ational, multicentre post market surveillance study on anterior pelvic prolapse reconstruction with a titanium-coated polypropylene mesh (TiLOOP® PRO A)

Not Applicable

• Conditions: N81; N81.1; Female genital prolapse; Cystocele

• Registration Number: DRKS00010001
• Lead Sponsor: pfm medical ag

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2016-03-01
• Study Completion: 2017-07-31
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: Female
• Target Recruitment: 54

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.

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Patients' quality of life 12 months after the implantation in copmarison to the pre-operative condition.<br>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

Name	Time	Method
(1) Feasibility of the mesh implantation<br>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.<br><br>(2) Adverse Events<br>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.<br><br>(3) Patient's Quality of Life<br>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.