Anterior Pelvic Organ ProlapsePhase 3Anterior SISNCT00955448
Trial of Small Intestine Submucosa (SIS) Mesh for Anterior Repair: A Pilot Study
A Phase 3 study testing SIS mesh (Cook Medical) and Anterior prolapse repair in people with Anterior Pelvic Organ Prolapse, run by University of Calgary at 1 site in Canada.
Trial summary
Prolapse occurs when pelvic organs drop down and cause a bulging of the tissues. An "anterior wall prolapse" occurs when the front of the vagina loses its support, and the bladder drops down and rotates into the vaginal opening. The bladder can cause a bulge out of the vagina. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Anterior Pelvic Organ Prolapse
- What is being tested?
- SIS mesh (Cook Medical) and Anterior prolapse repair
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 57 participants
- Where
- 1 siteCanada
- Study dates
- Dec 2009to Apr 2012
- Phase
- Phase 3
- 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Women who require surgical correction for anterior compartment prolapse. (Concomitant surgery is permitted.)
- Point Ba of 0 or greater: that is a positive Ba, indicating that the prolapse is beyond the introitus, not within the vagina.
- Patient must consent to participate in the study.
Who cannot join
- Having an obliterative procedure (Lefort procedure or colpocleisis).
- Allergy to graft material.
- Immunocompromised.
- Previous anterior compartment repair.
- Are unable to understand English.
- Will be unavailable for follow-up.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Controlled Trial of SIS Mesh for Anterior Repair: A Pilot Study
Prolapse occurs when pelvic organs drop down and cause a bulging of the tissues. An "anterior wall prolapse" occurs when the front of the vagina loses its support, and the bladder drops down and rotates into the vaginal opening. The bladder can cause a bulge out of the vagina.
One of the treatment options available is to repair the anterior wall surgically. The goals of surgery are to return the anatomy to its usual position, ensuring that all the pelvic floor organs (bladder, vagina and rectum) can function properly. The ideal surgical repair would also be long lasting.
Two surgical options are routinely performed in Calgary for repair of an anterior compartment prolapse. One option involves fixing the organs back in place using sutures. The other option uses sutures plus a mesh made of small intestine submucosa (SIS) that is already licensed for use in Canada. The SIS mesh is slowly absorbed after it is placed in the pelvic area. The investigators do not know which of these two options is the best surgical procedure. Both may have different advantages that would result in better results. This study is designed to try and find out if one of these procedures is better, and if a larger study may be needed.
- Conditions
- Anterior Pelvic Organ Prolapse
- Being tested
- SIS mesh (Cook Medical), Anterior prolapse repair
- Keywords
- Anterior pelvic organ prolapse, Surgical repair, Pelvic floor surgery, Randomized clinical trial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SIS mesh (Cook Medical)Device
Anterior prolapse repair will be reinforced using surgical mesh made from porcine small intestine mucosa (Cook Medical)
Anterior prolapse repairProcedure or surgery
Anterior prolapse repair will be conducted without using mesh reinforcement
| Study group | Role | What they receive |
|---|---|---|
| SIS Mesh (Cook Medical) | Experimental | Anterior prolapse repair will be reinforced using SIS mesh Receives: Device: SIS mesh (Cook Medical); Procedure: Anterior prolapse repair |
| No-mesh | Active comparator | Anterior prolapse repair with no mesh reinforcement Receives: Procedure: Anterior prolapse repair |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective assessment of prolapse. "Cure" is defined as point Ba (on POP-Q) of -1 or above (i.e., more negative)
Measured: 12 months postoperatively
Secondary outcomes (9)
Change in point Ba (on POP-Q) from baseline
Measured: 12 months postoperatively
Pelvic Organ Prolapse Quantification(POP-Q) stage
Measured: 12 months postoperatively
Change in POP-Q stage from baseline
Measured: 12 months postoperatively
Postoperative complications
Measured: 12 months postoperatively
Pelvic Floor Distress Inventory short form-20 (PFDI-20)
Measured: 12 months postoperatively
Pelvic Floor Impact Questionnaire short form-7 (PFIQ-7)
Measured: 12 months postoperatively
Sexual function (Pelvic Organ Prolapse/Urinary Incontinence Sexual Function Questionnaire (PISQ-12)
Measured: 12 months postoperatively
Surgical complications
Measured: Up to 6 weeks postoperatively
Satisfaction with surgical outcome
Measured: 12 months postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2009 (estimated)
- Study startDec 2009
- Primary completionApr 2012
- Study completionApr 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Anterior Pelvic Organ ProlapseStudies of the same condition, open and under way.
- More trials run by University of CalgaryThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Calgary
- Sponsor type
- University, hospital or other
- Collaborators
- Cook Group Incorporated, Alberta Health services
- Responsible party
- Principal investigator, Dr. Sue Ross, University of Calgary
- Investigators
- Magali Robert, MD, Principal investigator, University of Calgary
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00955448
- Sponsor's protocol ID
- Anterior SIS 300609
- Other IDs
- Ethics: E-22217
- Acronym
- Anterior SIS
- Status last verified
- Aug 2016
- First submitted
- 5 Aug 2009
- Last updated
- 31 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Robert M, Girard I, Brennand E, Tang S, Birch C, Murphy M, Ross S. Absorbable mesh augmentation compared with no mesh for anterior prolapse: a randomized controlled trial. Obstet Gynecol. 2014 Feb;123(2 Pt 1):288-294. doi: 10.1097/AOG.0000000000000105.
PubMed 24402595
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial of SIS Mesh for Anterior Repair: A Pilot Study
- ClinicalTrials.gov ID
- NCT00955448
- Acronym / sponsor ID
- Anterior SIS / Anterior SIS 300609
- Conditions
- Anterior Pelvic Organ Prolapse
- Keywords
- Anterior pelvic organ prolapse, Surgical repair, Pelvic floor surgery, Randomized clinical trial
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- University of CalgaryUniversity, hospital or other
- Collaborators
- Cook Group Incorporated, Alberta Health services
- Study start
- Dec 2009
- Primary completion
- Apr 2012 (actual)
- Study completion
- Apr 2012 (actual)
- First posted
- 10 Aug 2009 (estimated)
- 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.
Prolapse occurs when pelvic organs drop down and cause a bulging of the tissues. An "anterior wall prolapse" occurs when the front of the vagina loses its support, and the bladder drops down and rotates into the vaginal opening. The bladder can cause a bulge out of the vagina.
One of the treatment options available is to repair the anterior wall surgically. The goals of surgery are to return the anatomy to its usual position, ensuring that all the pelvic floor organs (bladder, vagina and rectum) can function properly. The ideal surgical repair would also be long lasting.
Two surgical options are routinely performed in Calgary for repair of an anterior compartment prolapse. One option involves fixing the organs back in place using sutures. The other option uses sutures plus a mesh made of small intestine submucosa (SIS) that is already licensed for use in Canada. The SIS mesh is slowly absorbed after it is placed in the pelvic area. The investigators do not know which of these two options is the best surgical procedure. Both may have different advantages that would result in better results. This study is designed to try and find out if one of these procedures is better, and if a larger study may be needed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SIS Mesh (Cook Medical) | Experimental | Device: SIS mesh (Cook Medical), Procedure: Anterior prolapse repairAnterior prolapse repair will be reinforced using SIS mesh |
| No-mesh | Active comparator | Procedure: Anterior prolapse repairAnterior prolapse repair with no mesh reinforcement |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Women who require surgical correction for anterior compartment prolapse. (Concomitant surgery is permitted.)
- Point Ba of 0 or greater: that is a positive Ba, indicating that the prolapse is beyond the introitus, not within the vagina.
- Patient must consent to participate in the study.
Key exclusion criteria (6 listed)
- Having an obliterative procedure (Lefort procedure or colpocleisis).
- Allergy to graft material.
- Immunocompromised.
- Previous anterior compartment repair.
- Are unable to understand English.
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 |
|---|---|---|
| SIS mesh (Cook Medical)Anterior prolapse repair will be reinforced using surgical mesh made from porcine small intestine mucosa (Cook Medical) | Device | SIS Mesh (Cook Medical) |
| Anterior prolapse repairAnterior prolapse repair will be conducted without using mesh reinforcement | Procedure or surgery | No-mesh, SIS Mesh (Cook Medical) |
Primary outcome
Objective assessment of prolapse. "Cure" is defined as point Ba (on POP-Q) of -1 or above (i.e., more negative)
Time frame: 12 months postoperatively
9 secondary outcomes
Change in point Ba (on POP-Q) from baseline
Time frame: 12 months postoperatively
Pelvic Organ Prolapse Quantification(POP-Q) stage
Time frame: 12 months postoperatively
Change in POP-Q stage from baseline
Time frame: 12 months postoperatively
Postoperative complications
Time frame: 12 months postoperatively
Pelvic Floor Distress Inventory short form-20 (PFDI-20)
Time frame: 12 months postoperatively
Pelvic Floor Impact Questionnaire short form-7 (PFIQ-7)
Time frame: 12 months postoperatively
Sexual function (Pelvic Organ Prolapse/Urinary Incontinence Sexual Function Questionnaire (PISQ-12)
Time frame: 12 months postoperatively
Surgical complications
Time frame: Up to 6 weeks postoperatively
Satisfaction with surgical outcome
Time frame: 12 months postoperatively
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 31 Aug 2016.
- Results publication: PubMed 24402595Robert M, Girard I, Brennand E, Tang S, Birch C, Murphy M, Ross S. Absorbable mesh augmentation compared with no mesh for anterior prolapse: a randomized controlled trial. Obstet Gynecol. 2014 Feb;123(2 Pt 1):288-294. doi: 10.1097/AOG.0000000000000105.
Related trials for Anterior Pelvic Organ Prolapse
Active, not recruitingObservational study
Clinical Outcomes of Rectopexy for Rectal Prolapse
Rectal Prolapse, Fecal Incontinence
Recruiting
Study Comparing Transobturator Cystocele vs. Anterior Vaginal RepairS
Pelvic Organ Prolapse, Cystocele
Active, not recruitingObservational study
To Explore the Surgical Outcomes and Safety of an Innovative Laparoscopic Uterine Pectopexy Technique Using Inverted T-meshes for Simultaneous Apical and Anterior Vaginal Repair.
Pelvic Organ Prolapse, Pelvic Organ Prolapse Vaginal Surgery
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.
Magali Robert, MD principal investigator
University of Calgary
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing SIS mesh (Cook Medical) and Anterior prolapse repair in people with Anterior Pelvic Organ Prolapse, run by University of Calgary at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. 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 31 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Objective assessment of prolapse. "Cure" is defined as point Ba (on POP-Q) of -1 or above (i.e., more negative) (time frame: 12 months postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00955448, which also lists 1 linked publication.
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 31 Aug 2016.