Pelvic Organ ProlapseNCT01749696
Alterations in Connective Tissue in Patients With or Without Pelvic Organ Prolapse
An observational study of Pelvic Organ Prolapse, run by Turku University Hospital at 1 site in Finland.
Trial summary
The aim of our study is to investigate the alterations in connective tissue of vaginal wall in patients with and without pelvic organ prolapse (POP). Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Pelvic Organ Prolapse
- How many people
- 78 participants
- Where
- 1 siteFinland
- Study dates
- Nov 2009to Apr 2014
- 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: 39 patients with pelvic organ prolapse and as controls 39 patients without prolapse.
Who may be able to join
- surgery for pelvic organ prolapse
- hysterectomy due to other benign reasons than pelvic organ prolapse
Who cannot join
- surgery due to malignancy
Trial locations and contacts
1 site in 1 country.
Finland1 site
Department of Obstetrics and Gynecology, Turku University Central Hospital
Turku, 20520
About this study
Official title: Alterations in Connective Tissue in Patients With or Without Pelvic Organ Prolapse.
The aim of our study is to investigate the alterations in connective tissue of vaginal wall in patients with and without pelvic organ prolapse (POP).
Read the detailed description
The tissue samples were taken from the anterior wall of vagina in the midline close to cervix or apex. The tissue samples were collected from the vaginal wall of the patients with pelvic organ prolapse (n=39) during vaginal prolapse surgery. Control samples (n=39) were taken from patients after vaginal or laparoscopic removal of the uterus.
The formalin-fixed and paraffin embedded tissue samples were stained with Verhoeff van Gieson and Movat's pentachrome. Samples were examined by pathologist and gynecologist blinded as to the other investigator and to the pelvic organ prolapse status. In case of discrepancy investigators evaluated the samples together to gain consensus.
- Conditions
- Pelvic Organ Prolapse
- Keywords
- Pelvic organ prolapse, Connective tissue, Elastin, Collagen
- Medical subject headings
- Pelvic Organ Prolapse, Aortic Stenosis, Supravalvular
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 |
|---|---|---|
| Patients with pelvic organ prolapse | Patients, who were operated on because of pelvic organ prolapse. | |
| Patients without pelvic organ prolapse | Patients, who had hysterectomy due to other reasons than pelvic organ prolapse. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The elastin content in tissue samples in patients with or without pelvic organ prolapse.
Measured: september 2012
Secondary outcomes (1)
The collagen content in tissue samples in women with or without pelvic organ prolapse.
Measured: September 2012
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2012 (estimated)
- Study startNov 2009
- Primary completionSep 2012
- Study completionApr 2014
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.
- More trials run by Turku University HospitalThe 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
- Observational
- Enrolment
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- Turku University Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01749696
- Sponsor's protocol ID
- 33/180/2009
- Status last verified
- May 2014
- First submitted
- 12 Dec 2012
- Last updated
- 9 May 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Alterations in Connective Tissue in Patients With or Without Pelvic Organ Prolapse.
- ClinicalTrials.gov ID
- NCT01749696
- Acronym / sponsor ID
- 33/180/2009
- Conditions
- Pelvic Organ Prolapse
- Keywords
- Pelvic organ prolapse, Connective tissue, Elastin, Collagen
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- Turku University HospitalOther government
- Study start
- Nov 2009
- Primary completion
- Sep 2012 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 17 Dec 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 aim of our study is to investigate the alterations in connective tissue of vaginal wall in patients with and without pelvic organ prolapse (POP).
Detailed description
The tissue samples were taken from the anterior wall of vagina in the midline close to cervix or apex. The tissue samples were collected from the vaginal wall of the patients with pelvic organ prolapse (n=39) during vaginal prolapse surgery. Control samples (n=39) were taken from patients after vaginal or laparoscopic removal of the uterus.
The formalin-fixed and paraffin embedded tissue samples were stained with Verhoeff van Gieson and Movat's pentachrome. Samples were examined by pathologist and gynecologist blinded as to the other investigator and to the pelvic organ prolapse status. In case of discrepancy investigators evaluated the samples together to gain consensus.
Study design
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with pelvic organ prolapse | – | –Patients, who were operated on because of pelvic organ prolapse. |
| Patients without pelvic organ prolapse | – | –Patients, who had hysterectomy due to other reasons than pelvic organ prolapse. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- 39 patients with pelvic organ prolapse and as controls 39 patients without prolapse.
Key inclusion criteria (2 listed)
- surgery for pelvic organ prolapse
- hysterectomy due to other benign reasons than pelvic organ prolapse
Key exclusion criteria (1 listed)
- surgery due to malignancy
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
The elastin content in tissue samples in patients with or without pelvic organ prolapse.
Time frame: september 2012
1 secondary outcome
The collagen content in tissue samples in women with or without pelvic organ prolapse.
Time frame: September 2012
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 May 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.
The record lists no contact. Use the official record to reach the sponsor.
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 Turku University Hospital at 1 site in Finland.
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 2 inclusion and 1 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 May 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 Finland. 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?
The elastin content in tissue samples in patients with or without pelvic organ prolapse. (time frame: september 2012). 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 9 May 2014.