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

Pelvic Organ Prolapse (POP) Clinical Trial

— (A&P)  

Official title:

Restorelle Direct Fix A&P for Female Pelvic Organ Prolapse: A Prospective Post Market Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01378065
• Other study ID #: US011
• Status: Completed
• Start date: June 2011
• Est. completion date: September 2013

Study information

• Verified date: April 2020
• Source: Coloplast A/S
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This is a prospective, multi-center study designed to assess the palpability of the Restorelle Direct Fix A&P mesh after vaginal reconstruction surgery.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: September 2013
• Est. primary completion date: September 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Pelvic Organ Prolapse
• Pelvic Organ Prolapse (POP)
• Prolapse

Intervention

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.

Locations

Country	Name	City	State
United States	MedStar Health Research Institute at Baltimore	Baltimore	Maryland
United States	Center for Pelvic Health	Franklin	Tennessee
United States	Female Pelvic Medicine & Urogynecology Institute of MI	Grand Rapids	Michigan
United States	Central Missouri Women's Healthcare	Marshall	Missouri
United States	Integrity Medical Research, LLC	Mountlake Terrace	Washington
United States	The Group for Women	Norfolk	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
Coloplast A/S

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Palpability of the Restorelle Direct Fix Anterior and Posterior (A&P)	Measured via palpability scale with possible outcomes of none, mild, moderate, or severe.	Baseline
Primary	Palpability of the Restorelle Direct Fix A&P	Measured via palpability scale with possible outcomes of none, mild, moderate, or severe.	6 weeks
Primary	Palpability of the Restorelle Direct Fix A&P	Measured via palpability scale with possible outcomes of none, mild, moderate, or severe.	3 months
Primary	Palpability of the Restorelle Direct Fix A&P	Measured via palpability scale with possible outcomes of none, mild, moderate, or severe.	6 months
Primary	Palpability of the Restorelle Direct Fix A&P	Measured via palpability scale with possible outcomes of none, mild, moderate, or severe.	12 months
Secondary	Rates of de Novo Dyspareunia	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
Secondary	Rates of de Novo Dyspareunia	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
Secondary	Rates of de Novo Dyspareunia	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
Secondary	Rates of de Novo Dyspareunia	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
Secondary	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	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
Secondary	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	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
Secondary	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	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
Secondary	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	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
Secondary	Percentage of Participants With Mesh Exposure/Extrusion After Vaginal Reconstruction Surgery at 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
Secondary	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	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
Secondary	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	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
Secondary	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	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
Secondary	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	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
Secondary	Patient Global Impression of Improvement (PGI-I) Questionnaire Since Treatment at 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
Secondary	Patient Global Impression of Improvement (PGI-I) Index Since Treatment at 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
Secondary	Patient Global Impression of Improvement (PGI-I) Index Since Treatment at 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
Secondary	Patient Global Impression of Improvement (PGI-I) Index Since Treatment at 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
Secondary	Bladder Function After Vaginal Reconstruction Surgery With Restorelle Direct Fix A & P Measured by Urinary Distress Inventory-6 (UDI-6) Questionnaire at 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
Secondary	Bladder Function After Vaginal Reconstruction Surgery With Restorelle Direct Fix A & P Measured by Urinary Distress Inventory-6 (UDI-6) Questionnaire at 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
Secondary	Bladder Function After Vaginal Reconstruction Surgery With Restorelle Direct Fix A & P Measured by Urinary Distress Inventory-6 (UDI-6) Questionnaire at 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
Secondary	Bladder Function After Vaginal Reconstruction Surgery With Restorelle Direct Fix A & P Measured by Urinary Distress Inventory-6 (UDI-6) Questionnaire at 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
Secondary	Sexual Function After Vaginal Reconstruction With Restorelle Direct Fix Measured by Participant Sexual Function Questionnaire-12 (PISQ-12) at 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
Secondary	Sexual Function After Vaginal Reconstruction With Restorelle Direct Fix Measured by Participant Sexual Function Questionnaire-12 (PISQ-12) at 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
Secondary	Sexual Function After Vaginal Reconstruction With Restorelle Direct Fix Measured by Participant Sexual Function Questionnaire-12 (PISQ-12) at 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
Secondary	Sexual Function After Vaginal Reconstruction With Restorelle Direct Fix Measured by Participant Sexual Function Questionnaire-12 (PISQ-12) at 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
Secondary	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	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
Secondary	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	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
Secondary	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	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
Secondary	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	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