Clinical trial NCT00521066: GYNECARE PROSIMA* Pelvic Floor Repair System for Pelvic Organ Prolapse
Official title: A Prospective, Multi-centre Study to Evaluate the Clinical Performance of the GYNECARE PROSIMA* Pelvic Floor Repair System as a Procedure for Pelvic Organ Prolapse
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pelvic Organ Prolapse
Lead sponsor: Ethicon, Inc.
Sponsor class: INDUSTRY
First posted: 2007-08-27
Enrollment: 150
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 II or III, suitable for surgical repair

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)

Detailed description: The GYNECARE PROSIMA\* system provides a simplified mesh repair, avoiding the need for dissection outside the pelvic cavity.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Success based on overall POP-Q score at 12 months post-procedure.
timeFrame: 12-months
Secondary outcomes:
measure: Success based on overall POP-Q score at 24 months post-procedure.
timeFrame: 24 months
measure: Success based on treated compartment ICS POP-Q stage
timeFrame: 12 months
measure: Success based on treated compartment ICS POP-Q stage
timeFrame: 24 months
measure: Success defined as the leading edge within the hymen
timeFrame: 12 months
measure: Success defined as the leading edge within the hymen
timeFrame: 24 months
measure: Mean PFDI-20 score
timeFrame: 12 months
measure: Mean PFDI-20 score
timeFrame: 24 months
measure: Mean change from baseline in PFDI-20 scores
timeFrame: 24 months
measure: Mean change from baseline in PFDI-20 scores
timeFrame: 12 months
measure: Mean POPDI score
timeFrame: 12 months
measure: Mean POPDI score
timeFrame: 24 months
measure: Mean change from baseline in POPDI score
timeFrame: 12 months
measure: Mean change from baseline in POPDI score
timeFrame: 24 months
measure: Mean CRADI score
timeFrame: 12 months
measure: Mean CRADI score
timeFrame: 24 months
measure: Mean change from baseline in CRADI score
timeFrame: 12 months
measure: Mean change from baseline in CRADI score
timeFrame: 24 months
measure: Mean UDI score
timeFrame: 12 months
measure: Mean UDI score
timeFrame: 24 months
measure: Mean change from baseline in UDI score
timeFrame: 12 months
measure: Mean change from baseline in UDI score
timeFrame: 24 months
measure: EuroQol (EQ-5D health state) change from baseline
timeFrame: 12 months
measure: EuroQol (EQ-5D health state) change from baseline
timeFrame: 24 months
measure: Mean PFIQ-7 score
timeFrame: 12 months
measure: Mean PFIQ-7 score
timeFrame: 24 months
measure: Mean change from baseline in PFIQ-7 score
timeFrame: 12 months
measure: Mean change from baseline in PFIQ-7 score
timeFrame: 24 months
measure: Mean POPIQ score
timeFrame: 12 months
measure: Mean POPIQ score
timeFrame: 24 months
measure: Mean change from baseline in POPIQ score
timeFrame: 12 months
measure: Mean change from baseline in POPIQ score
timeFrame: 24 months
measure: Mean CRAIQ score
timeFrame: 12 months
measure: Mean CRAIQ score
timeFrame: 24 months
measure: Mean change from baseline in CRAIQ score
timeFrame: 12 months
measure: Mean change from baseline in CRAIQ score
timeFrame: 24 months
measure: Mean UIQ score
timeFrame: 12 months
measure: Mean UIQ score
timeFrame: 24 months
measure: Mean change from baseline in UIQ score
timeFrame: 12 months
measure: Mean change from baseline in UIQ score
timeFrame: 24 months
measure: Mean PISQ-12 score
timeFrame: 12 months
measure: Mean PISQ-12 score
timeFrame: 24 months
measure: Mean change from baseline in PISQ-12 score
timeFrame: 12 months
measure: Mean change from baseline in PISQ-12 score
timeFrame: 24 months
measure: Incidence of new onset dyspareunia, resolution or continuance of pre-existing dyspareunia
timeFrame: ongoing
measure: Length of procedure
timeFrame: perioperative
measure: Pain score measured using Visual Analog Scale (VAS).
timeFrame: 24 hours post surgery and at the 3-4 week visit
measure: Discomfort of balloon removal, measured using VAS at time of removal.
timeFrame: 24 hrs post-surgical
measure: Subject perception of VSD: Awareness
timeFrame: 3-4 week visit
measure: Subject perception of VSD: Discomfort
timeFrame: 3-4 week visit
measure: Subject perception of VSD: Acceptability of discharge
timeFrame: 3-4 week visit
measure: Subject global impression
timeFrame: 12 month visit
measure: Subject global impression
timeFrame: 24 month visit
Other outcomes:
Locations:
city: Naples
country: United States
facility: Specialists in Urology
state: Florida
city: Dearborn
country: United States
facility: Female Pelvic Medicine and Urogynecology Institute of Michigan
state: Michigan
city: Grand Rapids
country: United States
facility: Female Pelvic Medicine & Urogynecology
state: Michigan
city: Allentown
country: United States
facility: The Institute for Female Pelvic Medicine & Reconstructive Surgery
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Magee Women's Hospital of the Universtiy of Pittsburgh
state: Pennsylvania
city: Melbourne
country: Australia
facility: Royal Women's Hospital
city: Halle
country: Germany
facility: Bereich Urogynakologie
city: Tubingen
country: Germany
facility: Universitatsklinik Tubingen
city: Cambridge
country: United Kingdom
facility: Addenbrookes Hospital
city: Hampshire
country: United Kingdom
facility: North Hampshire Hospital
city: Manchester
country: United Kingdom
facility: St. Mary's Hospital
Study officials:
affiliation: Ethicon, Inc.
name: David Robinson, M.D.
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.