Pelvic Organ ProlapseARCUSNCT04085952
Anterior Prolapse Repair With and Without Graft Augmentation
A study testing dermal graft (ARCUS repliform) for anterior colporrhaphy and suture based anterior colporrhaphy in people with Pelvic Organ Prolapse, run by Endeavor Health.
Trial summary
This is a randomized control trial comparing anterior colporrhaphy with augmentation with dermal allograft (ARCUS) to anterior colporrhaphy with a suture-based repair (native tissue). Patients were randomized to one treatment and then were followed post-operatively for 7-10 years. Read more about this study
- Who is it for?
- Ages 18 to 100 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pelvic Organ Prolapse
- What is being tested?
- dermal graft (ARCUS repliform) for anterior colporrhaphy and suture based anterior colporrhaphy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 114 participants
- Where
- No sites listed yet
- Study dates
- Jan 2005to Jan 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Inclusion Criteria: Any patient planning to undergo surgery for anterior compartment prolapse, English speaking.
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Exclusion Criteria: Any patient who does not speak English due to standardized English language based questionaires, and patients without anterior compartment prolapse.
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About this study
Official title: Comparing Anterior Prolapse Repair With and Without Allograft Use: A Randomized Control Trial With Long Term Follow-Up
This is a randomized control trial comparing anterior colporrhaphy with augmentation with dermal allograft (ARCUS) to anterior colporrhaphy with a suture-based repair (native tissue). Patients were randomized to one treatment and then were followed post-operatively for 7-10 years. Prior to surgery patients had a POPQ vaginal prolapse exam and completed a quality of life questionaire (PFDI). They had a repeat POPQ exam and quality of life questionaires at their post-op operative visits. We compare recurrent prolapse rates between these 2 groups.
Read the detailed description
Objective: To determine whether dermal allograft (ARCUS) reduces anterior prolapse recurrence at 1 and 7-10 years post-operatively. Our central question is whether we can reduce the rate of rate of anterior compartment prolapse recurrence after surgical repair, is the recurrence rate reduced with allograft use, and does this benefit hold up over time?
Methods: Patient will be randomized by computer generated block randomization to native tissue (suture based) anterior colporrhaphy or colporrhaphy with graft (ARCUS) usage. Neither patients nor surgeons will be blinded due to the nature of the surgery. Patients will be followed for 7-10 years post-operatively. Participants will complete a POPQ exam and the PFDI (Pelvic Floor Distress Inventory) questionnaire pre-operatively. Patients will return for a POPQ exam at 1 year post-operatively and complete the PFDI (Pelvic Floor Distress Inventory) and PISQ (Sexual Function for Women with: POP, Urinary Incontinence and/or Fecal Incontinence) questionnaires. Patients will be asked to return to the office for a research visit 7-10 years post-operatively for a POPQ exam and to complete quality of life questionnaires including PFDI 20 (Pelvic floor distress inventory), PISQ-R (Sexual Function for Women with: POP, Urinary Incontinence and/or Fecal Incontinence, Revised), and PGI (Patient global assessment of improvement).
- Conditions
- Pelvic Organ Prolapse
- Being tested
- dermal graft (ARCUS repliform) for anterior colporrhaphy, suture based anterior colporrhaphy
- Keywords
- pelvic organ prolapse, vaginal graft
- Medical subject headings
- Pelvic Organ Prolapse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dermal graft (ARCUS repliform) for anterior colporrhaphyProcedure or surgery
At the time of surgery patients were randomized to anterior colporrhaphy with dermal graft augmentation
suture based anterior colporrhaphyProcedure or surgery
At the time of surgery patients were randomized to anterior colporrhaphy with a suture based repair
| Study group | Role | What they receive |
|---|---|---|
| anterior colporrhaphy with dermal graft | Experimental | Patients randomized to this arm underwent anterior colporrhaphy with dermal graft augmentation (ARUCS) during their surgery for pelvic organ prolapse. Receives: Procedure: dermal graft (ARCUS repliform) for anterior colporrhaphy |
| anterior colporrhaphy suture based | Active comparator | Patients randomized to this arm underwent anterior colporrhaphy with suture based repair (native tissue) during their surgery for pelvic organ prolapse. This is and was the most common practice for anterior colporrhaphy. Receives: Procedure: suture based anterior colporrhaphy |
What is being measured
The primary outcome is the main question the study is designed to answer.
1-Year Recurrent prolapse- anatomic
Failure of prolapse surgery as measured by changes in POPQ measurements, Aa and Ba to -1 or greater
Measured: 1 year post-operative
7-10 Years Recurrent prolapse-anatomic
Failure of prolapse surgery as measured by changes in POPQ measurements, Aa and Ba to -1 or greater
Measured: 7-10 years post-operative
Secondary outcomes (2)
1 Year composite score
Failure of prolapse surgery as measured as a composite outcome including anatomic failure measured by changes to Aa and Ba points to -1 or greater, "yes" to PFDI question #3, and retreatment with pessary or surgery for anterior compartment prolapse
Measured: 1 year post-operative
7-10 years composite score
Failure of prolapse surgery as measured as a composite outcome including anatomic failure measured by changes to Aa and Ba points to -1 or greater, "yes" to PFDI question #3, and retreatment with pessary or surgery for anterior compartment prolapse
Measured: 7-10 years post-operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2019
- Study startJan 2005
- Primary completionJan 2009
- Study completionJan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pelvic Organ ProlapseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 114 participants (actual)
Sponsor and investigators
- Lead sponsor
- Endeavor Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Peter Sand, MD, Principal investigator, North Shore Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04085952
- Sponsor's protocol ID
- EH04-302
- Acronym
- ARCUS
- Status last verified
- Sep 2019
- First submitted
- 28 Apr 2017
- Last updated
- 11 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing Anterior Prolapse Repair With and Without Allograft Use: A Randomized Control Trial With Long Term Follow-Up
- ClinicalTrials.gov ID
- NCT04085952
- Acronym / sponsor ID
- ARCUS / EH04-302
- Conditions
- Pelvic Organ Prolapse
- Keywords
- pelvic organ prolapse, vaginal graft
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 114 participants (actual)
- Lead sponsor
- Endeavor HealthUniversity, hospital or other
- Study start
- Jan 2005
- Primary completion
- Jan 2009 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 11 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a randomized control trial comparing anterior colporrhaphy with augmentation with dermal allograft (ARCUS) to anterior colporrhaphy with a suture-based repair (native tissue). Patients were randomized to one treatment and then were followed post-operatively for 7-10 years. Prior to surgery patients had a POPQ vaginal prolapse exam and completed a quality of life questionaire (PFDI). They had a repeat POPQ exam and quality of life questionaires at their post-op operative visits. We compare recurrent prolapse rates between these 2 groups.
Detailed description
Objective: To determine whether dermal allograft (ARCUS) reduces anterior prolapse recurrence at 1 and 7-10 years post-operatively. Our central question is whether we can reduce the rate of rate of anterior compartment prolapse recurrence after surgical repair, is the recurrence rate reduced with allograft use, and does this benefit hold up over time?
Methods: Patient will be randomized by computer generated block randomization to native tissue (suture based) anterior colporrhaphy or colporrhaphy with graft (ARCUS) usage. Neither patients nor surgeons will be blinded due to the nature of the surgery. Patients will be followed for 7-10 years post-operatively. Participants will complete a POPQ exam and the PFDI (Pelvic Floor Distress Inventory) questionnaire pre-operatively. Patients will return for a POPQ exam at 1 year post-operatively and complete the PFDI (Pelvic Floor Distress Inventory) and PISQ (Sexual Function for Women with: POP, Urinary Incontinence and/or Fecal Incontinence) questionnaires. Patients will be asked to return to the office for a research visit 7-10 years post-operatively for a POPQ exam and to complete quality of life questionnaires including PFDI 20 (Pelvic floor distress inventory), PISQ-R (Sexual Function for Women with: POP, Urinary Incontinence and/or Fecal Incontinence, Revised), and PGI (Patient global assessment of improvement).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| anterior colporrhaphy with dermal graft | Experimental | Procedure: dermal graft (ARCUS repliform) for anterior colporrhaphyPatients randomized to this arm underwent anterior colporrhaphy with dermal graft augmentation (ARUCS) during their surgery for pelvic organ prolapse. |
| anterior colporrhaphy suture based | Active comparator | Procedure: suture based anterior colporrhaphyPatients randomized to this arm underwent anterior colporrhaphy with suture based repair (native tissue) during their surgery for pelvic organ prolapse. This is and was the most common practice for anterior colporrhaphy. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| dermal graft (ARCUS repliform) for anterior colporrhaphyAt the time of surgery patients were randomized to anterior colporrhaphy with dermal graft augmentation | Procedure or surgery | anterior colporrhaphy with dermal graft |
| suture based anterior colporrhaphyAt the time of surgery patients were randomized to anterior colporrhaphy with a suture based repair | Procedure or surgery | anterior colporrhaphy suture based |
Primary outcome
1-Year Recurrent prolapse- anatomic
Time frame: 1 year post-operative
Failure of prolapse surgery as measured by changes in POPQ measurements, Aa and Ba to -1 or greater
7-10 Years Recurrent prolapse-anatomic
Time frame: 7-10 years post-operative
Failure of prolapse surgery as measured by changes in POPQ measurements, Aa and Ba to -1 or greater
2 secondary outcomes
1 Year composite score
Time frame: 1 year post-operative
7-10 years composite score
Time frame: 7-10 years post-operative
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Peter Sand, MD principal investigator
North Shore Research Institute
Questions about this trial
What is this clinical trial studying?
A study testing dermal graft (ARCUS repliform) for anterior colporrhaphy and suture based anterior colporrhaphy in people with Pelvic Organ Prolapse, run by Endeavor Health.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
1-Year Recurrent prolapse- anatomic (time frame: 1 year post-operative). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2019.