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Vaginal Estriol Before and Vaginal Surgery for Prolapse (VSaE)

Primary Purpose

Genital Prolapse

Status
Unknown status
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
estriol
vaginal surgery
Sponsored by
Salvatore Caruso
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Genital Prolapse focused on measuring Estriol, Prolapse, Quality of life, Vaginal health, Vaginal surgery

Eligibility Criteria

56 Years - 63 Years (Adult)FemaleDoes not accept 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    Study Group on estriol vaginal gel

    Control group, no estriol treatment

    Arm 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

    Procedure: vaginal surgery

    Outcomes

    Primary Outcome Measures

    Vaginal Health Indexes

    Secondary Outcome Measures

    QoL and sexual function were investigated by the Short Form 36 (SF-36)
    Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire short form (PISQ-12), respectively

    Full Information

    First Posted
    August 24, 2016
    Last Updated
    September 14, 2016
    Sponsor
    Salvatore Caruso
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02906111
    Brief Title
    Vaginal Estriol Before and Vaginal Surgery for Prolapse
    Acronym
    VSaE
    Official Title
    Effects on Vaginal Health and Quality of Life in Postmenopausal Women Using Ultra Low Topic Estriol Before Vaginal Surgery for Pelvic Statics Disorders
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2016
    Overall Recruitment Status
    Unknown status
    Study Start Date
    November 2016 (undefined)
    Primary Completion Date
    June 2017 (Anticipated)
    Study Completion Date
    June 2017 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    Salvatore Caruso

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    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
    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).

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Genital Prolapse
    Keywords
    Estriol, Prolapse, Quality of life, Vaginal health, Vaginal surgery

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    88 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Study Group on estriol vaginal gel
    Arm Type
    Active Comparator
    Arm 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
    Arm Title
    Control group, no estriol treatment
    Arm Type
    Active Comparator
    Arm Description
    Procedure: vaginal surgery
    Intervention Type
    Drug
    Intervention Name(s)
    estriol
    Intervention Description
    Study Group, treated with estriol Control Group, no drug treatment Both groups will undergo vaginal surgery for prolapse
    Intervention Type
    Procedure
    Intervention Name(s)
    vaginal surgery
    Other Intervention Name(s)
    vaginal surgery for prolapse
    Intervention Description
    Control Group
    Primary Outcome Measure Information:
    Title
    Vaginal Health Indexes
    Time Frame
    vaginal gel containing 50 µg of estriol, daily, for a complete cycle of treatment of 12 weeks
    Secondary Outcome Measure Information:
    Title
    QoL and sexual function were investigated by the Short Form 36 (SF-36)
    Time Frame
    vaginal gel containing 50 µg of estriol, daily, for a complete cycle of treatment of 12 weeks
    Title
    Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire short form (PISQ-12), respectively
    Time Frame
    vaginal gel containing 50 µg of estriol, daily, for a complete cycle of treatment of 12 weeks

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    56 Years
    Maximum Age & Unit of Time
    63 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Salvatore Caruso, Prof
    Phone
    +390953781101
    Email
    scaruso@unict.it
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Antonio Cianci, Prof
    Organizational Affiliation
    Policlinico Catania
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    26079974
    Citation
    Caruso S, Cianci S, Amore FF, Ventura B, Bambili E, Spadola S, Cianci A. Quality of life and sexual function of naturally postmenopausal women on an ultralow-concentration estriol vaginal gel. Menopause. 2016 Jan;23(1):47-54. doi: 10.1097/GME.0000000000000485.
    Results Reference
    result

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    Vaginal Estriol Before and Vaginal Surgery for Prolapse

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