Vaginal ProlapseNCT00153257
Comparative Study of Mesh Versus No Mesh in Prolapse Surgery
A study testing Ugytex in people with Vaginal Prolapse and Cystocele, run by Centre Hospitalier Universitaire de Nīmes at 1 site in France.
Trial summary
Hypothesis / aims of study A RCT has shown that results of prolapse repair via vaginal approach could be improved when a polypropylene mesh is used as tissue support (1). However, non protected heavy-weight meshes were associated with a high rate of local complications such as vaginal erosions and dyspareunia (2). Read more about this study
- Who is it for?
- Ages 60 years and older, women only
- Conditions the study is for
- Vaginal Prolapse, Cystocele
- What is being tested?
- Ugytex
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 162 participants
- Where
- 1 siteFrance
- Study dates
- Apr 2005to Jan 2013
- 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 60 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients older than 60 years-old
- Anterior vaginal wall prolapse of stage 2 or more (POP-Q system)
- Symptomatic prolapse
- Informed consent signature obtained
Who cannot join
- Patient not able to read French language
- Patient with a anterior prolapse of stage 1
- Urinary of vaginal infection
- Hepatopathy with ascitis
- Diabetes uncontrolled
- Treatment by corticosteroids
- Previous pelvic irradiation
- Intraoperative bladder injury
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of the Prosthesis Ugytex by the Trans-obturator Approach and Anterior Colporrhaphy for the Surgical Treatment of Anterior Vaginal Wall Prolapse
Hypothesis / aims of study A RCT has shown that results of prolapse repair via vaginal approach could be improved when a polypropylene mesh is used as tissue support (1). However, non protected heavy-weight meshes were associated with a high rate of local complications such as vaginal erosions and dyspareunia (2). The aim of this multicentre study is to evaluate anatomical and functional results of an innovative low-weight polypropylene mesh protected by an absorbable hydrophilic film in the prolapse repair by vaginal route, in comparison by the standard anterior colporrhaphy.
Study design, materials and methods This study involves 15 centres in French Private or Public Hospital. Patients will be randomly allocated to be operated by a standard anterior colporrhaphy or by an anterior repair reinforced by a specially designed mesh: UgytexTM (Sofradim, France). Ugytex is a low-weight (38g/m²) and highly porous (average porosity: 89%, pores over 1.5mm) polypropylene monofilament mesh offering tissue ingrowth and connective differentiation for a stable and long-term support. The mesh is coated with a hydrophilic film composed of atelocollagen, polyethylene glycol and glycerol. The absorbable coating protects delicate pelvic viscera from the risk of acute inflammation during the healing's inflammatory peak. 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 (3), as well as a validated questionnaire on sexual problems. The difference on one-year cure rate should be 15% (80% for the anterior colporrhaphy and 95% for the mesh repair). Then the estimated number of patient is 97 in each arm.
- Conditions
- Vaginal Prolapse, Cystocele
- Being tested
- Ugytex
- Medical subject headings
- Uterine Prolapse, Cystocele
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UgytexDevice
Anterior repair reinforced by a specially designed mesh: UgytexTM
| Study group | Role | What they receive |
|---|---|---|
| Ugytex | Other | Anterior repair reinforced by a specially designed mesh: UgytexTM Receives: Device: Ugytex |
| No device | No intervention | standard anterior colporrhaphy |
What is being measured
The primary outcome is the main question the study is designed to answer.
number of anatomical recurrences of anterior vaginal wall prolapse of stage 2 or more (POP-Q system)
POP-Q score
Measured: 1 year
Secondary outcomes (4)
Perioperative and postoperative morbidity
Number of Major and minor complication
Measured: 3 years
Functionnal results following intervention
Symptoms and quality of life questionnaires
Measured: 3 years
Rate of local complications of prosthesis (vaginal erosion, prosthesis shrinkage)
Measured: 3 years
Post-operative sexuality
PISQ score
Measured: 3 years
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 startApr 2005
- Primary completionDec 2010
- Study completionJan 2013
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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 162 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nīmes
- Sponsor type
- University, hospital or other
- Collaborators
- DRRC, Medtronic - MITG
- Responsible party
- Sponsor
- Investigators
- Hervé Fernandez, MD, Study director, Hôpital Béclère, Clamart, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00153257
- Sponsor's protocol ID
- P040306
- Other IDs
- CRC04001
- Status last verified
- Oct 2019
- First submitted
- 8 Sep 2005
- Last updated
- 21 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Prosthesis Ugytex by the Trans-obturator Approach and Anterior Colporrhaphy for the Surgical Treatment of Anterior Vaginal Wall Prolapse
- ClinicalTrials.gov ID
- NCT00153257
- Acronym / sponsor ID
- P040306
- Conditions
- Vaginal Prolapse, Cystocele
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 162 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NīmesUniversity, hospital or other
- Collaborators
- DRRC, Medtronic - MITG
- Study start
- Apr 2005
- Primary completion
- Dec 2010 (actual)
- Study completion
- Jan 2013 (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 A RCT has shown that results of prolapse repair via vaginal approach could be improved when a polypropylene mesh is used as tissue support (1). However, non protected heavy-weight meshes were associated with a high rate of local complications such as vaginal erosions and dyspareunia (2). The aim of this multicentre study is to evaluate anatomical and functional results of an innovative low-weight polypropylene mesh protected by an absorbable hydrophilic film in the prolapse repair by vaginal route, in comparison by the standard anterior colporrhaphy.
Study design, materials and methods This study involves 15 centres in French Private or Public Hospital. Patients will be randomly allocated to be operated by a standard anterior colporrhaphy or by an anterior repair reinforced by a specially designed mesh: UgytexTM (Sofradim, France). Ugytex is a low-weight (38g/m²) and highly porous (average porosity: 89%, pores over 1.5mm) polypropylene monofilament mesh offering tissue ingrowth and connective differentiation for a stable and long-term support. The mesh is coated with a hydrophilic film composed of atelocollagen, polyethylene glycol and glycerol. The absorbable coating protects delicate pelvic viscera from the risk of acute inflammation during the healing's inflammatory peak. 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 (3), as well as a validated questionnaire on sexual problems. The difference on one-year cure rate should be 15% (80% for the anterior colporrhaphy and 95% for the mesh repair). Then the estimated number of patient is 97 in each arm.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ugytex | Other | Device: UgytexAnterior repair reinforced by a specially designed mesh: UgytexTM |
| No device | No intervention | –standard anterior colporrhaphy |
Who may qualify
- Ages
- 60 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients older than 60 years-old
- Anterior vaginal wall prolapse of stage 2 or more (POP-Q system)
- Symptomatic prolapse
- Informed consent signature obtained
Key exclusion criteria (8 listed)
- Patient not able to read French language
- Patient with a anterior prolapse of stage 1
- Urinary of vaginal infection
- Hepatopathy with ascitis
- Diabetes uncontrolled
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 |
|---|---|---|
| UgytexAnterior repair reinforced by a specially designed mesh: UgytexTM | Device | Ugytex |
Primary outcome
number of anatomical recurrences of anterior vaginal wall prolapse of stage 2 or more (POP-Q system)
Time frame: 1 year
POP-Q score
4 secondary outcomes
Perioperative and postoperative morbidity
Time frame: 3 years
Functionnal results following intervention
Time frame: 3 years
Rate of local complications of prosthesis (vaginal erosion, prosthesis shrinkage)
Time frame: 3 years
Post-operative sexuality
Time frame: 3 years
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 Nov 2019.
- Individual participant dataSharing planned: No
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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.
Hervé Fernandez, MD study director
Hôpital Béclère, Clamart, France
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ugytex in people with Vaginal Prolapse and Cystocele, 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 4 inclusion and 8 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 Nov 2019. 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.
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?
number of anatomical recurrences of anterior vaginal wall prolapse of stage 2 or more (POP-Q system) (time frame: 1 year). 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 Nov 2019.