Vaginal Vault ProlapseNCT01097200
Sacrocolpopexy Versus Vaginal Mesh Procedure for Pelvic Prolapse
A study testing Elevate mesh and Sacrocolpopexy in people with Vaginal Vault Prolapse and Enterocele, run by Francisco Carmona at 1 site in Spain.
Trial summary
Pelvic prolapse is one of the most frequent pathology in Gynecology. Recurrency of the prolapse after primary surgery is relatively high, 15-30%. Sacrocolpopexy has showed to be effective but it requires a long learning curves and is more aggressive. Read more about this study
- Who is it for?
- Ages 21 years and older, women only
- Conditions the study is for
- Vaginal Vault Prolapse, Enterocele, Uterine Prolapse
- What is being tested?
- Elevate mesh and Sacrocolpopexy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteSpain
- Study dates
- May 2010to Nov 2021
- Phase
- Interventional
- 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
Who may be able to join
- Subject has been diagnosed with one or more clinically significant anterior, apical, or posterior genital prolapse disorder(s)(symptomatic POP-Q stage II or higher) requiring surgical repair.
Who cannot join
- Investigator determines subject is not a candidate for surgical repair of her genital prolapse.
- Subject has had a prior prolapse procedure involving graft placement (synthetic or biologic)
- Subject has active or latent systemic infection or signs of tissue necrosis.
- Subject has restricted leg motion (inability to abduct or adduct leg positioning in the lithotomy position) with or without a hip replacement / prosthesis.
- Subject is currently pregnant or intends to become pregnant during the study period.
- Subject has had radiation therapy to the pelvic area.
Show all 13Show fewer
- Subject has pelvic cancer, has had pelvic cancer within the past 12 months or has been on cytostatic medication within the past 12 months.
- Subject has uncontrolled diabetes.
- Subject is on any medication with could result in compromised immune response, such as immune modulators.
- Subject has undergone previous pelvic surgery < 6 months prior to enrollment in this study.
- Subject is unwilling or unable to give valid informed consent.
- Subject is unwilling or unable to comply with the requirements of the protocol, complete all quality of Life questionnaires and return for all follow-up visits.
- Subject with contraindications for laparoscopy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Anatomic and Functional Outcomes of Vaginal Mesh ( ELEVATE) Compared With Laparoscopic Sacrocolpopexy for Pelvic Organ Prolapse
Pelvic prolapse is one of the most frequent pathology in Gynecology. Recurrency of the prolapse after primary surgery is relatively high, 15-30%. Sacrocolpopexy has showed to be effective but it requires a long learning curves and is more aggressive. New meshes techniques seem to be effective, as well, with less learning curve but they are expensive and there are no randomize studies published.
The investigators aim is to compare both techniques in terms of: anatomical and functional efficacy, cost, operating time and complications.
- Conditions
- Vaginal Vault Prolapse, Enterocele, Uterine Prolapse, Cystocele, Rectocele
- Being tested
- Elevate mesh, Sacrocolpopexy
- Keywords
- sacrocolpopexy, meshes, sacrospinous ligament
- Medical subject headings
- Pelvic Organ Prolapse, Hernia, Uterine Prolapse, Cystocele, Rectocele
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Elevate meshDevice
Also called Pelvic meshes
The correction of the prolapse can be made by this new technique.
SacrocolpopexyDevice
Also called Colpofixation
Attach a mesh between the vagina and the promontorium.
| Study group | Role | What they receive |
|---|---|---|
| Elevate meshes | Other | The use of Elevate (American Systems trade mark) meshes for the treatment of pelvic prolapse. Receives: Device: Elevate mesh |
| Sacrocolpopexy | Other | Sacrocolpopexy for the correction of the prolapse Receives: Device: Sacrocolpopexy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional and anatomical efficacy
Measured: 1 year
Secondary outcomes (1)
operating time, cost and complications of both techniques
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2010 (estimated)
- Study startMay 2010
- Primary completionNov 2016
- Study completionNov 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Vaginal Vault 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Francisco Carmona
- Sponsor type
- University, hospital or other
- Collaborators
- American Medical Systems
- Responsible party
- Sponsor-investigator, Francisco Carmona, Hospital Clinic of Barcelona
- Investigators
- Eduardo Bataller, M.D., Ph. D., Principal investigator, Hospital Clinic, Barcelona, Spain.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01097200
- Sponsor's protocol ID
- Bataller01
- Status last verified
- Mar 2021
- First submitted
- 30 Mar 2010
- Last updated
- 23 Mar 2021
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: First article has been submitted to the European Urology on feb 13th 2017, was rejected. Article accepted for publishing in may 2018 in IUJ
Publications
Sanses TV, Shahryarinejad A, Molden S, Hoskey KA, Abbasy S, Patterson D, Saks EK, Weber LeBrun EE, Gamble TL, King VG, Nguyen AL, Abed H, Young SB; Fellows' Pelvic Research Network. Anatomic outcomes of vaginal mesh procedure (Prolift) compared with uterosacral ligament suspension and abdominal sacrocolpopexy for pelvic organ prolapse: a Fellows' Pelvic Research Network study. Am J Obstet Gynecol. 2009 Nov;201(5):519.e1-8. doi: 10.1016/j.ajog.2009.07.004. Epub 2009 Aug 28.
PubMed 19716533Cosson M, Rosenthal C, Clave H, et al. Prospective clinical assessment of the total transvaginal mesh (TVM) technique for treatment of pelvic organ prolapse-6 and 12 month results. Int Urogynecol J 2006; 17: S142.
Nygaard IE, McCreery R, Brubaker L, Connolly A, Cundiff G, Weber AM, Zyczynski H; Pelvic Floor Disorders Network. Abdominal sacrocolpopexy: a comprehensive review. Obstet Gynecol. 2004 Oct;104(4):805-23. doi: 10.1097/01.AOG.0000139514.90897.07.
PubMed 15458906
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anatomic and Functional Outcomes of Vaginal Mesh ( ELEVATE) Compared With Laparoscopic Sacrocolpopexy for Pelvic Organ Prolapse
- ClinicalTrials.gov ID
- NCT01097200
- Acronym / sponsor ID
- Bataller01
- Conditions
- Vaginal Vault Prolapse, Enterocele, Uterine Prolapse, Cystocele, Rectocele
- Keywords
- sacrocolpopexy, meshes, sacrospinous ligament
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Francisco CarmonaUniversity, hospital or other
- Collaborators
- American Medical Systems
- Study start
- May 2010
- Primary completion
- Nov 2016 (actual)
- Study completion
- Nov 2021 (estimated)
- First posted
- 1 Apr 2010 (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.
Pelvic prolapse is one of the most frequent pathology in Gynecology. Recurrency of the prolapse after primary surgery is relatively high, 15-30%. Sacrocolpopexy has showed to be effective but it requires a long learning curves and is more aggressive. New meshes techniques seem to be effective, as well, with less learning curve but they are expensive and there are no randomize studies published.
The investigators aim is to compare both techniques in terms of: anatomical and functional efficacy, cost, operating time and complications.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Elevate meshes | Other | Device: Elevate meshThe use of Elevate (American Systems trade mark) meshes for the treatment of pelvic prolapse. |
| Sacrocolpopexy | Other | Device: SacrocolpopexySacrocolpopexy for the correction of the prolapse |
Who may qualify
- Ages
- 21 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Subject has been diagnosed with one or more clinically significant anterior, apical, or posterior genital prolapse disorder(s)(symptomatic POP-Q stage II or higher) requiring surgical repair.
Key exclusion criteria (13 listed)
- Investigator determines subject is not a candidate for surgical repair of her genital prolapse.
- Subject has had a prior prolapse procedure involving graft placement (synthetic or biologic)
- Subject has active or latent systemic infection or signs of tissue necrosis.
- Subject has restricted leg motion (inability to abduct or adduct leg positioning in the lithotomy position) with or without a hip replacement / prosthesis.
- Subject is currently pregnant or intends to become pregnant during the study period.
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 |
|---|---|---|
| Elevate meshAlso: Pelvic meshesThe correction of the prolapse can be made by this new technique. | Device | Elevate meshes |
| SacrocolpopexyAlso: ColpofixationAttach a mesh between the vagina and the promontorium. | Device | Sacrocolpopexy |
Primary outcome
Functional and anatomical efficacy
Time frame: 1 year
1 secondary outcome
operating time, cost and complications of both techniques
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2021.
- Background: PubMed 19716533Sanses TV, Shahryarinejad A, Molden S, Hoskey KA, Abbasy S, Patterson D, Saks EK, Weber LeBrun EE, Gamble TL, King VG, Nguyen AL, Abed H, Young SB; Fellows' Pelvic Research Network. Anatomic outcomes of vaginal mesh procedure (Prolift) compared with uterosacral ligament suspension and abdominal sacrocolpopexy for pelvic organ prolapse: a Fellows' Pelvic Research Network study. Am J Obstet Gynecol. 2009 Nov;201(5):519.e1-8. doi: 10.1016/j.ajog.2009.07.004. Epub 2009 Aug 28.
- BackgroundCosson M, Rosenthal C, Clave H, et al. Prospective clinical assessment of the total transvaginal mesh (TVM) technique for treatment of pelvic organ prolapse-6 and 12 month results. Int Urogynecol J 2006; 17: S142.
- Background: PubMed 15458906Nygaard IE, McCreery R, Brubaker L, Connolly A, Cundiff G, Weber AM, Zyczynski H; Pelvic Floor Disorders Network. Abdominal sacrocolpopexy: a comprehensive review. Obstet Gynecol. 2004 Oct;104(4):805-23. doi: 10.1097/01.AOG.0000139514.90897.07.
- Individual participant dataSharing planned: Yes. First article has been submitted to the European Urology on feb 13th 2017, was rejected. Article accepted for publishing in may 2018 in IUJ
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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.
Eduardo Bataller, M.D., Ph. D. principal investigator
Hospital Clinic, Barcelona, Spain.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Elevate mesh and Sacrocolpopexy in people with Vaginal Vault Prolapse and Enterocele, run by Francisco Carmona at 1 site in Spain.
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 1 inclusion and 13 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: status not confirmed, as of the sponsor's last update on 23 Mar 2021. 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 Spain. 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?
Results are not available in the source record.
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?
Functional and anatomical efficacy (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01097200, which also lists 3 linked publications.
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 23 Mar 2021.