A Phase 4 interventional study of estriol and vaginal surgery in Genital Prolapse, sponsored by Salvatore Caruso. Status unknown. Open to female participants aged 56 Years to 63 Years. Per ClinicalTrials.gov, last updated 2016-09-19.
Sponsored by Salvatore Caruso · Phase 4, Interventional, and Treatment
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.
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).
676 studies on the registry are indexed under Prolapse; 79 are open to participants now.
This study's planned enrollment of 88 is above the median of 74 across 435 interventional studies indexed under Prolapse.
Browse Prolapse studies →This is the only study on the registry with Salvatore Caruso as lead sponsor.
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Exclusion Criteria:
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 · Procedure: vaginal surgery
Procedure: vaginal surgery
Procedure: vaginal surgery
Study Group, treated with estriol Control Group, no drug treatment Both groups will undergo vaginal surgery for prolapse
Control Group
Also known as: vaginal surgery for prolapse
Vaginal Health Indexes
Time frame: vaginal gel containing 50 µg of estriol, daily, for a complete cycle of treatment of 12 weeks
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
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
No study locations are listed for this record.
Plan to share: No
This study is status unknown, as verified in Sep 2016. You cannot join it, but the record below documents what was studied.
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