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

NCT ID: NCT00372190

Last Updated: 2017-07-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 194 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-08-31
• Study Completion Date: 2015-12-31

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.

Detailed Description

Patients with recurrent prolapse after surgery can participate in this study. A total of 194 women will be included. At random 97 patients undergo a standard prolapse operation and 97 patients undergo an operation with the mesh. Evaluation will take place during surgery, at the postoperative visit after six weeks, and after six months and twelve months. Quality of life, degree of vaginal prolapse, subjective effectiveness, safety and incidence of complications will be evaluated.

An amendment to the original study has been approved by the Ethical Committee to examine long term outcome of this RCT at 7 years. This study was completed in december 2015.

Conditions

Pelvic Organ Prolapse

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Mesh surgery

Trocar guided tension free vaginal mesh insertion by Prolift mesh kit

Group Type: EXPERIMENTAL

Tensionfree vaginal mesh kit (Prolift)

Intervention Type: DEVICE

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

Conventional vaginal surgery

Classical vaginal prolapse surgery (fascia plication)

Group Type: ACTIVE_COMPARATOR

classic vaginal prolapse surgery (fascia plication)

Intervention Type: PROCEDURE

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

Interventions

Tensionfree vaginal mesh kit (Prolift)

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

Intervention Type: DEVICE

classic vaginal prolapse surgery (fascia plication)

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

Intervention Type: PROCEDURE

Other Intervention Names

Prolift mesh; Conventional

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• patient is or wants to become pregnant
• patient has had previous synthetic mesh procedure (a previous mid-urethral sling procedure is NOT an exclusion criterion)
• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Radboud University Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Mariella Withagen

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mariella ij Withagen, Drs.

Role: PRINCIPAL_INVESTIGATOR

UMC St Radboud

Locations

Gelre ziekenhuizen

Apeldoorn, , Netherlands

Slysis Zorggroep, location Rijnstate

Arnhem, , Netherlands

Reinier de Graaf Gasthuis

Delft, , Netherlands

Medisch Spectrum Twente

Enschede, , Netherlands

Groene Hart Ziekenhuis

Gouda, , Netherlands

St. Antonius Ziekenhuis

Nieuwegein, , Netherlands

UMC St Radboud

Nijmegen, , Netherlands

Ikazia

Rotterdam, , Netherlands

Refaja

Stadskanaal, , Netherlands

St. Elisabeth hospital

Tilburg, , Netherlands

Twee Steden Ziekenhuis

Tilburg, , Netherlands

Zaans Medisch Centrum

Zaandam, , Netherlands

Isala klinieken

Zwolle, , Netherlands

Countries

Netherlands

References

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.

Reference Type: RESULT

PMID: 21252735 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 29167974 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 22239416 (View on PubMed)

Other Identifiers

P0609

Identifier Type: -

Identifier Source: org_study_id