Clinical trial NCT01378065: Restorelle Direct Fix Anterior and Posterior (A&P) for Female Pelvic Organ Prolapse: A Prospective Post Market Study
Official title: Restorelle Direct Fix A&P for Female Pelvic Organ Prolapse: A Prospective Post Market Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pelvic Organ Prolapse (POP)
Keywords: POP
pelvic organ prolapse
anterior prolapse
posterior prolapse
vaginal prolapse
vaginal floor reconstruction
Lead sponsor: Coloplast A/S
Sponsor class: INDUSTRY
First posted: 2011-06-22
Enrollment: 31
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects satisfying criteria for inclusion in the study were enrolled.

Brief 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.


Eligibility 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

Primary outcomes:
measure: Palpability of the Restorelle Direct Fix Anterior and Posterior (A&P)
timeFrame: Baseline
measure: Palpability of the Restorelle Direct Fix A&P
timeFrame: 6 weeks
measure: Palpability of the Restorelle Direct Fix A&P
timeFrame: 3 months
measure: Palpability of the Restorelle Direct Fix A&P
timeFrame: 6 months
measure: Palpability of the Restorelle Direct Fix A&P
timeFrame: 12 months
Secondary outcomes:
measure: Rates of de Novo Dyspareunia
timeFrame: 6 weeks
measure: Rates of de Novo Dyspareunia
timeFrame: 3 months
measure: Rates of de Novo Dyspareunia
timeFrame: 6 months
measure: Rates of de Novo Dyspareunia
timeFrame: 12 months
measure: 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
timeFrame: 6 weeks
measure: 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
timeFrame: 3 months
measure: 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
timeFrame: 6 months
measure: 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
timeFrame: 12 months
measure: Percentage of Participants With Mesh Exposure/Extrusion After Vaginal Reconstruction Surgery at 12 Months.
timeFrame: 12 months
measure: 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
timeFrame: 6 week
measure: 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
timeFrame: 3 month
measure: 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
timeFrame: 6 month
measure: 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
timeFrame: 12 month
measure: Patient Global Impression of Improvement (PGI-I) Questionnaire Since Treatment at 6 Weeks.
timeFrame: 6 weeks
measure: Patient Global Impression of Improvement (PGI-I) Index Since Treatment at 3 Months.
timeFrame: 3 months
measure: Patient Global Impression of Improvement (PGI-I) Index Since Treatment at 6 Months.
timeFrame: 6 months
measure: Patient Global Impression of Improvement (PGI-I) Index Since Treatment at 12 Months.
timeFrame: 12 months
measure: Bladder Function After Vaginal Reconstruction Surgery With Restorelle Direct Fix A & P Measured by Urinary Distress Inventory-6 (UDI-6) Questionnaire at 6 Weeks
timeFrame: Baseline and 6 weeks
measure: Bladder Function After Vaginal Reconstruction Surgery With Restorelle Direct Fix A & P Measured by Urinary Distress Inventory-6 (UDI-6) Questionnaire at 3 Months
timeFrame: Baseline and 3 months
measure: Bladder Function After Vaginal Reconstruction Surgery With Restorelle Direct Fix A & P Measured by Urinary Distress Inventory-6 (UDI-6) Questionnaire at 6 Months
timeFrame: Baseline and 6 months
measure: Bladder Function After Vaginal Reconstruction Surgery With Restorelle Direct Fix A & P Measured by Urinary Distress Inventory-6 (UDI-6) Questionnaire at 12 Months
timeFrame: Baseline and 12 months
measure: Sexual Function After Vaginal Reconstruction With Restorelle Direct Fix Measured by Participant Sexual Function Questionnaire-12 (PISQ-12) at 6 Weeks
timeFrame: Baseline and 6 weeks
measure: Sexual Function After Vaginal Reconstruction With Restorelle Direct Fix Measured by Participant Sexual Function Questionnaire-12 (PISQ-12) at 3 Months
timeFrame: Baseline and 3 months
measure: Sexual Function After Vaginal Reconstruction With Restorelle Direct Fix Measured by Participant Sexual Function Questionnaire-12 (PISQ-12) at 6 Months
timeFrame: Baseline and 6 months
measure: Sexual Function After Vaginal Reconstruction With Restorelle Direct Fix Measured by Participant Sexual Function Questionnaire-12 (PISQ-12) at 12 Months
timeFrame: Baseline and 12 months
measure: 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
timeFrame: Baseline and 6 weeks
measure: 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
timeFrame: Baseline and 3 months
measure: 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
timeFrame: Baseline and 6 months
measure: 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
timeFrame: Baseline and 12 months
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: MedStar Health Research Institute at Baltimore
state: Maryland
city: Grand Rapids
country: United States
facility: Female Pelvic Medicine & Urogynecology Institute of MI
state: Michigan
city: Marshall
country: United States
facility: Central Missouri Women's Healthcare
state: Missouri
city: Franklin
country: United States
facility: Center for Pelvic Health
state: Tennessee
city: Norfolk
country: United States
facility: The Group for Women
state: Virginia
city: Mountlake Terrace
country: United States
facility: Integrity Medical Research, LLC
state: Washington
Study officials:
affiliation: Center for Pelvic Health, Franklin, TN, United States
name: Barry Jarnagin, MD
role: PRINCIPAL_INVESTIGATOR
References: