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Comparing catheter mediated uterine vessel occlusion with uterine removal by surgery for treatment of uterine fibroids

A Pilot study comparing efficacy of Uterine artery embolisation vs hysterectomy in patients with symptomatic uterine fibroids. - UAE

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2017/11/010501
Enrollment
100
Registered
2017-11-15
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

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

Conditions

Health Condition 1: null- Patients presenting with menorrhagia(PBAC score 100) and pelvic pain, pressure symptoms attributable to uterine fibroids.

Interventions

Intervention1: Uterine artery embolisation: Endovascular catheter uterine artery embolisation will be done using particulate material like poly vinyl alcohol(PVA) to reduce the vascular supply and cau

Sponsors

Department of Radiodiagnosis
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Menstruating women with symptomatic uterine fibroids who have completed their family Uterus size= 3 cm diameter in size

Exclusion criteria

Exclusion criteria: 1.Uterine size > 24 weeks on clinical examination. 2. Any single myoma size > 12 cm on ultrasonography. Patients can also be taken up for UAE post trial of GnRH agonists if the fibroid 3. size at presentation is more than 12 cm at initial presentation 4.Active pelvic infection or pregnancy 5.Suspected or known case of gynecological cancer/atypical endometrial hyperplasia. 6. Known case of uncontrolled coagulation disorder, renal insufficiency, severe contrast allergy 7. Large uterine polyp ( >2 cm), Submucosal fibroid (class 0 & 1 under myoma sub-classification system) 8. Large subserosal fibroids with narrow stalk

Design outcomes

Primary

MeasureTime frame
Fibroid size as assessed by USG or MRI Uterine fibroid Quality of life assessment score Timepoint: 6 months after treatment

Secondary

MeasureTime frame
Relief of symptoms like pain, pressure symptoms and menorrhagia Percentage necrosis of myoma on post embolization MRITimepoint: Relief of symptoms in 6 months Percentage necrosis on post embolisation MRI in 6 weeks

Countries

India

Contacts

Public ContactProf Shivanand R Gamanagatti

All India Institute of Medical Sciences

Shiv223@gmail.com01126594567

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026