Clinical Performance of the GYNECARE PROLIFT + M* Pelvic Floor Repair System as a Device for Pelvic Organ Prolapse

NCT00833001 | Completed

• 1 other identifier: 300-07-006
• Study Type: observational
• Target: 126
• Locations: 4 countries
• Sites: 8

Brief Summary

The purpose of this study is to evaluate the clinical performance of the PROLIFT system with a new lighter-weight mesh in repair of vaginal prolapse.

Conditions

Cystocele; Rectocele; Enterocele

Keywords

Anterior vaginal prolapse (medial, lateral,apical cystocele); Posterior vaginal prolapse (rectocele and/or enterocele); Vault prolapse (enterocele, uterine/vaginal vault prolapse)

Outcome Measures

Primary Outcomes (1)

• Pelvic Organ Prolapse Quantification (POP-Q) score

  12 months post-procedure

Secondary Outcomes (11)

• Summary of treated compartment ICS POP-Q stage

  3, 12, 24 and 36 months

• Proportion of subjects with the leading edge within the hymen and without further re-intervention for POP

  12, 24 and 36 months

• Incidence of de novo prolapse (a post-operative prolapse)only in the untreated compartment, provided there was no pre-operative defect in that compartment

  Procedure to 36 months

• Mean scores and change from baseline in PFDI-20 scores, including sub scores (POPDI, CRADI and UDI

  3, 12, 24 and 36 months

• Mean scores and change from baseline in PFIQ-7, including sub-scores (POPIQ, CRAIQ and UIQ).

  3, 12, 24 and 36 months

Study Arms (1)

1

GYNECARE PROLIFT+M\* Pelvic Floor Repair System

Device: GYNECARE PROLIFT+M* Pelvic Floor Repair System

Interventions

GYNECARE PROLIFT+M* Pelvic Floor Repair System DEVICE

Pre-shaped mesh implants made of GYNECARE GYNEMESH M composite mesh, comprised of absorbable polyglecaprone 25 monofilament fiber and nonabsorbable polypropylene monofilament fiber

Also known as: ULTRAPRO* mesh

1

Eligibility Criteria

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

Study Population

Women over 18 with symptomatic pelvic organ prolapse of ICS POP-Q Stage III or IV, suitable for surgical repair.

You may qualify if:

• Candidates with symptomatic pelvic organ prolapse of ICS POP-Q Stage III or IV, suitable for surgical repair. Perineal repair, vaginal hysterectomy and/or mid urethral sling procedures for incontinence may be performed concurrently.
• Age \> or = 18 years.
• Agrees to participate in the study, including completion of all study-related procedures, evaluations and questionnaires, and documents this agreement by signing the Ethics Committee / IRB approved informed consent.

You may not qualify if:

• Additional surgical intervention for POP repair concurrent to the Gynecare Prolift+M procedure (e.g. paravaginal repair, sacrocolpopexy, colporrhaphy in a non-Gynecare Prolift+M treated compartment).
• Previous repair of pelvic organ prolapse involving insertion of mesh.
• Previous hysterectomy within 6 months of scheduled surgery.
• Experimental drug or experimental medical device within 3 months prior to the planned procedure.
• Active genital, urinary or systemic infection at the time of the surgical procedure. Surgery may be delayed in such subjects until the infection is cleared.
• Coagulation disorder or on therapeutic anticoagulant therapy at the time of surgery.
• History of any pelvic radiation therapy.
• History of chemotherapy within 6 months of the planned procedure.
• Systemic disease known to affect bladder or bowel function (e.g. Parkinson's disease, multiple sclerosis, spina bifida, spinal cord injury or trauma).
• Current evaluation or treatment for chronic pelvic pain (e.g. interstitial cystitis, endometriosis, coccydynia, vulvodynia).
• Nursing or pregnant or intends future pregnancy.
• In the investigator's opinion, any medical condition or psychiatric illness that could potentially be life threatening or affect their ability to complete the study visits according to this protocol.

Sponsors & Collaborators

• Ethicon, Inc.: lead

Study Sites (8)

Sint Lodewijkstraat 78

Genk, Belgium

Location

CHRU de Lille

Lille, 59037, France

Location

DRT Krankenhaus

Chemnitz, 09034, Germany

Location

Martin Luther University

Halle, 06097, Germany

Location

Kreiskrankenhaus

Hamelin, 31785, Germany

Location

Universitatsklinik Tubingen

Tübingen, 72076, Germany

Location

St. Marien-Hospital

Vechta, D-49377, Germany

Location

Reinier de Graaf Gasthuis

Delft, Netherlands

Location

Related Publications (1)

• Milani AL, Hinoul P, Gauld JM, Sikirica V, van Drie D, Cosson M; Prolift+M Investigators. Trocar-guided mesh repair of vaginal prolapse using partially absorbable mesh: 1 year outcomes. Am J Obstet Gynecol. 2011 Jan;204(1):74.e1-8. doi: 10.1016/j.ajog.2010.08.036. Epub 2010 Oct 20.

  PMID: 20965491 RESULT

MeSH Terms

Conditions

Cystocele; Rectocele; Hernia; Pelvic Organ Prolapse

Condition Hierarchy (Ancestors)

Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Prolapse; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Rectal Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Officials

• David Robinson, MD

  Ethicon, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 26, 2009
• First Posted: January 30, 2009
• Study Start: April 1, 2008
• Primary Completion: November 1, 2009
• Study Completion: December 1, 2011
• Last Updated: May 6, 2014

Record last verified: 2014-05

Locations

NL (1); BE (1); FR (1); DE (5)