- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01378065
Restorelle Direct Fix Anterior and Posterior (A&P) for Female Pelvic Organ Prolapse: A Prospective Post Market Study ((A&P))
April 29, 2020 updated by: Coloplast A/S
Restorelle Direct Fix A&P for Female Pelvic Organ Prolapse: A Prospective Post Market Study
This is a prospective, multi-center study designed to assess the palpability of the Restorelle Direct Fix A&P mesh after vaginal reconstruction surgery.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
31
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Maryland
-
Baltimore, Maryland, United States, 21237
- MedStar Health Research Institute at Baltimore
-
-
Michigan
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Grand Rapids, Michigan, United States, 49503
- Female Pelvic Medicine & Urogynecology Institute of MI
-
-
Missouri
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Marshall, Missouri, United States, 65340
- Central Missouri Women's Healthcare
-
-
Tennessee
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Franklin, Tennessee, United States, 37067
- Center for Pelvic Health
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Virginia
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Norfolk, Virginia, United States, 23502
- The Group for Women
-
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Washington
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Mountlake Terrace, Washington, United States, 98043
- Integrity Medical Research, LLC
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Sampling Method
Non-Probability Sample
Study Population
Subjects satisfying criteria for inclusion in the study were enrolled.
Description
Inclusion Criteria:
- Adult female at least 18 years of age
- Willing and able to provide written informed consent
- Diagnosed with clinically significant pelvic organ prolapse of Stage 2 or higher as determined by Pelvic Organ Prolapse Quantification System (POP-Q) requiring surgical intervention in the anterior and/or posterior compartment
- Willing and able to complete all follow-up visits and procedures indicated in the protocol
Exclusion Criteria:
- Concurrent surgical treatment of pelvic organ prolapse using anything other than the Restorelle Direct Fix A&P
- Confirmed Stage 2 or higher prolapse as determined by POP-Q for a compartment that is not being repaired in the same procedure
- Previous pelvic organ prolapse repair using synthetic grafts
- Patients requiring a total hysterectomy (i.e. removal of the cervix) at the time of vaginal reconstruction
- Patients requiring a procedure for fecal incontinence (i.e.) anal sphincteroplasty) at the time of vaginal reconstruction
- Pregnant or a desire to become pregnant
- Previous radiation or other treatments for cancer in the pelvic area
- Immunosuppression and/or current systemic steroid user
- On any anticoagulation therapy at the time of implant or with bleeding diathesis
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Palpability of the Restorelle Direct Fix Anterior and Posterior (A&P)
Time Frame: Baseline
|
Measured via palpability scale with possible outcomes of none, mild, moderate, or severe.
|
Baseline
|
Palpability of the Restorelle Direct Fix A&P
Time Frame: 6 weeks
|
Measured via palpability scale with possible outcomes of none, mild, moderate, or severe.
|
6 weeks
|
Palpability of the Restorelle Direct Fix A&P
Time Frame: 3 months
|
Measured via palpability scale with possible outcomes of none, mild, moderate, or severe.
|
3 months
|
Palpability of the Restorelle Direct Fix A&P
Time Frame: 6 months
|
Measured via palpability scale with possible outcomes of none, mild, moderate, or severe.
|
6 months
|
Palpability of the Restorelle Direct Fix A&P
Time Frame: 12 months
|
Measured via palpability scale with possible outcomes of none, mild, moderate, or severe.
|
12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Rates of de Novo Dyspareunia
Time Frame: 6 weeks
|
Percentage of de novo dyspareunia measured via validated Participant Sexual Function Questionnaire-12 (PISQ-12) questionnaire at 6 weeks.
The specific PISQ-12 score was based upon Question 3.5, "Do you feel pain during sexual intercourse?"
The subjects' response was counted as having de novo dyspareunia if the response was "sometimes" "usually" or "always."
|
6 weeks
|
Rates of de Novo Dyspareunia
Time Frame: 3 months
|
Percentage of de novo dyspareunia measured via validated Participant Sexual Function Questionnaire-12 (PISQ-12) questionnaire at 3 months.
The specific PISQ-12 score was based upon Question 3.5, "Do you feel pain during sexual intercourse?"
The subjects' response was counted as having de novo dyspareunia if the response was "sometimes" "usually" or "always."
|
3 months
|
Rates of de Novo Dyspareunia
Time Frame: 6 months
|
Percentage of de novo dyspareunia measured via validated Participant Sexual Function Questionnaire-12 (PISQ-12) questionnaire at six months.
The specific PISQ-12 score was based upon Question 3.5, "Do you feel pain during sexual intercourse?"
The subjects' response was counted as having de novo dyspareunia if the response was "sometimes" "usually" or "always."
|
6 months
|
Rates of de Novo Dyspareunia
Time Frame: 12 months
|
Percentage of de novo dyspareunia measured via validated Participant Sexual Function Questionnaire-12 (PISQ-12) questionnaire at 12 months.
The specific PISQ-12 score was based upon Question 3.5, "Do you feel pain during sexual intercourse?"
The subjects' response was counted as having de novo dyspareunia if the response was "sometimes" "usually" or "always."
|
12 months
|
Percentage of Participants With Surgical Success Rates of the Anterior Compartment After Vaginal Reconstruction Surgery Via Pelvic Organ Prolapse Quantification System (POP-Q) at 6 Weeks
Time Frame: 6 weeks
|
Surgical success rates of the anterior compartments after vaginal reconstruction surgery via Pelvic Organ Prolapse Quantification system (POP-Q) at 6 weeks.
Surgical success rate is defined as the post-operative point of maximal prolapse being less than 0 cm (i.e.
above the hymenal ring).
|
6 weeks
|
Percentage of Participants With Surgical Success Rates of the Anterior Compartment After Vaginal Reconstruction Surgery Via Pelvic Organ Prolapse Quantification System (POP-Q) at 3 Months
Time Frame: 3 months
|
Percentage of participants with surgical success rates of the anterior compartments after vaginal reconstruction surgery via Pelvic Organ Prolapse Quantification system (POP-Q) at 3 months.
Surgical success rate is defined as the post-operative point of maximal prolapse being less than 0 cm (i.e.
above the hymenal ring).
|
3 months
|
Percentage of Participants With Surgical Success Rates of the Anterior Compartment After Vaginal Reconstruction Surgery Via Pelvic Organ Prolapse Quantification System (POP-Q) at 6 Months
Time Frame: 6 months
|
Percentage of participants with surgical success rates of the anterior compartments after vaginal reconstruction surgery via Pelvic Organ Prolapse Quantification system (POP-Q) at 6 months.
Surgical success rate is defined as the post-operative point of maximal prolapse being less than 0 cm (i.e.
above the hymenal ring).
|
6 months
|
Percentage of Participants With Surgical Success Rates of the Anterior Compartment After Vaginal Reconstruction Surgery Via Pelvic Organ Prolapse Quantification System (POP-Q) at 12 Months
Time Frame: 12 months
|
Percentage of participants with surgical success rates of the anterior compartments after vaginal reconstruction surgery via Pelvic Organ Prolapse Quantification system (POP-Q) at 12 months.
Surgical success rate is defined as the post-operative point of maximal prolapse being less than 0 cm (i.e.
above the hymenal ring).
|
12 months
|
Percentage of Participants With Mesh Exposure/Extrusion After Vaginal Reconstruction Surgery at 12 Months.
Time Frame: 12 months
|
Percentage of participants with anterior and posterior compartment mesh exposure/extrusion after vaginal reconstruction with Restorelle Direct Fix at 12 months.
Per the protocol, mesh extrusion is defined as "passage gradually out of a body structure or tissue."
Mesh exposure is defined as " a condition of displaying, revealing, exhibiting or making accessible e.g.
vaginal mesh visualized through separated vaginal epithelium."
|
12 months
|
Percentage of Participants With Surgical Success of the Posterior Compartment After Vaginal Reconstruction Surgery Via Pelvic Organ Prolapse Quantification System (POP-Q) at the 6 Week Visit
Time Frame: 6 week
|
Percentage of participants with surgical success of the posterior compartment after vaginal reconstruction surgery via Pelvic Organ Prolapse Quantification system (POP-Q) at the 6 week visit.
Surgical success is defined as the post-operative point of maximal prolapse being less than 0 cm (i.e.
above the hymenal ring).
|
6 week
|
Percentage of Participants With Surgical Success of the Posterior Compartment After Vaginal Reconstruction Surgery Via Pelvic Organ Prolapse Quantification System (POP-Q) at the 3 Month Visit
Time Frame: 3 month
|
Percentage of participants with surgical success of the posterior compartment after vaginal reconstruction surgery via Pelvic Organ Prolapse Quantification system (POP-Q) at the 3 month visit.
Surgical success is defined as the post-operative point of maximal prolapse being less than 0 cm (i.e.
above the hymenal ring).
|
3 month
|
Percentage of Participants With Surgical Success of the Posterior Compartment After Vaginal Reconstruction Surgery Via Pelvic Organ Prolapse Quantification System (POP-Q) at the 6 Month Visit
Time Frame: 6 month
|
Percentage of participants with surgical success of the posterior compartment after vaginal reconstruction surgery via Pelvic Organ Prolapse Quantification system (POP-Q) at the 6 month visit Surgical success is defined as the post-operative point of maximal prolapse being less than 0 cm (i.e.
above the hymenal ring).
|
6 month
|
Percentage of Participants With Surgical Success of the Posterior Compartment After Vaginal Reconstruction Surgery Via Pelvic Organ Prolapse Quantification System (POP-Q) at the12 Month Visit
Time Frame: 12 month
|
Percentage of participants with surgical success of the posterior compartment after vaginal reconstruction surgery via Pelvic Organ Prolapse Quantification system (POP-Q) at the 12 month visit.
Surgical success is defined as the post-operative point of maximal prolapse being less than 0 cm (i.e.
above the hymenal ring).
|
12 month
|
Patient Global Impression of Improvement (PGI-I) Questionnaire Since Treatment at 6 Weeks.
Time Frame: 6 weeks
|
The PGI-I Index consists on one question and was collected at 6 weeks.
The question is "Check the box that best describes how your condition is now, compared with how it was before you had the operation."
There are seven possible responses including "very much better," "much better," "a little better," "no change," "a little worse," "much worse" and "very much worse" and the subject chooses one response.
|
6 weeks
|
Patient Global Impression of Improvement (PGI-I) Index Since Treatment at 3 Months.
Time Frame: 3 months
|
The PGI-I Index consists on one question and was collected at 3 months.
The question is "Check the box that best describes how your condition is now, compared with how it was before you had the operation.
There are seven possible responses including "very much better," "much better," "a little better," "no change," "a little worse," "much worse" and "very much worse" and the subject chooses one response.
|
3 months
|
Patient Global Impression of Improvement (PGI-I) Index Since Treatment at 6 Months.
Time Frame: 6 months
|
The PGI-I Index consists on one question and was collected at 6 months.
The question is "Check the box that best describes how your condition is now, compared with how it was before you had the operation.
There are seven possible responses including "very much better," "much better," "a little better," "no change," "a little worse," "much worse" and "very much worse" and the subject chooses one response.
|
6 months
|
Patient Global Impression of Improvement (PGI-I) Index Since Treatment at 12 Months.
Time Frame: 12 months
|
The PGI-I Index consists on one question and was collected at 12 months.
The question is "Check the box that best describes how your condition is now, compared with how it was before you had the operation.
There are seven possible responses including "very much better," "much better," "a little better," "no change," "a little worse," "much worse" and "very much worse" and the subject chooses one response.
|
12 months
|
Bladder Function After Vaginal Reconstruction Surgery With Restorelle Direct Fix A & P Measured by Urinary Distress Inventory-6 (UDI-6) Questionnaire at 6 Weeks
Time Frame: Baseline and 6 weeks
|
Bladder function is measured by UDI-6 Questionnaire at 6 weeks.
The UDI-6 measures bladder function.
The range of responses is: 1-4 with (1) not at all, (2) somewhat, (3) moderately, and (4 quite a bit).
To allow for missing responses, the average score of items responded to, rather than the total, is taken.
The average, which ranges from 1 to 4, is multiplied by 25 to put scores on a scale of 0 to 100.
Higher scores indicate worse symptoms.
|
Baseline and 6 weeks
|
Bladder Function After Vaginal Reconstruction Surgery With Restorelle Direct Fix A & P Measured by Urinary Distress Inventory-6 (UDI-6) Questionnaire at 3 Months
Time Frame: Baseline and 3 months
|
Bladder function is measured by UDI-6 Questionnaire at 3 months.
The UDI-6 measures bladder function.
The range of responses is: 1-4 with (1) not at all, (2) somewhat, (3) moderately, and (4 quite a bit).
To allow for missing responses, the average score of items responded to, rather than the total, is taken.
The average, which ranges from 1 to 4, is multiplied by 25 to put scores on a scale of 0 to 100.
Higher scores indicate worse symptoms.
|
Baseline and 3 months
|
Bladder Function After Vaginal Reconstruction Surgery With Restorelle Direct Fix A & P Measured by Urinary Distress Inventory-6 (UDI-6) Questionnaire at 6 Months
Time Frame: Baseline and 6 months
|
Bladder function is measured by UDI-6 Questionnaire at 6 months.
The UDI-6 measures bladder function.
The range of responses is: 1-4 with (1) not at all, (2) somewhat, (3) moderately, and (4 quite a bit).
To allow for missing responses, the average score of items responded to, rather than the total, is taken.
The average, which ranges from 1 to 4, is multiplied by 25 to put scores on a scale of 0 to 100.
Higher scores indicate worse symptoms.
|
Baseline and 6 months
|
Bladder Function After Vaginal Reconstruction Surgery With Restorelle Direct Fix A & P Measured by Urinary Distress Inventory-6 (UDI-6) Questionnaire at 12 Months
Time Frame: Baseline and 12 months
|
Bladder function is measured by UDI-6 Questionnaire at 12 months.
The UDI-6 measures bladder function.
The range of responses is: 1-4 with (1) not at all, (2) somewhat, (3) moderately, and (4 quite a bit).
To allow for missing responses, the average score of items responded to, rather than the total, is taken.
The average, which ranges from 1 to 4, is multiplied by 25 to put scores on a scale of 0 to 100.
Higher scores indicate worse symptoms.
|
Baseline and 12 months
|
Sexual Function After Vaginal Reconstruction With Restorelle Direct Fix Measured by Participant Sexual Function Questionnaire-12 (PISQ-12) at 6 Weeks
Time Frame: Baseline and 6 weeks
|
Sexual function in women with pelvic organ prolapse is measured by the PISQ-12 at 6 weeks.
The scores range from 0-48 with lower scores indicating better sexual function.
Scores are calculated by totalling the scores for each question with (4) always, (3) usually, (2) sometimes, (1) seldom, and (0) never.
Reverse scoring is used for items 1, 2, 3 and 4. The short form questionnaire can be used with up to two missing responses.
To handle missing values, the sum is calculated by multiplying the number of items by the mean of the answered items.
|
Baseline and 6 weeks
|
Sexual Function After Vaginal Reconstruction With Restorelle Direct Fix Measured by Participant Sexual Function Questionnaire-12 (PISQ-12) at 3 Months
Time Frame: Baseline and 3 months
|
Sexual function in women with pelvic organ prolapse is measured by the PISQ-12 at 3 months.
The scores range from 0-48 with lower scores indicating better sexual function.
Scores are calculated by totalling the scores for each question with (4) always, (3) usually, (2) sometimes, (1) seldom, and (0) never.
Reverse scoring is used for items 1, 2, 3 and 4. The short form questionnaire can be used with up to two missing responses.
To handle missing values, the sum is calculated by multiplying the number of items by the mean of the answered items.
|
Baseline and 3 months
|
Sexual Function After Vaginal Reconstruction With Restorelle Direct Fix Measured by Participant Sexual Function Questionnaire-12 (PISQ-12) at 6 Months
Time Frame: Baseline and 6 months
|
Sexual function in women with pelvic organ prolapse is measured by the PISQ-12 at 6 months.
The scores range from 0-48 with lower scores indicating better sexual function.
Scores are calculated by totalling the scores for each question with (4) always, (3) usually, (2) sometimes, (1) seldom, and (0) never.
Reverse scoring is used for items 1, 2, 3 and 4. The short form questionnaire can be used with up to two missing responses.
To handle missing values, the sum is calculated by multiplying the number of items by the mean of the answered items.
|
Baseline and 6 months
|
Sexual Function After Vaginal Reconstruction With Restorelle Direct Fix Measured by Participant Sexual Function Questionnaire-12 (PISQ-12) at 12 Months
Time Frame: Baseline and 12 months
|
Sexual function in women with pelvic organ prolapse is measured by the PISQ-12 at12 months.
The scores range from 0-48 with lower scores indicating better sexual function.
Scores are calculated by totalling the scores for each question with (4) always, (3) usually, (2) sometimes, (1) seldom, and (0) never.
Reverse scoring is used for items 1, 2, 3 and 4. The short form questionnaire can be used with up to two missing responses.
To handle missing values, the sum is calculated by multiplying the number of items by the mean of the answered items.
|
Baseline and 12 months
|
Bowel Function After Vaginal Reconstruction Surgery With Restorelle Direct Fix A & P Measured by Colorectal-Anal Distress Inventory 8 (CRADI-8) Questionnaire at the 6 Week Visit
Time Frame: Baseline and 6 weeks
|
Colorectal-anal Distress Inventory is measured by the CRADI-8 at 6 weeks.
The range of responses is 1-4 with (1) Not at all, (2) Somewhat, (3) Moderately, and (4), Quite a bit.
Scores are calculated by multiplying the mean value of all questions answered by 25.
The range of responses is: 0-100 with 0 (least distress) to 100 (most distress).
|
Baseline and 6 weeks
|
Bowel Function After Vaginal Reconstruction Surgery With Restorelle Direct Fix A & P Measured by Colorectal-Anal Distress Inventory 8 (CRADI-8) Questionnaire at the 3 Month Visit
Time Frame: Baseline and 3 months
|
Colorectal-anal Distress Inventory is measured by the CRADI-8 at 3 months.
The range of responses is 1-4 with (1) Not at all, (2) Somewhat, (3) Moderately, and (4), Quite a bit.
Scores are calculated by multiplying the mean value of all questions answered by 25.
The range of responses is: 0-100 with 0 (least distress) to 100 (most distress).
|
Baseline and 3 months
|
Bowel Function After Vaginal Reconstruction Surgery With Restorelle Direct Fix A & P Measured by Colorectal-Anal Distress Inventory 8 (CRADI-8) Questionnaire at the 6 Month Visit
Time Frame: Baseline and 6 months
|
Colorectal-anal Distress Inventory is measured by the CRADI-8 at 6 months.
The range of responses is 1-4 with (1) Not at all, (2) Somewhat, (3) Moderately, and (4), Quite a bit.
Scores are calculated by multiplying the mean value of all questions answered by 25.
The range of responses is: 0-100 with 0 (least distress) to 100 (most distress).
|
Baseline and 6 months
|
Bowel Function After Vaginal Reconstruction Surgery With Restorelle Direct Fix A & P Measured by Colorectal-Anal Distress Inventory 8 (CRADI-8) Questionnaire at the12 Month Visit
Time Frame: Baseline and 12 months
|
Colorectal-anal Distress Inventory is measured by the CRADI-8 at 12 months.
The range of responses is 1-4 with (1) Not at all, (2) Somewhat, (3) Moderately, and (4), Quite a bit.
Scores are calculated by multiplying the mean value of all questions answered by 25.
The range of responses is: 0-100 with 0 (least distress) to 100 (most distress).
|
Baseline and 12 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Barry Jarnagin, MD, Center for Pelvic Health, Franklin, TN, United States
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2011
Primary Completion (Actual)
September 1, 2013
Study Completion (Actual)
September 1, 2013
Study Registration Dates
First Submitted
June 20, 2011
First Submitted That Met QC Criteria
June 21, 2011
First Posted (Estimate)
June 22, 2011
Study Record Updates
Last Update Posted (Actual)
May 12, 2020
Last Update Submitted That Met QC Criteria
April 29, 2020
Last Verified
April 1, 2020
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- US011
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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