Restorelle Direct Fix Anterior and Posterior (A&P) for Female Pelvic Organ Prolapse: A Prospective Post Market Study ((A&P))

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Coloplast A/S
ClinicalTrials.gov Identifier:
NCT01378065
First received: June 20, 2011
Last updated: September 29, 2015
Last verified: September 2015
  Purpose
This is a prospective, multi-center study designed to assess the palpability of the Restorelle Direct Fix A&P mesh after vaginal reconstruction surgery.

Condition Intervention
Pelvic Organ Prolapse (POP)
Device: Restorelle Direct Fix A&P

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Restorelle Direct Fix A&P for Female Pelvic Organ Prolapse: A Prospective Post Market Study

Resource links provided by NLM:


Further study details as provided by Coloplast A/S:

Primary Outcome Measures:
  • Palpability of the Restorelle Direct Fix Anterior and Posterior (A&P) [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    Measured via palpability scale with possible outcomes of none, mild, moderate, or severe.

  • Palpability of the Restorelle Direct Fix A&P [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    Measured via palpability scale with possible outcomes of none, mild, moderate, or severe.

  • Palpability of the Restorelle Direct Fix A&P [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Measured via palpability scale with possible outcomes of none, mild, moderate, or severe.

  • Palpability of the Restorelle Direct Fix A&P [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Measured via palpability scale with possible outcomes of none, mild, moderate, or severe.

  • Palpability of the Restorelle Direct Fix A&P [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Measured via palpability scale with possible outcomes of none, mild, moderate, or severe.


Secondary Outcome Measures:
  • Rates of de Novo Dyspareunia [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]
    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."

  • Rates of de Novo Dyspareunia [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
    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."

  • Rates of de Novo Dyspareunia [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    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."

  • Rates of de Novo Dyspareunia [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    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."

  • 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 ] [ Designated as safety issue: No ]
    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).

  • 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 ] [ Designated as safety issue: No ]
    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).

  • 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 ] [ Designated as safety issue: No ]
    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).

  • 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 ] [ Designated as safety issue: No ]
    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).

  • Percentage of Participants With Mesh Exposure/Extrusion After Vaginal Reconstruction Surgery at 12 Months. [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    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."

  • 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 ] [ Designated as safety issue: No ]
    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).

  • 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 ] [ Designated as safety issue: No ]
    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).

  • 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 ] [ Designated as safety issue: No ]
    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).

  • 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 ] [ Designated as safety issue: No ]
    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).

  • Patient Global Impression of Improvement (PGI-I) Questionnaire Since Treatment at 6 Weeks. [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    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.

  • Patient Global Impression of Improvement (PGI-I) Index Since Treatment at 3 Months. [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    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.

  • Patient Global Impression of Improvement (PGI-I) Index Since Treatment at 6 Months. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    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.

  • Patient Global Impression of Improvement (PGI-I) Index Since Treatment at 12 Months. [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    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.

  • 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 ] [ Designated as safety issue: No ]
    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.

  • 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 ] [ Designated as safety issue: No ]
    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.

  • 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 ] [ Designated as safety issue: No ]
    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.

  • 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 ] [ Designated as safety issue: No ]
    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.

  • 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 ] [ Designated as safety issue: No ]
    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.

  • 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 ] [ Designated as safety issue: No ]
    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.

  • 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 ] [ Designated as safety issue: No ]
    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.

  • 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 ] [ Designated as safety issue: No ]
    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.

  • 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 ] [ Designated as safety issue: No ]
    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).

  • 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 ] [ Designated as safety issue: No ]
    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).

  • 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 ] [ Designated as safety issue: No ]
    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).

  • 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 ] [ Designated as safety issue: No ]
    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).


Enrollment: 31
Study Start Date: June 2011
Study Completion Date: September 2013
Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: Restorelle Direct Fix A&P
    Restorelle Direct Fix A&P is a permanently implantable synthetic mesh for reconstruction of the pelvic floor secondary to the prolapse or protrusion of the pelvic organs into or out of the vaginal canal.
  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Subjects satisfying criteria for inclusion in the study were enrolled.
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01378065

Locations
United States, Maryland
MedStar Health Research Institute at Baltimore
Baltimore, Maryland, United States, 21237
United States, Michigan
Female Pelvic Medicine & Urogynecology Institute of MI
Grand Rapids, Michigan, United States, 49503
United States, Missouri
Central Missouri Women's Healthcare
Marshall, Missouri, United States, 65340
United States, Tennessee
Center for Pelvic Health
Franklin, Tennessee, United States, 37067
United States, Virginia
The Group for Women
Norfolk, Virginia, United States, 23502
United States, Washington
Integrity Medical Research, LLC
Mountlake Terrace, Washington, United States, 98043
Sponsors and Collaborators
Coloplast A/S
Investigators
Principal Investigator: Barry Jarnagin, MD Center for Pelvic Health, Franklin, TN, United States
  More Information

Responsible Party: Coloplast A/S
ClinicalTrials.gov Identifier: NCT01378065     History of Changes
Other Study ID Numbers: US011 
Study First Received: June 20, 2011
Results First Received: August 20, 2015
Last Updated: September 29, 2015
Health Authority: United States: Institutional Review Board

Keywords provided by Coloplast A/S:
POP
pelvic organ prolapse
anterior prolapse
posterior prolapse
vaginal prolapse
vaginal floor reconstruction

Additional relevant MeSH terms:
Prolapse
Pelvic Organ Prolapse
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on August 23, 2016