Pelvic Organ ProlapseNCT01614587
Do Patients With Early Post Operative Recurrence of Pelvic Organ Prolapse Have a Genetic Predisposition?
An observational study of Pelvic Organ Prolapse, run by Atlantic Health System at 1 site in United States.
Trial summary
The objective is to explore the genetic predisposition to early pelvic organ prolapse after adequate surgical repair by exploring the association between pelvic organ prolapse recurrences and certain polymorphisms. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Pelvic Organ Prolapse
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2012to Apr 2015
- Phase
- Observational
- 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
Study population: Women suffering from pelvic organ prolapse
Who may be able to join
- Cases: early, unexplained recurrence (within 6 months of procedure) after sacrocolpopexy), the recurrence required treatment (surgery or pessary) Controls: sacrocolpopexy during the same period, no recurrence, no reoperation, no retreatment to date (minimum of 12 months from surgery)
Who cannot join
- Obvious surgical technical failure
- Use of other graft material than polypropylene mesh
- Planned two staged operation
- Contraindications to surgery based on existing medical conditions
- Pregnancy
- Desire for pregnancy in the future
Trial locations and contacts
1 site in 1 country.
United States1 site
Atlantic Health System
Morristown, New Jersey, 07960
About this study
The objective is to explore the genetic predisposition to early pelvic organ prolapse after adequate surgical repair by exploring the association between pelvic organ prolapse recurrences and certain polymorphisms.
Read the detailed description
Pelvic organ prolapse develops as a result of a loss of support provided by the muscles and fascia that constitute the pelvic floor. Several recent population studies have estimated the prevalence of pelvic organ prolapse at between 10% and 30%. One in nine women will undergo surgery for these disorders in her lifetime and of these, one third will undergo repeated surgeries. The correction of pelvic organ protrusion is aimed at restoring the pelvic floor functional status and ultimately improving the patients quality of life. There are a few studies that have explored the genetic predisposition to developing pelvic organ prolapse but none so far looks at genetic factors involved in prolapse recurrence after adequate prolapse repair. There are two groups of women: women who underwent adequate repair of their prolapse and had an unexplained early recurrence. And a second control group of women who underwent the same prolapse repair procedure and had no further prolapse recurrence.
- Conditions
- Pelvic Organ Prolapse
- Keywords
- pelvic organ prolapse, recurrence of pelvic organ prolapse, genetic predisposition, SNP microarray analysis, pelvic floor, genetic factors, adequate prolapse repair, polymorphisms, surgical failure, reoperation, DNA, buccal swabs, TaqMan SNP allelic discriminiation assays, duplex real-time PCR, genome-wide SNP microarrays, next-generation sequencing
- Medical subject headings
- Pelvic Organ Prolapse, Genetic Predisposition to Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Cases | 1. Early, unexplained recurrence (within six months of procedure) after Sacrocolpopexy 2. The recurrence required treatment (surgery or pessary) | |
| Controls | 1. Sacrocolpopexy during the same period 2. No recurrence, no reoperation, no retreatment to date (minimum of 12 months from surgery) |
What is being measured
The primary outcome is the main question the study is designed to answer.
SNP microarray analysis from recurrent prolapse subjects and controls
DNA will be evaluated by a variety of methods. For example, candidate polymorphisms may be evaluated using TaqMan SNP allelic discrimination assays which are based upon duplex real-time PCR. In addition, genome-wide SNP microarrays may be employed in order to perform a whole genome association study. Additional analysis such as DNA resequencing may also be required in order to identify causative polymorphisms linked to the newly associated SNPs. Other methods of DNA analysis such as next-generation sequencing may also be warranted.
Measured: 12 months post-operative, DNA will be collected
Secondary outcomes (1)
Compare all peri-operative characteristics and demographics between groups
Perioperative data will include: age, date of surgery, repeat procedure or treatment, procedure and mesh used, mesh related complications, early post-operative complications. Descriptive statistics will be derived for the entire group. The two subgroups (case and control) will then be compared using: Student t test, Fisher exact test, and Wilcoxon rank-sum test for continuous, nonparametric categorical and nonparametric ordinal variables, respectively.
Measured: 12 months post-operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2012 (estimated)
- Study startMar 2012
- Primary completionApr 2015
- Study completionApr 2015
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 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Atlantic Health System
- Sponsor type
- University, hospital or other
- Collaborators
- Reproductive Medicine Associates of New Jersey
- Responsible party
- Sponsor
- Investigators
- Richard Scott, MD, Principal investigator, Reproductive Medicine AssociatesPatrick Culligan, MD, Principal investigator, Atlantic Health SystemCharbel Salamon, MD, Principal investigator, Atlantic Health System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01614587
- Sponsor's protocol ID
- R11-10-004
- Status last verified
- Jun 2017
- First submitted
- 31 May 2012
- Last updated
- 9 Jun 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
St Louis S, Scott R, Lewis C, Salamon C, Pagnillo J, Treff N, Taylor D, Culligan P. Genetic Mutation that May Contribute to Failure of Prolapse Surgery in White Women: A Case-Control Study. J Minim Invasive Gynecol. 2016 Jul-Aug;23(5):726-30. doi: 10.1016/j.jmig.2016.02.019. Epub 2016 Mar 2.
PubMed 26944198
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Do Patients With Early Post Operative Recurrence of Pelvic Organ Prolapse Have a Genetic Predisposition?
- ClinicalTrials.gov ID
- NCT01614587
- Acronym / sponsor ID
- R11-10-004
- Conditions
- Pelvic Organ Prolapse
- Keywords
- pelvic organ prolapse, recurrence of pelvic organ prolapse, genetic predisposition, SNP microarray analysis, pelvic floor, genetic factors, adequate prolapse repair, polymorphisms
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Atlantic Health SystemUniversity, hospital or other
- Collaborators
- Reproductive Medicine Associates of New Jersey
- Study start
- Mar 2012
- Primary completion
- Apr 2015 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 8 Jun 2012 (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.
The objective is to explore the genetic predisposition to early pelvic organ prolapse after adequate surgical repair by exploring the association between pelvic organ prolapse recurrences and certain polymorphisms.
Detailed description
Pelvic organ prolapse develops as a result of a loss of support provided by the muscles and fascia that constitute the pelvic floor. Several recent population studies have estimated the prevalence of pelvic organ prolapse at between 10% and 30%. One in nine women will undergo surgery for these disorders in her lifetime and of these, one third will undergo repeated surgeries. The correction of pelvic organ protrusion is aimed at restoring the pelvic floor functional status and ultimately improving the patients quality of life. There are a few studies that have explored the genetic predisposition to developing pelvic organ prolapse but none so far looks at genetic factors involved in prolapse recurrence after adequate prolapse repair. There are two groups of women: women who underwent adequate repair of their prolapse and had an unexplained early recurrence. And a second control group of women who underwent the same prolapse repair procedure and had no further prolapse recurrence.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cases | – | –1. Early, unexplained recurrence (within six months of procedure) after Sacrocolpopexy 2. The recurrence required treatment (surgery or pessary) |
| Controls | – | –1. Sacrocolpopexy during the same period 2. No recurrence, no reoperation, no retreatment to date (minimum of 12 months from surgery) |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Women suffering from pelvic organ prolapse
Key inclusion criteria (1 listed)
- Cases: early, unexplained recurrence (within 6 months of procedure) after sacrocolpopexy), the recurrence required treatment (surgery or pessary) Controls: sacrocolpopexy during the same period, no recurrence, no reoperation, no retreatment to date (minimum of 12 months from surgery)
Key exclusion criteria (6 listed)
- Obvious surgical technical failure
- Use of other graft material than polypropylene mesh
- Planned two staged operation
- Contraindications to surgery based on existing medical conditions
- Pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
SNP microarray analysis from recurrent prolapse subjects and controls
Time frame: 12 months post-operative, DNA will be collected
DNA will be evaluated by a variety of methods. For example, candidate polymorphisms may be evaluated using TaqMan SNP allelic discrimination assays which are based upon duplex real-time PCR. In addition, genome-wide SNP microarrays may be employed in order to perform a whole genome association study. Additional analysis such as DNA resequencing may also be required in order to identify causative polymorphisms linked to the newly associated SNPs. Other methods of DNA analysis such as next-generation sequencing may also be warranted.
1 secondary outcome
Compare all peri-operative characteristics and demographics between groups
Time frame: 12 months 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 9 Jun 2017.
- Derived from this study: PubMed 26944198St Louis S, Scott R, Lewis C, Salamon C, Pagnillo J, Treff N, Taylor D, Culligan P. Genetic Mutation that May Contribute to Failure of Prolapse Surgery in White Women: A Case-Control Study. J Minim Invasive Gynecol. 2016 Jul-Aug;23(5):726-30. doi: 10.1016/j.jmig.2016.02.019. Epub 2016 Mar 2.
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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.
Richard Scott, MD principal investigator
Reproductive Medicine Associates
Patrick Culligan, MD principal investigator
Atlantic Health System
Charbel Salamon, MD principal investigator
Atlantic Health System
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pelvic Organ Prolapse, run by Atlantic Health System at 1 site in United States.
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 1 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 9 Jun 2017. 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 United States. 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.
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?
SNP microarray analysis from recurrent prolapse subjects and controls (time frame: 12 months post-operative, DNA will be collected). 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 NCT01614587, 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 9 Jun 2017.