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

Cystocele Clinical Trial

Official title:

A Prospective, Multi-center Study to Evaluate the Clinical Performance of the GYNECARE PROLIFT + M* Pelvic Floor Repair System as a Device for Pelvic Organ Prolapse

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00833001
• Other study ID #: 300-07-006
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: January 26, 2009
• Last updated: May 5, 2014
• Start date: April 2008
• Est. completion date: December 2011

Study information

• Verified date: May 2014
• Source: Ethicon, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationBelgium: Federal Agency for Medicinal Products and Health ProductsFrance: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)Germany: German Institute of Medical Documentation and InformationNetherlands: Dutch Health Care Inspectorate
• Study type: Observational

Clinical Trial 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.

Description:

Vaginal prolapse (a feeling of bulge in the vagina) may cause some distressing symptoms such as loss of control of the bowel or bladder, and may also cause problems with women's sex life. There are a number of different surgical procedures which are used to repair prolapse. Sometimes a mesh is placed in the pelvis to support the weakened tissues. There is a lot of research going on to find the most suitable type of mesh to repair vaginal prolapse. The GYNECARE PROLIFT + M* Pelvic Floor Repair system is similar to a mesh already used for this procedure called ULTRAPRO*, but is lighter in weight. Currently, ULTRAPRO* is only approved for use in hernia repair and is not licensed for gynecological procedures. This study will be the first clinical investigation of this mesh in vaginal prolapse.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 126
• Est. completion date: December 2011
• Est. primary completion date: November 2009
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Cystocele
• Enterocele
• Pelvic Organ Prolapse
• Prolapse
• Rectocele

Intervention

Device:
• GYNECARE PROLIFT+M* Pelvic Floor Repair System
Pre-shaped mesh implants made of GYNECARE GYNEMESH M composite mesh, comprised of absorbable polyglecaprone 25 monofilament fiber and nonabsorbable polypropylene monofilament fiber

Locations

Country	Name	City	State
Belgium	Sint Lodewijkstraat 78	Genk
France	CHRU de Lille	Lille
Germany	DRT Krankenhaus	Chemnitz
Germany	Martin Luther University	Halle
Germany	Kreiskrankenhaus	Hameln
Germany	Universitatsklinik Tubingen	Tubingen
Germany	St. Marien-Hospital	Vechta
Netherlands	Reinier de Graaf Gasthuis	Delft

Sponsors (1)

Lead Sponsor	Collaborator
Ethicon, Inc.

Countries where clinical trial is conducted

Belgium,  France,  Germany,  Netherlands, 

References & 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.201 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pelvic Organ Prolapse Quantification (POP-Q) score		12 months post-procedure	No
Secondary	Summary of treated compartment ICS POP-Q stage		3, 12, 24 and 36 months	No
Secondary	Proportion of subjects with the leading edge within the hymen and without further re-intervention for POP		12, 24 and 36 months	No
Secondary	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	No
Secondary	Mean scores and change from baseline in PFDI-20 scores, including sub scores (POPDI, CRADI and UDI		3, 12, 24 and 36 months	No
Secondary	Mean scores and change from baseline in PFIQ-7, including sub-scores (POPIQ, CRAIQ and UIQ).		3, 12, 24 and 36 months	No
Secondary	Days to return to normal activities (walking, driving, work, household activities and sexual intercourse)		1, 3, and 12 months	No
Secondary	Assessment of sexual function using PISQ-12 (mean scores and change from baseline) in subjects sexually active at baseline		12, 24 and 36 months	No
Secondary	Incidence of new onset dyspareunia, resolution or continuance of pre-existing dyspareunia		Baseline to 36 months	Yes
Secondary	Adverse Events		Procedure to 36 months	Yes
Secondary	Determination of any exposures/erosions including location		Procedure to 36 months	Yes
Secondary	Summary of International Continence Society (ICS) Stages		3, 24, and 36 months	No