Vaginal ProlapseNCT00627549
Avaulta Versus Anterior Repair
A study testing Avaulta (surgical procedure using a mesh implant) and Conventional surgery (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 18 years and older, women only
- Conditions the study is for
- Vaginal Prolapse
- What is being tested?
- Avaulta (surgical procedure using a mesh implant) and Conventional surgery (anterior repair)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- Not given
- Where
- 1 siteDenmark
- Study dates
- Start not givento not given
- 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 18 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 previous 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 2
- Patients with previous TVT performed through the obturator membrane
- History of genital or abdominal cancer
- Patients treated with corticosteroids
- Not able to understand the study protocol (language problems, cognitive dysfunction etc.)
Trial locations and contacts
1 site in 1 country.
Martin Rudnicki, professor contact
Denmark1 site
Roskilde University Hospital
Roskilde, 4000
Martin Rudnicki, Professor
Ulla Hviid, MD
About this study
Official title: The Use of Avaulta Plus 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. We 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 our standard treatment.
The study is performed in all the Scandinavian countries.
- Conditions
- Vaginal Prolapse
- Being tested
- Avaulta (surgical procedure using a mesh implant), Conventional surgery (anterior repair)
- Keywords
- cystocele, anterior repair, mesh
- 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.
Avaulta (surgical procedure using a mesh implant)Procedure or surgery
The use of Avaulta
Conventional surgery (anterior repair)Procedure or surgery
Anterior repair surgery
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Not described Receives: Procedure: Avaulta (surgical procedure using a mesh implant) |
| 2 | Active comparator | Not described Receives: Procedure: Conventional surgery (anterior repair) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Does Avaulta Plus reduce the recurrence rate defined as a POP-Q Aa <-2 cm at follow-up after 1 yr.
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2008 (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 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
Sponsor and investigators
- Lead sponsor
- Zealand University Hospital
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00627549
- Sponsor's protocol ID
- Avaulta 17431
- Status last verified
- Feb 2008
- First submitted
- 22 Feb 2008
- Last updated
- 3 Mar 2008
- Results posted
- No
Publications
Rudnicki M, Laurikainen E, Pogosean R, Kinne I, Jakobsson U, Teleman P. A 3-year follow-up after anterior colporrhaphy compared with collagen-coated transvaginal mesh for anterior vaginal wall prolapse: a randomised controlled trial. BJOG. 2016 Jan;123(1):136-42. doi: 10.1111/1471-0528.13628. Epub 2015 Sep 30.
PubMed 26420345Teleman P, Laurikainen E, Kinne I, Pogosean R, Jakobsson U, Rudnicki M. Relationship between the Pelvic Organ Prolapse Quantification system (POP-Q), the Pelvic Floor Impact Questionnaire (PFIQ-7), and the Pelvic Floor Distress Inventory (PFDI-20) before and after anterior vaginal wall prolapse surgery. Int Urogynecol J. 2015 Feb;26(2):195-200. doi: 10.1007/s00192-014-2434-6. Epub 2014 May 28.
PubMed 24866279Rudnicki M, Laurikainen E, Pogosean R, Kinne I, Jakobsson U, Teleman P. Anterior colporrhaphy compared with collagen-coated transvaginal mesh for anterior vaginal wall prolapse: a randomised controlled trial. BJOG. 2014 Jan;121(1):102-10; discussion 110-1. doi: 10.1111/1471-0528.12454. Epub 2013 Oct 1.
PubMed 24118844
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Avaulta Plus for Anterior Repair. A Multicenter Randomised Prospective Controlled Study
- ClinicalTrials.gov ID
- NCT00627549
- Acronym / sponsor ID
- Avaulta 17431
- Conditions
- Vaginal Prolapse
- Keywords
- cystocele, anterior repair, mesh
- Study type
- Interventional
- Recruitment status
- Unknown status
- Lead sponsor
- Zealand University HospitalUniversity, hospital or other
- First posted
- 3 Mar 2008 (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. We 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 our standard treatment.
The study is performed in all the Scandinavian countries.
Study design
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Procedure: Avaulta (surgical procedure using a mesh implant) |
| 2 | Active comparator | Procedure: Conventional surgery (anterior repair) |
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)
- 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 previous 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 2
- 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 (surgical procedure using a mesh implant)The use of Avaulta | Procedure or surgery | 1 |
| Conventional surgery (anterior repair)Anterior repair surgery | Procedure or surgery | 2 |
Primary outcome
Does Avaulta Plus reduce the recurrence rate defined as a POP-Q Aa <-2 cm at follow-up after 1 yr.
Time frame: one year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2008.
- Derived from this study: PubMed 26420345Rudnicki M, Laurikainen E, Pogosean R, Kinne I, Jakobsson U, Teleman P. A 3-year follow-up after anterior colporrhaphy compared with collagen-coated transvaginal mesh for anterior vaginal wall prolapse: a randomised controlled trial. BJOG. 2016 Jan;123(1):136-42. doi: 10.1111/1471-0528.13628. Epub 2015 Sep 30.
- Derived from this study: PubMed 24866279Teleman P, Laurikainen E, Kinne I, Pogosean R, Jakobsson U, Rudnicki M. Relationship between the Pelvic Organ Prolapse Quantification system (POP-Q), the Pelvic Floor Impact Questionnaire (PFIQ-7), and the Pelvic Floor Distress Inventory (PFDI-20) before and after anterior vaginal wall prolapse surgery. Int Urogynecol J. 2015 Feb;26(2):195-200. doi: 10.1007/s00192-014-2434-6. Epub 2014 May 28.
- Derived from this study: PubMed 24118844Rudnicki M, Laurikainen E, Pogosean R, Kinne I, Jakobsson U, Teleman P. Anterior colporrhaphy compared with collagen-coated transvaginal mesh for anterior vaginal wall prolapse: a randomised controlled trial. BJOG. 2014 Jan;121(1):102-10; discussion 110-1. doi: 10.1111/1471-0528.12454. Epub 2013 Oct 1.
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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.
Martin Rudnicki, professor contact
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 (surgical procedure using a mesh implant) and Conventional surgery (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 3 Mar 2008. 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, professor (+4547324007), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Does Avaulta Plus reduce the recurrence rate defined as a POP-Q Aa <-2 cm at follow-up after 1 yr. (time frame: one 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 NCT00627549, 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 3 Mar 2008.