Trial Outcomes & Findings for Doppler-Guided Uterine Artery Occlusion (DUAO) Device for Fibroid Related Bleeding (NCT NCT00496080)

NCT ID: NCT00496080

Last Updated: 2012-09-10

Results Overview

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.

• Recruitment status: TERMINATED
• Study phase: NA
• Target enrollment: 87 participants
• Primary outcome timeframe: Study completion
• Results posted on: 2012-09-10

Participant Flow

Recruitment took place from June 2007 through May 2009. Sites included hospitals, surgical centers and private practices in North America.

Participant milestones

Measure	DUAO Device Doppler-guided uterine artery occlusion device (Single-arm study)
Overall Study STARTED	87
Overall Study COMPLETED	60
Overall Study NOT COMPLETED	27

Reasons for withdrawal

Measure	DUAO Device Doppler-guided uterine artery occlusion device (Single-arm study)
Overall Study Lost to Follow-up	9
Overall Study Surgical re-intervention	7
Overall Study Withdrawal by Subject	5
Overall Study Physician Decision	6

Baseline Characteristics

Doppler-Guided Uterine Artery Occlusion (DUAO) Device for Fibroid Related Bleeding

Baseline characteristics by cohort

Measure	DUAO Device n=87 Participants Doppler-guided uterine artery occlusion device (Single-arm study)
Age Continuous	42.3 years STANDARD_DEVIATION 4.9 • n=5 Participants
Sex: Female, Male Female	87 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Region of Enrollment United States	48 participants n=5 Participants
Region of Enrollment Mexico	30 participants n=5 Participants
Region of Enrollment Canada	9 participants n=5 Participants

PRIMARY outcome

Timeframe: Study completion

Population: ITT (Data missing for 5 participants)

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.

Outcome measures

Measure	DUAO Device n=82 Participants Doppler-guided uterine artery occlusion device
No Surgical Re-intervention	74 participants Interval 82.7 to 95.9

PRIMARY outcome

Timeframe: From baseline to 12 months

Population: ITT (No data for 18 participants)

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.

Outcome measures

Measure	DUAO Device n=69 Participants Doppler-guided uterine artery occlusion device
Improvement in Pictorial Blood Loss Assessment Chart (PBLAC) Score	15 participants Interval 12.7 to 33.3

SECONDARY outcome

Timeframe: From baseline to 12 months

Population: ITT (No data for 20 participants)

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.

Outcome measures

Measure	DUAO Device n=67 Participants Doppler-guided uterine artery occlusion device
Mean Improvement in Health Related Quality of Life (HRQOL) Scores	54 participants

SECONDARY outcome

Timeframe: 12 months

Population: ITT (No data for 30 participants)

Number of participants with continuation of menstrual cycles without interruption for three consecutive months

Outcome measures

Measure	DUAO Device n=57 Participants Doppler-guided uterine artery occlusion device
Maintenance of Menses	53 participants

SECONDARY outcome

Timeframe: 12 months

Population: ITT (No data for 19 participants)

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)

Outcome measures

Measure	DUAO Device n=68 Participants Doppler-guided uterine artery occlusion device
Procedural Satisfaction Undecided	11 participants
Procedural Satisfaction Very Dissatisfied	2 participants
Procedural Satisfaction Dissatisfied	5 participants
Procedural Satisfaction Satisfied	21 participants
Procedural Satisfaction Very Satisfied	29 participants

SECONDARY outcome

Timeframe: From baseline to 12-months

Population: ITT (Due to early termination, only 39 subjects had MRIs. No data for 8 participants.)

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.

Outcome measures

Measure	DUAO Device n=31 Participants Doppler-guided uterine artery occlusion device
Decrease in Fibroid Bulk	10 participants

SECONDARY outcome

Timeframe: From baseline to 12 months

Population: ITT (No data for 18 participants.)

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.

Outcome measures

Measure	DUAO Device n=69 Participants Doppler-guided uterine artery occlusion device
Mean Improvement in Uterine Fibroid Symptom Quality of Life (UFS-QOL) Symptom Severity Scores	55 participants

Adverse Events

DUAO Device

Serious events: 4 serious events

Other events: 37 other events

Deaths: 0 deaths

Serious adverse events

Measure	DUAO Device n=87 participants at risk Doppler-guided uterine artery occlusion device (Single-arm study)
Renal and urinary disorders Urinary Retention	2.3% 2/87 • Number of events 2 • 3 years Due to early study termination the longest timeframe of a patient's study participation was 2 years and 9 days. The shortest timeframe of study participation was 11 months 9 days.
Infections and infestations Diverticulitis	1.1% 1/87 • Number of events 1 • 3 years Due to early study termination the longest timeframe of a patient's study participation was 2 years and 9 days. The shortest timeframe of study participation was 11 months 9 days.
Injury, poisoning and procedural complications Medication Error	1.1% 1/87 • Number of events 1 • 3 years Due to early study termination the longest timeframe of a patient's study participation was 2 years and 9 days. The shortest timeframe of study participation was 11 months 9 days.
Reproductive system and breast disorders Dysfunctional uterine bleeding	1.1% 1/87 • Number of events 1 • 3 years Due to early study termination the longest timeframe of a patient's study participation was 2 years and 9 days. The shortest timeframe of study participation was 11 months 9 days.

Other adverse events

Measure	DUAO Device n=87 participants at risk Doppler-guided uterine artery occlusion device (Single-arm study)
Gastrointestinal disorders Nausea	11.5% 10/87 • Number of events 10 • 3 years Due to early study termination the longest timeframe of a patient's study participation was 2 years and 9 days. The shortest timeframe of study participation was 11 months 9 days.
Injury, poisoning and procedural complications Procedural pain	5.7% 5/87 • Number of events 6 • 3 years Due to early study termination the longest timeframe of a patient's study participation was 2 years and 9 days. The shortest timeframe of study participation was 11 months 9 days.
Musculoskeletal and connective tissue disorders Back Pain	6.9% 6/87 • Number of events 7 • 3 years Due to early study termination the longest timeframe of a patient's study participation was 2 years and 9 days. The shortest timeframe of study participation was 11 months 9 days.
Nervous system disorders Headache	8.0% 7/87 • Number of events 7 • 3 years Due to early study termination the longest timeframe of a patient's study participation was 2 years and 9 days. The shortest timeframe of study participation was 11 months 9 days.
Renal and urinary disorders Hydronephrosis	10.3% 9/87 • Number of events 9 • 3 years Due to early study termination the longest timeframe of a patient's study participation was 2 years and 9 days. The shortest timeframe of study participation was 11 months 9 days.
Reproductive system and breast disorders Dysmenorrhea	6.9% 6/87 • Number of events 7 • 3 years Due to early study termination the longest timeframe of a patient's study participation was 2 years and 9 days. The shortest timeframe of study participation was 11 months 9 days.
Reproductive system and breast disorders Vaginal Discharge	10.3% 9/87 • Number of events 10 • 3 years Due to early study termination the longest timeframe of a patient's study participation was 2 years and 9 days. The shortest timeframe of study participation was 11 months 9 days.
Injury, poisoning and procedural complications Pelvic pain	11.5% 10/87 • Number of events 13 • 3 years Due to early study termination the longest timeframe of a patient's study participation was 2 years and 9 days. The shortest timeframe of study participation was 11 months 9 days.

Additional Information

Piet Hinoul MD

Ethicon

Phone: 908-218-2585

Email: phinoul@its.jnj.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: LTE60