Anterior Vaginal Wall ProlapseNCT02469584
Small Stitch Study
A study testing small stitch anterior colporrhaphy in people with Anterior Vaginal Wall Prolapse, run by Medical University of Vienna at 1 site in Austria.
Trial summary
A descent of the anterior vaginal wall is the most common form of female pelvic organ prolapse (POP). Although anterior colporrhaphy (AC) is accepted worldwide as a "standard procedure", its exact steps are not well standardized. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Anterior Vaginal Wall Prolapse
- What is being tested?
- small stitch anterior colporrhaphy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteAustria
- Study dates
- Oct 2014to Aug 2015
- 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 older than 18 years of age
- Able to read, understand and sign informed consent
- symptomatic cystocele described as Points Aa or Ba >= 0 according to the International Continence Society pelvic organ prolapse quantification system (POP-Q)
Who cannot join
- previous urogynecological operation
- gynecologic malignancy
- planned concomitant incontinence operation
- other contraindications for surgery
- pregnancy
- systemic glucocorticoid treatment
- contraindication for the surgery
Trial locations and contacts
1 site in 1 country.
Engelbert Hanzal, DR contact
Austria1 site, 1 recruiting
- Recruiting
Medical University of Vienna
Vienna, Austria, 1090
Ksenia Halpern, Dr, 004314040029150
About this study
Official title: Continuous Small Stitch Technique for Anterior Colporrhaphy: a Pilot Study
A descent of the anterior vaginal wall is the most common form of female pelvic organ prolapse (POP). Although anterior colporrhaphy (AC) is accepted worldwide as a "standard procedure", its exact steps are not well standardized.
We developed a small stitch anterior colporrhaphy (SSTAC) in an effort to increase the strength and durability of AC
Objectives
The aim of this pilot study is to demonstrate the feasibility and complication rate of the SSTAC and to assess the anatomical and functional outcomes after this method of cystocele repair.
Read the detailed description
A prospective case series evaluation of SSTAC following the recommendations of IDEAL-Collaboration (www.ideal-collaboration.net) will be performed. The newly developed procedure will be tested in a group of 10 patients, who equals stage 2a in the development and innovation of surgical innovations. In this stage safety and technical success is the main outcome. As technical modifications may be common during stage 2a and their nature and timing should be meticulously recorded, the videotaping during all surgical procedures will be performed.
- Conditions
- Anterior Vaginal Wall Prolapse
- Being tested
- small stitch anterior colporrhaphy
- Keywords
- prolapse, anterior colporrhaphy
- Medical subject headings
- Prolapse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
small stitch anterior colporrhaphyProcedure or surgery
A midline plication will be performed with continuous delayed absorbable sutures (3-0 polydioxanone) and the distance between the sutures will be 0.5 cm.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | symptomatic cystocele described as Points Aa or Ba >= 0 according to the International Continence Society pelvic organ prolapse quantification system (POP-Q). The changes in POPQ score preoperatively and three months after the anterior colporrhaphy with the new small stitch technic will be analyzed. Receives: Procedure: small stitch anterior colporrhaphy |
What is being measured
The primary outcome is the main question the study is designed to answer.
the most distal point of the anterior vaginal wall- postoperative anterior vaginal support described as Point Ba (POP-Q score)
The changes in POPQ score preoperatively and three months after the anterior colporrhaphy with the new small stitch technic will be analyzed.
Measured: 4-6 weeks, 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2015 (estimated)
- Study startOct 2014
- Primary completionAug 2015 (estimated)
- Study completionAug 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anterior Vaginal Wall ProlapseStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Halpern Ksenia, Medical University of Vienna
- Investigators
- Engelbert Hanzal, Dr, Principal investigator, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02469584
- Sponsor's protocol ID
- 1236/2014
- Status last verified
- Jun 2015
- First submitted
- 5 Jun 2015
- Last updated
- 11 Jun 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Continuous Small Stitch Technique for Anterior Colporrhaphy: a Pilot Study
- ClinicalTrials.gov ID
- NCT02469584
- Acronym / sponsor ID
- 1236/2014
- Conditions
- Anterior Vaginal Wall Prolapse
- Keywords
- prolapse, anterior colporrhaphy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- Oct 2014
- Primary completion
- Aug 2015 (estimated)
- Study completion
- Aug 2015 (estimated)
- First posted
- 11 Jun 2015 (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.
A descent of the anterior vaginal wall is the most common form of female pelvic organ prolapse (POP). Although anterior colporrhaphy (AC) is accepted worldwide as a "standard procedure", its exact steps are not well standardized.
We developed a small stitch anterior colporrhaphy (SSTAC) in an effort to increase the strength and durability of AC
Objectives
The aim of this pilot study is to demonstrate the feasibility and complication rate of the SSTAC and to assess the anatomical and functional outcomes after this method of cystocele repair.
Detailed description
A prospective case series evaluation of SSTAC following the recommendations of IDEAL-Collaboration (www.ideal-collaboration.net) will be performed. The newly developed procedure will be tested in a group of 10 patients, who equals stage 2a in the development and innovation of surgical innovations. In this stage safety and technical success is the main outcome. As technical modifications may be common during stage 2a and their nature and timing should be meticulously recorded, the videotaping during all surgical procedures will be performed.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Procedure: small stitch anterior colporrhaphysymptomatic cystocele described as Points Aa or Ba >= 0 according to the International Continence Society pelvic organ prolapse quantification system (POP-Q). The changes in POPQ score preoperatively and three months after the anterior colporrhaphy with the new small stitch technic will be analyzed. |
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 older than 18 years of age
- Able to read, understand and sign informed consent
- symptomatic cystocele described as Points Aa or Ba >= 0 according to the International Continence Society pelvic organ prolapse quantification system (POP-Q)
Key exclusion criteria (7 listed)
- previous urogynecological operation
- gynecologic malignancy
- planned concomitant incontinence operation
- other contraindications for surgery
- pregnancy
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 |
|---|---|---|
| small stitch anterior colporrhaphyA midline plication will be performed with continuous delayed absorbable sutures (3-0 polydioxanone) and the distance between the sutures will be 0.5 cm. | Procedure or surgery | 1 |
Primary outcome
the most distal point of the anterior vaginal wall- postoperative anterior vaginal support described as Point Ba (POP-Q score)
Time frame: 4-6 weeks, 3 months
The changes in POPQ score preoperatively and three months after the anterior colporrhaphy with the new small stitch technic will be analyzed.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2015.
Related trials for Anterior Vaginal Wall Prolapse
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To Explore the Surgical Outcomes and Safety of an Innovative Laparoscopic Uterine Pectopexy Technique Using Inverted T-meshes for Simultaneous Apical and Anterior Vaginal Repair.
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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.
Engelbert Hanzal, DR contact
Engelbert Hanzal, Dr principal investigator
Medical University of Vienna
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing small stitch anterior colporrhaphy in people with Anterior Vaginal Wall Prolapse, run by Medical University of Vienna at 1 site in Austria.
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 7 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 2015. 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 Austria. 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 Ksenia Halpern, Dr (00431404040029150, ksenia.halpern@meduniwien.ac.at), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the most distal point of the anterior vaginal wall- postoperative anterior vaginal support described as Point Ba (POP-Q score) (time frame: 4-6 weeks, 3 months). 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 2015.