Pelvic Organ ProlapseNCT00572702
Randomized,Multicentric Study to Treat Prolapse After Hysterectomy With Amreich Procedure or Total Prolift Procedure
A study testing Vaginal fixation Amreich-Richter and Prolift total in people with Pelvic Organ Prolapse, run by Charles University, Czech Republic at 5 sites in Czechia.
Trial summary
Head to Head comparison of perioperative complications and secondary the impact of operation techniques with or without mesh on patients suffering from pelvic organ prolapse on quality of life. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Pelvic Organ Prolapse
- What is being tested?
- Vaginal fixation Amreich-Richter and Prolift total
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 5 sitesCzechia
- Study dates
- Jan 2007to Dec 2009
- 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
- female sex
- age 18 and more
- subscribed informed consent
- objective symptoms of prolapse-POP-Q 3 and more according to ICS standards
- compliance of the patient
Who cannot join
- patients with evidence of malignant lesion in small pelvis
- history of radiotherapy in small pelvis
- patients suffering from any form of PID within inclusion process
- pregnancy
- lactation
- total eversion of uterus and vagina
Show all 12Show fewer
- serious internal disorders
- history of recto- or vesico-vaginal fistula
- history of rejection of any artificial material
- symptoms of primary genuine stress urinary incontinence
- patients who were not able to subscribe the informed consent
- patients, who couldn´t be reached for further follow-up
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Czechia5 sites, 5 recruiting
- Recruiting
Dpt. Obstetrics and gynecology, General Teaching Hospital
Prague, 12800
Kamil Svabik, MD., +420603583456, kamil@svabik.cz
- Recruiting
Institute for the care of mother and child
Prague, 147 10
Ladislav Krofta, MD.,PhD., +420604480886, ladislav.krofta@post.cz
- Recruiting
Dpt. of gynecology, Central military hospital
Prague, 169 02
Tomas Rittstein, MD., +420606369793, urogyn@volny.cz
- Recruiting
Dpt. Obstetrics and gynecology, Teaching hospital Bulovka
Prague, 18000
Michal Krcmar, MD., +420607675842, xkrcmar@centrum.cz
- Recruiting
Dpt. of Obstetrics and gynecology, Bata hospital
Zlín, 762 75
Zdenek Adamik, MD., PhD., +420603241176, adamik@mediclub.cz
About this study
Official title: Open, Randomized, Prospective, Comparative, Multicentric to Treat Prolapse of Vaginal Cuff After Hysterectomy With Amreich Procedure or Total Prolift Procedure
Head to Head comparison of perioperative complications and secondary the impact of operation techniques with or without mesh on patients suffering from pelvic organ prolapse on quality of life.
Read the detailed description
During the last decade a substantial progress in the detailed knowledge of morphology and function of different compartments of the female pelvic floor was achieved. The obtained informations were quickly implemented in the clinical practice especially in the application of special meshes and of novel techniques of their implantation. Their success rate was evaluated only in pilot companies supported studies. We do miss randomised studies not sponsored by company comparing different surgical techniques and their impact on the quality of life (QoL); the objective estimation of those consequences is for the longlasting effect of the surgery inevitable. The new methods bring also new complications which were not yet relevantly and objectively documented.
In the study we compare the techniques contemporary used - in the groups with or without mesh, in size relevant for the statistical evaluation
- Conditions
- Pelvic Organ Prolapse
- Being tested
- Vaginal fixation Amreich-Richter, Prolift total
- Keywords
- Biocompatible Materials, Female, Humans, Pelvic Floor, Polypropylenes, Prostheses and Implants, Surgical Mesh, Uterine Prolapse/*therapy
- 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.
Vaginal fixation Amreich-RichterProcedure or surgery
Descending vaginal cuff will be treated with fixation of the cuff on sacrospinous ligament
Prolift totalProcedure or surgery
Also called Prolift total - polypropylen mesh
Descending vaginal cuff will be treated with insertion of site-specific mesh into the vesico-vaginal and recto-vaginal space
| Study group | Role | What they receive |
|---|---|---|
| A | Active comparator | Patients with 3 compartment pelvic organ prolapse after hysterectomy, treated with Amreich-Richter procedure; it will be set randomly Receives: Procedure: Vaginal fixation Amreich-Richter |
| B | Active comparator | Patients with 3 compartment pelvic organ prolapse after hysterectomy, treated with total Prolift procedure; it will be set randomly Receives: Procedure: Prolift total |
What is being measured
The primary outcome is the main question the study is designed to answer.
The objective evaluation o perioperative complications and comparison of patients with pelvic organ prolapse treated with Amreich-Richter procedure or Prolift implants.
Measured: 3 month
Secondary outcomes (1)
Ultrasound, urodynamics, clinical examinations, magnetic resonance imaging, validated QoL questionnaires
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2007 (estimated)
- Study startJan 2007
- Primary completionDec 2009 (estimated)
- Study completionDec 2009 (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.
- More trials run by Charles University, Czech RepublicThe 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
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Charles University, Czech Republic
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health, Czech Republic
- Investigators
- Michael Halaska, MD,PhD, Principal investigator, Charles University, Prague, Czech Republic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00572702
- Sponsor's protocol ID
- NR/9309-3 IGA
- Other IDs
- NR/9309-3 IGA
- Status last verified
- Jul 2009
- First submitted
- 12 Dec 2007
- Last updated
- 3 Aug 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open, Randomized, Prospective, Comparative, Multicentric to Treat Prolapse of Vaginal Cuff After Hysterectomy With Amreich Procedure or Total Prolift Procedure
- ClinicalTrials.gov ID
- NCT00572702
- Acronym / sponsor ID
- NR/9309-3 IGA
- Conditions
- Pelvic Organ Prolapse
- Keywords
- Biocompatible Materials, Female, Humans, Pelvic Floor, Polypropylenes, Prostheses and Implants, Surgical Mesh, Uterine Prolapse/*therapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Charles University, Czech RepublicUniversity, hospital or other
- Collaborators
- Ministry of Health, Czech Republic
- Study start
- Jan 2007
- Primary completion
- Dec 2009 (estimated)
- Study completion
- Dec 2009 (estimated)
- First posted
- 13 Dec 2007 (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.
Head to Head comparison of perioperative complications and secondary the impact of operation techniques with or without mesh on patients suffering from pelvic organ prolapse on quality of life.
Detailed description
During the last decade a substantial progress in the detailed knowledge of morphology and function of different compartments of the female pelvic floor was achieved. The obtained informations were quickly implemented in the clinical practice especially in the application of special meshes and of novel techniques of their implantation. Their success rate was evaluated only in pilot companies supported studies. We do miss randomised studies not sponsored by company comparing different surgical techniques and their impact on the quality of life (QoL); the objective estimation of those consequences is for the longlasting effect of the surgery inevitable. The new methods bring also new complications which were not yet relevantly and objectively documented.
In the study we compare the techniques contemporary used - in the groups with or without mesh, in size relevant for the statistical evaluation
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Active comparator | Procedure: Vaginal fixation Amreich-RichterPatients with 3 compartment pelvic organ prolapse after hysterectomy, treated with Amreich-Richter procedure; it will be set randomly |
| B | Active comparator | Procedure: Prolift totalPatients with 3 compartment pelvic organ prolapse after hysterectomy, treated with total Prolift procedure; it will be set randomly |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- female sex
- age 18 and more
- subscribed informed consent
- objective symptoms of prolapse-POP-Q 3 and more according to ICS standards
- compliance of the patient
Key exclusion criteria (12 listed)
- patients with evidence of malignant lesion in small pelvis
- history of radiotherapy in small pelvis
- patients suffering from any form of PID within inclusion process
- pregnancy
- lactation
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 |
|---|---|---|
| Vaginal fixation Amreich-RichterDescending vaginal cuff will be treated with fixation of the cuff on sacrospinous ligament | Procedure or surgery | A |
| Prolift totalAlso: Prolift total - polypropylen meshDescending vaginal cuff will be treated with insertion of site-specific mesh into the vesico-vaginal and recto-vaginal space | Procedure or surgery | B |
Primary outcome
The objective evaluation o perioperative complications and comparison of patients with pelvic organ prolapse treated with Amreich-Richter procedure or Prolift implants.
Time frame: 3 month
1 secondary outcome
Ultrasound, urodynamics, clinical examinations, magnetic resonance imaging, validated QoL questionnaires
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2009.
Related trials for Pelvic Organ Prolapse
Active, not recruitingObservational study
Return to Physical Activity After Retropublic Transvaginal Sling and Laparoscopic Sacrocolpopexy
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i-Stitch for Bilateral Sacrospinous Ligament Fixation (SSLF)
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Safety and Performance of a Pelvic Floor Mesh Implant for Laparoscopic Sacrocolpopexy (ProGYNious)
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Perineal Protection Device for Reducing Perineal Trauma During Vaginal Delivery in First-time Mothers: a Multicenter Randomized Controlled Trial
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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.
Michael Halaska, MD,PhD principal investigator
Charles University, Prague, Czech Republic
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vaginal fixation Amreich-Richter and Prolift total in people with Pelvic Organ Prolapse, run by Charles University, Czech Republic at 5 sites in Czechia.
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 5 inclusion and 12 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 Aug 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Czechia. 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 Michael Krcmar, MD (+420607675842, xkrcmar@centrum.cz), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The objective evaluation o perioperative complications and comparison of patients with pelvic organ prolapse treated with Amreich-Richter procedure or Prolift implants. (time frame: 3 month). 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 3 Aug 2009.