Clinical trial NCT00833001: Clinical Performance of the GYNECARE PROLIFT + M* Pelvic Floor Repair System as a Device for Pelvic Organ Prolapse
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 type: OBSERVATIONAL
Overall status: COMPLETED
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)
Lead sponsor: Ethicon, Inc.
Sponsor class: INDUSTRY
First posted: 2009-01-30
Enrollment: 126
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Pelvic Organ Prolapse Quantification (POP-Q) score
timeFrame: 12 months post-procedure
Secondary outcomes:
measure: Summary of treated compartment ICS POP-Q stage
timeFrame: 3, 12, 24 and 36 months
measure: Proportion of subjects with the leading edge within the hymen and without further re-intervention for POP
timeFrame: 12, 24 and 36 months
measure: Incidence of de novo prolapse (a post-operative prolapse)only in the untreated compartment, provided there was no pre-operative defect in that compartment
timeFrame: Procedure to 36 months
measure: Mean scores and change from baseline in PFDI-20 scores, including sub scores (POPDI, CRADI and UDI
timeFrame: 3, 12, 24 and 36 months
measure: Mean scores and change from baseline in PFIQ-7, including sub-scores (POPIQ, CRAIQ and UIQ).
timeFrame: 3, 12, 24 and 36 months
measure: Days to return to normal activities (walking, driving, work, household activities and sexual intercourse)
timeFrame: 1, 3, and 12 months
measure: Assessment of sexual function using PISQ-12 (mean scores and change from baseline) in subjects sexually active at baseline
timeFrame: 12, 24 and 36 months
measure: Incidence of new onset dyspareunia, resolution or continuance of pre-existing dyspareunia
timeFrame: Baseline to 36 months
measure: Adverse Events
timeFrame: Procedure to 36 months
measure: Determination of any exposures/erosions including location
timeFrame: Procedure to 36 months
measure: Summary of International Continence Society (ICS) Stages
timeFrame: 3, 24, and 36 months
Other outcomes:
Locations:
city: Genk
country: Belgium
facility: Sint Lodewijkstraat 78
city: Lille
country: France
facility: CHRU de Lille
city: Chemnitz
country: Germany
facility: DRT Krankenhaus
city: Halle
country: Germany
facility: Martin Luther University
city: Hameln
country: Germany
facility: Kreiskrankenhaus
city: Tubingen
country: Germany
facility: Universitatsklinik Tubingen
city: Vechta
country: Germany
facility: St. Marien-Hospital
city: Delft
country: Netherlands
facility: Reinier de Graaf Gasthuis
Study officials:
affiliation: Ethicon, Inc.
name: David Robinson, MD
role: STUDY_DIRECTOR
References:
citation: 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.