Performance of Tension Free Vaginal Mesh (Prolift) Versus Conventional Vaginal Prolapse Surgery in Recurrent Prolapse.

NCT00372190 | Completed Results

• 1 other identifier: P0609
• Study Type: interventional
• Target: 194
• Locations: 1 country
• Sites: 13

Brief Summary

Pelvic organ prolapse is a common problem. A lot of women have surgery for prolapse. The recurrence rate op pelvic organ prolapse after surgical treatment is high. Placement of a mesh aims at reducing the recurrence rate, but mesh implants can cause complications. This study is designed to determine the effectiveness of one type of mesh (tensionfree vaginal mesh; Prolift), compared with the standard prolapse surgery. A secondary objective is to track the complications of both procedures.

Conditions

Pelvic Organ Prolapse

Keywords

Pelvic organ prolapse; recurrence; mesh; complications; treatment

Outcome Measures

Primary Outcomes (1)

• Prolapse by "Pelvic Organ Prolapse Quantification System" (POP-Q), at 12 Months

  Number of participants with anatomic failures defined as "Pelvic Organ Prolapse" (POP) stage II or higher

  12 months

Secondary Outcomes (3)

• Mesh Exposure at 12 Months

  12 months

• "Patient Global Impression of Improvement" (PGI-I) at 12 Months

  at 12 months

• Bulge Symptoms

  12 months

Study Arms (2)

Mesh surgery

EXPERIMENTAL

Trocar guided tension free vaginal mesh insertion by Prolift mesh kit

Device: Tensionfree vaginal mesh kit (Prolift)

Conventional vaginal surgery

ACTIVE COMPARATOR

Classical vaginal prolapse surgery (fascia plication)

Procedure: classic vaginal prolapse surgery (fascia plication)

Interventions

Tensionfree vaginal mesh kit (Prolift) DEVICE

Insertion of a tension free vaginal mesh using a Prolift mesh kit

Also known as: Prolift mesh

Mesh surgery

classic vaginal prolapse surgery (fascia plication) PROCEDURE

classic vaginal prolapse surgery (fascia plication) to correct Pelvic Organ prolapse

Also known as: Conventional

Conventional vaginal surgery

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• recurrent anterior and/or posterior prolapse POP-Q stage 2 or more
• patient has agreed to undergo implantation of TVM (prolift) or fascial plication
• patient is willing to return for follow-up evaluation at 6 weeks, 6 months and 12 months
• patient is willing to complete quality of life questionnaires at 6 and 12 months

You may not qualify if:

• patient is or wants to become pregnant
• patient has current urinary tract or vaginal infections
• patient has a blood coagulation disorder
• patient has a compromised immune system or any other condition that would compromise healing
• patient has renal insufficiency and/or upper urinary tract obstruction
• patient is unwilling or unable to return for evaluation
• patient has had previous irradiation
• patient has any malignancy
• patient has large ovarian cysts of large myoma

Sponsors & Collaborators

• Radboud University Medical Center: lead

Study Sites (13)

Gelre ziekenhuizen

Apeldoorn, Netherlands

Location

Slysis Zorggroep, location Rijnstate

Arnhem, Netherlands

Location

Reinier de Graaf Gasthuis

Delft, Netherlands

Location

Medisch Spectrum Twente

Enschede, Netherlands

Location

Groene Hart Ziekenhuis

Gouda, Netherlands

Location

St. Antonius Ziekenhuis

Nieuwegein, Netherlands

Location

UMC St Radboud

Nijmegen, Netherlands

Location

Ikazia

Rotterdam, Netherlands

Location

Refaja

Stadskanaal, Netherlands

Location

St. Elisabeth hospital

Tilburg, Netherlands

Location

Twee Steden Ziekenhuis

Tilburg, Netherlands

Location

Zaans Medisch Centrum

Zaandam, Netherlands

Location

Isala klinieken

Zwolle, Netherlands

Location

Related Publications (3)

• Withagen MI, Milani AL, den Boon J, Vervest HA, Vierhout ME. Trocar-guided mesh compared with conventional vaginal repair in recurrent prolapse: a randomized controlled trial. Obstet Gynecol. 2011 Feb;117(2 Pt 1):242-250. doi: 10.1097/AOG.0b013e318203e6a5.

  PMID: 21252735 RESULT

• Milani AL, Damoiseaux A, IntHout J, Kluivers KB, Withagen MIJ. Long-term outcome of vaginal mesh or native tissue in recurrent prolapse: a randomized controlled trial. Int Urogynecol J. 2018 Jun;29(6):847-858. doi: 10.1007/s00192-017-3512-3. Epub 2017 Nov 22.

  PMID: 29167974 DERIVED

• Withagen MI, Milani AL, de Leeuw JW, Vierhout ME. Development of de novo prolapse in untreated vaginal compartments after prolapse repair with and without mesh: a secondary analysis of a randomised controlled trial. BJOG. 2012 Feb;119(3):354-60. doi: 10.1111/j.1471-0528.2011.03231.x.

  PMID: 22239416 DERIVED

MeSH Terms

Conditions

Pelvic Organ Prolapse; Recurrence

Interventions

Congresses as Topic

Condition Hierarchy (Ancestors)

Prolapse; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Disease Attributes; Pathologic Processes

Intervention Hierarchy (Ancestors)

Organizations; Health Care Economics and Organizations

Results Point of Contact

• Title: Dr. M.I.J.Withagen
• Organization: Radboud University Medical Center

M.I.J.Withagen@umcutrecht.nl

+31 6 51262468

Study Officials

• Mariella ij Withagen, Drs.

  UMC St Radboud

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

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: Principal Investigator

Study Record Dates

• First Submitted: September 5, 2006
• First Posted: September 6, 2006
• Study Start: August 1, 2006
• Primary Completion: December 1, 2009
• Study Completion: December 1, 2015
• Last Updated: July 3, 2017
• Results First Posted: July 3, 2017

Record last verified: 2017-04

Data Sharing

• IPD Sharing: Will not share

Locations

NL (13)