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

Sponsor

Ethicon, Inc. (Industry)

Overall Status

Completed

CT.gov ID

NCT00833001

Collaborator

(none)

126

Enrollment

Locations

Duration (Months)

15.8

Patients Per Site

0.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cystocele Rectocele Enterocele	Device: GYNECARE PROLIFT+M* Pelvic Floor Repair System

Detailed 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.

Study Design

Study Type:

Observational

Actual Enrollment :

126 participants

Observational Model:

Cohort

Time Perspective:

Prospective

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

Study Start Date :

Apr 1, 2008

Actual Primary Completion Date :

Nov 1, 2009

Actual Study Completion Date :

Dec 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
1 GYNECARE PROLIFT+M* Pelvic Floor Repair System	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 Other Names: ULTRAPRO* mesh

Arm

Intervention/Treatment

GYNECARE PROLIFT+M* Pelvic Floor Repair System

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

Other Names:

ULTRAPRO* mesh

Outcome Measures

Primary Outcome Measures

Pelvic Organ Prolapse Quantification (POP-Q) score [12 months post-procedure]

Secondary Outcome Measures

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]
Days to return to normal activities (walking, driving, work, household activities and sexual intercourse) [1, 3, and 12 months]
Assessment of sexual function using PISQ-12 (mean scores and change from baseline) in subjects sexually active at baseline [12, 24 and 36 months]
Incidence of new onset dyspareunia, resolution or continuance of pre-existing dyspareunia [Baseline to 36 months]
Adverse Events [Procedure to 36 months]
Determination of any exposures/erosions including location [Procedure to 36 months]
Summary of International Continence Society (ICS) Stages [3, 24, and 36 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	Sint Lodewijkstraat 78	Genk	Belgium
2	CHRU de Lille	Lille	France	59037
3	DRT Krankenhaus	Chemnitz	Germany	09034
4	Martin Luther University	Halle	Germany	06097
5	Kreiskrankenhaus	Hameln	Germany	31785
6	Universitatsklinik Tubingen	Tubingen	Germany	72076
7	St. Marien-Hospital	Vechta	Germany	D-49377
8	Reinier de Graaf Gasthuis	Delft	Netherlands