Ignite Creation Date:
2024-10-25 @ 7:59 PM
Last Modification Date:
2024-10-26 @ 3:43 PM
Study NCT ID:
NCT06652945
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-10-15
Brief Title:
Efficacy of Uterine Artery Embolization UAE in Management of Symptomatic Uterine Adenomyosis
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Efficacy of Uterine Artery Embolization UAE in Management of Symptomatic Uterine Adenomyosis
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Aim of the work
Evaluating the efficiency of uterine artery embolization as a minimally invasive method of treatment in management of symptomatic women with uterine adenomyosis
Evaluating the efficiency of uterine artery embolization as a minimally invasive method of treatment in management of symptomatic women with uterine adenomyosis
Detailed Description:
Adenomyosis is defined as a non-neoplastic disease caused by benign invasion of the myometrial layer by endometrial tissue associated with myometrial smooth muscle hyperplasia This ectopic endometrium shows two main patterns of distribution in the myometrium either focal endometrial implant of endometrial glands or diffuse invasion of the myometrium Uterine enlargement is often seen with diffuse adenomyosis while in cases with focal adenomyosis characteristic feature in ultrasound US can be misdiagnosed as leiomyoma appearing as focal heterogeneous myometrial thickening or myometrial cysts
Usually adenomyosis is presented with dysmenorrhea menorrhagia and abnormal uterine bleeding Previously adenomyosis was diagnosed in multiparous women older than 40 years causing abnormal uterine bleeding AUB But recently it has been widely recognized among larger group including nulliparous women earlier in reproductive life owing to increased availability and better imaging techniques
The first imaging modality to diagnose adenomyosis is transabdominal sonography TAS or transvaginal sonography TVS While magnetic resonance MR imaging is considered the gold standard diagnosis method due to its accuracy being noninvasive modality and its ability for better soft tissue characterization to differentiate adenomyosis from other pathologies
First line of management of adenomyosis include medications as non-steroidal anti-inflammatory drugs andor hormonal therapy Yet other methods of treatment are needed in different cases
For many years the most common line of treatment for symptomatic uterine adenomyosis is hysterectomy Some studies discussed the possibility of uterine-sparing surgeries to treat adenomyosis despite the controversy of application Many patients prefer uterine-sparing lines of treatment over hysterectomy especially after failure of medical treatment Recent studies have been investigating uterine artery embolization UAE as a promising line of treatment of adenomyosis
In 1995 the study of Ravina was the first to discuss UAE Ever since UAE was established as a treatment option for symptomatic patients with adenomyosis as well as uterine fibroids owing to its earliest positive results The objective of UAE is to produce more than 34 necrosis of adenomyotic tissues using trans-arterial catheters Recent studies show increasing success rates of managing adenomyosis using UAE with rates ranging from 60 to 70 and from 72 to 943 respectively
To evaluate uterine volume and areas of necrosis patients are referred to perform MRI following the UAE as in cases with fibroid disease With regard of different symptoms and presentations of adenomyosis having a cut-off value to evaluate effectiveness of the procedure to alleviate the symptoms is considered challenging
Some major complications and side effects can occur such as infections and pain caused by ischemic necrosis especially the first hours after the procedure which require strong regimen for pain control Six percent of the cases complained of persistent amenorrhea and they were above the age of 40 years old
Usually adenomyosis is presented with dysmenorrhea menorrhagia and abnormal uterine bleeding Previously adenomyosis was diagnosed in multiparous women older than 40 years causing abnormal uterine bleeding AUB But recently it has been widely recognized among larger group including nulliparous women earlier in reproductive life owing to increased availability and better imaging techniques
The first imaging modality to diagnose adenomyosis is transabdominal sonography TAS or transvaginal sonography TVS While magnetic resonance MR imaging is considered the gold standard diagnosis method due to its accuracy being noninvasive modality and its ability for better soft tissue characterization to differentiate adenomyosis from other pathologies
First line of management of adenomyosis include medications as non-steroidal anti-inflammatory drugs andor hormonal therapy Yet other methods of treatment are needed in different cases
For many years the most common line of treatment for symptomatic uterine adenomyosis is hysterectomy Some studies discussed the possibility of uterine-sparing surgeries to treat adenomyosis despite the controversy of application Many patients prefer uterine-sparing lines of treatment over hysterectomy especially after failure of medical treatment Recent studies have been investigating uterine artery embolization UAE as a promising line of treatment of adenomyosis
In 1995 the study of Ravina was the first to discuss UAE Ever since UAE was established as a treatment option for symptomatic patients with adenomyosis as well as uterine fibroids owing to its earliest positive results The objective of UAE is to produce more than 34 necrosis of adenomyotic tissues using trans-arterial catheters Recent studies show increasing success rates of managing adenomyosis using UAE with rates ranging from 60 to 70 and from 72 to 943 respectively
To evaluate uterine volume and areas of necrosis patients are referred to perform MRI following the UAE as in cases with fibroid disease With regard of different symptoms and presentations of adenomyosis having a cut-off value to evaluate effectiveness of the procedure to alleviate the symptoms is considered challenging
Some major complications and side effects can occur such as infections and pain caused by ischemic necrosis especially the first hours after the procedure which require strong regimen for pain control Six percent of the cases complained of persistent amenorrhea and they were above the age of 40 years old
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None