Anterior Pelvic Prolapse Reconstruction With TiLOOP® PRO A Polypropylene Mesh

P

pfm medical

Status

Completed

Conditions

Uterine Prolapse
Cystocele

Treatments

Device: TiLOOP® PRO Plus A

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT02690220
pfm15k001 TiLOOP® PRO A

Details and patient eligibility

About

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.

Full description

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.

Enrollment

54 patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

54 participants in 1 patient group

surgical mesh implantation
Other group
Description:
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.
Treatment:
Device: TiLOOP® PRO Plus A

Trial contacts and locations

5

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Data sourced from clinicaltrials.gov

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