NCT02690220

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
54

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2016

Geographic Reach
1 country

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2016

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

February 5, 2016

Completed
19 days until next milestone

First Posted

Study publicly available on registry

February 24, 2016

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2017

Completed
Last Updated

October 23, 2019

Status Verified

January 1, 2019

Enrollment Period

1.5 years

First QC Date

February 5, 2016

Last Update Submit

October 21, 2019

Conditions

CystoceleUterine Prolapse

Keywords

polypropylene meshprolapsecystocelesurgical mesh

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • Patient's Quality of Life

    6 months

  • Adverse Events (AE)

    6 weeks, 6 and 12 months

  • Feasibility Check of Mesh implantation

    1 day

  • Number of complications and concomitant procedures

    1 day

Study Arms (1)

surgical mesh implantation

OTHER

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

Interventions

TiLOOP® PRO Plus ADEVICE

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.

surgical mesh implantation

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Klinik Tettnang GmbH

Tettnang, Baden-Wurttemberg, 88069, Germany

Location

Klinikum Augsburg

Augsburg, Bavaria, 86156, Germany

Location

Klinikum Dresden-Friedrichstadt

Dresden, Saxony, 01067, Germany

Location

Klinikum Oberlausitzer Bergland gemeinnützige GmbH

Zittau, Saxony, 02763, Germany

Location

Ev. Amalie-Sieveking-Krankenhaus

Hamburg, 22359, Germany

Location

Related Publications (1)

  • 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.

    PMID: 31523096BACKGROUND

MeSH Terms

Conditions

CystoceleUterine ProlapseProlapse

Condition Hierarchy (Ancestors)

Urinary Bladder DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesPelvic Organ ProlapsePathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsUterine DiseasesGenital Diseases, FemaleGenital Diseases

Study Officials

  • Christian Fünfgeld, Dr. med.

    Klinik Tettnang GmbH

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 5, 2016

First Posted

February 24, 2016

Study Start

February 1, 2016

Primary Completion

July 31, 2017

Study Completion

July 31, 2017

Last Updated

October 23, 2019

Record last verified: 2019-01

Data Sharing

IPD Sharing
Will not share

Locations

DE(5)