Menorrhagia, Uterine Fibroids
Conditions
Keywords
Menorrhagia associated with Uterine Fibroids
Brief summary
The objective of this study is to evaluate the safety and effectiveness of Doppler guided uterine artery occlusion (D-UAO) for the reduction of fibroid associated bleeding.
Detailed description
The GYNECARE GYNOCCLUDE D-UAO Instruments are single-use disposable instruments consisting of a GYNECARE GYNOCCLUDE Uterine Stabilizer, a GYNECARE GYNOCCLUDEM Introducer Sheath, a GYNECARE GYNOCCLUDE Doppler Clamp, and a GYNECARE GYNOCCLUDE Coupler.
Interventions
DEVICEDoppler-Guided Uterine Artery Occlusion Device (DUAO)
Investigational transvaginal clamp inserted one time for 6 hours.
Sponsors
Ethicon, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
25 Years to 50 Years
Healthy volunteers
No
Inclusion criteria
* 25 to 50 years of age; * PBLAC score of 150 or greater; * Completed child-bearing; * Normal Pap smear within 12 months; * Cervix suitable for tenaculum placement as determined by pelvic exam; * At least one uterine fibroid of 3 cm diameter or greater with a prevailing pathology (e.g., as opposed to adenomyosis) of fibroids determined through ultrasound; * Willing to maintain use or non-use of hormonal contraception from 3 months pre-study throughout the 12-month follow-up period; * Willing to maintain use or non-use of anti-fibrinolytic agents from 3 months pre-study throughout the 12-month follow-up period; * Able to tolerate the required prolonged supine position during treatment (approximately 6 hours); * Willing and able to provide informed consent and to follow study-related requirements;
Exclusion criteria
* Pregnancy (as confirmed immediately prior to procedure) * Fibroid diameter greater than 8.0 cm determined through transvaginal ultrasound; \[or if 2 dimensions are measured, total dimension greater than 16 cm; or if the 3 dimensions (length, height, width) are measured, total dimension greater than 24 cm\]; * Presence of a pedunculated fibroid determined by ultrasound; hysteroscopy, or saline infused sonography; * Hydronephrosis as determined by radiologist interpretation on renal ultrasound pre-procedurally; * Menopausal; * Clinical history of any thromboembolic disease; * Blood urine nitrogen (BUN) greater than 20 mg/dL and/or serum creatinine greater than 1.2 mg/dL unresolved with change in diet or hydration; · One or more lower uterine segment fibroids determined through pelvic exam; * History of gynecologic malignancy, atypical endometrial hyperplasia, or pelvic inflammatory disease; * Abnormal endometrial biopsy within the last 6 months prior to procedure; * Pelvic mass outside the uterus suggesting other disease processes; * Any current acute or chronic systemic infection or localized pelvic infection, including an unresolved urinary tract infection; * Using GnRH agonist or mifepristone within 6-months prior to the start of the study; * An intrauterine device (IUD) in place; * Using anticoagulation therapy (except OTC treatments (e.g. aspirin)), or have an underlying bleeding disorder; * Unsuitable for MRI examination, if within study subgroup to undergo MRI evaluation (e.g. severe claustrophobia, non-MRI-compatible implanted metalloid devices); * Prior endometrial ablation, uterine artery embolization, or uterine artery ligation; * Poor procedural candidate due to medical conditions as determined by the investigator (e.g. anesthesia class, renal insufficiency, heart disease); * Grade 1 for 3D Color Doppler or no flow observed for cystoscopy on ureter flow assessment if applicable.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| No Surgical Re-intervention | Study completion | Number of participants without any subsequent surgical procedure intended to manage fibroid symptoms performed. Potential procedures included surgical hysterectomy or dilatation and curettage (D&C) for treatment of menorrhagia; uterine artery embolization (UAE) or laparoscopic uterine artery occlusion; endometrial resection or ablation; myomectomy or myolysis. |
| Improvement in Pictorial Blood Loss Assessment Chart (PBLAC) Score | From baseline to 12 months | Number of participants with a 50% or greater reduction in PBLAC score from baseline at 12 mo and a PBLAC score of less than 250. PBLAC is a simple validated semiquantitative method of measuring total menstrual blood loss using a pictorial representation of blood loss, where higher scores indicate more blood loss. This hybrid endpoint combined the reduction in PBLAC score with the total PBLAC score. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Procedural Satisfaction | 12 months | Number of participants with responses of either satisfied or very satisfied on a qualitative survey that ranged from very dissatisfied (worst) to very satisfied (best) |
| Mean Improvement in Health Related Quality of Life (HRQOL) Scores | From baseline to 12 months | Participants categorized as better in the total UFS-QOL questionnaire, indicating an overall improvement in health-related quality of life. On this scale, higher scores are indicative of better quality of life, with a maximum(best)score of 100 and a minimum (worst)score of 0. Better was defined as a change of +12 or more from baseline at 12 mo. |
| Mean Improvement in Uterine Fibroid Symptom Quality of Life (UFS-QOL) Symptom Severity Scores | From baseline to 12 months | Number of participants categorized as better in the UFS-QOL sympton severity questionnaire, indicating an overall improvement in fibroid related symptoms. On this scale, higher scores are indicative of increasing symptom distress, with a maximum(worst)score of 100 and a minimum (best)score of 0. Better was defined as a change of -11 or less from baseline at 12 mo. |
| Decrease in Fibroid Bulk | From baseline to 12-months | Number of participants with a minimum 15% decrease in fibroid bulk based on independent magnetic resonance imaging (MRI) review from baseline at 12 mo. Note: As per protocol, MRIs were planned only for subjects 1 - 40, 81 - 120, and 161-200. |
| Maintenance of Menses | 12 months | Number of participants with continuation of menstrual cycles without interruption for three consecutive months |
Countries
Canada, Mexico, United States
Participant flow
Recruitment details
Recruitment took place from June 2007 through May 2009. Sites included hospitals, surgical centers and private practices in North America.
Participants by arm
| Arm | Count |
|---|---|
| DUAO Device Doppler-guided uterine artery occlusion device (Single-arm study) | 87 |
| Total | 87 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 9 |
| Overall Study | Physician Decision | 6 |
| Overall Study | Surgical re-intervention | 7 |
| Overall Study | Withdrawal by Subject | 5 |
Baseline characteristics
| Characteristic | DUAO Device |
|---|---|
| Age Continuous | 42.3 years STANDARD_DEVIATION 4.9 |
| Region of Enrollment Canada | 9 participants |
| Region of Enrollment Mexico | 30 participants |
| Region of Enrollment United States | 48 participants |
| Sex: Female, Male Female | 87 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 37 / 87 |
| serious Total, serious adverse events | 4 / 87 |
Outcome results
Primary
Improvement in Pictorial Blood Loss Assessment Chart (PBLAC) Score
Number of participants with a 50% or greater reduction in PBLAC score from baseline at 12 mo and a PBLAC score of less than 250. PBLAC is a simple validated semiquantitative method of measuring total menstrual blood loss using a pictorial representation of blood loss, where higher scores indicate more blood loss. This hybrid endpoint combined the reduction in PBLAC score with the total PBLAC score.
Time frame: From baseline to 12 months
Population: ITT (No data for 18 participants)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| DUAO Device | Improvement in Pictorial Blood Loss Assessment Chart (PBLAC) Score | 15 participants |
Primary
No Surgical Re-intervention
Number of participants without any subsequent surgical procedure intended to manage fibroid symptoms performed. Potential procedures included surgical hysterectomy or dilatation and curettage (D&C) for treatment of menorrhagia; uterine artery embolization (UAE) or laparoscopic uterine artery occlusion; endometrial resection or ablation; myomectomy or myolysis.
Time frame: Study completion
Population: ITT (Data missing for 5 participants)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| DUAO Device | No Surgical Re-intervention | 74 participants |
Secondary
Decrease in Fibroid Bulk
Number of participants with a minimum 15% decrease in fibroid bulk based on independent magnetic resonance imaging (MRI) review from baseline at 12 mo. Note: As per protocol, MRIs were planned only for subjects 1 - 40, 81 - 120, and 161-200.
Time frame: From baseline to 12-months
Population: ITT (Due to early termination, only 39 subjects had MRIs. No data for 8 participants.)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| DUAO Device | Decrease in Fibroid Bulk | 10 participants |
Secondary
Maintenance of Menses
Number of participants with continuation of menstrual cycles without interruption for three consecutive months
Time frame: 12 months
Population: ITT (No data for 30 participants)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| DUAO Device | Maintenance of Menses | 53 participants |
Secondary
Mean Improvement in Health Related Quality of Life (HRQOL) Scores
Participants categorized as better in the total UFS-QOL questionnaire, indicating an overall improvement in health-related quality of life. On this scale, higher scores are indicative of better quality of life, with a maximum(best)score of 100 and a minimum (worst)score of 0. Better was defined as a change of +12 or more from baseline at 12 mo.
Time frame: From baseline to 12 months
Population: ITT (No data for 20 participants)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| DUAO Device | Mean Improvement in Health Related Quality of Life (HRQOL) Scores | 54 participants |
Secondary
Mean Improvement in Uterine Fibroid Symptom Quality of Life (UFS-QOL) Symptom Severity Scores
Number of participants categorized as better in the UFS-QOL sympton severity questionnaire, indicating an overall improvement in fibroid related symptoms. On this scale, higher scores are indicative of increasing symptom distress, with a maximum(worst)score of 100 and a minimum (best)score of 0. Better was defined as a change of -11 or less from baseline at 12 mo.
Time frame: From baseline to 12 months
Population: ITT (No data for 18 participants.)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| DUAO Device | Mean Improvement in Uterine Fibroid Symptom Quality of Life (UFS-QOL) Symptom Severity Scores | 55 participants |
Secondary
Procedural Satisfaction
Number of participants with responses of either satisfied or very satisfied on a qualitative survey that ranged from very dissatisfied (worst) to very satisfied (best)
Time frame: 12 months
Population: ITT (No data for 19 participants)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| DUAO Device | Procedural Satisfaction | Undecided | 11 participants |
| DUAO Device | Procedural Satisfaction | Very Dissatisfied | 2 participants |
| DUAO Device | Procedural Satisfaction | Dissatisfied | 5 participants |
| DUAO Device | Procedural Satisfaction | Satisfied | 21 participants |
| DUAO Device | Procedural Satisfaction | Very Satisfied | 29 participants |