Vaginal ProlapsePhase 4NCT00153231
Posterior IVS Versus Sacrospinous Suspension in Vaginal Vault Prolapse Repair
A Phase 4 study testing IVS and Sacrospinofixation in people with Vaginal Prolapse, run by Centre Hospitalier Universitaire de Nīmes at 1 site in France.
Trial summary
Hypothesis / aims of study The aim of this multicentre study is to evaluate anatomical and functional results of an innovative posterior tape in vaginal prolapse repair by vaginal route, in comparison to the sacrospinous suspension. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Vaginal Prolapse
- What is being tested?
- IVS and Sacrospinofixation
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 49 participants
- Where
- 1 siteFrance
- Study dates
- Mar 2003to May 2007
- Phase
- Phase 4
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age more than 18
- Vaginal vault prolapse of grade 2 or more (POP-Q system)
- Symptomatic prolapse
Who cannot join
- Patient unable to read French language
- Cystocele without vaginal vault prolapse
- Vaginal vault prolapse of grade 1
- Associated rectal prolapse
- Rectal inflammatory disease (Crohn, RCH).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Evaluation of Morbidity and Efficacy of Posterior IVS (Infracoccygeal Sacropexy), in Comparison to the Standard Sacrospinous Suspension in the Surgical Treatment of Vaginal Vault Prolapse by the Vaginal Route.
Hypothesis / aims of study The aim of this multicentre study is to evaluate anatomical and functional results of an innovative posterior tape in vaginal prolapse repair by vaginal route, in comparison to the sacrospinous suspension.
Study design, materials and methods This study involves 5 centres in French Public Hospital. Patients will be randomly allocated to be operated by a sacrospinous suspension or by an posterior IVSTM (Tyco Healthcare, France). Prolapse severity will be evaluated using the POP-Q system. In order to evaluate the patient's quality of life, the validated PFDI and the PFIQ questionnaires will be used preoperatively and during follow-up, as well as a validated questionnaire on sexual problems. The difference on early post-operative pain should be 30% (40% for the sacrospinous suspension and 10% for the posterior IVS). Then the estimated number of patient is 40 in each arm.
- Conditions
- Vaginal Prolapse
- Being tested
- IVS, Sacrospinofixation
- Medical subject headings
- Uterine Prolapse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IVSDevice
Infracoccygeal sacropexy
SacrospinofixationProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Infracoccygeal sacropexy | Experimental | Intervention: IVS Receives: Device: IVS |
| Sacrospinofixation | Active comparator | Intervention: Sacrospinofixation Receives: Procedure: Sacrospinofixation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Early post-operative pain evaluated by a visual analogic pain the next day after the operation.
Secondary outcomes (5)
- Peri-operative morbidity
- Patient satisfaction
- Quality of life
- Post-operative sexuality
- Anatomical cure rate on vaginal vault support
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2005 (estimated)
- Study startMar 2003
- Primary completionDec 2005
- Study completionMay 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vaginal ProlapseStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NīmesThe 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
- Interventional
- Phase
- Phase 4
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nīmes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Renaud de Tayrac, MD, Principal investigator, Hôpital Carémeau, Nimes, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00153231
- Sponsor's protocol ID
- SPIC
- Status last verified
- Mar 2015
- First submitted
- 8 Sep 2005
- Last updated
- 27 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of Morbidity and Efficacy of Posterior IVS (Infracoccygeal Sacropexy), in Comparison to the Standard Sacrospinous Suspension in the Surgical Treatment of Vaginal Vault Prolapse by the Vaginal Route.
- ClinicalTrials.gov ID
- NCT00153231
- Acronym / sponsor ID
- SPIC
- Conditions
- Vaginal Prolapse
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NīmesUniversity, hospital or other
- Study start
- Mar 2003
- Primary completion
- Dec 2005 (actual)
- Study completion
- May 2007 (actual)
- First posted
- 12 Sep 2005 (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.
Hypothesis / aims of study The aim of this multicentre study is to evaluate anatomical and functional results of an innovative posterior tape in vaginal prolapse repair by vaginal route, in comparison to the sacrospinous suspension.
Study design, materials and methods This study involves 5 centres in French Public Hospital. Patients will be randomly allocated to be operated by a sacrospinous suspension or by an posterior IVSTM (Tyco Healthcare, France). Prolapse severity will be evaluated using the POP-Q system. In order to evaluate the patient's quality of life, the validated PFDI and the PFIQ questionnaires will be used preoperatively and during follow-up, as well as a validated questionnaire on sexual problems. The difference on early post-operative pain should be 30% (40% for the sacrospinous suspension and 10% for the posterior IVS). Then the estimated number of patient is 40 in each arm.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Infracoccygeal sacropexy | Experimental | Device: IVSIntervention: IVS |
| Sacrospinofixation | Active comparator | Procedure: SacrospinofixationIntervention: Sacrospinofixation |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age more than 18
- Vaginal vault prolapse of grade 2 or more (POP-Q system)
- Symptomatic prolapse
Key exclusion criteria (5 listed)
- Patient unable to read French language
- Cystocele without vaginal vault prolapse
- Vaginal vault prolapse of grade 1
- Associated rectal prolapse
- Rectal inflammatory disease (Crohn, RCH).
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 |
|---|---|---|
| IVSInfracoccygeal sacropexy | Device | Infracoccygeal sacropexy |
| Sacrospinofixation | Procedure or surgery | Sacrospinofixation |
Primary outcome
Early post-operative pain evaluated by a visual analogic pain the next day after the operation.
5 secondary outcomes
- Peri-operative morbidity
- Patient satisfaction
- Quality of life
- Post-operative sexuality
- Anatomical cure rate on vaginal vault support
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 27 Mar 2015.
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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.
Renaud de Tayrac, MD principal investigator
Hôpital Carémeau, Nimes, France
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing IVS and Sacrospinofixation in people with Vaginal Prolapse, run by Centre Hospitalier Universitaire de Nīmes at 1 site in France.
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 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 27 Mar 2015. 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 France. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Early post-operative pain evaluated by a visual analogic pain the next day after the operation.. 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 27 Mar 2015.