Urinary Incontinence, StressNCT01358214
Quality of Life After Tension Free Transvaginal Sling / Tape Operation With a Titanized Surgical Tape (TiLOOP® Tape)
An observational study of Urinary Incontinence, Stress, run by pfm medical gmbh at 1 site in Germany.
Trial summary
Validation of a new Quality of Life (QoL) questionnaire in a population of patient gaining a TiLOOP® TAPE surgical mesh for stabilization of the urethra. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Urinary Incontinence, Stress
- What is being tested?
- Questionnaire on Quality of Life.
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 21 participants
- Where
- 1 siteGermany
- Study dates
- May 2011to Feb 2012
- 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 Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: The indicated or treated population of women showing stress urinary incontinence that should / has been treated with a surgical mesh. The sample of patients treated with TiLOOP® Tape at the single center between 2007 and 2009 represents the patient population for which the medical device is intended. The clinic continues to examine women with incontinence symptoms requiring a mesh implant. This group of patients is assumed to be similar to the study arm of treated patients. The Non-symptomatic Population consists of women comparable in age but without urinary incontinence
Who may be able to join
- Depending on study arm:
- Women with a TiLOOP® Tape implant, Implanted between 2007 and 2009 at the study center - OR -
- Woman with a planned Tape implantation at the study center - OR -
- Woman with no disease related to incontinence
- Subject is able to understand the nature, relevance and significance of the clinical trial
- Subject has given informed consent
Who cannot join
- Subject revoked consent
- Lack of subject's compliance regarding data collection or examination in the scope of the trial (Non-Compliance)
- Subject institutionalized by court or official order (MPG §20.3)
- Subject participates in another clinical investigation
Trial locations and contacts
1 site in 1 country.
Germany1 site
Franziskus-Krankenhaus Berlin Akademisches Lehrkrankenhaus der Charité - Universtätsmedizin Berlin
Berlin, 10787
About this study
Official title: Single-center, Non-randomized, Comparative, Post-marketing Surveillance Cohort Study on Validation of a Questionnaire on Quality of Life After Surgical Stabilization of the Urethra With Titanized Polypropylene Mesh (TiLOOP® Tape)
Validation of a new Quality of Life (QoL) questionnaire in a population of patient gaining a TiLOOP® TAPE surgical mesh for stabilization of the urethra.
Read the detailed description
The prevalence of urinary incontinence in the adult female population has been estimated between 10% and 40%. Several treatment alternatives have been suggested until now. Nevertheless, the ideal treatment has not been identified yet. On the one hand this is related to the low amount of valid scientific information regarding different treatment methods. On the other hand the impact of patients' quality of life, which plays a major role, has not been fully considered. To date, there is no established Questionnaire on Quality of Life that provides physicians an assistance to obtain information on the subjective effects caused by stress urinary incontinence.
In the present study the patients' Quality of Life will be assessed by use of two questionnaires, that is a new one and an already validated questionnaire. The study population consists of patients who already received an implantation of a sub-urethral surgical mesh (TiLOOP® Tape), of symptomatic patients before an operation, and of a group of non-symptomatic women. Subjects will be asked in a single visit only to fill in both questionnaires.
Furthermore the safety and effectiveness of the TiLOOP® Tape mesh will be evaluated in the study arm of treated patients.
Study has been terminated after major recruitment failure (only 21 instead of 240 patients has been included).
- Conditions
- Urinary Incontinence, Stress
- Being tested
- Questionnaire on Quality of Life.
- Keywords
- Sub-urethral Sling, Treatment Outcome, Quality of Life
- Medical subject headings
- Urinary Incontinence, Stress
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Questionnaire on Quality of Life.Behavioural
Also called QoL
The impact of a disease on patient's Quality of Life has meanwhile gained more influences on the choice of treatment alternatives. The benefit of a method is currently not only defined by the objective outcome but also influenced by the Quality of Life. Two questionnaires with 20 respectively 40 Questions should be filled in by the patients.
| Study group | Role | What they receive |
|---|---|---|
| Patients treated with a surgical mesh | This arm of study patients is defined by patients treated with a TiLOOP® Tape mesh between 2007 and 2009 at the Franziskus Krankenhaus, Berlin. The sample of the treated population represents the patient population for which the medical device is intended. To minimize selection bias without compromising patients' rights and welfare, all treated patients will be invited. These patients will be asked to participate in the validation of the questionnaire on quality of life. In addition to this safety and effectiveness of the surgical mesh implantation will be collected Receives: Behavioral: Questionnaire on Quality of Life. | |
| Intended to be treated with a mesh | This arm of the study populations is defined by patients in whom a clinical anamnesis independent of the requirements of this study suggests that a sub-urethral sling operation is indicated. These patients will be asked to participate in the validation of the questionnaire on quality of life. Receives: Behavioral: Questionnaire on Quality of Life. | |
| Non-symptomatic Population | This arm of the study population is defined by women that show no symptoms of incontinence. They will be asked to participate in the validation of the questionnaire on quality of life. Receives: Behavioral: Questionnaire on Quality of Life. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Validation of a new questionnaire on quality of life
It is expected that the newly developed questionnaire on quality of life (QoL) is equal or better in description of the impact on QoL regarding the differentiation of the study populations, as compared to the standard questionnaire.
Measured: before treatment (baseline) or 6 to 24 months after treatment, respectively
Secondary outcomes (2)
Safety of surgical mesh implantation for treatment of urinary incontinence
In the study arm of treated patients the study outcome will describe all safety relevant events occurred within the period from implantation until scheduled study examination. The time between scheduled examination and implantation varies as the implantation it not part of this study. The findings will therefore be stratified by 6 months, 12 months and 24 months after implantation.
Measured: 6-24 months after treatment
Effectiveness of surgical mesh implantation for treatment of urinary incontinence
In the study arm of treated patients, the study outcome will describe the efficacy of the TiLOOP® Tape implantation based on successful implantation and complications observed during the period from implantation until discharge from the hospital. The time between scheduled examination and implantation varies as the implantation it not part of this study. The findings will therefore be stratified by 6 months, 12 months and 24 months after implantation.
Measured: 6-24 months after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2011 (estimated)
- Study startMay 2011
- Primary completionFeb 2012
- Study completionFeb 2012
Why it stopped: major recruitment failure
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urinary Incontinence, StressStudies 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-control
- Time perspective
- Cross-sectional
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- pfm medical gmbh
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Aix Scientifics
- Responsible party
- Sponsor
- Investigators
- Manfred Beer, Prof. MD, Principal investigator, Franziskus-Krankenhaus Berlin Akademisches Lehrkrankenhaus der Charité - Universtätsmedizin Berlin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01358214
- Sponsor's protocol ID
- pfm 10k003 TiLOOP® Tape
- Status last verified
- Aug 2012
- First submitted
- 18 May 2011
- Last updated
- 23 Aug 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single-center, Non-randomized, Comparative, Post-marketing Surveillance Cohort Study on Validation of a Questionnaire on Quality of Life After Surgical Stabilization of the Urethra With Titanized Polypropylene Mesh (TiLOOP® Tape)
- ClinicalTrials.gov ID
- NCT01358214
- Acronym / sponsor ID
- pfm 10k003 TiLOOP® Tape
- Conditions
- Urinary Incontinence, Stress
- Keywords
- Sub-urethral Sling, Treatment Outcome, Quality of Life
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: major recruitment failure
- Enrolment
- 21 participants (actual)
- Lead sponsor
- pfm medical gmbhIndustry (pharma, biotech, devices)
- Collaborators
- Aix Scientifics
- Study start
- May 2011
- Primary completion
- Feb 2012 (actual)
- Study completion
- Feb 2012 (actual)
- First posted
- 23 May 2011 (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.
Validation of a new Quality of Life (QoL) questionnaire in a population of patient gaining a TiLOOP® TAPE surgical mesh for stabilization of the urethra.
Detailed description
The prevalence of urinary incontinence in the adult female population has been estimated between 10% and 40%. Several treatment alternatives have been suggested until now. Nevertheless, the ideal treatment has not been identified yet. On the one hand this is related to the low amount of valid scientific information regarding different treatment methods. On the other hand the impact of patients' quality of life, which plays a major role, has not been fully considered. To date, there is no established Questionnaire on Quality of Life that provides physicians an assistance to obtain information on the subjective effects caused by stress urinary incontinence.
In the present study the patients' Quality of Life will be assessed by use of two questionnaires, that is a new one and an already validated questionnaire. The study population consists of patients who already received an implantation of a sub-urethral surgical mesh (TiLOOP® Tape), of symptomatic patients before an operation, and of a group of non-symptomatic women. Subjects will be asked in a single visit only to fill in both questionnaires.
Furthermore the safety and effectiveness of the TiLOOP® Tape mesh will be evaluated in the study arm of treated patients.
Study has been terminated after major recruitment failure (only 21 instead of 240 patients has been included).
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Patients treated with a surgical mesh | – | Behavioral: Questionnaire on Quality of Life.This arm of study patients is defined by patients treated with a TiLOOP® Tape mesh between 2007 and 2009 at the Franziskus Krankenhaus, Berlin. The sample of the treated population represents the patient population for which the medical device is intended. To minimize selection bias without compromising patients' rights and welfare, all treated patients will be invited. These patients will be asked to participate in the validation of the questionnaire on quality of life. In addition to this safety and effectiveness of the surgical mesh implantation will be collected |
| Intended to be treated with a mesh | – | Behavioral: Questionnaire on Quality of Life.This arm of the study populations is defined by patients in whom a clinical anamnesis independent of the requirements of this study suggests that a sub-urethral sling operation is indicated. These patients will be asked to participate in the validation of the questionnaire on quality of life. |
| Non-symptomatic Population | – | Behavioral: Questionnaire on Quality of Life.This arm of the study population is defined by women that show no symptoms of incontinence. They will be asked to participate in the validation of the questionnaire on quality of life. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The indicated or treated population of women showing stress urinary incontinence that should / has been treated with a surgical mesh. The sample of patients treated with TiLOOP® Tape at the single center between 2007 and 2009 represents the patient population for which the medical device is intended. The clinic continues to examine women with incontinence symptoms requiring a mesh implant. This group of patients is assumed to be similar to the study arm of treated patients. The Non-symptomatic Population consists of women comparable in age but without urinary incontinence
Key inclusion criteria (6 listed)
- Depending on study arm:
- Women with a TiLOOP® Tape implant, Implanted between 2007 and 2009 at the study center - OR -
- Woman with a planned Tape implantation at the study center - OR -
- Woman with no disease related to incontinence
- Subject is able to understand the nature, relevance and significance of the clinical trial
Key exclusion criteria (4 listed)
- Subject revoked consent
- Lack of subject's compliance regarding data collection or examination in the scope of the trial (Non-Compliance)
- Subject institutionalized by court or official order (MPG §20.3)
- Subject participates in another clinical investigation
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 |
|---|---|---|
| Questionnaire on Quality of Life.Also: QoLThe impact of a disease on patient's Quality of Life has meanwhile gained more influences on the choice of treatment alternatives. The benefit of a method is currently not only defined by the objective outcome but also influenced by the Quality of Life. Two questionnaires with 20 respectively 40 Questions should be filled in by the patients. | Behavioural | Intended to be treated with a mesh, Non-symptomatic Population, Patients treated with a surgical mesh |
Primary outcome
Validation of a new questionnaire on quality of life
Time frame: before treatment (baseline) or 6 to 24 months after treatment, respectively
It is expected that the newly developed questionnaire on quality of life (QoL) is equal or better in description of the impact on QoL regarding the differentiation of the study populations, as compared to the standard questionnaire.
2 secondary outcomes
Safety of surgical mesh implantation for treatment of urinary incontinence
Time frame: 6-24 months after treatment
Effectiveness of surgical mesh implantation for treatment of urinary incontinence
Time frame: 6-24 months after treatment
Results and safety
The study was stopped early (reason given: major recruitment failure). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2012.
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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.
Manfred Beer, Prof. MD principal investigator
Franziskus-Krankenhaus Berlin Akademisches Lehrkrankenhaus der Charité - Universtätsmedizin Berlin
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 Urinary Incontinence, Stress, run by pfm medical gmbh at 1 site in Germany.
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 6 inclusion and 4 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: stopped early, as of the sponsor's last update on 23 Aug 2012. 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 Germany. 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 was stopped early (reason given: major recruitment failure). 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?
Validation of a new questionnaire on quality of life (time frame: before treatment (baseline) or 6 to 24 months after treatment, respectively). 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 23 Aug 2012.