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Completed

NCT Number: NCT02690220

Anterior Pelvic Prolapse Reconstruction With TiLOOP® PRO A Polypropylene Mesh

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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Key information

Conditions

Cystocele Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Male Urogenital Diseases Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Pelvic Organ Prolapse Prolapse Urinary Bladder Diseases Urogenital Diseases Urologic Diseases Uterine Diseases Uterine Prolapse

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Klinik Tettnang GmbH, Tettnang, Baden-Wurttemberg, Germany

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.
  • Patient is mentally able to understand the nature, aims, or possible consequences of the clinical investigation.
  • Patient information has been handed out and written consent is at hand.
  • Patient has attained full age (18 years or older).

Exclusion criteria

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

Treatment and study plan

TiLOOP® PRO Plus A

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.

Primary outcomes

  1. Patient's Quality of Life

    Time frame: 12 months

    By means of a validated questionnaire it will be shown whether the subjective quality of life after 12 months is significantly better than before implantation.

Secondary outcomes

  1. Patient's Quality of Life

    Time frame: 6 months

    The evaluation of changes in quality of life assessed by the P-QoL 6 months after implantation of the TiLOOP® PRO A surgical mesh compared to before implantation.

  2. Adverse Events (AE)

    Time frame: 6 weeks, 6 and 12 months

    Assessment and analysis of all [serious] adverse events ([S]AEs) during the first 12 months after implantation along with a contextual placement of safety data based on current literature.

  3. Feasibility Check of Mesh implantation

    Time frame: 1 day

    To evaluate mesh implantation, information about the duration of the procedure (minutes from cut to stitches) and the operability of the application set (easy, suitable, difficult, no set used) will be collected during the surgery. Taking together, this information will encapsulate the feasibility of the mesh implantation descriptively.

  4. Number of complications and concomitant procedures

    Time frame: 1 day

    Counting the number of intraoperative complications (e. g. lesion of the bladder, the urethra or the intestines) and concomitant procedures (e. g. hysterectomy, colporrhaphy, vaginal sacrospinal fixation) procedure-related adverse events as assessed by CTCAE v4.0 and common concomitant procedures will be evaluated.

Sponsors and collaborators

Lead sponsor

pfm medical gmbh

Industry

Collaborators

  • Aix Scientifics
  • Bayes GmbH
  • Crolll Gmbh

Registry information

Official study title

National, Multicentre Post Market Surveillance Study on Anterior Pelvic Prolapse Reconstruction With a Titanium-coated Polypropylene Mesh (TiLOOP® PRO A)

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Feb 24, 2016
Registry last updated
Oct 23, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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