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

pfm medical

Status: Terminated

Conditions: Urinary Incontinence, Stress

Treatments: Behavioral: Questionnaire on Quality of Life.

Study type: Observational

Funder types: Industry

Identifiers

NCT01358214

pfm 10k003 TiLOOP® Tape

Details and patient eligibility

About

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.

Full 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).

Enrollment: 21 patients

Sex: Female

Volunteers: Accepts Healthy Volunteers

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

Trial design

21 participants in 3 patient groups

Patients treated with a surgical mesh

Description:

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

Treatment:

Behavioral: Questionnaire on Quality of Life.

Intended to be treated with a mesh

Description:

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.

Treatment:

Behavioral: Questionnaire on Quality of Life.

Non-symptomatic Population

Description:

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.

Treatment:

Behavioral: Questionnaire on Quality of Life.