Female Genital ProlapseNCT02092623
Single Incision Transvaginal Mesh in Treatment of Posterior Vaginal Wall Prolapse
A study testing Transvaginal posterior mesh in people with Female Genital Prolapse, run by Turku University Hospital at 1 site in Finland.
Trial summary
Definition: To find out complications, objective and subjective outcomes of patients with symptomatic posterior vaginal wall prolapse undergoing posterior mesh operation in nine Finnish hospitals during September 2010 and August 2013. Read more about this study
- Who is it for?
- Ages 30 to 90 years, women only
- Conditions the study is for
- Female Genital Prolapse
- What is being tested?
- Transvaginal posterior mesh
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 111 participants
- Where
- 1 siteFinland
- Study dates
- Sep 2010to Dec 2014
- 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 30 to 90 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients with symptomatic posterior vaginal wall with or without apical prolapse with stage II or more
Who cannot join
- concomitant surgery, immunosuppressive treatment of any kind, previous or forthcoming bowel operation with low anastomosis creation and previous vaginal radiation therapy
Trial locations and contacts
1 site in 1 country.
Finland1 site
Turku University Central Hospital
Turku, Southwest Finland, 20520
About this study
Official title: Single Incision Transvaginal Mesh (Elevate® Posterior) in Treatment of Posterior Vaginal Wall Prolapse Without Concurrent Surgery - National Prospective Multicenter Study
Definition: To find out complications, objective and subjective outcomes of patients with symptomatic posterior vaginal wall prolapse undergoing posterior mesh operation in nine Finnish hospitals during September 2010 and August 2013. The study hypothesis is that complications are acceptable and both objective and subjective outcomes are satisfying.
Read the detailed description
The aim of this study is to investigate the safety and efficacy of Elevate®Posterior transvaginal mesh kit. Secondly the investigators want to evaluate the effect of this surgical method on non-affected anterior vaginal compartment as well as patients' outcome.
This prospective multicenter national study include patients (n=111) with symptomatic posterior vaginal wall with or without apical prolapse with stage II or more. Patients were recruited at four university hospitals and five central hospitals in Finland between September 2010 and August 2013. The study protocol was approved by the Ethics Committees in participating hospitals and all attending patients gave written consent after oral and written counseling. Baseline evaluation include standardized gynecological examination in supine position using the POP-Q system. Detailed information on patients' characteristics and medical history is gathered, focusing on especially gynecological issues. Patients fill in Pelvic Floor Distress Inventory (PFDI-20) and Pelvic organ prolapse/urinary Incontinence Sexual Questionnaire (PISQ-12).
The operations are performed by qualified surgeons (n=9) familiar with transvaginal mesh surgery. Intraoperative data is collected and immediate postoperative problems are registered.
The first follow-up visit take place at three months postoperatively. Gynecological examination with POP-Q measurements are performed and complications documented. As preoperatively, PFDI-20 and PISQ-12 questionnaires are filled in by the patients.
The second visit take place at one year postoperatively. Gynecological examination with POP-Q measurements are performed and possible late complications documented. PFDI-20 and PISQ-12 questionnaires are filled in again by the patients.
- Conditions
- Female Genital Prolapse
- Being tested
- Transvaginal posterior mesh
- Keywords
- Female, Prolapse surgery with transvaginal mesh, Subjective outcome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transvaginal posterior meshDevice
Also called Elevate®Posterior
A trocar-free fixation system with low-weight mesh
| Study group | Role | What they receive |
|---|---|---|
| Transvaginal posterior mesh surgery | Other | All study patients undergo transvaginal mesh operation. Receives: Device: Transvaginal posterior mesh |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with adverse events as a measure of safety and tolerability
Measured: up to 1 year
Secondary outcomes (3)
POP-Q measurement
Objective results of the operation (vaginal anatomy)
Measured: preoperatively, 3 months and 1 year
Pelvic floor distress inventory (PFDI-20)
Subjective outcome of the operation on pelvic floor symptoms
Measured: preoperatively, 3 months and 1 year
Pelvic organ prolapse/urinary incontinence sexual questionnaire (PISQ-12)
Subjective outcome of the operation on sexual functioning
Measured: preoperatively, 3 months and 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2014 (estimated)
- Study startSep 2010
- Primary completionNov 2013
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Female Genital ProlapseStudies of the same condition, open and under way.
- More trials run by Turku 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 111 participants (actual)
Sponsor and investigators
- Lead sponsor
- Turku University Hospital
- Sponsor type
- Other government
- Collaborators
- Oulu University Hospital, Helsinki University Central Hospital, Tampere University Hospital
- Responsible party
- Principal investigator, Seija Ala-Nissilä, Turku University Hospital
- Investigators
- Mervi Haarala, MD, Study director, Turku University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02092623
- Sponsor's protocol ID
- 50/180/2010
- Other IDs
- 21011
- Status last verified
- May 2015
- First submitted
- 17 Mar 2014
- Last updated
- 27 May 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single Incision Transvaginal Mesh (Elevate® Posterior) in Treatment of Posterior Vaginal Wall Prolapse Without Concurrent Surgery - National Prospective Multicenter Study
- ClinicalTrials.gov ID
- NCT02092623
- Acronym / sponsor ID
- 50/180/2010
- Conditions
- Female Genital Prolapse
- Keywords
- Female, Prolapse surgery with transvaginal mesh, Subjective outcome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 111 participants (actual)
- Lead sponsor
- Turku University HospitalOther government
- Collaborators
- Oulu University Hospital, Helsinki University Central Hospital, Tampere University Hospital
- Study start
- Sep 2010
- Primary completion
- Nov 2013 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 20 Mar 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.
Definition: To find out complications, objective and subjective outcomes of patients with symptomatic posterior vaginal wall prolapse undergoing posterior mesh operation in nine Finnish hospitals during September 2010 and August 2013. The study hypothesis is that complications are acceptable and both objective and subjective outcomes are satisfying.
Detailed description
The aim of this study is to investigate the safety and efficacy of Elevate®Posterior transvaginal mesh kit. Secondly the investigators want to evaluate the effect of this surgical method on non-affected anterior vaginal compartment as well as patients' outcome.
This prospective multicenter national study include patients (n=111) with symptomatic posterior vaginal wall with or without apical prolapse with stage II or more. Patients were recruited at four university hospitals and five central hospitals in Finland between September 2010 and August 2013. The study protocol was approved by the Ethics Committees in participating hospitals and all attending patients gave written consent after oral and written counseling. Baseline evaluation include standardized gynecological examination in supine position using the POP-Q system. Detailed information on patients' characteristics and medical history is gathered, focusing on especially gynecological issues. Patients fill in Pelvic Floor Distress Inventory (PFDI-20) and Pelvic organ prolapse/urinary Incontinence Sexual Questionnaire (PISQ-12).
The operations are performed by qualified surgeons (n=9) familiar with transvaginal mesh surgery. Intraoperative data is collected and immediate postoperative problems are registered.
The first follow-up visit take place at three months postoperatively. Gynecological examination with POP-Q measurements are performed and complications documented. As preoperatively, PFDI-20 and PISQ-12 questionnaires are filled in by the patients.
The second visit take place at one year postoperatively. Gynecological examination with POP-Q measurements are performed and possible late complications documented. PFDI-20 and PISQ-12 questionnaires are filled in again by the patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Transvaginal posterior mesh surgery | Other | Device: Transvaginal posterior meshAll study patients undergo transvaginal mesh operation. |
Who may qualify
- Ages
- 30 to 90 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patients with symptomatic posterior vaginal wall with or without apical prolapse with stage II or more
Key exclusion criteria (1 listed)
- concomitant surgery, immunosuppressive treatment of any kind, previous or forthcoming bowel operation with low anastomosis creation and previous vaginal radiation therapy
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 |
|---|---|---|
| Transvaginal posterior meshAlso: Elevate®PosteriorA trocar-free fixation system with low-weight mesh | Device | Transvaginal posterior mesh surgery |
Primary outcome
Number of participants with adverse events as a measure of safety and tolerability
Time frame: up to 1 year
3 secondary outcomes
POP-Q measurement
Time frame: preoperatively, 3 months and 1 year
Pelvic floor distress inventory (PFDI-20)
Time frame: preoperatively, 3 months and 1 year
Pelvic organ prolapse/urinary incontinence sexual questionnaire (PISQ-12)
Time frame: preoperatively, 3 months and 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2015.
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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.
Mervi Haarala, MD study director
Turku University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transvaginal posterior mesh in people with Female Genital Prolapse, run by Turku University Hospital at 1 site in Finland.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 27 May 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 Finland. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Number of participants with adverse events as a measure of safety and tolerability (time frame: up to 1 year). 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 27 May 2015.