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Trial record 1 of 1 for:    NCT02690220
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Anterior Pelvic Prolapse Reconstruction With TiLOOP® PRO A Polypropylene Mesh

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ClinicalTrials.gov Identifier: NCT02690220
Recruitment Status : Completed
First Posted : February 24, 2016
Last Update Posted : February 4, 2019
Sponsor:
Collaborators:
Crolll Gmbh
Bayes GmbH
Aix Scientifics
Information provided by (Responsible Party):
pfm medical ag

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Cystocele Uterine Prolapse Device: TiLOOP® PRO Plus A Not Applicable

Detailed 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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 54 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: National, Multicentre Post Market Surveillance Study on Anterior Pelvic Prolapse Reconstruction With a Titanium-coated Polypropylene Mesh (TiLOOP® PRO A)
Actual Study Start Date : February 1, 2016
Actual Primary Completion Date : July 31, 2017
Actual Study Completion Date : July 31, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.
Device: 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.




Primary Outcome Measures :
  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 Outcome Measures :
  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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02690220


Locations
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Germany
Klinik Tettnang GmbH
Tettnang, Baden-Württemberg, Germany, 88069
Klinikum Augsburg
Augsburg, Bayern, Germany, 86156
Klinikum Dresden-Friedrichstadt
Dresden, Sachsen, Germany, 01067
Klinikum Oberlausitzer Bergland gemeinnützige GmbH
Zittau, Sachsen, Germany, 02763
Ev. Amalie-Sieveking-Krankenhaus
Hamburg, Germany, 22359
Sponsors and Collaborators
pfm medical ag
Crolll Gmbh
Bayes GmbH
Aix Scientifics
Investigators
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Principal Investigator: Christian Fünfgeld, Dr. med. Klinik Tettnang GmbH

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Responsible Party: pfm medical ag
ClinicalTrials.gov Identifier: NCT02690220     History of Changes
Other Study ID Numbers: pfm15k001 TiLOOP® PRO A
First Posted: February 24, 2016    Key Record Dates
Last Update Posted: February 4, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by pfm medical ag:
polypropylene mesh
prolapse
cystocele
surgical mesh

Additional relevant MeSH terms:
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Prolapse
Cystocele
Uterine Prolapse
Pathological Conditions, Anatomical
Urinary Bladder Diseases
Urologic Diseases
Pelvic Organ Prolapse
Uterine Diseases
Genital Diseases, Female