the study;
• Patients already enrolled in this study;
• Center staff directly involved in the study and close relatives

Trial design

60 participants in 1 patient group

fitostimoline vaginal pessaries

Treatment:

Drug: fitostimoline vaginal pessaries

Other: standard of care