Anterior Pelvic Prolapse Reconstruction With TiLOOP® PRO A Polypropylene Mesh

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

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

54 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-02-01

Study Completion Date

2017-07-31

Brief Summary

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The purpose of this study is to determine the influence of anterior pelvic prolapse reconstruction with a titanized polypropylene mesh on patients quality of life.

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Detailed Description

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This multicentre, non-randomized, observational clinical investigation will be performed to obtain usability and postmarket information on the TiLOOP® pelvic floor reconstruction meshes and in particular to obtain the improvement of patients' quality of life.

It is expected that the patient's quality of life is meliorated after implantation of a TiLOOP® PRO A mesh. To verify this, it will be shown that by means of a validated questionnaire the subjective quality of life after 12 months is significantly better than before implantation.

Conditions

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Cystocele Uterine Prolapse

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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surgical mesh implantation

Standard method to implant the TiLOOP® PRO A surgical mesh transvaginally. Women with a symptomatic genital descensus: at least stage II (ICS-classification according Pelvic Organ Prolapse Quantification System (POP-Q system)). This applies to primary as well as recurrent intervention.

Group Type OTHER

TiLOOP® PRO Plus A

Intervention Type DEVICE

The standard operation method for the surgical repair of anterior prolapse is via the obturator membrane. The mesh is placed trans-vaginally using the TiLOOP® Application Set to place the mesh arms.

Interventions

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TiLOOP® PRO Plus A

The standard operation method for the surgical repair of anterior prolapse is via the obturator membrane. The mesh is placed trans-vaginally using the TiLOOP® Application Set to place the mesh arms.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

1. Existence of a cystocele. Women with a symptomatic genital descensus: at least stage II (ICS-classification according POP-Q system). This applies to primary as well as recurrent intervention.
2. Patient is mentally able to understand the nature, aims, or possible consequences of the clinical investigation.
3. Patient information has been handed out and written consent is at hand.
4. Patient has attained full age (18 years or older).

Exclusion Criteria

1. Unfinished family planning, pregnancy or breast-feeding mother.
2. Known intolerance to the mesh-implants under investigation.
3. Lack of written patients' informed consent.
4. Lack of patient compliance regarding data collection, treatment or follow-up investigations in the scope of the protocol.
5. Patients with acute (within the last 12 months) carcinoma in the pelvic area.
6. Patients with history of radiotherapy in the pelvic area.
7. Patients with implanted anterior pelvic floor mesh.
8. Patient is institutionalized by court or official order (MPG §20.3).
9. Participation in another interventional clinical investigation.

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No