Pelvic Organ ProlapseNCT01548105
Systemic Markers of Collagen Metabolism and Vitamin C in Smokers and Non-Smokers With Pelvic Organ Prolapse
An observational study of Pelvic Organ Prolapse, run by TriHealth Inc. at 1 site in United States.
Trial summary
Data on smoking and POP are conflicting. In a study done by Alnaif et al, smoking was found to be associated with severe POP. The authors' proposed explanation was that smoking impairs tissue and wound healing. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pelvic Organ Prolapse
- What is being tested?
- Blood draw for the study participants
- How many people
- 96 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2012to Mar 2013
- 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 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients with pelvic organ prolapse and without prolapse will be identified based on a manual review of patients in a tertiary care referral-based Urogynecology practice
Who may be able to join
- More than 18 years old
- Symptomatic POP at or beyond the hymen as determined by physical examination and a positive answer to the screening questions
- For smoker group- smoke more than one pack per day
- For non smoker group- non smoker for more than 7 years
- No Prolapse group:
- Absence of prolapse and negative answer to the screening questions
Who cannot join
- Using Hormone Replacement Therapy (systemic estrogen, progesterone or testosterone)
- Using vaginal estrogen (cream, ring, tablet)
- Chronic steroid use
- Past medical history of connective tissue disease
- Scurvy, malabsorption, alcoholism, pregnancy, hyperthyroidism, liver disease and renal failure
Trial locations and contacts
1 site in 1 country.
About this study
Data on smoking and POP are conflicting. In a study done by Alnaif et al, smoking was found to be associated with severe POP. The authors' proposed explanation was that smoking impairs tissue and wound healing. Our primary objective is to document whether smokers with pelvic organ prolapse (POP) are different from non-smokers with POP with respect to collagen biosynthesis and breakdown using systemic markers of collagen metabolism and Vitamin C.
Read the detailed description
Tissue destructive disorders are more common in smokers than in non-smokers. Alterations in wound healing and connective tissue turnover are suggested mechanisms, but exact details remain to be discovered. The synthesis of subcutaneous collagen in smokers is specifically impeded, and that smokers have less collagen compared to non-smokers. Jorgensen et al study showed that smokers tend to have less procollagen I N-propeptide (PINP) levels in the blood, less vitamin C and higher levels of matrix metalloproteinase (MMP-9), these findings reversed after smoking cessation.
Since smoking is one of the promoting and modifiable factors in the development of prolapse, understanding its effects on the support of pelvic organs may help modify the course of the POP condition in the future. Understanding the connective tissue effects of smoking using systemic markers of collagen metabolism in female smokers with prolapse may help future management and counseling of these patients. In addition, description of the markers of collagen metabolism in POP has not previously been documented.
- Conditions
- Pelvic Organ Prolapse
- Being tested
- Blood draw for the study participants
- Keywords
- Pelvic organ prolapse, smoking and collagen metabolism
- Medical subject headings
- Pelvic Organ Prolapse, Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood draw for the study participantsOther
These will include:
- Procollagen 1-N propeptide levels (PINP)
- Matrix metalloproteinase (MMP9)
- Plasma Vitamin C levels
| Study group | Role | What they receive |
|---|---|---|
| Prolapse and Smoker | Patients in this arm have been determined to have more than stage 2 pelvic organ prolapse and have been smoking more than one pack per day Blood draw for the study participants will be done. These will include: Procollagen 1-N propeptide levels (PINP), Matrix metalloproteinase (MMP9) and Plasma Vitamin C levels Receives: Other: Blood draw for the study participants | |
| Prolapse and non smoker | Patients in this arm have been determined to have more than stage 2 pelvic organ prolapse and non smoker for more than 7 years Blood draw for the study participants will be done. These will include: Procollagen 1-N propeptide levels (PINP), Matrix metalloproteinase (MMP9) and Plasma Vitamin C levels Receives: Other: Blood draw for the study participants | |
| No prolapse and smoker | Patients in this arm, have been determined not to have prolapse and smokes more than 1 pack per day Blood draw for the study participants will be done. These will include: Procollagen 1-N propeptide levels (PINP), Matrix metalloproteinase (MMP9) and Plasma Vitamin C levels Receives: Other: Blood draw for the study participants | |
| No prolapse and non smoker | Patients in this arm have been determined not to have prolapse and non smoker for more than 7 years Blood draw for the study participants will be done. These will include: Procollagen 1-N propeptide levels (PINP), Matrix metalloproteinase (MMP9) and Plasma Vitamin C levels Receives: Other: Blood draw for the study participants |
What is being measured
The primary outcome is the main question the study is designed to answer.
Our primary objective is to document whether smokers with pelvic organ prolapse (POP) are different from non-smokers with POP with respect to collagen biosynthesis and breakdown using systemic markers of collagen metabolism.
These will include blood levels of the following:
- Procollagen 1-N propeptide levels (PINP)
- Matrix metalloproteinase (MMP9)
- Plasma Vitamin C levels
Measured: One day- day of blood draw
Secondary outcomes (1)
• A secondary objective will be to determine whether women with pelvic organ prolapse are different than healthy controls with respect to the same systemic markers
Measured: One day- day of blood draw
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2012 (estimated)
- Study startMar 2012
- Primary completionJan 2013
- Study completionMar 2013
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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- TriHealth Inc.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Maria Victoria C Estanol, MD, Principal investigator, Good Samaritan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01548105
- Sponsor's protocol ID
- Smoking and prolapse
- Status last verified
- Feb 2014
- First submitted
- 4 Mar 2012
- Last updated
- 17 Oct 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Systemic Markers of Collagen Metabolism and Vitamin C in Smokers and Non-Smokers With Pelvic Organ Prolapse
- ClinicalTrials.gov ID
- NCT01548105
- Acronym / sponsor ID
- Smoking and prolapse
- Conditions
- Pelvic Organ Prolapse
- Keywords
- Pelvic organ prolapse, smoking and collagen metabolism
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- TriHealth Inc.University, hospital or other
- Study start
- Mar 2012
- Primary completion
- Jan 2013 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 8 Mar 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.
Data on smoking and POP are conflicting. In a study done by Alnaif et al, smoking was found to be associated with severe POP. The authors' proposed explanation was that smoking impairs tissue and wound healing. Our primary objective is to document whether smokers with pelvic organ prolapse (POP) are different from non-smokers with POP with respect to collagen biosynthesis and breakdown using systemic markers of collagen metabolism and Vitamin C.
Detailed description
Tissue destructive disorders are more common in smokers than in non-smokers. Alterations in wound healing and connective tissue turnover are suggested mechanisms, but exact details remain to be discovered. The synthesis of subcutaneous collagen in smokers is specifically impeded, and that smokers have less collagen compared to non-smokers. Jorgensen et al study showed that smokers tend to have less procollagen I N-propeptide (PINP) levels in the blood, less vitamin C and higher levels of matrix metalloproteinase (MMP-9), these findings reversed after smoking cessation.
Since smoking is one of the promoting and modifiable factors in the development of prolapse, understanding its effects on the support of pelvic organs may help modify the course of the POP condition in the future. Understanding the connective tissue effects of smoking using systemic markers of collagen metabolism in female smokers with prolapse may help future management and counseling of these patients. In addition, description of the markers of collagen metabolism in POP has not previously been documented.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Prolapse and Smoker | – | Other: Blood draw for the study participantsPatients in this arm have been determined to have more than stage 2 pelvic organ prolapse and have been smoking more than one pack per day Blood draw for the study participants will be done. These will include: Procollagen 1-N propeptide levels (PINP), Matrix metalloproteinase (MMP9) and Plasma Vitamin C levels |
| Prolapse and non smoker | – | Other: Blood draw for the study participantsPatients in this arm have been determined to have more than stage 2 pelvic organ prolapse and non smoker for more than 7 years Blood draw for the study participants will be done. These will include: Procollagen 1-N propeptide levels (PINP), Matrix metalloproteinase (MMP9) and Plasma Vitamin C levels |
| No prolapse and smoker | – | Other: Blood draw for the study participantsPatients in this arm, have been determined not to have prolapse and smokes more than 1 pack per day Blood draw for the study participants will be done. These will include: Procollagen 1-N propeptide levels (PINP), Matrix metalloproteinase (MMP9) and Plasma Vitamin C levels |
| No prolapse and non smoker | – | Other: Blood draw for the study participantsPatients in this arm have been determined not to have prolapse and non smoker for more than 7 years Blood draw for the study participants will be done. These will include: Procollagen 1-N propeptide levels (PINP), Matrix metalloproteinase (MMP9) and Plasma Vitamin C levels |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with pelvic organ prolapse and without prolapse will be identified based on a manual review of patients in a tertiary care referral-based Urogynecology practice
Key inclusion criteria (6 listed)
- More than 18 years old
- Symptomatic POP at or beyond the hymen as determined by physical examination and a positive answer to the screening questions
- For smoker group- smoke more than one pack per day
- For non smoker group- non smoker for more than 7 years
- Absence of prolapse and negative answer to the screening questions
Key exclusion criteria (5 listed)
- Using Hormone Replacement Therapy (systemic estrogen, progesterone or testosterone)
- Using vaginal estrogen (cream, ring, tablet)
- Chronic steroid use
- Past medical history of connective tissue disease
- Scurvy, malabsorption, alcoholism, pregnancy, hyperthyroidism, liver disease and renal failure
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 |
|---|---|---|
| Blood draw for the study participantsThese will include: * Procollagen 1-N propeptide levels (PINP) * Matrix metalloproteinase (MMP9) * Plasma Vitamin C levels | Other | No prolapse and non smoker, No prolapse and smoker, Prolapse and Smoker, Prolapse and non smoker |
Primary outcome
Our primary objective is to document whether smokers with pelvic organ prolapse (POP) are different from non-smokers with POP with respect to collagen biosynthesis and breakdown using systemic markers of collagen metabolism.
Time frame: One day- day of blood draw
These will include blood levels of the following: * Procollagen 1-N propeptide levels (PINP) * Matrix metalloproteinase (MMP9) * Plasma Vitamin C levels
1 secondary outcome
• A secondary objective will be to determine whether women with pelvic organ prolapse are different than healthy controls with respect to the same systemic markers
Time frame: One day- day of blood draw
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 17 Oct 2014.
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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.
Maria Victoria C Estanol, MD principal investigator
Good Samaritan Hospital
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 TriHealth Inc. 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 6 inclusion and 5 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 17 Oct 2014. 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?
Our primary objective is to document whether smokers with pelvic organ prolapse (POP) are different from non-smokers with POP with respect to collagen biosynthesis and breakdown using systemic markers of collagen metabolism. (time frame: One day- day of blood draw). 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 17 Oct 2014.