Vaginal Estriol Before and Vaginal Surgery for Prolapse (VSaE)

Salvatore Caruso

Status and phase: Unknown; Phase 4

Conditions: Genital Prolapse

Treatments: Procedure: vaginal surgery; Drug: estriol

Study type: Interventional

Funder types: Other

Identifiers

NCT02906111

MenSurgE2

Details and patient eligibility

About

The purpose of this study is to determine whether the vaginal estriol before vaginal surgery for pelvic statics disorders is more efficacy of no estriol treatment on vaginal health and quality of life.

Full description

The aim of this randomized study was to evaluate the efficacy of low concentration of vaginal estriol gel (0.005%, 50 micrograms/1 g vaginal gel) in women with pelvic statics disorders before vaginal surgical treatment (group A), assessing the vaginal dryness, dysuria, vaginal maturation index (VMI), pH and the Vaginal Health Index (VHI). Secondary, to investigate the changes of sexual function and QoL. Women without pre surgical estriol treatment constituted the control group (group B).

Enrollment: 88 estimated patients

Sex: Female

Ages: 56 to 63 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• genital dryness,
• irritation/burning/itching of vulvas or vagina
• decreased lubrication with sexual activity
• discomfort or pain with sexual activity
• decreased arousal, orgasm, desire
• dysuria.

Exclusion criteria

• previous surgeries for pelvic organ prolapse
• urinary incontinence
• usage of medication
• chronic medical illness
• body mass index (BMI) ≥ 35 kg/m2
• endometrial thickness equal to or greater than 4 mm
• abnormal uterine bleeding
• hormone-dependent malignancies
• history of thromboembolic disease
• liver disease
• usage of HT for less than 3 months
• usage of phytoestrogens within 1 month before the start of the study
• partner affected by sexual disorder
• conflicting with the partner

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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88 participants in 2 patient groups

Study Group on estriol vaginal gel

Active Comparator group

Description:

Drug: 1 g/daily of vaginal gel containing 50 μg of estriol (0.005%) for 3 weeks and then twice weekly for 9 weeks, for a complete cycle of treatment of 12 weeks

Treatment:

Drug: estriol

Procedure: vaginal surgery

Control group, no estriol treatment

Active Comparator group

Description:

Procedure: vaginal surgery

Treatment:

Procedure: vaginal surgery