Vaginal Estriol Before and Vaginal Surgery for Prolapse

Genital Prolapse Clinical Trial

— 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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02906111
• Other study ID #: MenSurgE2
• Status: Not yet recruiting
• Phase: Phase 4
• First received: August 24, 2016
• Last updated: September 14, 2016
• Start date: November 2016
• Est. completion date: June 2017

Study information

• Verified date: September 2016
• Source: Policlinico Universitario, Catania
• Contact: Salvatore Caruso, Prof
• Phone: +390953781101
• Email: scaruso[@]unict.it
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 88
• Est. completion date: June 2017
• Est. primary completion date: June 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 56 Years to 63 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Genital Prolapse
• Prolapse

Intervention

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

Procedure:
• vaginal surgery
Control Group

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Salvatore Caruso

References & Publications (1)

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.000000000000 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Vaginal Health Indexes		vaginal gel containing 50 µg of estriol, daily, for a complete cycle of treatment of 12 weeks	No
Secondary	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	No
Secondary	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	No