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Xenform Postmarket Surveillance Study (Xenform)

Primary Purpose

Pelvic Organ Prolapse

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Prolapse Repair
Sponsored by
Boston Scientific Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pelvic Organ Prolapse focused on measuring POP, Transvaginal, Native Tissue Repair, Repair Augmented with Mesh, Biologic Graft, Pelvic Organ Prolapse

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • University of California, Irvine Medical Center
  • Emory Hospital
  • Augusta University
  • Cherokee Womens Health Specialist
  • NorthShore University Health System
  • Acadia Women's Health
  • Chesapeake Urology Research Associates
  • Chesapeake Urology Research Associates
  • Mount Auburn Hospital
  • Beyer Research
  • Cooper University Hospital
  • University of Buffalo
  • Beth Israel Medical Center
  • NYU Langone Medical Center
  • University of North Carolina
  • Carolina Urology Partners
  • Lyndhurst Clinical Research
  • Prime Care of SEO
  • Prisma Health System
  • Southern Urogynecology
  • Center for Pelvic Health
  • Practice Research Organization
  • Houston Metro Urology
  • Las Colinas ObGyn
  • MultiCare Women's Health Care

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Xenform

Control

Arm Description

Prolapse Repair with Xenform Soft Tissue Repair Matrix

Prolapse Repair with Native Tissue Only

Outcomes

Primary Outcome Measures

Number of Participants With Success at 36 Months
The primary endpoint of the study was to achieve non-inferiority of transvaginal repair with Xenform over NTR at 36 months as compared to baseline. Success was based on a composite of objective and subjective measures. Subjective success was achieved if the patient denied symptoms of vaginal bulging per Pelvic Floor Distress Inventory (PFDI-20) question 3, answering "no" or "yes" but "Not at all" bothersome (< 2). Anatomic success (in the operated compartment): Anterior segment: Leading edge of anterior prolapse was at or above the hymen or Pelvic Organ Prolapse Quantification System (POP-Q) point Ba ≤ 0. Apical segment: The vaginal apex did not descend more than one-half into the vaginal canal (i.e., POP-Q point C < -1/2 TVL) for multi-compartment prolapse or POP-Q point C ≤ 0 for single compartment apical prolapse. No retreatment for POP: no additional surgical treatment for POP in the segment(s) of the vagina treated at the index surgery or no pessary use
Number of Participants With One or More Serious Device-related and/or Procedure-Related Adverse Events
Co-primary endpoint of the study was to achieve non-inferiority of transvaginal mesh repair with Xenform to NTR for safety by comparing rates of serious device-related or serious procedure-related complications between baseline and the 36-month time point.

Secondary Outcome Measures

Number of Participants With Mesh Erosion
Incidence of Mesh Erosion at 36 months
Number of Participants With Mesh Exposure
Incidence of mesh exposure at 36 months
Number of Participants With de Novo Dyspareunia
Incidence of de novo dyspareunia at 36 months
Subject Specific Outcomes Measured With the Pelvic Floor Impact Questionnaire (PFIQ-7)]
Improvement in subject specific outcomes at 36 months compared to baseline [quality of life (QOL) per the Pelvic Floor Impact Questionnaire (PFIQ-7)] The PFIQ-7 is composed of three separate but related assessments: the UIQ-7 addresses the impact of urinary incontinence symptoms, the CRAIQ-7 addresses the impact of colorectal-anal or bowel symptoms, and the POPIQ-7 addresses impact of vaginal and pelvic symptoms. For each question, the low score (0) corresponds to "not at all" and the high score (3) corresponds to "quite a bit". The scores for the UIQ-7, CRAIQ-7 and POPIQ-7 are additive to yield the final PFIQ-7 score. The scale scores are then added together to get the total PFIQ-7 score, which ranges from 0-300. A lower score means there is a lesser effect on quality of life. Reported score is change from baseline at 36 months.
Subject Specific Outcomes Measured by the Pelvic Floor Symptoms Per the Pelvic Floor Distress Inventory (PFDI-20)
Improvement in subject specific outcomes at 36 months compared to baseline [pelvic floor symptoms per the Pelvic Floor Distress Inventory (PFDI-20)] The Pelvic Floor Distress Inventory-20 (PFDI-20) is complimentary to the PFIQ-7 and focuses on symptoms of distress in the same compartmentalized fashion as the PFIQ-7. Like the PFIQ-7, the PFDI-20 consists of three components: Urinary Distress Inventory (UDI; 6 questions), the Pelvic Organ Prolapse Distress Inventory (POPDI; 6 questions), and Colorectal-Anal Distress Inventory (CRADI; 8 questions). The scoring for the PFDI-20 is similar to the PFIQ-7 where each individual component score is summed. The total ranges from 0 to 300 with a higher score indicating a greater impact to QOL (i.e., distress symptoms are more noticeable) and a lower score indicating a lesser impact to QOL (i.e., distress symptoms are less noticeable). The reported result is change from baseline at 36 months.
Subject Specific Outcomes Measured by the Pelvic Organ Prolapse/Urinary Incontinence Sexual Function Questionnaire (PISQ-12)
Improvement in subject specific outcomes at 36 months compared to baseline [change in sexual functioning per the Pelvic Organ Prolapse/Urinary Incontinence Sexual Function Questionnaire (PISQ-12)] This is a self-administered questionnaire and the responses are graded on a five-point Likert scale ranging from 0 (always) to 4 (never). Values range from 0 to 48 and a higher score indicates better sexual function. The reported result is change from baseline at 36 months.
Subject Specific Outcomes: Pain Measured by the TOMUS Pain Scale
Improvement in subject specific outcomes at 36 months compared to baseline [pain per the TOMUS pain scale] The TOMUS Pain Score, a visual analog instrument with a scale of 0 (no pain sensation) to 10 (most intense pain sensation imaginable), was used to assess pain associated with surgery for pelvic organ prolapse in this study. There are seven (7) questions each with a maximum score of 10 and a possible score range of 0-70). The reported results are change from baseline at 36 months.
Subject Improvement Measured by the Patient Global Impression of Improvement for Prolapse (PGI-I)
Assessment of subject's level of improvement, measured by the Patient Global Impression of Improvement for Prolapse (PGI-I) The Patient Global Impression of Improvement (PGI-I) for prolapse symptoms is a validated QOL instrument that assesses patient perception of overall improvement after surgical interventions for POP.12 The scale rates the patient's improvement or worsening of prolapse symptoms relative to baseline. The scale is as follows: 1- Very much better; 2- Much better; 3- A little better; 4- No change; 5- A little worse; 6- Much worse; 7- Very much worse. Assessments were performed at 6-month intervals beginning 6 months after the index procedure.
Number of Participants With Re-Intervention or Re-Surgery
Absence of re-intervention or re-surgery for recurrence or persistence of POP or Xenform exposure/erosion
Surgical Success
Surgical success based on the following composite outcome: Subjective success: Patient denied symptoms of vaginal bulging per PFDI-20 question 3, answering "no" or "yes" but "Not at all" bothersome (˂ 2) Anatomic success (in the operated compartment): Anterior Segment: No anterior prolapse at or beyond the hymen or POP-Q point Ba ˂ 0 Apical Segment: The vaginal apex did not descend more than one-half into the vaginal canal (i.e., POP-Q point C ˂ 1/2 TVL) for multi-compartment prolapse or POP-Q point C ˂ 0 for prolapse of the apical compartment alone No retreatment for POP (treated segment): No additional surgical treatment for POP in the segment(s) of the vagina treated at the index surgery or no pessary use since index surgery ('treated segment' refers to the target compartments in this study, which are the anterior and apical compartments)
Incidence of Complications
Incidence of the following device-related or procedure-related adverse events (AEs): pelvic pain, infection, vaginal shortening, atypical vaginal discharge, neuromuscular problems, vaginal scarring, de novo vaginal bleeding, fistula formation and/or de novo voiding dysfunction.

Full Information

First Posted
September 15, 2013
Last Updated
March 19, 2021
Sponsor
Boston Scientific Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT01945580
Brief Title
Xenform Postmarket Surveillance Study
Acronym
Xenform
Official Title
A Prospective, Non-Randomized, Parallel Cohort, Multi-Center Study of Xenform vs. Native Tissue for the Treatment of Women With Anterior/Apical Pelvic Organ Prolapse
Study Type
Interventional

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
February 10, 2014 (Actual)
Primary Completion Date
February 12, 2020 (Actual)
Study Completion Date
February 12, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Boston Scientific Corporation

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.
Detailed Description
The primary objective is to evaluate clinical effectiveness of transvaginal repair with Xenform against traditional native tissue repair in women surgically treated for anterior and/or apical pelvic organ prolapse. Secondary objectives are to evaluate Xenform-related complications and subject reported outcomes. The primary endpoint of the study is to achieve non-inferiority of transvaginal repair with Xenform over native tissue repair at 36 months as compared to baseline. Success will be based on a composite of objective and subjective measures. Additionally, a co-primary endpoint of the study is to achieve non-inferiority of transvaginal repair with 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. The secondary endpoints of the study include assessments of complications and subject reported outcomes.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pelvic Organ Prolapse
Keywords
POP, Transvaginal, Native Tissue Repair, Repair Augmented with Mesh, Biologic Graft, Pelvic Organ Prolapse

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
374 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Xenform
Arm Type
Active Comparator
Arm Description
Prolapse Repair with Xenform Soft Tissue Repair Matrix
Arm Title
Control
Arm Type
Active Comparator
Arm Description
Prolapse Repair with Native Tissue Only
Intervention Type
Procedure
Intervention Name(s)
Prolapse Repair
Other Intervention Name(s)
Transvaginal, Prolapse, POP Repair, Anterior, Apical
Intervention Description
Transvaginal anterior/apical pelvic organ prolapse repair
Primary Outcome Measure Information:
Title
Number of Participants With Success at 36 Months
Description
The primary endpoint of the study was to achieve non-inferiority of transvaginal repair with Xenform over NTR at 36 months as compared to baseline. Success was based on a composite of objective and subjective measures. Subjective success was achieved if the patient denied symptoms of vaginal bulging per Pelvic Floor Distress Inventory (PFDI-20) question 3, answering "no" or "yes" but "Not at all" bothersome (< 2). Anatomic success (in the operated compartment): Anterior segment: Leading edge of anterior prolapse was at or above the hymen or Pelvic Organ Prolapse Quantification System (POP-Q) point Ba ≤ 0. Apical segment: The vaginal apex did not descend more than one-half into the vaginal canal (i.e., POP-Q point C < -1/2 TVL) for multi-compartment prolapse or POP-Q point C ≤ 0 for single compartment apical prolapse. No retreatment for POP: no additional surgical treatment for POP in the segment(s) of the vagina treated at the index surgery or no pessary use
Time Frame
36 Months
Title
Number of Participants With One or More Serious Device-related and/or Procedure-Related Adverse Events
Description
Co-primary endpoint of the study was to achieve non-inferiority of transvaginal mesh repair with Xenform to NTR for safety by comparing rates of serious device-related or serious procedure-related complications between baseline and the 36-month time point.
Time Frame
36 months
Secondary Outcome Measure Information:
Title
Number of Participants With Mesh Erosion
Description
Incidence of Mesh Erosion at 36 months
Time Frame
36 months
Title
Number of Participants With Mesh Exposure
Description
Incidence of mesh exposure at 36 months
Time Frame
36 Months
Title
Number of Participants With de Novo Dyspareunia
Description
Incidence of de novo dyspareunia at 36 months
Time Frame
36 months
Title
Subject Specific Outcomes Measured With the Pelvic Floor Impact Questionnaire (PFIQ-7)]
Description
Improvement in subject specific outcomes at 36 months compared to baseline [quality of life (QOL) per the Pelvic Floor Impact Questionnaire (PFIQ-7)] The PFIQ-7 is composed of three separate but related assessments: the UIQ-7 addresses the impact of urinary incontinence symptoms, the CRAIQ-7 addresses the impact of colorectal-anal or bowel symptoms, and the POPIQ-7 addresses impact of vaginal and pelvic symptoms. For each question, the low score (0) corresponds to "not at all" and the high score (3) corresponds to "quite a bit". The scores for the UIQ-7, CRAIQ-7 and POPIQ-7 are additive to yield the final PFIQ-7 score. The scale scores are then added together to get the total PFIQ-7 score, which ranges from 0-300. A lower score means there is a lesser effect on quality of life. Reported score is change from baseline at 36 months.
Time Frame
36 months
Title
Subject Specific Outcomes Measured by the Pelvic Floor Symptoms Per the Pelvic Floor Distress Inventory (PFDI-20)
Description
Improvement in subject specific outcomes at 36 months compared to baseline [pelvic floor symptoms per the Pelvic Floor Distress Inventory (PFDI-20)] The Pelvic Floor Distress Inventory-20 (PFDI-20) is complimentary to the PFIQ-7 and focuses on symptoms of distress in the same compartmentalized fashion as the PFIQ-7. Like the PFIQ-7, the PFDI-20 consists of three components: Urinary Distress Inventory (UDI; 6 questions), the Pelvic Organ Prolapse Distress Inventory (POPDI; 6 questions), and Colorectal-Anal Distress Inventory (CRADI; 8 questions). The scoring for the PFDI-20 is similar to the PFIQ-7 where each individual component score is summed. The total ranges from 0 to 300 with a higher score indicating a greater impact to QOL (i.e., distress symptoms are more noticeable) and a lower score indicating a lesser impact to QOL (i.e., distress symptoms are less noticeable). The reported result is change from baseline at 36 months.
Time Frame
36 months
Title
Subject Specific Outcomes Measured by the Pelvic Organ Prolapse/Urinary Incontinence Sexual Function Questionnaire (PISQ-12)
Description
Improvement in subject specific outcomes at 36 months compared to baseline [change in sexual functioning per the Pelvic Organ Prolapse/Urinary Incontinence Sexual Function Questionnaire (PISQ-12)] This is a self-administered questionnaire and the responses are graded on a five-point Likert scale ranging from 0 (always) to 4 (never). Values range from 0 to 48 and a higher score indicates better sexual function. The reported result is change from baseline at 36 months.
Time Frame
36 months
Title
Subject Specific Outcomes: Pain Measured by the TOMUS Pain Scale
Description
Improvement in subject specific outcomes at 36 months compared to baseline [pain per the TOMUS pain scale] The TOMUS Pain Score, a visual analog instrument with a scale of 0 (no pain sensation) to 10 (most intense pain sensation imaginable), was used to assess pain associated with surgery for pelvic organ prolapse in this study. There are seven (7) questions each with a maximum score of 10 and a possible score range of 0-70). The reported results are change from baseline at 36 months.
Time Frame
36 months
Title
Subject Improvement Measured by the Patient Global Impression of Improvement for Prolapse (PGI-I)
Description
Assessment of subject's level of improvement, measured by the Patient Global Impression of Improvement for Prolapse (PGI-I) The Patient Global Impression of Improvement (PGI-I) for prolapse symptoms is a validated QOL instrument that assesses patient perception of overall improvement after surgical interventions for POP.12 The scale rates the patient's improvement or worsening of prolapse symptoms relative to baseline. The scale is as follows: 1- Very much better; 2- Much better; 3- A little better; 4- No change; 5- A little worse; 6- Much worse; 7- Very much worse. Assessments were performed at 6-month intervals beginning 6 months after the index procedure.
Time Frame
36 months
Title
Number of Participants With Re-Intervention or Re-Surgery
Description
Absence of re-intervention or re-surgery for recurrence or persistence of POP or Xenform exposure/erosion
Time Frame
36 months
Title
Surgical Success
Description
Surgical success based on the following composite outcome: Subjective success: Patient denied symptoms of vaginal bulging per PFDI-20 question 3, answering "no" or "yes" but "Not at all" bothersome (˂ 2) Anatomic success (in the operated compartment): Anterior Segment: No anterior prolapse at or beyond the hymen or POP-Q point Ba ˂ 0 Apical Segment: The vaginal apex did not descend more than one-half into the vaginal canal (i.e., POP-Q point C ˂ 1/2 TVL) for multi-compartment prolapse or POP-Q point C ˂ 0 for prolapse of the apical compartment alone No retreatment for POP (treated segment): No additional surgical treatment for POP in the segment(s) of the vagina treated at the index surgery or no pessary use since index surgery ('treated segment' refers to the target compartments in this study, which are the anterior and apical compartments)
Time Frame
36 months
Title
Incidence of Complications
Description
Incidence of the following device-related or procedure-related adverse events (AEs): pelvic pain, infection, vaginal shortening, atypical vaginal discharge, neuromuscular problems, vaginal scarring, de novo vaginal bleeding, fistula formation and/or de novo voiding dysfunction.
Time Frame
36 Months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter Rosenblatt, MD
Organizational Affiliation
Mount Auburn Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California, Irvine Medical Center
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Facility Name
Emory Hospital
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
Augusta University
City
Augusta
State/Province
Georgia
ZIP/Postal Code
30912
Country
United States
Facility Name
Cherokee Womens Health Specialist
City
Canton
State/Province
Georgia
ZIP/Postal Code
30114
Country
United States
Facility Name
NorthShore University Health System
City
Skokie
State/Province
Illinois
ZIP/Postal Code
60076
Country
United States
Facility Name
Acadia Women's Health
City
Crowley
State/Province
Louisiana
ZIP/Postal Code
70526
Country
United States
Facility Name
Chesapeake Urology Research Associates
City
Hanover
State/Province
Maryland
ZIP/Postal Code
21061
Country
United States
Facility Name
Chesapeake Urology Research Associates
City
Owings Mills
State/Province
Maryland
ZIP/Postal Code
21117
Country
United States
Facility Name
Mount Auburn Hospital
City
Cambridge
State/Province
Massachusetts
ZIP/Postal Code
02138
Country
United States
Facility Name
Beyer Research
City
Kalamazoo
State/Province
Michigan
ZIP/Postal Code
49009
Country
United States
Facility Name
Cooper University Hospital
City
Voorhees
State/Province
New Jersey
ZIP/Postal Code
08043
Country
United States
Facility Name
University of Buffalo
City
Buffalo
State/Province
New York
ZIP/Postal Code
14222
Country
United States
Facility Name
Beth Israel Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10003
Country
United States
Facility Name
NYU Langone Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
University of North Carolina
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States
Facility Name
Carolina Urology Partners
City
Gastonia
State/Province
North Carolina
ZIP/Postal Code
28054
Country
United States
Facility Name
Lyndhurst Clinical Research
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Facility Name
Prime Care of SEO
City
Dresden
State/Province
Ohio
ZIP/Postal Code
43821
Country
United States
Facility Name
Prisma Health System
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29605
Country
United States
Facility Name
Southern Urogynecology
City
West Columbia
State/Province
South Carolina
ZIP/Postal Code
29169
Country
United States
Facility Name
Center for Pelvic Health
City
Franklin
State/Province
Tennessee
ZIP/Postal Code
37067
Country
United States
Facility Name
Practice Research Organization
City
Dallas
State/Province
Texas
ZIP/Postal Code
75230
Country
United States
Facility Name
Houston Metro Urology
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Las Colinas ObGyn
City
Irving
State/Province
Texas
ZIP/Postal Code
75062
Country
United States
Facility Name
MultiCare Women's Health Care
City
Covington
State/Province
Washington
ZIP/Postal Code
98042
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Xenform Postmarket Surveillance Study

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