Clinical trial NCT01358214: Quality of Life After Tension Free Transvaginal Sling / Tape Operation With a Titanized Surgical Tape (TiLOOP® Tape)
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)
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Urinary Incontinence, Stress
Keywords: Sub-urethral Sling
Treatment Outcome
Quality of Life
Lead sponsor: pfm medical gmbh
Sponsor class: INDUSTRY
Collaborators: name: Aix Scientifics
First posted: 2011-05-23
Enrollment: 21
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
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

Brief 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.

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 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

Primary outcomes:
measure: Validation of a new questionnaire on quality of life
timeFrame: before treatment (baseline) or 6 to 24 months after treatment, respectively
Secondary outcomes:
measure: Safety of surgical mesh implantation for treatment of urinary incontinence
timeFrame: 6-24 months after treatment
measure: Effectiveness of surgical mesh implantation for treatment of urinary incontinence
timeFrame: 6-24 months after treatment
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Franziskus-Krankenhaus Berlin Akademisches Lehrkrankenhaus der Charité - Universtätsmedizin Berlin
Study officials:
affiliation: Franziskus-Krankenhaus Berlin Akademisches Lehrkrankenhaus der Charité - Universtätsmedizin Berlin
name: Manfred Beer, Prof. MD
role: PRINCIPAL_INVESTIGATOR
References: