Trial Outcomes & Findings for The ELEGANT Trial: Elevate Transvaginal Mesh vs. Anterior Colporrhaphy (NCT NCT01497171)

Results Overview

Anatomical success will be measured using a composite index including: lack of specific prolapse symptoms, no interval treatment and no observed prolapse beyond 1 cm from the hymen.

Recruitment status

TERMINATED

Study phase

PHASE4

Target enrollment

5 participants

Primary outcome timeframe

12 months

Results posted on

2014-08-21

Participant Flow

5 women were enrolled at the German site (St. Hedwig's). No subjects were enrolled at the US sites.

Participant milestones

Participant milestones
Measure	Elevate Mesh Elevate transvaginal mesh - surgical repair of prolapse Elevate Mesh: Transvaginal mesh repair of anterior vaginal prolapse	Anterior Colporrhaphy Anterior colporrhaphy - surgical repair of prolapse Anterior Colporrhaphy: Traditional suture repair of anterior vaginal prolapse
Overall Study STARTED	2	3
Overall Study COMPLETED	2	3
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

The ELEGANT Trial: Elevate Transvaginal Mesh vs. Anterior Colporrhaphy

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Elevate Mesh n=2 Participants Transvaginal mesh repair of anterior vaginal prolapse	Anterior Colporrhaphy n=3 Participants Traditional suture repair of anterior vaginal prolapse	Total n=5 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Age, Categorical Between 18 and 65 years	1 Participants n=93 Participants	1 Participants n=4 Participants	2 Participants n=27 Participants
Age, Categorical >=65 years	1 Participants n=93 Participants	2 Participants n=4 Participants	3 Participants n=27 Participants
Sex: Female, Male Female	2 Participants n=93 Participants	3 Participants n=4 Participants	5 Participants n=27 Participants
Sex: Female, Male Male	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Region of Enrollment Germany	2 participants n=93 Participants	3 participants n=4 Participants	5 participants n=27 Participants

PRIMARY outcome

Timeframe: 12 months

Population: No analysis was done due to early termination of the study.

Anatomical success will be measured using a composite index including: lack of specific prolapse symptoms, no interval treatment and no observed prolapse beyond 1 cm from the hymen.

Outcome measures

Outcome data not reported

Adverse Events

Elevate Mesh

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Anterior Colporrhaphy

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Elevate Mesh n=2 participants at risk Elevate transvaginal mesh - surgical repair of prolapse Elevate Mesh: Transvaginal mesh repair of anterior vaginal prolapse	Anterior Colporrhaphy n=3 participants at risk Anterior colporrhaphy - surgical repair of prolapse Anterior Colporrhaphy: Traditional suture repair of anterior vaginal prolapse
Reproductive system and breast disorders Endometrial Cancer	0.00% 0/2	33.3% 1/3 • Number of events 1

Additional Information

Dr. Emanuel C. Trabuco

Mayo Clinic

Phone: 507-284-7519

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place