Pelvic Organ ProlapseNCT02925585
Vaginal Tactile Imaging for Pelvic Floor Prolapse
An observational study of Pelvic Organ Prolapse, run by Artann Laboratories at 5 sites in United States.
Trial summary
The investigators will analyze biomechanical transformation of pelvic floor tissues and support structures under affected pelvic floor conditions and repaired states after the surgery. Read more about this study
- Who is it for?
- Ages 21 years and older, women only
- Conditions the study is for
- Pelvic Organ Prolapse
- What is being tested?
- Pre/post imaging
- How many people
- 119 participants
- Where
- 5 sitesUnited States
- Study dates
- Sep 2016to Dec 2018
- 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 21 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Patients scheduled for pelvic floor surgery
Who may be able to join
- Subject is female of 21 years or older, and
- No prior pelvic floor surgery, and
- One of the following:
- Normal pelvic floor conditions, or POP Stage I affecting one or more vaginal compartment, or POP Stage II affecting one or more vaginal compartment, or POP Stage III affecting one or more vaginal compartment, or POP Stage IV affecting one or more vaginal compartment
Who cannot join
- Active skin infection or ulceration within the vagina
- Presence of a vaginal septum;
- Active cancer of the colon, rectum wall, cervix, vaginal, uterus or bladder;
- Ongoing radiation therapy for pelvic cancer;
- Impacted stool;
- Significant pre-existing pelvic pain including levator ani syndrome, severe vaginismus or vulvadynia;
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- Severe hemorrhoids;
- Significant circulatory or cardiac conditions that could cause excessive risk from the examination as determined by attending physician;
- Current pregnancy.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
The Institute for Female Pelvic Medicine and Reconstructive Surgery
Allentown, Pennsylvania, 18103
Inova Health System Foundation
Falls Church, Virginia, 22042
Eastern Virginia Medical School
Norfolk, Virginia, 23501
Princeton Urogynecology PU
Princeton, New Jersey, 08540
The Pelvic Floor Institute
Tampa, Florida, 33606
About this study
Official title: Vaginal Tactile Imaging in Assessment of Pelvic Floor Conditions
The investigators will analyze biomechanical transformation of pelvic floor tissues and support structures under affected pelvic floor conditions and repaired states after the surgery.
- Conditions
- Pelvic Organ Prolapse
- Being tested
- Pre/post imaging
- 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.
Pre/post imagingOther
| Study group | Role | What they receive |
|---|---|---|
| Pre/post pelvic floor surgery imaging | Not described Receives: Other: Pre/post imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tissue elasticity change after the surgery measured as a gradient in tactile image. Unit of measure: mmHg/mm
Tissue elasticity is measured for entire anterior and posterior compartments
Measured: pre-surgery and post-surgery (4-6 months after surgery) measurements
Pelvic floor muscle strength change after the surgery measured as a pressure dynamic feedback during muscle contractions. Unit of measure: mmHg
Muscle strength is measured during voluntary and involuntary muscle contractions, involuntary relaxation and Valsalva maneuver.
Measured: pre-surgery and post-surgery (4-6 months after surgery) measurements
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2016 (estimated)
- Study startSep 2016
- Primary completionDec 2018
- Study completionDec 2018
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
- 119 participants (actual)
Sponsor and investigators
- Lead sponsor
- Artann Laboratories
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02925585
- Sponsor's protocol ID
- VTI09
- Other IDs
- SB1AG034714
- Status last verified
- Mar 2019
- First submitted
- 3 Oct 2016
- Last updated
- 21 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: Scientific Publications of the study results
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vaginal Tactile Imaging in Assessment of Pelvic Floor Conditions
- ClinicalTrials.gov ID
- NCT02925585
- Acronym / sponsor ID
- VTI09
- Conditions
- Pelvic Organ Prolapse
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 119 participants (actual)
- Lead sponsor
- Artann LaboratoriesIndustry (pharma, biotech, devices)
- Collaborators
- National Institute on Aging (NIA)
- Study start
- Sep 2016 (actual)
- Primary completion
- Dec 2018 (actual)
- Study completion
- Dec 2018 (actual)
- First posted
- 6 Oct 2016 (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 investigators will analyze biomechanical transformation of pelvic floor tissues and support structures under affected pelvic floor conditions and repaired states after the surgery.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pre/post pelvic floor surgery imaging | – | Other: Pre/post imaging |
Who may qualify
- Ages
- 21 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients scheduled for pelvic floor surgery
Key inclusion criteria (4 listed)
- Subject is female of 21 years or older, and
- No prior pelvic floor surgery, and
- One of the following:
- Normal pelvic floor conditions, or POP Stage I affecting one or more vaginal compartment, or POP Stage II affecting one or more vaginal compartment, or POP Stage III affecting one or more vaginal compartment, or POP Stage IV affecting one or more vaginal compartment
Key exclusion criteria (9 listed)
- Active skin infection or ulceration within the vagina
- Presence of a vaginal septum;
- Active cancer of the colon, rectum wall, cervix, vaginal, uterus or bladder;
- Ongoing radiation therapy for pelvic cancer;
- Impacted stool;
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 |
|---|---|---|
| Pre/post imaging | Other | Pre/post pelvic floor surgery imaging |
Primary outcome
Tissue elasticity change after the surgery measured as a gradient in tactile image. Unit of measure: mmHg/mm
Time frame: pre-surgery and post-surgery (4-6 months after surgery) measurements
Tissue elasticity is measured for entire anterior and posterior compartments
Pelvic floor muscle strength change after the surgery measured as a pressure dynamic feedback during muscle contractions. Unit of measure: mmHg
Time frame: pre-surgery and post-surgery (4-6 months after surgery) measurements
Muscle strength is measured during voluntary and involuntary muscle contractions, involuntary relaxation and Valsalva maneuver.
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 21 Mar 2019.
- Individual participant dataSharing planned: Yes. Scientific Publications of the study results
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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.
5 sites 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 Artann Laboratories at 5 sites 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 4 inclusion and 9 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 21 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites 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?
Tissue elasticity change after the surgery measured as a gradient in tactile image. Unit of measure: mmHg/mm (time frame: pre-surgery and post-surgery (4-6 months after surgery) measurements). 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 21 Mar 2019.