Vaginal Estriol Before and Vaginal Surgery for Prolapse

Phase 4

• Conditions: Genital Prolapse
• Interventions: Drug: estriol; Procedure: vaginal surgery

• Registration Number: NCT02906111
• Lead Sponsor: Salvatore Caruso

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).

Study Timeline

• Study First Submitted: 2016-08-24
• Status Verified: 2016-09
• Study First Submitted QC: 2016-09-14
• Last Update Submitted: 2016-09-14
• Study First Posted: 2016-09-19
• Last Update Posted: 2016-09-19
• Study Start: 2016-11
• Primary Completion: 2017-06
• Study Completion: 2017-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 88

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Study Group on estriol vaginal gel	vaginal surgery	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
Control group, no estriol treatment	vaginal surgery	Procedure: vaginal surgery
Study Group on estriol vaginal gel	estriol	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

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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