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Anterior Pelvic Prolapse Reconstruction With TiLOOP® PRO A Polypropylene Mesh

Primary Purpose

Cystocele, Uterine Prolapse

Status

Completed

Phase

Not Applicable

Locations

Germany

Study Type

Interventional

Intervention

TiLOOP® PRO Plus A

About this trial

This is an interventional treatment trial for Cystocele focused on measuring polypropylene mesh, prolapse, cystocele, surgical mesh

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

Klinik Tettnang GmbH
Klinikum Augsburg
Klinikum Dresden-Friedrichstadt
Klinikum Oberlausitzer Bergland gemeinnützige GmbH
Ev. Amalie-Sieveking-Krankenhaus

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

surgical mesh implantation

Arm 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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

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.

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.

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.

Full Information

NCT ID

NCT02690220

First Posted

February 5, 2016

Last Updated

October 21, 2019

Sponsor

pfm medical ag

Collaborators

Crolll Gmbh, Bayes GmbH, Aix Scientifics

1. Study Identification

Unique Protocol Identification Number

NCT02690220

Brief Title

Anterior Pelvic Prolapse Reconstruction With TiLOOP® PRO A Polypropylene Mesh

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2019

Overall Recruitment Status

Completed

Study Start Date

February 1, 2016 (Actual)

Primary Completion Date

July 31, 2017 (Actual)

Study Completion Date

July 31, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

pfm medical ag

Collaborators

Crolll Gmbh, Bayes GmbH, Aix Scientifics

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cystocele, Uterine Prolapse

Keywords

polypropylene mesh, prolapse, cystocele, surgical mesh

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

54 (Actual)

8. Arms, Groups, and Interventions

Arm Title

surgical mesh implantation

Arm Type

Other

Arm Description

Intervention Type

Device

Intervention Name(s)

TiLOOP® PRO Plus A

Intervention Description

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 Measure Information:

Title

Patient's Quality of Life

Description

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.

Time Frame

12 months

Secondary Outcome Measure Information:

Title

Patient's Quality of Life

Description

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.

Time Frame

6 months

Title

Adverse Events (AE)

Description

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.

Time Frame

6 weeks, 6 and 12 months

Title

Feasibility Check of Mesh implantation

Description

Time Frame

1 day

Title

Number of complications and concomitant procedures

Description

Time Frame

1 day

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Christian Fünfgeld, Dr. med.

Organizational Affiliation

Klinik Tettnang GmbH

Official's Role

Principal Investigator

Facility Information:

Facility Name

Klinik Tettnang GmbH

City

Tettnang

State/Province

Baden-Württemberg

ZIP/Postal Code

88069

Country

Germany

Facility Name

Klinikum Augsburg

City

Augsburg

State/Province

Bayern

ZIP/Postal Code

86156

Country

Germany

Facility Name

Klinikum Dresden-Friedrichstadt

City

Dresden

State/Province

Sachsen

ZIP/Postal Code

01067

Country

Germany

Facility Name

Klinikum Oberlausitzer Bergland gemeinnützige GmbH

City

Zittau

State/Province

Sachsen

ZIP/Postal Code

02763

Country

Germany

Facility Name

Ev. Amalie-Sieveking-Krankenhaus

City

Hamburg

ZIP/Postal Code

22359

Country

Germany

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

31523096

Citation

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.

Results Reference

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Anterior Pelvic Prolapse Reconstruction With TiLOOP® PRO A Polypropylene Mesh

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