Quality of Life After Tension Free Transvaginal Sling / Tape Operation With a Titanized Surgical Tape (TiLOOP® Tape)

This study has been terminated.
(major recruitment failure)
Sponsor:
Collaborator:
Aix Scientifics
Information provided by (Responsible Party):
pfm medical ag
ClinicalTrials.gov Identifier:
NCT01358214
First received: May 18, 2011
Last updated: August 22, 2012
Last verified: August 2012
  Purpose

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.


Condition Intervention
Urinary Incontinence, Stress
Behavioral: Questionnaire on Quality of Life.

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Cross-Sectional
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)

Resource links provided by NLM:


Further study details as provided by pfm medical ag:

Primary Outcome Measures:
  • Validation of a new questionnaire on quality of life [ Time Frame: before treatment (baseline) or 6 to 24 months after treatment, respectively ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Safety of surgical mesh implantation for treatment of urinary incontinence [ Time Frame: 6-24 months after treatment ] [ Designated as safety issue: Yes ]
    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.

  • Effectiveness of surgical mesh implantation for treatment of urinary incontinence [ Time Frame: 6-24 months after treatment ] [ Designated as safety issue: No ]
    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.


Enrollment: 21
Study Start Date: May 2011
Study Completion Date: February 2012
Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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
Behavioral: Questionnaire on Quality of Life.
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.
Other Name: QoL
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.
Behavioral: Questionnaire on Quality of Life.
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.
Other Name: QoL
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.
Behavioral: Questionnaire on Quality of Life.
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.
Other Name: QoL

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).

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
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

Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01358214

Locations
Germany
Franziskus-Krankenhaus Berlin Akademisches Lehrkrankenhaus der Charité - Universtätsmedizin Berlin
Berlin, Germany, 10787
Sponsors and Collaborators
pfm medical ag
Aix Scientifics
Investigators
Principal Investigator: Manfred Beer, Prof. MD Franziskus-Krankenhaus Berlin Akademisches Lehrkrankenhaus der Charité - Universtätsmedizin Berlin
  More Information

No publications provided

Responsible Party: pfm medical ag
ClinicalTrials.gov Identifier: NCT01358214     History of Changes
Other Study ID Numbers: pfm 10k003 TiLOOP® Tape
Study First Received: May 18, 2011
Last Updated: August 22, 2012
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by pfm medical ag:
Sub-urethral Sling
Treatment Outcome
Quality of Life

Additional relevant MeSH terms:
Urinary Incontinence
Urinary Incontinence, Stress
Urination Disorders
Urologic Diseases
Urological Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on July 23, 2014