Overview

This trial is active, not recruiting.

Conditions cystocele, uterine prolapse
Treatment tiloop® pro a (surgical mesh implant)
Sponsor pfm medical ag
Collaborator Crolll Gmbh
Start date January 2016
End date September 2017
Trial size 54 participants
Trial identifier NCT02690220, pfm15k001 TiLOOP® PRO A

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Other)
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. Standard method to implant the TiLOOP® PRO A surgical mesh transvaginally.
tiloop® pro a (surgical mesh implant)
The standard operation method for the surgical repair of anterior prolapse is via the obturator membrane. The mesh is placed trans-vaginal using the TiLOOP® Application Set to place the mesh arms.

Primary Outcomes

Measure
Patient's Quality of Life
time frame: 12 months

Secondary Outcomes

Measure
Patient's Quality of Life
time frame: 6 weeks/6months
Adverse Events (AE)
time frame: 6 weeks, 6 and 12 months
Feasibility Check of Mesh implantation
time frame: 1 day
Number of complications and concomitant procedures
time frame: 1 day

Eligibility Criteria

Female participants at least 18 years old.

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.

Additional Information

Official title National, Multicentre Post Market Surveillance Study on Anterior Pelvic Prolapse Reconstruction With a Titanium-coated Polypropylene Mesh (TiLOOP® PRO A)
Principal investigator Christian Fünfgeld, Dr. med.
Description This multicentre, non-randomized, observational clinical investigation will be performed to obtain usability and post-marketing 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.
Trial information was received from ClinicalTrials.gov and was last updated in September 2016.
Information provided to ClinicalTrials.gov by pfm medical ag.