NCT02231099

Brief Summary

Pelvic organ prolapse is highly prevalent in the female population. The recurrence rate of pelvic organ prolapse after surgical treatment is high. This emphasizes the clinical need for improvement of the surgical techniques currently used. Placement of a mesh aims at reducing the recurrence rate. In this study the investigators compare the effectiveness of the Tension free Vaginal mesh + Monocryl with standard vaginal prolapse surgery without mesh.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
176

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2011

Longer than P75 for not_applicable

Geographic Reach
1 country

5 active sites

Status
unknown

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

January 1, 2011

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

January 27, 2012

Completed
2.6 years until next milestone

First Posted

Study publicly available on registry

September 4, 2014

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2015

Completed
Last Updated

February 6, 2015

Status Verified

February 1, 2015

Enrollment Period

4.7 years

First QC Date

January 27, 2012

Last Update Submit

February 5, 2015

Conditions

Pelvic Organ ProlapseCystoceleRectoceleUterine Prolapse

Keywords

recurrent pelvic organ prolapsemesh

Outcome Measures

Primary Outcomes (1)

  • objective anatomic success (POPQ stage <2)

    clinical investigation including POPQ

    24 months

Secondary Outcomes (5)

  • subjective improvement in quality of life

    24 months

  • sexual function/dysfunction

    24 months

  • complications

    24 months

  • recovery

    6 weeks

  • cost-effectiveness

    24 months

Study Arms (2)

prolift + m

EXPERIMENTAL

surgery with mesh (prolift+M)

Procedure: Prolift + M

conventional vaginal prolapse surgery

ACTIVE COMPARATOR

conventional vaginal prolapse surgery; anterior colporrhaphy or posterior colporrhaphy or spinal ligament fixation

Procedure: conventional vaginal prolapse surgery

Interventions

Prolift + MPROCEDURE

prolapse surgery with mesh

prolift + m
conventional vaginal prolapse surgeryPROCEDURE

conventional vaginal prolapse surgery;anterior colporrhaphy, posterior colporrhaphy

Also known as: anterior colporrhaphy, posterior colporrhaphy
conventional vaginal prolapse surgery

Eligibility Criteria

Age45 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Subject has a anterior and/or posterior prolapse POP-Q stage II or more. Subjects with a middle compartment prolapse may only be included if there is a co-existing anterior or posterior defect which needs surgical correction.
  • Subject has agreed to undergo implantation of Prolift+MTM or fascial plication
  • Subject is willing to return for follow-up evaluation and QoL questionnaires completion at 6weeks, 6 months, 12 months and 24 months follow-ups.

You may not qualify if:

  • Pregnancy
  • Age \< 45 years
  • Have current urinary tract or vaginal infections
  • Have blood coagulation disorders
  • Have a compromised immune system or any other conditions that would compromise healing
  • Are unwilling or unable to return for evaluation
  • Previous irradiation
  • Presence of any malignancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Gelre ziekenhuizen Apeldoorn

Apeldoorn, Netherlands

Location

Reinier de Graaf Group

Delft, 2625 AD, Netherlands

Location

UMC St Radboud

Nijmegen, 6500 HB, Netherlands

Location

Zaans Medisch Centre

Zaandam, 1500 EE, Netherlands

Location

Isala clinics

Zwolle, 8025 AB, Netherlands

Location

MeSH Terms

Conditions

Pelvic Organ ProlapseCystoceleRectoceleUterine Prolapse

Condition Hierarchy (Ancestors)

ProlapsePathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsUrinary Bladder DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesRectal DiseasesIntestinal DiseasesGastrointestinal DiseasesDigestive System DiseasesHerniaUterine DiseasesGenital Diseases, FemaleGenital Diseases

Study Officials

  • Mariella IJ Withagen, MD, PhD

    Radboud Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr. M.I.J. Withagen

Study Record Dates

First Submitted

January 27, 2012

First Posted

September 4, 2014

Study Start

January 1, 2011

Primary Completion

September 1, 2015

Study Completion

September 1, 2015

Last Updated

February 6, 2015

Record last verified: 2015-02

Locations

NL(5)