Clinical Trial: Anterior Pelvic Prolapse Reconstruction With TiLOOP® PRO A Polypropylene Mesh

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

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

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.

Detailed Summary:

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.

Sponsor: pfm medical ag

Current Primary Outcome: Patient's Quality of Life [ Time Frame: 12 months ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

• 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.
• 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.
• 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.
• 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.

Original Secondary Outcome:

• Patient's Quality of Life [ Time Frame: 6 weeks/6months ]
  The evaluation of changes in quality of life assessed by the P-QoL 6 weeks and 6 months after implantation of the TiLOOP® PRO A surgical mesh compared to before implantation.
• 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.
• 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.
• 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.

Information By: pfm medical ag

Dates:
Date Received: February 5, 2016
Date Started: January 2016
Date Completion: September 2017
Last Updated: April 20, 2017
Last Verified: April 2017