Clinical trial NCT02690220: 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
Overall status: COMPLETED
Phase: NA
Conditions: Cystocele
Uterine Prolapse
Keywords: polypropylene mesh
prolapse
cystocele
surgical mesh
Lead sponsor: pfm medical gmbh
Sponsor class: INDUSTRY
Collaborators: name: Crolll Gmbh
name: Bayes GmbH
name: Aix Scientifics
First posted: 2016-02-24
Enrollment: 54
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Patient's Quality of Life
timeFrame: 12 months
Secondary outcomes:
measure: Patient's Quality of Life
timeFrame: 6 months
measure: Adverse Events (AE)
timeFrame: 6 weeks, 6 and 12 months
measure: Feasibility Check of Mesh implantation
timeFrame: 1 day
measure: Number of complications and concomitant procedures
timeFrame: 1 day
Other outcomes:
Locations:
city: Tettnang
country: Germany
facility: Klinik Tettnang GmbH
state: Baden-Württemberg
city: Augsburg
country: Germany
facility: Klinikum Augsburg
state: Bayern
city: Dresden
country: Germany
facility: Klinikum Dresden-Friedrichstadt
state: Sachsen
city: Zittau
country: Germany
facility: Klinikum Oberlausitzer Bergland gemeinnützige GmbH
state: Sachsen
city: Hamburg
country: Germany
facility: Ev. Amalie-Sieveking-Krankenhaus
Study officials:
affiliation: Klinik Tettnang GmbH
name: Christian Fünfgeld, Dr. med.
role: PRINCIPAL_INVESTIGATOR
References:
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.