Anterior Pelvic Prolapse Reconstruction With TiLOOP® PRO A Polypropylene Mesh

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

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.

Study Overview

• Status: Completed
• Conditions: Cystocele; Uterine Prolapse
• Intervention / Treatment: Device: TiLOOP® PRO Plus A

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.

• Study Type: Interventional
• Enrollment (Actual): 54
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Hamburg, Germany, 22359
    • Ev. Amalie-Sieveking-Krankenhaus
  • Baden-Württemberg
    • Tettnang, Baden-Württemberg, Germany, 88069
      • Klinik Tettnang GmbH
  • Bayern
    • Augsburg, Bayern, Germany, 86156
      • Klinikum Augsburg
  • Sachsen
    • Dresden, Sachsen, Germany, 01067
      • Klinikum Dresden-Friedrichstadt
    • Zittau, Sachsen, Germany, 02763
      • Klinikum Oberlausitzer Bergland gemeinnützige GmbH

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient's Quality of Life	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.	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient's Quality of Life	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.	6 months
Adverse Events (AE)	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.	6 weeks, 6 and 12 months
Feasibility Check of Mesh implantation	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.	1 day
Number of complications and concomitant procedures	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.	1 day

Collaborators and Investigators

• Sponsor: pfm medical ag
• Collaborators: Aix Scientifics; Crolll Gmbh; Bayes GmbH
• Investigators: Principal Investigator: Christian Fünfgeld, Dr. med., Klinik Tettnang GmbH

Publications and helpful links

General Publications

• Cadenbach-Blome T, Grebe M, Mengel M, Pauli F, Greser A, Funfgeld C. Significant Improvement in Quality of Life, Positive Effect on Sexuality, Lasting Reconstructive Result and Low Rate of Complications Following Cystocele Correction Using a Lightweight, Large-Pore, Titanised Polypropylene Mesh: Final Results of a National, Multicentre Observational Study. Geburtshilfe Frauenheilkd. 2019 Sep;79(9):959-968. doi: 10.1055/a-0984-6614. Epub 2019 Sep 11.

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2016
• Primary Completion (Actual): July 31, 2017
• Study Completion (Actual): July 31, 2017

Study Registration Dates

• First Submitted: February 5, 2016
• First Submitted That Met QC Criteria: February 18, 2016
• First Posted (Estimate): February 24, 2016

Study Record Updates

• Last Update Posted (Actual): October 23, 2019
• Last Update Submitted That Met QC Criteria: October 21, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Keywords: prolapse; surgical mesh; cystocele; polypropylene mesh
• Additional Relevant MeSH Terms: Urologic Diseases; Urinary Bladder Diseases; Uterine Diseases; Pathological Conditions, Anatomical; Pelvic Organ Prolapse; Prolapse; Cystocele; Uterine Prolapse
• Other Study ID Numbers: pfm15k001 TiLOOP® PRO A

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No