GYNECARE PROSIMA* Pelvic Floor Repair System for Pelvic Organ Prolapse

Pelvic Organ Prolapse Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00521066
• Other study ID #: 300-06-005
• Status: Completed
• Phase: N/A
• First received: August 24, 2007
• Last updated: May 5, 2014
• Start date: June 2007
• Est. completion date: June 2010

Study information

• Verified date: May 2014
• Source: Ethicon, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardUnited Kingdom: Research Ethics CommitteeGermany: Ethics CommissionAustralia: Human Research Ethics Committee
• Study type: Observational

Clinical Trial 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)

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: June 2010
• Est. primary completion date: October 2008
• 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 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.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Pelvic Organ Prolapse
• Prolapse

Intervention

Device:
• GYNECARE PROSIMA* Pelvic Floor Repair System
procedure for pelvic organ prolapse

Locations

Country	Name	City	State
Australia	Royal Women's Hospital	Melbourne
Germany	Bereich Urogynakologie	Halle
Germany	Universitatsklinik Tubingen	Tubingen
United Kingdom	Addenbrookes Hospital	Cambridge
United Kingdom	North Hampshire Hospital	Hampshire
United Kingdom	St. Mary's Hospital	Manchester
United States	The Institute for Female Pelvic Medicine & Reconstructive Surgery	Allentown	Pennsylvania
United States	Female Pelvic Medicine and Urogynecology Institute of Michigan	Dearborn	Michigan
United States	Female Pelvic Medicine & Urogynecology	Grand Rapids	Michigan
United States	Specialists in Urology	Naples	Florida
United States	Magee Women's Hospital of the Universtiy of Pittsburgh	Pittsburgh	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Ethicon, Inc.

Countries where clinical trial is conducted

United States,  Australia,  Germany,  United Kingdom, 

References & Publications (2)

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 — View 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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Success based on overall POP-Q score at 24 months post-procedure.	Success is determined by achievement of an overall POP-Q score of ICS Stage =1, without further re-intervention for POP	24 months	No
Secondary	Success based on treated compartment ICS POP-Q stage	Success will be determined by achievement of treated compartment POP-Q score of ICS Stage =1, without further re-intervention for POP.	12 months	No
Secondary	Success based on treated compartment ICS POP-Q stage	Success will be determined by achievement of treated compartment POP-Q score of ICS Stage =1, without further re-intervention for POP.	24 months	No
Secondary	Success defined as the leading edge within the hymen	Success defined as the leading edge within the hymen (i.e. all POP-Q values to be less than 0, without further re-intervention for POP)	12 months	No
Secondary	Success defined as the leading edge within the hymen	Success defined as the leading edge within the hymen (i.e. all POP-Q values to be less than 0, without further re-intervention for POP)	24 months	No
Secondary	Mean PFDI-20 score		12 months	No
Secondary	Mean PFDI-20 score		24 months	No
Secondary	Mean change from baseline in PFDI-20 scores		24 months	No
Secondary	Mean change from baseline in PFDI-20 scores		12 months	No
Secondary	Mean POPDI score	POPDI is a sub score of PFDI-20	12 months	No
Secondary	Mean POPDI score	POPDI is a sub score of PFDI-20	24 months	No
Secondary	Mean change from baseline in POPDI score	POPDI is a sub scores of PFDI-20	12 months	No
Secondary	Mean change from baseline in POPDI score	POPDI is a sub score of PFDI-20	24 months	No
Secondary	Mean CRADI score	CRADI is a sub score of PFDI-20	12 months	No
Secondary	Mean CRADI score	CRADI is a sub score of PFDI-20	24 months	No
Secondary	Mean change from baseline in CRADI score	CRADI is a sub score of PFDI-20	12 months	No
Secondary	Mean change from baseline in CRADI score	CRADI is a sub score of PFDI-20	24 months	No
Secondary	Mean UDI score	UDI is a sub score of PFDI-20	12 months	No
Secondary	Mean UDI score	UDI is a sub score of PFDI-20	24 months	No
Secondary	Mean change from baseline in UDI score	UDI is a sub score of PFDI-20	12 months	No
Secondary	Mean change from baseline in UDI score	UDI is a sub score of PFDI-20	24 months	No
Secondary	EuroQol (EQ-5D health state) change from baseline		12 months	No
Secondary	EuroQol (EQ-5D health state) change from baseline		24 months	No
Secondary	Mean PFIQ-7 score		12 months	No
Secondary	Mean PFIQ-7 score		24 months	No
Secondary	Mean change from baseline in PFIQ-7 score		12 months	No
Secondary	Mean change from baseline in PFIQ-7 score		24 months	No
Secondary	Mean POPIQ score	POPIQ is a sub-score of PFIQ-7	12 months	No
Secondary	Mean POPIQ score	POPIQ is a sub-score of PFIQ-7	24 months	No
Secondary	Mean change from baseline in POPIQ score	POPIQ is a sub-score of PFIQ-7	12 months	No
Secondary	Mean change from baseline in POPIQ score	POPIQ is a sub-score of PFIQ-7	24 months	No
Secondary	Mean CRAIQ score	CRAIQ is a sub-score of PFIQ-7	12 months	No
Secondary	Mean CRAIQ score	CRAIQ is a sub-score of PFIQ-7	24 months	No
Secondary	Mean change from baseline in CRAIQ score	CRAIQ is a sub-score of PFIQ-7	12 months	No
Secondary	Mean change from baseline in CRAIQ score	CRAIQ is a sub-score of PFIQ-7	24 months	No
Secondary	Mean UIQ score	UIQ is a sub-score of PFIQ-7	12 months	No
Secondary	Mean UIQ score	UIQ is a sub-score of PFIQ-7	24 months	No
Secondary	Mean change from baseline in UIQ score	UIQ is a sub-score of PFIQ-7	12 months	No
Secondary	Mean change from baseline in UIQ score	UIQ is a sub-score of PFIQ-7	24 months	No
Secondary	Mean PISQ-12 score	In subjects sexually active at baseline, assessment of sexual function	12 months	No
Secondary	Mean PISQ-12 score	In subjects sexually active at baseline, assessment of sexual function	24 months	No
Secondary	Mean change from baseline in PISQ-12 score	In subjects sexually active at baseline, assessment of sexual function	12 months	No
Secondary	Mean change from baseline in PISQ-12 score	In subjects sexually active at baseline, assessment of sexual function	24 months	No
Secondary	Incidence of new onset dyspareunia, resolution or continuance of pre-existing dyspareunia		ongoing	Yes
Secondary	Length of procedure	From time to first incision to time of last suture used to secure VSD	perioperative	Yes
Secondary	Pain score measured using Visual Analog Scale (VAS).		24 hours post surgery and at the 3-4 week visit	Yes
Secondary	Discomfort of balloon removal, measured using VAS at time of removal.		24 hrs post-surgical	Yes
Secondary	Subject perception of VSD: Awareness	Measured by visual analogue scale	3-4 week visit	No
Secondary	Subject perception of VSD: Discomfort	Measured by visual analogue scale	3-4 week visit	No
Secondary	Subject perception of VSD: Acceptability of discharge	Measured by visual analogue scale	3-4 week visit	No
Secondary	Subject global impression	assessed on a 5 point Likert scale	12 month visit	No
Secondary	Subject global impression	assessed on a 5 point Likert scale	24 month visit	No