Pelvic Organ ProlapseNCT01842464
Sacro-Spinous Ligaments Anterior Apical Anchoring
An observational study of Pelvic Organ Prolapse, run by Western Galilee Hospital-Nahariya.
Trial summary
Anterior-apical compartment mesh implants for pelvic floor reconstruction are anchored here to the Sacro-Spinous ligaments and evaluated being a feasible and effective method. Read more about this study
- Who is it for?
- Ages 35 to 95 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pelvic Organ Prolapse
- What is being tested?
- Anterior Sacro-Spinous
- Type of treatment
- Surgery or procedure
- How many people
- 44 participants
- Where
- No sites listed yet
- Study dates
- Sep 2011to Jan 2012
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 35 to 95 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Female patients suffering advanced pelvic organ prolapse with anterior predominance and apical supportive defect, reffered to mesh reconstruction.
Who may be able to join
- Pelvic Floor Prolapse > Gr 2,
- Anterior > Posterior defect,
- Apical Supportive Defect
Who cannot join
- Active Pelvic Inflammation,
- Patient Refusal
About this study
Official title: Sacro-Spinous Ligaments Anterior Apical Anchoring for Needle-Guided Mesh in Advanced Pelvic Organ Prolapse
Anterior-apical compartment mesh implants for pelvic floor reconstruction are anchored here to the Sacro-Spinous ligaments and evaluated being a feasible and effective method.
Read the detailed description
Anterior-apical compartment mesh implants for pelvic floor reconstruction are frequently anchored to the Arcus Tendinous Fascia Pelvis (ATFP) rather than to the Sacro-Spinous (SS) ligaments commonly used for the posterior compartment reconstruction. The SS ligament suspension for apical support mesh fixation is thought to yield higher and stronger anchoring point than the ATFP. The authors presumed that anterior mesh fixation to the sacro-spinous ligament are both, feasible and effective.
- Conditions
- Pelvic Organ Prolapse
- Being tested
- Anterior Sacro-Spinous
- 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.
Anterior Sacro-SpinousProcedure or surgery
Anterior Sacro-Spinous
| Study group | Role | What they receive |
|---|---|---|
| Anterior Sacro-Spinous Support | Anterior sacro-spinous mesh implants supported patients Receives: Procedure: Anterior Sacro-Spinous |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Change With Distance Between the Vaginal Apex and the Introitus
The change with distance measured by centimeters, between the vaginal apex and the introitus
Measured: One year
Efficacy of Sacro-Spinous Ligaments Anterior Apical Anchoring
Level of support with the Sacro-Spinous Ligaments Anterior Apical Anchoring higher than 4 centimeters above vaginal opening.
Measured: one year
Number of Participants Involving in Complications: Operative Damage and Bleeding, Post Operative Infection and Mesh Exposure
Number of participants involving in complications: operative damage and bleeding, post operative infection and mesh exposure.
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2013 (estimated)
- Study startSep 2011
- Primary completionDec 2011
- Study completionJan 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Western Galilee Hospital-Nahariya
- Sponsor type
- Other government
- Responsible party
- Principal investigator, menahem neuman, Western Galilee Hospital-Nahariya
- Investigators
- Menahem Neuman, Prof., Principal investigator, Western Galilee MC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01842464
- Sponsor's protocol ID
- WesternGalileeH
- Status last verified
- Jun 2015
- First submitted
- 24 Apr 2013
- Last updated
- 19 Jun 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sacro-Spinous Ligaments Anterior Apical Anchoring for Needle-Guided Mesh in Advanced Pelvic Organ Prolapse
- ClinicalTrials.gov ID
- NCT01842464
- Acronym / sponsor ID
- WesternGalileeH
- Conditions
- Pelvic Organ Prolapse
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Western Galilee Hospital-NahariyaOther government
- Study start
- Sep 2011
- Primary completion
- Dec 2011 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 29 Apr 2013 (estimated)
- Results
- Posted 19 Jun 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Anterior-apical compartment mesh implants for pelvic floor reconstruction are anchored here to the Sacro-Spinous ligaments and evaluated being a feasible and effective method.
Detailed description
Anterior-apical compartment mesh implants for pelvic floor reconstruction are frequently anchored to the Arcus Tendinous Fascia Pelvis (ATFP) rather than to the Sacro-Spinous (SS) ligaments commonly used for the posterior compartment reconstruction. The SS ligament suspension for apical support mesh fixation is thought to yield higher and stronger anchoring point than the ATFP. The authors presumed that anterior mesh fixation to the sacro-spinous ligament are both, feasible and effective.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Anterior Sacro-Spinous Support | – | Procedure: Anterior Sacro-SpinousAnterior sacro-spinous mesh implants supported patients |
Who may qualify
- Ages
- 35 to 95 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Female patients suffering advanced pelvic organ prolapse with anterior predominance and apical supportive defect, reffered to mesh reconstruction.
Key inclusion criteria (3 listed)
- Pelvic Floor Prolapse > Gr 2,
- Anterior > Posterior defect,
- Apical Supportive Defect
Key exclusion criteria (2 listed)
- Active Pelvic Inflammation,
- Patient Refusal
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 |
|---|---|---|
| Anterior Sacro-SpinousAnterior Sacro-Spinous | Procedure or surgery | Anterior Sacro-Spinous Support |
Primary outcome
The Change With Distance Between the Vaginal Apex and the Introitus
Time frame: One year
The change with distance measured by centimeters, between the vaginal apex and the introitus
Efficacy of Sacro-Spinous Ligaments Anterior Apical Anchoring
Time frame: one year
Level of support with the Sacro-Spinous Ligaments Anterior Apical Anchoring higher than 4 centimeters above vaginal opening.
Number of Participants Involving in Complications: Operative Damage and Bleeding, Post Operative Infection and Mesh Exposure
Time frame: one year
Number of participants involving in complications: operative damage and bleeding, post operative infection and mesh exposure.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jun 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Menahem Neuman, Prof. principal investigator
Western Galilee MC
Questions about this trial
What is this clinical trial studying?
An observational study of Pelvic Organ Prolapse, run by Western Galilee Hospital-Nahariya.
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 2 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 19 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.
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?
Yes. Results are posted in the registry (first posted 19 Jun 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 Change With Distance Between the Vaginal Apex and the Introitus (time frame: One year). The study lists 3 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 19 Jun 2015.