Vaginal Estriol Before and Vaginal Surgery for Prolapse

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

88 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-11-30

Study Completion Date

2017-06-30

Brief Summary

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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.

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Detailed Description

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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).

Conditions

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Genital Prolapse

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Study Group on estriol vaginal gel

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

Group Type ACTIVE_COMPARATOR

estriol

Intervention Type DRUG

Study Group, treated with estriol

Control Group, no drug treatment

Both groups will undergo vaginal surgery for prolapse

vaginal surgery

Intervention Type PROCEDURE

Control Group

Control group, no estriol treatment

Procedure: vaginal surgery

Group Type ACTIVE_COMPARATOR

vaginal surgery

Intervention Type PROCEDURE

Control Group

Interventions

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estriol

Study Group, treated with estriol

Control Group, no drug treatment

Both groups will undergo vaginal surgery for prolapse

Intervention Type DRUG

vaginal surgery

Control Group

Intervention Type PROCEDURE

Other Intervention Names

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vaginal surgery for prolapse

Eligibility Criteria

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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

Minimum Eligible Age

56 Years

Maximum Eligible Age

63 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No