Anterior Pelvic Prolapse Reconstruction With TiLOOP® PRO A Polypropylene Mesh

Cystocele Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02690220
• Other study ID #: pfm15k001 TiLOOP® PRO A
• Status: Completed
• Phase: N/A
• Start date: February 1, 2016
• Est. completion date: July 31, 2017

Study information

• Verified date: January 2019
• Source: pfm medical ag
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 54
• Est. completion date: July 31, 2017
• Est. primary completion date: July 31, 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cystocele
• Prolapse
• Uterine Prolapse

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.

Locations

Country	Name	City	State
Germany	Klinikum Augsburg	Augsburg	Bayern
Germany	Klinikum Dresden-Friedrichstadt	Dresden	Sachsen
Germany	Ev. Amalie-Sieveking-Krankenhaus	Hamburg
Germany	Klinik Tettnang GmbH	Tettnang	Baden-Württemberg
Germany	Klinikum Oberlausitzer Bergland gemeinnützige GmbH	Zittau	Sachsen

Sponsors (4)

Lead Sponsor	Collaborator
pfm medical ag	Aix Scientifics, Bayes GmbH, Crolll Gmbh

Country where clinical trial is conducted

Germany, 

References & Publications (1)

Cadenbach-Blome T, Grebe M, Mengel M, Pauli F, Greser A, Fünfgeld 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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