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522 Postmarket Surveillance Studies Database

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The FDA has the authority to require device manufacturers to perform postmarket surveillance under Section 522 of the Food, Drugs and Cosmetics (FD&C) Act, when questions are identified for devices that meet the statutory criteria. This database contains information about 522 Postmarket Surveillance Studies that have been required. This database allows you to search information about the postmarket surveillance requirements by manufacturer or device.

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POP AE and Effectiveness rates, registry


 
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General
Study Status Completed
522 Number / Requirement Number PS120081 / PSS002
Date Current Plan Accepted 02/20/2015
Study Name POP AE and Effectiveness rates, registry
Root Document Number K060984 
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source External Registry
Comparison Group Concurrent Control
Analysis Type Analytical
Study Population Transit. Adolescent B (as adults) : 18-21 yrs, Adult: >21
Detailed Study Protocol Parameters
Study Design Description This is a prospective, non-randomized, parallel cohort, multi-center study to compare transvaginal repair with XenForm (a biologic mesh) to traditional native tissue repair in women surgically treated for anterior/apical pelvic organ prolapse with or without concurrent cystocele. The study is using the Pelvic Floor Disorders Outcome Registry (PFD Registry).
Study Population Description Subjects who undergo a medical intervention (surgical or non-surgical) to treat recurrence, persistence of pelvic organ prolapse or a treatment complication
Sample Size 454 subjects (227 patients treated with Xenform Soft Tissue Repair Matrix and 227 patients treated with Native Tissue Repair as controls) will be enrolled at up to 30 study centers
Data Collection Primary Endpoints: 1. Non-inferiority of transvaginal repair with Xenform over native tissue repair at 36 months as compared to baseline; 2. Non-inferiority of Xenform to native tissue repair for safety by comparing rates of serious device or serious procedure related complications between baseline and the 36 month time point. Secondary Endpoints: 1. Incidence of Xenform erosion; 2. Incidence of Xenform exposure; 3. Incidence of de novo dyspareunia; 4. Improvement in subject specific outcomes at 36 months compared to Baseline (pelvic floor symptoms (PFDI-20), QOL (PFIQ-7), change in sexual functioning (PISQ-12), TOMUS pain scale); 5. Assessment of subject¿s level of improvement, measured by the Patient Global Impression of Improvement for Prolapse (PGI-I for Prolapse); 6. Absence of re-intervention or re-surgery for recurrence or persistence of POP or Xenform exposure/erosion; 7. Surgical success; 8. Device or procedure related incidence of the following: pelvic pain, infection, vaginal shortening, atypical vaginal discharge, neuromuscular problems, vaginal scarring, de novo vaginal bleeding, fistula formation and/or de novo voiding dysfunction.
Follow-up Visits and Length of Follow-up The length of study follow-up is 3 years. Follow-up will be conducted at 2 months, 6 months, 12 months, 18 months, 24 months and 36 months.
Interim or Final Data Summary
Actual Number of Patients Enrolled There were 374 subjects enrolled from sites, 228 in the Xenform arm and 146 in the native tissue repair (NTR) arm. An additional 339 NTR subjects were pulled from the AUGS PFD Registry for a total of 713 subjects.
Actual Number of Sites Enrolled 25
Patient Followup Rate 12-month: 89.8% (640/713) Overall, 86.0% (196/228) Xenform, 91.5% (444/485) NTR
24-month: 83.7% (597/713) Overall, 78.9% (180/228) Xenform, 86.0% (417/485) NTR
36-month: 80.9% (577/713) Overall, 77.2% (176/228) Xenform, 82.7% (401/485) NTR
Final Safety Findings Primary Endpoint
The following rates of severe adverse events (SAEs) were reported in the intent-to-treat (ITT) population within 36 months post index procedure using the multiple imputation method for missing data:

Xenform: 5.3% (12/228)
NTR: 2.7% (13/485)

Non-inferiority of Xenform vs. NTR for safety was established. The use of Xenform for treatment of anterior and/or apical vaginal prolapse was as safe as NTR with respect to the overall rate of SAEs at 36 months. Please note that while the two groups had a comparable overall rate of SAEs, the types of SAE differed between groups.

Secondary Endpoints
1. Incidence of mesh erosion, defined as the passage or perforation of mesh into hollow visceral organs, such as the bladder or rectum, per the protocol.

No reports of mesh erosion

2. Incidence of mesh exposure, defined as mesh visualized through the vaginal epithelium, such as through a separated incision line, per the protocol.

Mesh exposure incidence within 36 months is noted at 0.9% (2/228).

3. Incidence of de novo dyspareunia

Xenform: 0.9% (2/228) per 3 years
NTR: 1.2% (6/485) per 3 years

4. Device or procedure related incidence of the following: pelvic pain, infection, vaginal shortening, atypical vaginal discharge, neuromuscular problems, vaginal scarring, de novo vaginal bleeding, fistula formation and/or de novo voiding dysfunction

Within 36 months post-procedure
Pelvic pain: 6.1% (14/228) Xenform; 5.8% (28/485) NTR Infection: 11.0% (25/228) Xenform; 14.0% (68/485) NTR Vaginal shortening: none
Atypical vaginal discharge: 0.9% (2/228) Xenform; 0.6% (3/485) NTR Neuromuscular problems: 1.3% (3/228) Xenform; 2.9% (14/485) NTR Vaginal scarring: 1.3% (3/228) Xenform; 0.2% (1/485) NTR

De novo vaginal bleeding: 1.3% (3/228) Xenform; 1.4% (7/485) NTR Fistula formation: none
De novo voiding dysfunction: 15.4% (35/228) Xenform; 4.7% (23/485) NTR
Final Effectiveness Findings Primary Endpoint
The following success rates were reported in the intent-to-treat (ITT) population at the 36-month follow-up time point using the multiple imputation method for missing data:

Xenform: 83.6% (191/228)
NTR: 80.5% (390/485)

Non-inferiority of Xenform transvaginal mesh (TVM) vs. NTR for efficacy was established. The use of Xenform for the treatment of anterior and/or apical vaginal prolapse, as defined per the protocol, was as effective as NTR.

Secondary Endpoints
1. Improvement in subject specific outcomes at 36 months compared to Baseline (pelvic floor symptoms (PFDI-20), QOL (PFIQ-7), change in sexual functioning (PISQ- 12), TOMUS pain scale)

PFDI-20: -80.8 ± 58.6 (175 subjects) Xenform; -77.2 ± 56.1 (400 subjects) NTR
PFIQ-7: -55.2 ± 62.8 (174 subjects) Xenform; -41.9 ± 55.0 (399 subjects) NTR
PISQ-12: 5.0 ± 7.2 (78 subjects) Xenform; 4.3 ± 5.8 (156 subjects) NTR
TOMUS: -4.3 ± 8.8 (175 subjects) Xenform; -4.0 ± 8.3 (399 subject) NTR

There was no statistically significant difference between the Xenform and NTR arms.

2. Assessment of subject’s level of improvement, measured by the Patient Global Impression of Improvement for Prolapse (PGI-I for Prolapse)

Xenform: 1.6 ± 0.9 (175 subjects)
NTR: 1.4 ± 0.9 (399 subjects)

There was no statistically significant difference between the Xenform and NTR arms.

3. Absence of re-intervention or re-surgery for recurrence or persistence of POP or Xenform exposure/erosion

Recurrence or persistence of POP: 2.6% (6/228) Xenform; 3.5% (17/485) NTR Mesh exposure: no exposure events required intervention

There was no statistically significant difference between the Xenform and NTR arms.

4. Surgical success

Xenform: 80.3% (183/228)
NTR: 72.3% (351/485)

There was no statistically significant difference between the Xenform and NTR arms.

Study Strengths and Weaknesses
I. There is an unbalanced rate of subjects lost to follow-up between the Xenform treatment arm and the NTR control arm beginning with 12-month follow-up and carried through to 36 months. The unbalance of the missing data should not be considered missing at random. The estimated treatment effect could be biased no matter which statistical analysis method is used.

II. The adverse event (AE) rates presented in the current clinical report could underestimate the actual AE rates since for those subjects who discontinued or were lost to follow-up prior to 36 months, as they were imputed as no events if they had not reported any AEs prior to discontinuation.

III. There are some limitations to the interpretation of this study due to multiple issues like patients lost to follow up, missing data, the lack of diversity in the subject’s demographics, the imbalance of baseline characteristics in each arm, how each investigator reports adverse events and the distinction between surgical procedures done in the office or in the hospital to assess whether they should be named a surgical procedure or office-based.

Recommendations for Labeling Changes n/a


POP AE and Effectiveness rates, registry Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
6 month report 03/28/2014 03/28/2014 On Time
1 yr report 09/27/2014 09/25/2014 On Time
18 month report 03/28/2015 03/31/2015 Overdue/Received
2 yr report 09/27/2015 09/28/2015 Overdue/Received
3 year report 09/26/2016 09/26/2016 On Time
4 yr report 09/26/2017 09/22/2017 On Time
5 yr report 09/26/2018 09/26/2018 On Time
6 year report 09/20/2019 09/20/2019 On Time
Final report 06/26/2020 11/02/2020 Overdue/Received


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