N/A
N=713
Xenform Postmarket Surveillance Study
Pelvic Organ Prolapse
Bottom Line
View on ClinicalTrials.gov: NCT01945580 ↗Enrolled (actual)
713
Serious AEs
6.6%
Results posted
Apr 2021
Primary outcome: Primary: Number of Participants With Success at 36 Months — 191; 390 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Prolapse Repair (Procedure)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Boston Scientific Corporation
- Primary completion
- Feb 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Success at 36 Months |
191; 390 | — |
| PRIMARY Number of Participants With One or More Serious Device-related and/or Procedure-Related Adverse Events |
12; 13 | — |
| SECONDARY Number of Participants With Mesh Erosion |
0; 0; 0; 0 | — |
| SECONDARY Number of Participants With Mesh Exposure |
2; 2; 0; 0 | — |
| SECONDARY Number of Participants With de Novo Dyspareunia |
2; 6 | — |
| SECONDARY Subject Specific Outcomes Measured With the Pelvic Floor Impact Questionnaire (PFIQ-7)] |
-55.2; -41.9 | — |
| SECONDARY Subject Specific Outcomes Measured by the Pelvic Floor Symptoms Per the Pelvic Floor Distress Inventory (PFDI-20) |
-80.8; -77.2 | — |
| SECONDARY Subject Specific Outcomes Measured by the Pelvic Organ Prolapse/Urinary Incontinence Sexual Function Questionnaire (PISQ-12) |
5.0; 4.3 | — |
| SECONDARY Subject Specific Outcomes: Pain Measured by the TOMUS Pain Scale |
-4.8; -4.0 | — |
| SECONDARY Subject Improvement Measured by the Patient Global Impression of Improvement for Prolapse (PGI-I) |
1.6; 1.4 | — |
| SECONDARY Number of Participants With Re-Intervention or Re-Surgery |
1; 2; 5; 15; 23; 40 | — |
| SECONDARY Surgical Success |
183; 351 | — |
| SECONDARY Incidence of Complications |
14; 28; 25; 68; 0; 0 | — |
Summary
To compare transvaginal repair with a biologic graft to traditional native tissue repair in women surgically treated for anterior and/or apical pelvic organ prolapse.
Eligibility Criteria
Inclusion Criteria
- Subject is female
- Subject is at least 18 years of age
- Subject has pelvic organ prolapse with the leading edge at or beyond the hymen. At or beyond the hymen is defined as POP-Q scores of Ba≥0 (for prolapse of the anterior compartment alone) or C≥0 (for prolapse of the apical compartment alone) or C≥-1/2 TVL and Ba≥0 (for a multi-compartment prolapse that includes the anterior and apical compartments).
- Subject reports a bothersome bulge they can see or feel per PFDI-20, question 3, response of 2 or higher (i.e., responses of "somewhat", "moderately", or "quite a bit")
- Subject or subject's legally authorized representative is willing to provide written informed consent
- Subject is willing and able to comply with the follow-up regimen
Exclusion Criteria
- Subject is pregnant or intends to become pregnant during the study
- Subject has an active or chronic systemic infection including any gynecologic infection, untreated urinary tract infection (UTI) or tissue necrosis
- Subject has history of pelvic organ cancer (e.g. uterine, ovarian, bladder, colo-rectal or cervical)
- Subject has had prior or is currently undergoing radiation, laser therapy, or chemotherapy in the pelvic area
- Subject has taken systemic steroids (within the last month), or immunosuppressive or immunomodulatory treatment (within the last 3 months)
- Subject has systemic connective tissue disease (e.g. scleroderma, systemic lupus erythematosus (SLE), Marfan syndrome, Ehlers Danlos, collagenosis, polymyositis, polymyalgia rheumatica)
- Subject has chronic systemic pain that includes the pelvic area or chronic focal pain that involves the pelvis
- Subject has uncontrolled diabetes mellitus (DM)
- Subject has a known neurologic or medical condition affecting bladder function (e.g., multiple sclerosis, spinal cord injury or stroke with residual neurologic deficit)
- Subject is seeking obliterative vaginal surgery as treatment for pelvic organ prolapse (colpocleisis)
- Subject is not able to conform to the modified dorsal lithotomy position
- Subject is currently participating in or plans to participate in another device or drug study during this study
- Subject has a known sensitivity to any Xenform component
- Subject has had previous prolapse repair with mesh in the target compartment
- Subject is planning to undergo a concomitant prolapse repair with use of mesh in the non-target compartment
Data sourced from ClinicalTrials.gov (NCT01945580). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.