Pelvic Organ Prolapse
Conditions
Keywords
Cystocele, Bladder prolapse, Anterior prolapse, Vaginal prolapse, Uterine prolapse, Urinary incontinence
Brief summary
This study is designed to compare the safety and efficacy of a commercially available mesh kit used for surgical repair of anterior vaginal wall prolapse with traditional suture repair surgery.
Detailed description
This is a multicenter, double blinded, randomized controlled trial, comparing Elevate® System with Interpro® Lite™, Anterior and Apical Prolapse Repair System (American Medical Systems) and Anterior Colporrhaphy (anterior suture repair) in women with symptomatic pelvic organ prolapse, who have opted to have surgical repair. The goals of the study are to compare both efficacy and safety of the two procedures and to compare the surgical impact of mesh and suture repairs on vaginal function. The principal investigator is from Mayo Clinic in Rochester, Minnesota. Mayo Clinic will serve as the data gathering and coordination site for this multicenter trial.
Interventions
PROCEDUREElevate Mesh
Transvaginal mesh repair of anterior vaginal prolapse
PROCEDUREAnterior Colporrhaphy
Traditional suture repair of anterior vaginal prolapse
Sponsors
American Medical Systems
Emanuel Trabuco
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
FEMALE
Age
21 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Women with symptomatic pelvic organ prolapse who opt for a vaginal repair * Require both apical and anterior compartment repairs * Willing to return for follow-up visit * Understand and have signed informed consent to undergo randomization * Need both an apical and anterior repair * All trial participants who have a uterus will require a hysterectomy
Exclusion criteria
* Known or suspected vulvodynia * Known or suspected interstitial cystitis * History of chronic pelvic pain * Current pregnancy * Desire to maintain fertility * History of reconstructive pelvic surgery with synthetic mesh * History of radical pelvic surgery * History of pelvic radiation therapy * Currently undergoing treatment for a malignancy * Medically poor candidates for surgery
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Comparison of the Proportion of Subjects in Each Group, Who Achieve Anatomic Success at 12 Month Follow-up. | 12 months | 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. |
Countries
Germany, United States
Participant flow
Recruitment details
5 women were enrolled at the German site (St. Hedwig's). No subjects were enrolled at the US sites.
Participants by arm
| Arm | Count |
|---|---|
| Elevate Mesh Transvaginal mesh repair of anterior vaginal prolapse | 2 |
| Anterior Colporrhaphy Traditional suture repair of anterior vaginal prolapse | 3 |
| Total | 5 |
Baseline characteristics
| Characteristic | Elevate Mesh | Anterior Colporrhaphy | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 1 Participants | 2 Participants | 3 Participants |
| Age, Categorical Between 18 and 65 years | 1 Participants | 1 Participants | 2 Participants |
| Region of Enrollment Germany | 2 participants | 3 participants | 5 participants |
| Sex: Female, Male Female | 2 Participants | 3 Participants | 5 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 2 | 1 / 3 |
| serious Total, serious adverse events | 0 / 2 | 0 / 3 |
Outcome results
Primary
Comparison of the Proportion of Subjects in Each Group, Who Achieve Anatomic Success at 12 Month Follow-up.
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.
Time frame: 12 months
Population: No analysis was done due to early termination of the study.