Vaginal ProlapseNCT00918099
The Use of Avaulta for Anterior Repair
A study testing Avaulta mesh and Anterior repair in people with Vaginal Prolapse, run by Zealand University Hospital at 1 site in Denmark.
Trial summary
Summary: Vaginal prolapse is a well-known disease and is observed in approximately 11% of all postmenopausal women and tending to increase with age. Consequently, many surgical procedures have been developed in order to ensure sufficient support for the bladder, rectum or vaginal vault depending on the site of the… Read more about this study
- Who is it for?
- Ages 55 years and older, women only
- Conditions the study is for
- Vaginal Prolapse
- What is being tested?
- Avaulta mesh and Anterior repair
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 1 siteDenmark
- Study dates
- Oct 2008to Jul 2010
- 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 55 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women aged > 55 yr
- Women with anterior vaginal wall prolapse stage >2 according to POP-Q classification
- Good understanding the language in word and writing
Who cannot join
- A history of pervious major pelvic surgery with the exception of a hysterectomy for reasons other than genital prolapse
- Patients with previous vaginal surgery because of defects in the anterior of posterior compartments
- Previous hysterectomy because of vaginal prolapse
- Patients with prolapse of uterus or an enterocele > stage 1
- Patients with previous TVT performed through the obturator membrane
- History of genital or abdominal cancer
- Patients treated with corticostaroids
- Not able to understand the study protocol (language problems, cognitive dysfunction etc.)
Trial locations and contacts
1 site in 1 country.
Denmark1 site, 1 recruiting
- Recruiting
Roskilde University Hospital
Roskilde, 4000
Martin Rudnicki, ass professor, pmru@regionsjaelland.dk
Martin Rudnicki
About this study
Official title: The Use of Avaulta for Anterior Repair. A Multicenter Randomised Prospective Controlled Study
Summary:
Vaginal prolapse is a well-known disease and is observed in approximately 11% of all postmenopausal women and tending to increase with age. Consequently, many surgical procedures have been developed in order to ensure sufficient support for the bladder, rectum or vaginal vault depending on the site of the defect. However, many procedures are associated with a high recurrence rate up to 40 % even within one to two years after the surgical procedure.
Read more
Due to the high recurrence rate new methods include the use of mesh, either biologically or synthetic. The latter is a permanent implant and therefore theoretically may result in a long-lasting anatomically correct position of the prolapse.
Although the recurrence rate may be lower using a mesh such surgical procedures may be associated with adverse events such as erosions of the vaginal mucosa. Others have observed shrinkage of the vaginal mucosa. However, in these studies large prolene mesh have been used. In contrast the recurrence rate is lowered up to 25%.
The above-mentioned advantage of synthetic mesh is however, mostly based on few non-randomised studies. The investigators therefore find it of importance to evaluate whether a surgical procedure using a mesh implant is superior to conventional surgical techniques. The present study is a clinical controlled study where patients with anterior vaginal prolapse are randomised to either a mesh technique or a standard anterior procedure.
The present study includes only two more visits at the outpatient clinic after the surgical procedure. Furthermore the patients have to fulfil questionnaires regarding urinary and faecal leakage and sexual habits.
Any participation in the study is totally voluntary and the patient may at any time withdraw herself. In any case the patient will receive the investigators' standard treatment.
Read the detailed description
RESEARCH PROTOCOL:
The use of Avaulta for anterior repair. A multicenter randomised prospective controlled study.
BACKGROUND:
During the resent years the methods for pelvic organ prolapse repair have changed rapidly. The reason for this is several. Firstly, there is a relative high recurrence rate in patients having an anterior vaginal repair. Thus, the rate has been estimated to be close to 40% or even higher and most often the recurrences occurs within the first two years. Weber et al and Sand et al reported various techniques of the anterior colporrhaphy without the use of mesh to be successful in the management of cystoceles in only 42 and 57%, respectively. In contrast others have shown a much lower 1-year recurrence rate. Shull reported on the safety and efficacy of the paravaginal repair but this procedure may also vary in success from 67 - 100%. Taken all together however, interpretation of these studies is difficult since the patients included have undergone at least one (in most cases several) vaginal surgical procedures at the same time and some studies even include patients with recurrence together with patients scheduled for primary vaginal surgery. Secondly, there is a need for simple procedures, which can be performed in an outpatient clinic and thirdly, the surgery should be acceptable for the women, i.e. without postoperative pain, short recovery period and no need for further surgical intervention.
In most centers a vaginal surgical repair of an anterior genital prolapse is performed in a standard manner through a midline incision followed by dissection of the vaginal mucosa from the pubocervical fascia. Interrupted sutures approximating the fascia at the midline then repair the cystocele. However, this may not be sufficient in those cases where no fascia is present or the presence of huge defects in the pubocervical fascia. As a consequence the use of mesh have been more popular. Several studies report a reduced recurrence rate following anterior repair using different types of mesh such as biomesh (6,7) or nonabsorbable mesh. The latter has been shown to be associated with vaginal erosion 8 - 2%%, which probably is related to the strong inflammatory response observed after implementation of such mesh. Another complication is shrinkage of the vaginal mucosa and this may be followed by sexual dysfunction or dyspareunia.
Polypropylene mesh appears to induce less inflammatory respons compared to other types. A specific type of mesh is the Avaulta Biosynthetic Mesh, which is a polypropylene mesh coated with collagen. This layer protects against inflammatory response and is slowly resolved.
Since most studies have included patients undergoing several vaginal surgical procedures at the same time, it is difficult to conclude whether or not the use of mesh is superior compared to conventional technique. Furthermore, only sparse information is available regarding sexual function and dyspareunia following vaginal prolapse surgery. Especially there is a lack of information regarding new mesh types.
The purpose of the present study is therefore to test the hypothesis that the Avaulta Biosynthetic Mesh is associated with a lower recurrence rate after two years of follow-up compared to conventional anterior repair. Secondly, the study is planned to evaluate the frequency of sexual dysfunction following vaginal anterior repair, and if there is any difference between the two surgical methods.
- Conditions
- Vaginal Prolapse
- Being tested
- Avaulta mesh, Anterior repair
- Keywords
- Mesh, vaginal prolapse, Recurrence rate
- Medical subject headings
- Uterine Prolapse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Avaulta meshProcedure or surgery
Insertion of a mesh vs conventional repair
Anterior repairProcedure or surgery
Conventional repair
| Study group | Role | What they receive |
|---|---|---|
| Avaulta mesh | Active comparator | Avaulta mesh Receives: Procedure: Avaulta mesh |
| Anterior repair | Active comparator | Anterior repair Receives: Procedure: Anterior repair |
What is being measured
The primary outcome is the main question the study is designed to answer.
Does Avaulta reduce the recurrence rate
Measured: 0ct 2008 - July 2010
Secondary outcomes (1)
Does Avaulta improve prolapse symptoms, quality of life and sexual function
Measured: oct 2008-July 2010
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2009 (estimated)
- Study startOct 2008
- Primary completionJul 2010 (estimated)
- Study completionJul 2010 (estimated)
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 Zealand University HospitalThe 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
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 130 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zealand University Hospital
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00918099
- Sponsor's protocol ID
- Avaulta
- Status last verified
- Jun 2009
- First submitted
- 9 Jun 2009
- Last updated
- 11 Jun 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Avaulta for Anterior Repair. A Multicenter Randomised Prospective Controlled Study
- ClinicalTrials.gov ID
- NCT00918099
- Acronym / sponsor ID
- Avaulta
- Conditions
- Vaginal Prolapse
- Keywords
- Mesh, vaginal prolapse, Recurrence rate
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 130 participants (estimated)
- Lead sponsor
- Zealand University HospitalUniversity, hospital or other
- Study start
- Oct 2008
- Primary completion
- Jul 2010 (estimated)
- Study completion
- Jul 2010 (estimated)
- First posted
- 11 Jun 2009 (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.
Summary:
Vaginal prolapse is a well-known disease and is observed in approximately 11% of all postmenopausal women and tending to increase with age. Consequently, many surgical procedures have been developed in order to ensure sufficient support for the bladder, rectum or vaginal vault depending on the site of the defect. However, many procedures are associated with a high recurrence rate up to 40 % even within one to two years after the surgical procedure.
Due to the high recurrence rate new methods include the use of mesh, either biologically or synthetic. The latter is a permanent implant and therefore theoretically may result in a long-lasting anatomically correct position of the prolapse.
Although the recurrence rate may be lower using a mesh such surgical procedures may be associated with adverse events such as erosions of the vaginal mucosa. Others have observed shrinkage of the vaginal mucosa. However, in these studies large prolene mesh have been used. In contrast the recurrence rate is lowered up to 25%.
The above-mentioned advantage of synthetic mesh is however, mostly based on few non-randomised studies. The investigators therefore find it of importance to evaluate whether a surgical procedure using a mesh implant is superior to conventional surgical techniques. The present study is a clinical controlled study where patients with anterior vaginal prolapse are randomised to either a mesh technique or a standard anterior procedure.
The present study includes only two more visits at the outpatient clinic after the surgical procedure. Furthermore the patients have to fulfil questionnaires regarding urinary and faecal leakage and sexual habits.
Any participation in the study is totally voluntary and the patient may at any time withdraw herself. In any case the patient will receive the investigators' standard treatment.
Detailed description
RESEARCH PROTOCOL:
The use of Avaulta for anterior repair. A multicenter randomised prospective controlled study.
BACKGROUND:
During the resent years the methods for pelvic organ prolapse repair have changed rapidly. The reason for this is several. Firstly, there is a relative high recurrence rate in patients having an anterior vaginal repair. Thus, the rate has been estimated to be close to 40% or even higher and most often the recurrences occurs within the first two years. Weber et al and Sand et al reported various techniques of the anterior colporrhaphy without the use of mesh to be successful in the management of cystoceles in only 42 and 57%, respectively. In contrast others have shown a much lower 1-year recurrence rate. Shull reported on the safety and efficacy of the paravaginal repair but this procedure may also vary in success from 67 - 100%. Taken all together however, interpretation of these studies is difficult since the patients included have undergone at least one (in most cases several) vaginal surgical procedures at the same time and some studies even include patients with recurrence together with patients scheduled for primary vaginal surgery. Secondly, there is a need for simple procedures, which can be performed in an outpatient clinic and thirdly, the surgery should be acceptable for the women, i.e. without postoperative pain, short recovery period and no need for further surgical intervention.
In most centers a vaginal surgical repair of an anterior genital prolapse is performed in a standard manner through a midline incision followed by dissection of the vaginal mucosa from the pubocervical fascia. Interrupted sutures approximating the fascia at the midline then repair the cystocele. However, this may not be sufficient in those cases where no fascia is present or the presence of huge defects in the pubocervical fascia. As a consequence the use of mesh have been more popular. Several studies report a reduced recurrence rate following anterior repair using different types of mesh such as biomesh (6,7) or nonabsorbable mesh. The latter has been shown to be associated with vaginal erosion 8 - 2%%, which probably is related to the strong inflammatory response observed after implementation of such mesh. Another complication is shrinkage of the vaginal mucosa and this may be followed by sexual dysfunction or dyspareunia.
Polypropylene mesh appears to induce less inflammatory respons compared to other types. A specific type of mesh is the Avaulta Biosynthetic Mesh, which is a polypropylene mesh coated with collagen. This layer protects against inflammatory response and is slowly resolved.
Since most studies have included patients undergoing several vaginal surgical procedures at the same time, it is difficult to conclude whether or not the use of mesh is superior compared to conventional technique. Furthermore, only sparse information is available regarding sexual function and dyspareunia following vaginal prolapse surgery. Especially there is a lack of information regarding new mesh types.
The purpose of the present study is therefore to test the hypothesis that the Avaulta Biosynthetic Mesh is associated with a lower recurrence rate after two years of follow-up compared to conventional anterior repair. Secondly, the study is planned to evaluate the frequency of sexual dysfunction following vaginal anterior repair, and if there is any difference between the two surgical methods.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Avaulta mesh | Active comparator | Procedure: Avaulta meshAvaulta mesh |
| Anterior repair | Active comparator | Procedure: Anterior repairAnterior repair |
Who may qualify
- Ages
- 55 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Women aged > 55 yr
- Women with anterior vaginal wall prolapse stage >2 according to POP-Q classification
- Good understanding the language in word and writing
Key exclusion criteria (8 listed)
- A history of pervious major pelvic surgery with the exception of a hysterectomy for reasons other than genital prolapse
- Patients with previous vaginal surgery because of defects in the anterior of posterior compartments
- Previous hysterectomy because of vaginal prolapse
- Patients with prolapse of uterus or an enterocele > stage 1
- Patients with previous TVT performed through the obturator membrane
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 |
|---|---|---|
| Avaulta meshInsertion of a mesh vs conventional repair | Procedure or surgery | Avaulta mesh |
| Anterior repairConventional repair | Procedure or surgery | Anterior repair |
Primary outcome
Does Avaulta reduce the recurrence rate
Time frame: 0ct 2008 - July 2010
1 secondary outcome
Does Avaulta improve prolapse symptoms, quality of life and sexual function
Time frame: oct 2008-July 2010
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2009.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Avaulta mesh and Anterior repair in people with Vaginal Prolapse, run by Zealand University Hospital at 1 site in Denmark.
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 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: status not confirmed, as of the sponsor's last update on 11 Jun 2009. 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 Denmark. 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?
Contact Martin Rudnicki, ass professor (+4547324007, pmru@regionsjaelland.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Does Avaulta reduce the recurrence rate (time frame: 0ct 2008 - July 2010). 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 11 Jun 2009.