Vaginal Estriol Before and Vaginal Surgery for Prolapse

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

Status

UNKNOWN

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02906111

Acronym

VSaE

Enrollment

Registered

2016-09-19

Start date

2016-11-30

Completion date

2017-06-30

Last updated

2016-09-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Genital Prolapse

Keywords

Estriol, Prolapse, Quality of life, Vaginal health, Vaginal surgery

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).

Interventions

DRUGestriol

Study Group, treated with estriol Control Group, no drug treatment Both groups will undergo vaginal surgery for prolapse

PROCEDUREvaginal surgery

Control Group

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

56 Years to 63 Years

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

Design outcomes

Primary

Measure	Time frame
Vaginal Health Indexes	vaginal gel containing 50 µg of estriol, daily, for a complete cycle of treatment of 12 weeks

Secondary

Measure	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

Contacts

Primary ContactSalvatore Caruso, Prof

scaruso@unict.it+390953781101

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026