Abnormal Uterine Bleeding, Dysmenorrhea
Conditions
Keywords
abnormal uterine bleeding, pain, dysmenorrhea, endometrial ablation
Brief summary
The objective of this study is to assess the efficacy of an implantable etonogestrel device in reducing hysterectomy rate in patients with a failed endometrial ablation.
Detailed description
The researchers aim to determine whether use of etonogestrel implant in patients with failed endometrial ablation significantly decreases hysterectomy rate. Changes in pelvic pain and vaginal bleeding will be assessed. Time to hysterectomy will be examined. The researchers hypothesize that treatment of failed endometrial ablation with etonogestrel implant will decrease pelvic pain and vaginal bleeding resulting in a significantly decreased need for hysterectomy.
Interventions
Implant will be inserted
Sponsors
University of Saskatchewan
Saskatchewan Health Authority - Regina Area
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Previous endometrial ablation * Pelvic pain and/or vaginal bleeding seeking treatment
Exclusion criteria
* Previous or current VTE * Liver tumour, benign or malignant, or active liver disease * Undiagnosed abnormal genital bleeding * Known or suspected breast cancer * Uncontrolled hypertension * Allergy to component of etonogestrel implant * Lack of patient consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Hysterectomy | Occurrence of hysterectomy will be documented any time during the 3 year follow up period | occurrence of hysterectomy |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pelvic Pain | VAS will be documented at baseline and 3, 6, 12, 18, 24, 30, and 36 months | Assessment of pelvic pain using Visual Analogue Scale (VAS), minimum score = 0, maximum score = 10, higher score indicates more pain |
| Time to Hysterectomy | Time of hysterectomy will be documented any time during the 3 year follow up period | Time from booking of hysterectomy to actual hysterectomy will be documented |
| Vaginal bleeding | PBAC score will be documented at baseline and 3, 6, 12, 18, 24, 30, and 36 months | Pictorial Blood Loss Assessment Chart (PBAC) score, minimum score = 0mL, maximum score = n/a, higher score indicates higher menstrual blood loss |
Countries
Canada
Outcome results
None listed