Vaginal Estriol Before and Vaginal Surgery for Prolapse

Study Overview
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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.

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).

Official Title
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Effects on Vaginal Health and Quality of Life in Postmenopausal Women Using Ultra Low Topic Estriol Before Vaginal Surgery for Pelvic Statics Disorders

Conditions
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Genital Prolapse

Intervention / Treatment
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* Drug: estriol
* Procedure: vaginal surgery


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 56 Years
Maximum Age: 63 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Study Group on estriol vaginal gel<br>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 | Drug: estriol<br>* Study Group, treated with estriol Control Group, no drug treatment Both groups will undergo vaginal surgery for prolapse<br>Procedure: vaginal surgery<br>* Control Group<br>* Other names: vaginal surgery for prolapse;|
| Active Comparator: Control group, no estriol treatment<br>Procedure: vaginal surgery | Procedure: vaginal surgery<br>* Control Group<br>* Other names: vaginal surgery for prolapse;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Vaginal Health Indexes |  | vaginal gel containing 50 µg of estriol, daily, for a complete cycle of treatment of 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| QoL and sexual function were investigated by the Short Form 36 (SF-36) |  | vaginal gel containing 50 µg of estriol, daily, for a complete cycle of treatment of 12 weeks | 
| Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire short form (PISQ-12), respectively |  | vaginal gel containing 50 µg of estriol, daily, for a complete cycle of treatment of 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Estriol, Prolapse, Quality of life, Vaginal health, Vaginal surgery