CystoceleBCRNCT02272322
Transvaginal Treatment of Symptomatic Cystocele Grade II-III
An observational study of Cystocele, run by Slabbaert Koen at 1 site in Belgium.
Trial summary
This observational study will evaluate treatment of symptomatic cystocele grade II-III with Cousin Biomesh and Allium Medical Endofast Reliant. Data about 100 patients will be collected. Follow-up till 3 years after the procedure. Primary endpoint is absence of recurrence. Read more about this study
- Who is it for?
- Ages 40 to 90 years, women only
- Conditions the study is for
- Cystocele
- What is being tested?
- cystocele repair with biomesh soft prolaps and endofast reliant
- Type of treatment
- Medical device
- How many people
- 100 participants
- Where
- 1 siteBelgium
- Study dates
- Jun 2014to Dec 2019
- Phase
- Observational
- 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 40 to 90 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Patients with symptomatic anterior prolapse
Who may be able to join
- Patient is a woman
- Patient is between 40 and 90 years old
- Patient has to sign the informed consent form prior to the procedure
- Patient has to agree with the scheduled follow-up visits on month 1, month 6, year 1, year 2 and year 3
- Patient has symptomatic anterior prolapse
Who cannot join
- Recurrence cystocele
- Patient is pregnant
- Patient has a wish to become pregnant
- Patient is taking Plavix, Sintrom, Marcoumar, Marevan, Brilique, Efient, Ticlid, Xarelto, Eliquis or Pradaxa. If intake is stopped prior to procedure, patient is allowed to be included.
- Patient is taking LMWH in a dose of more than 40 mg/day
- Patient has a life expectancy < 1 year
Show all 9Show fewer
- Patient has a known connective tissue disease
- Patient has a history of surgery of the anterior vaginal wall or pelvis
- A scheduled hysterectomy during the index-procedure
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Transvaginal Treatment of Symptomatic Cystocele Grade II-III Using Cousin Biomesh Soft Prolaps or Allium Medical Endofast Reliant
This observational study will evaluate treatment of symptomatic cystocele grade II-III with Cousin Biomesh and Allium Medical Endofast Reliant. Data about 100 patients will be collected. Follow-up till 3 years after the procedure. Primary endpoint is absence of recurrence.
- Conditions
- Cystocele
- Being tested
- cystocele repair with biomesh soft prolaps and endofast reliant
- Keywords
- Anterior prolapse
- Medical subject headings
- Cystocele
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cystocele repair with biomesh soft prolaps and endofast reliantDevice
What is being measured
The primary outcome is the main question the study is designed to answer.
Absence of recurrence
Measured: 3 years
Secondary outcomes (5)
Technical success
Correct positioning of the mesh as intended by the surgeon
Measured: day 1
Procedural success
Technical success without complications till 30 days after the index-procedure
Measured: 30 days
Peroperative complications
Perforation bowels, bladder or arteries
Measured: day 1
Postoperative complications
Infection, bleeding, recurrence, mesh erosion, pain during sexual activities, pain, discomfort
Measured: 3 years
Quality of life
PFDI-20, PFIQ-7, PISQ-12
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 posted22 Oct 2014 (estimated)
- Study startJun 2014
- Primary completionDec 2017 (estimated)
- Study completionDec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CystoceleStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Slabbaert Koen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Slabbaert Koen, Regionaal Ziekenhuis Heilig Hart Tienen
- Investigators
- Koen Slabbaert, MD, Principal investigator, RZ Heilig Hart Tienen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02272322
- Sponsor's protocol ID
- BCR-11-01
- Acronym
- BCR
- Status last verified
- Jan 2017
- First submitted
- 1 Oct 2014
- Last updated
- 1 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transvaginal Treatment of Symptomatic Cystocele Grade II-III Using Cousin Biomesh Soft Prolaps or Allium Medical Endofast Reliant
- ClinicalTrials.gov ID
- NCT02272322
- Acronym / sponsor ID
- BCR / BCR-11-01
- Conditions
- Cystocele
- Keywords
- Anterior prolapse
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Slabbaert KoenUniversity, hospital or other
- Study start
- Jun 2014
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 22 Oct 2014 (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.
This observational study will evaluate treatment of symptomatic cystocele grade II-III with Cousin Biomesh and Allium Medical Endofast Reliant. Data about 100 patients will be collected. Follow-up till 3 years after the procedure. Primary endpoint is absence of recurrence.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 40 to 90 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with symptomatic anterior prolapse
Key inclusion criteria (5 listed)
- Patient is a woman
- Patient is between 40 and 90 years old
- Patient has to sign the informed consent form prior to the procedure
- Patient has to agree with the scheduled follow-up visits on month 1, month 6, year 1, year 2 and year 3
- Patient has symptomatic anterior prolapse
Key exclusion criteria (9 listed)
- Recurrence cystocele
- Patient is pregnant
- Patient has a wish to become pregnant
- Patient is taking Plavix, Sintrom, Marcoumar, Marevan, Brilique, Efient, Ticlid, Xarelto, Eliquis or Pradaxa. If intake is stopped prior to procedure, patient is allowed to be included.
- Patient is taking LMWH in a dose of more than 40 mg/day
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 |
|---|---|---|
| cystocele repair with biomesh soft prolaps and endofast reliant | Device | – |
Primary outcome
Absence of recurrence
Time frame: 3 years
5 secondary outcomes
Technical success
Time frame: day 1
Procedural success
Time frame: 30 days
Peroperative complications
Time frame: day 1
Postoperative complications
Time frame: 3 years
Quality of life
Time frame: 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2017.
Related trials for Cystocele
Active, not recruiting
Apical Suspension Repair for Vault Prolapse In a Three-Arm Randomized Trial Design
Visceral Prolapse
Recruiting
Poly-L-Lactic Acid for Vulvovaginal Tissue Regeneration
Pelvic Organ Prolapse (POP), Cystocele
RecruitingObservational study
Long Term Follow Up Of Transvaginal Cystocele Repair Using Four Armed Collagen Coated Polyester Mesh
Long Term Follow-Up, Transvaginal Cystocele Repair
Recruiting
Study Comparing Transobturator Cystocele vs. Anterior Vaginal RepairS
Pelvic Organ Prolapse, Cystocele
Recruiting
Biological OviTex Versus Synthetic Graft in Robotic Prolapse Surgery
Colorectal Disorders, Prolapse
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.
Koen Slabbaert, MD principal investigator
RZ Heilig Hart Tienen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cystocele, run by Slabbaert Koen at 1 site in Belgium.
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 9 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 1 Feb 2017. 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 Belgium. 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?
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?
Absence of recurrence (time frame: 3 years). 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 1 Feb 2017.