GYNECARE PROSIMA* Pelvic Floor Repair System for Pelvic Organ Prolapse

NCT00521066 | Completed

• 1 other identifier: 300-06-005
• Study Type: observational
• Target: 150
• Locations: 4 countries
• Sites: 11

Brief Summary

The purpose of this study is to is to evaluate the success of the GYNECARE PROSIMA\* system in women with symptoms for pelvic organ prolapse (POP) requiring surgical correction of POP. (\*TRADEMARK)

Conditions

Pelvic Organ Prolapse

Outcome Measures

Primary Outcomes (1)

• Success based on overall POP-Q score at 12 months post-procedure.

  Success is determined by achievement of an overall POP-Q score of ICS Stage ≤1, without further re-intervention for POP.

  12-months

Secondary Outcomes (52)

• Success based on overall POP-Q score at 24 months post-procedure.

  24 months

• Success based on treated compartment ICS POP-Q stage

  12 months

• Success based on treated compartment ICS POP-Q stage

  24 months

• Success defined as the leading edge within the hymen

  12 months

• Success defined as the leading edge within the hymen

  24 months

Study Arms (1)

1

Prosima Pelvic Floor Repair System

Device: GYNECARE PROSIMA* Pelvic Floor Repair System

Interventions

GYNECARE PROSIMA* Pelvic Floor Repair System DEVICE

procedure for pelvic organ prolapse

Also known as: mesh pelvic floor repari

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 II or III, suitable for surgical repair

You may qualify if:

• Candidates with symptomatic pelvic organ prolapse of ICS POP-Q Stage II or III, suitable for surgical repair. Vaginal hysterectomy, perineal repair and/or mid urethral sling procedures for incontinence may be performed concurrently.
• Age ≥ 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 concurrent to the PROSIMA procedure (e.g. sacrocolpopexy, paravaginal repair, tubal sterilisation).
• 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 chemotherapy or pelvic radiation therapy.
• 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 (11)

Specialists in Urology

Naples, Florida, 34102, United States

Location

Female Pelvic Medicine and Urogynecology Institute of Michigan

Dearborn, Michigan, 48124, United States

Location

Female Pelvic Medicine & Urogynecology

Grand Rapids, Michigan, 49506, United States

Location

The Institute for Female Pelvic Medicine & Reconstructive Surgery

Allentown, Pennsylvania, 18104, United States

Location

Magee Women's Hospital of the Universtiy of Pittsburgh

Pittsburgh, Pennsylvania, 15213, United States

Location

Royal Women's Hospital

Melbourne, 3053, Australia

Location

Bereich Urogynakologie

Halle, 06097, Germany

Location

Universitatsklinik Tubingen

Tübingen, 72076, Germany

Location

Addenbrookes Hospital

Cambridge, CB2 0QQ, United Kingdom

Location

North Hampshire Hospital

Hampshire, RG24 9NA, United Kingdom

Location

St. Mary's Hospital

Manchester, M13 0JH, United Kingdom

Location

Related Publications (2)

• Zyczynski HM, Carey MP, Smith AR, Gauld JM, Robinson D, Sikirica V, Reisenauer C, Slack M; Prosima Study Investigators. One-year clinical outcomes after prolapse surgery with nonanchored mesh and vaginal support device. Am J Obstet Gynecol. 2010 Dec;203(6):587.e1-8. doi: 10.1016/j.ajog.2010.08.001.

  PMID: 20934681 RESULT

• Sayer T, Lim J, Gauld JM, Hinoul P, Jones P, Franco N, Van Drie D, Slack M; Prosima Study Investigators. Medium-term clinical outcomes following surgical repair for vaginal prolapse with tension-free mesh and vaginal support device. Int Urogynecol J. 2012 Apr;23(4):487-93. doi: 10.1007/s00192-011-1600-3. Epub 2011 Dec 6.

  PMID: 22143448 RESULT

MeSH Terms

Conditions

Pelvic Organ Prolapse

Condition Hierarchy (Ancestors)

Prolapse; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• David Robinson, M.D.

  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: August 24, 2007
• First Posted: August 27, 2007
• Study Start: June 1, 2007
• Primary Completion: October 1, 2008
• Study Completion: June 1, 2010
• Last Updated: May 6, 2014

Record last verified: 2014-05

Locations

DE (2); US (5); AU (1); GB (3)