Pelvic Organ ProlapseNCT02536001
Prospective Randomized Study to Compare Results of Pelvic Organ Prolapse Repair With One Versus Two Vaginal Meshes
A study testing One mesh Endofast reliant system and two meshes Endofast reliant system in people with Pelvic Organ Prolapse, run by Ziv Hospital.
Trial summary
The purpose of this study is to compare anatomical differences, quality of life and sexual function and complications rate between apical support with one anterior vaginal mesh versus repair with two separate meshes. Read more about this study
- Who is it for?
- Ages 30 to 85 years, women only
- Conditions the study is for
- Pelvic Organ Prolapse
- What is being tested?
- One mesh Endofast reliant system and two meshes Endofast reliant system
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Sep 2015to Jul 2018
- 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 30 to 85 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- At least anterior compartment prolapse stage III and uterine prolapse stage II.
Who cannot join
- Women without uterine prolapse, or with uterine prolapse < stage 2.
- Women with uterine prolapse > stage 2.
- Hysterectomy in the past.
- Women with an indication for hysterectomy.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Prospective Randomized Study to Compare Anatomical, Functional and Sexual Results of Pelvic Organ Prolapse Repair With One Versus Two Vaginal Meshes While Preserving the Uterus
The purpose of this study is to compare anatomical differences, quality of life and sexual function and complications rate between apical support with one anterior vaginal mesh versus repair with two separate meshes.
Read the detailed description
In the presence of stage 3 anterior wall prolapse (cystocele) with second stage apical prolapse (uterine or vault prolapse) there are 2 optional ways to repair with vaginal mesh: (a) to use 2 separated meshes: anterior mesh to correct the anterior compartment and posterior mesh to correct the apical prolapse to the sacrospinous ligament (SSL). (b) To correct both anterior compartment and the apical prolapse with the same mesh while using the posterior arms of the mesh to fix the apical prolapse to the SSL. Each way has its advantages and disadvantages. The first way was described at the beginning of mesh use and might be more anatomical then the second newest way. The addition of apical support to the anterior mesh might theoretically shorten the vagina. There are several recent studies describing the anatomical outcomes both for anterior compartment and apical compartment with a single mesh. Mesh-related complications, which can be also related to the amount of vaginal meshes, can potentially decrease with one mesh as compare with 2 meshes.
The aim of the study:
If the anatomical results, vaginal length and quality of life, will be with no significant differences between the two groups, the investigators will recommend to use a single mesh, in order to avoid / minimize potential complications of vaginal mesh.
If there will be no differences in complications in both groups but will be a significant difference in vaginal length and sexual function, the investigators will recommend using two meshes.
- Conditions
- Pelvic Organ Prolapse
- Being tested
- One mesh Endofast reliant system, two meshes Endofast reliant system
- Keywords
- Vaginal mesh, Total vaginal length, Quality of life
- 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.
One mesh Endofast reliant systemDevice
One mesh (anterior One mesh Endofast reliant system) will be used to correct both anterior and apical prolapse
two meshes Endofast reliant systemDevice
Two meshes (anterior and posterior Endofast reliant system) will be used to correct separately the anterior compartment and the apical compartment
| Study group | Role | What they receive |
|---|---|---|
| One mesh Endofast reliant system | Other | Patients with anterior compartment stage III and uterus prolapse grade II will be treated with one mesh - Anterior Endofast reliant system (fixation of posterior arms to the sacrospinous ligament) Receives: Device: One mesh Endofast reliant system |
| two meshes Endofast reliant system | Other | intervention: Patients with anterior compartment stage III and uterus prolapse grade II will be treated with 2 meshes: anterior Endofast reliant system mesh to correct the anterior compartment and posterior Endofast reliant system mesh to correct the apical prolapse (fixation to the sacrospinous ligament) Receives: Device: two meshes Endofast reliant system |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vaginal length between the arms
measure total vaginal length after surgery
Measured: 2 years
Quality of life
use validated questionnaires before and after surgery
Measured: 2 years
Complications rate
comparing complications rate between groups
Measured: 2 years
Sexual function
use validated questionnaires before and after surgery
Measured: 2 years
Secondary outcomes (2)
To examine anatomical results
use POP-Q and compare between the groups
Measured: 2 years
Success rate of uterus preservation
success will be define as no bulge symptoms and <stage II
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2015 (estimated)
- Study startSep 2015
- Primary completionJul 2017 (estimated)
- Study completionJul 2018 (estimated)
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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ziv Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Naama Marcus Braun, MD, Study chair, Ziv Medical center, Israel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02536001
- Sponsor's protocol ID
- 0032-15-ZIV
- Status last verified
- May 2015
- First submitted
- 6 Jul 2015
- Last updated
- 31 Aug 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Randomized Study to Compare Anatomical, Functional and Sexual Results of Pelvic Organ Prolapse Repair With One Versus Two Vaginal Meshes While Preserving the Uterus
- ClinicalTrials.gov ID
- NCT02536001
- Acronym / sponsor ID
- 0032-15-ZIV
- Conditions
- Pelvic Organ Prolapse
- Keywords
- Vaginal mesh, Total vaginal length, Quality of life
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Ziv HospitalOther government
- Study start
- Sep 2015
- Primary completion
- Jul 2017 (estimated)
- Study completion
- Jul 2018 (estimated)
- First posted
- 31 Aug 2015 (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 purpose of this study is to compare anatomical differences, quality of life and sexual function and complications rate between apical support with one anterior vaginal mesh versus repair with two separate meshes.
Detailed description
In the presence of stage 3 anterior wall prolapse (cystocele) with second stage apical prolapse (uterine or vault prolapse) there are 2 optional ways to repair with vaginal mesh: (a) to use 2 separated meshes: anterior mesh to correct the anterior compartment and posterior mesh to correct the apical prolapse to the sacrospinous ligament (SSL). (b) To correct both anterior compartment and the apical prolapse with the same mesh while using the posterior arms of the mesh to fix the apical prolapse to the SSL. Each way has its advantages and disadvantages. The first way was described at the beginning of mesh use and might be more anatomical then the second newest way. The addition of apical support to the anterior mesh might theoretically shorten the vagina. There are several recent studies describing the anatomical outcomes both for anterior compartment and apical compartment with a single mesh. Mesh-related complications, which can be also related to the amount of vaginal meshes, can potentially decrease with one mesh as compare with 2 meshes.
The aim of the study:
If the anatomical results, vaginal length and quality of life, will be with no significant differences between the two groups, the investigators will recommend to use a single mesh, in order to avoid / minimize potential complications of vaginal mesh.
If there will be no differences in complications in both groups but will be a significant difference in vaginal length and sexual function, the investigators will recommend using two meshes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| One mesh Endofast reliant system | Other | Device: One mesh Endofast reliant systemPatients with anterior compartment stage III and uterus prolapse grade II will be treated with one mesh - Anterior Endofast reliant system (fixation of posterior arms to the sacrospinous ligament) |
| two meshes Endofast reliant system | Other | Device: two meshes Endofast reliant systemintervention: Patients with anterior compartment stage III and uterus prolapse grade II will be treated with 2 meshes: anterior Endofast reliant system mesh to correct the anterior compartment and posterior Endofast reliant system mesh to correct the apical prolapse (fixation to the sacrospinous ligament) |
Who may qualify
- Ages
- 30 to 85 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- At least anterior compartment prolapse stage III and uterine prolapse stage II.
Key exclusion criteria (4 listed)
- Women without uterine prolapse, or with uterine prolapse < stage 2.
- Women with uterine prolapse > stage 2.
- Hysterectomy in the past.
- Women with an indication for hysterectomy.
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 |
|---|---|---|
| One mesh Endofast reliant systemOne mesh (anterior One mesh Endofast reliant system) will be used to correct both anterior and apical prolapse | Device | One mesh Endofast reliant system |
| two meshes Endofast reliant systemTwo meshes (anterior and posterior Endofast reliant system) will be used to correct separately the anterior compartment and the apical compartment | Device | two meshes Endofast reliant system |
Primary outcome
Vaginal length between the arms
Time frame: 2 years
measure total vaginal length after surgery
Quality of life
Time frame: 2 years
use validated questionnaires before and after surgery
Complications rate
Time frame: 2 years
comparing complications rate between groups
Sexual function
Time frame: 2 years
use validated questionnaires before and after surgery
2 secondary outcomes
To examine anatomical results
Time frame: 2 years
Success rate of uterus preservation
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2015.
Related trials for Pelvic Organ Prolapse
Active, not recruitingObservational study
Return to Physical Activity After Retropublic Transvaginal Sling and Laparoscopic Sacrocolpopexy
Stress Urinary Incontinence, Pelvic Organ Prolapse
Active, not recruitingObservational study
i-Stitch for Bilateral Sacrospinous Ligament Fixation (SSLF)
Pelvic Organ Prolapse, Genital Prolapse
Recruiting
Safety and Performance of a Pelvic Floor Mesh Implant for Laparoscopic Sacrocolpopexy (ProGYNious)
Pelvic Organ Prolapse (POP), Synthetic Mesh
Recruiting
Pelvic Floor Muscle Training During Pregnancy
Urinary Incontinence, Anal Incontinence
Not yet recruiting
Perineal Protection Device for Reducing Perineal Trauma During Vaginal Delivery in First-time Mothers: a Multicenter Randomized Controlled Trial
Pelvic Floor Dysfunction, Perineal Laceration
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.
Naama Marcus Braun, MD study chair
Ziv Medical center, Israel
Questions about this trial
What is this clinical trial studying?
A study testing One mesh Endofast reliant system and two meshes Endofast reliant system in people with Pelvic Organ Prolapse, run by Ziv Hospital.
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 4 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 31 Aug 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Naama Marcus braun, MD (+972506266090, naama.m@ziv.health.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Vaginal length between the arms (time frame: 2 years). The study lists 4 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 31 Aug 2015.