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

Urinary Incontinence, Stress Clinical Trial

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)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01358214
• Other study ID #: pfm 10k003 TiLOOP® Tape
• Status: Terminated
• Phase: N/A
• First received: May 18, 2011
• Last updated: August 22, 2012
• Start date: May 2011
• Est. completion date: February 2012

Study information

• Verified date: August 2012
• Source: pfm medical ag
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Observational

Clinical 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.

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).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 21
• Est. completion date: February 2012
• Est. primary completion date: February 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: N/A and older

Eligibility

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

Study Design

Observational Model: Case Control, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Urinary Incontinence
• Urinary Incontinence, Stress

Intervention

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.

Locations

Country	Name	City	State
Germany	Franziskus-Krankenhaus Berlin Akademisches Lehrkrankenhaus der Charité - Universtätsmedizin Berlin	Berlin

Sponsors (2)

Lead Sponsor	Collaborator
pfm medical ag	Aix Scientifics

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	before treatment (baseline) or 6 to 24 months after treatment, respectively	No
Secondary	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.	6-24 months after treatment	Yes
Secondary	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.	6-24 months after treatment	No