Anterior Pelvic Prolapse Reconstruction With TiLOOP® Total 6

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

292 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-04-30

Study Completion Date

2016-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The purpose of this study is to determine the influence of Anterior Pelvic Prolapse Reconstruction with a titanised polypropylene mesh on rate of erosion and patients quality of live.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Anterior Pelvic Prolapse Reconstruction With TiLOOP® PRO A Polypropylene Mesh

NCT02690220

Cystocele Uterine Prolapse

COMPLETED NA

Real-Life Use of Transabdominal Restorelle® Meshes in Apical Prolapse Repair

NCT06296316

Genital Prolapse

TERMINATED

Comparison of 2 Lightweight Y-meshes After Laparoscopic Sacrocolpopexy

NCT02248935

Pelvic Organ Prolapse

COMPLETED

Performance of Tension Free Vaginal Mesh (Prolift) Versus Conventional Vaginal Prolapse Surgery in Recurrent Prolapse.

NCT00372190

Pelvic Organ Prolapse

COMPLETED NA

Axis(TM) Solvent-dehydrate Dermal Allograft in the Treatment of Pelvic Organ Prolapse.

NCT06263985

Pelvic Organ Prolapse

ACTIVE_NOT_RECRUITING PHASE4

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

This multicentre, non-randomised, observational clinical device investigation will be performed to obtain post-marketing information on the TiLOOP® pelvic floor reconstruction meshes and in particular on the rate of rare erosions of the device under investigation as well as on the improvement of patients' quality of life. It is expected that the rate of erosions is equal or lower compared to competitor devices currently on the market. To verify this, it will be shown that within the first year the erosion rate found for the product under investigation is in the range of 7.9 ± 5.4 %, which is the mean erosion rate found in the recent literature. Erosion, in the sense of the hypothesis, is any erosion 1 requiring more than simply the cut off of a single short filament.

It is also expected that the patient's quality of life is meliorated after implantation of a TiLOOP® Total 6 mesh. To verify this, it will be shown that by means of a validated questionnaire the subjective quality of life after 6 months is significantly better than before implantation.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Cystocele Uterine Prolapse

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

symptomatic genital descensus

Women with a symptomatic genital descensus : at least stage II (ICS-classification according pelvic organ prolapse quanification (POP-Q) system), or stage I with a symptomatic requiring intervention.

Standard method to implant the TiLOOP® Total 6 surgical mesh transvaginally.

surgical mesh implantation (TiLOOP® Total 6)

Intervention Type DEVICE

The standard procedure for the surgical repair of anterior prolapse is via the obturator membrane. The surgical mesh TiLOOP® Total 6 is placed transvaginal by the aid of TiLOOP® surgical instruments to place the mesh arms.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

surgical mesh implantation (TiLOOP® Total 6)

The standard procedure for the surgical repair of anterior prolapse is via the obturator membrane. The surgical mesh TiLOOP® Total 6 is placed transvaginal by the aid of TiLOOP® surgical instruments to place the mesh arms.

Intervention Type DEVICE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

TiLOOP® Total 6

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Women with a symptomatic genital descensus : at least stage II (ICS-classification according POP-Q system), or stage I with a symptomatic requiring intervention. This applies to primary as well as recurrent intervention
* Existence of a cystocele.
* Patient is mentally able to understand the nature, aims, or possible consequences of the clinical investigation
* Patient information has been handed out and all written consents are at hand.
* Patient has attained full age.

Exclusion Criteria

* Pregnancy or unfinished family planning.
* Known intolerance to the mesh-implants under investigation.
* Patients with acute (last 12 months) carcinoma.
* Patients with history of radiotherapy in the pelvic area.
* Genital descensus without any complaints.
* Patients with implanted pelvic floor mesh.
* Systemic steroid treatment.
* Lack of written patients' informed consent.
* Lack of patient compliance regarding data collection, treatment or follow-up investigations in the scope of the protocol.
* Patient is institutionalised by court or official order (MPG §20.3).
* Participation in another clinical investigation.

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No