Anterior Pelvic Prolapse Reconstruction With TiLOOP® PRO A Polypropylene Mesh

Sponsor

pfm medical ag (Industry)

Overall Status

Completed

CT.gov ID

NCT02690220

Collaborator

Crolll Gmbh (Other), Bayes GmbH (Other), Aix Scientifics (Industry)

Enrollment

Locations

Arm

17.9

Actual Duration (Months)

10.8

Patients Per Site

0.6

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Cystocele Uterine Prolapse	Device: TiLOOP® PRO Plus A	N/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 Design

Study Type:

Interventional

Actual Enrollment :

54 participants

Allocation:

N/A

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 :

Feb 1, 2016

Actual Primary Completion Date :

Jul 31, 2017

Actual Study Completion Date :

Jul 31, 2017

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Patient's Quality of Life [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

Patient's Quality of Life [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) [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 [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 [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Klinik Tettnang GmbH	Tettnang	Baden-Württemberg	Germany	88069
2	Klinikum Augsburg	Augsburg	Bayern	Germany	86156
3	Klinikum Dresden-Friedrichstadt	Dresden	Sachsen	Germany	01067
4	Klinikum Oberlausitzer Bergland gemeinnützige GmbH	Zittau	Sachsen	Germany	02763
5	Ev. Amalie-Sieveking-Krankenhaus	Hamburg		Germany	22359