Study of Cytrix Use in Pelvic Floor Prolapse Treatment

Vaginal Vault Prolapse Clinical Trial

Official title:

Clinical Investigation of Fetal Bovine Dermis Material (Cytrix) for Use in the Treatment of Pelvic Floor Prolapse

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01244165
• Other study ID #: WH-2004-01
• Status: Completed
• Phase: Phase 4
• First received: November 17, 2010
• Last updated: November 18, 2010
• Start date: January 2002
• Est. completion date: October 2006

Study information

• Verified date: November 2010
• Source: Boston Scientific Corporation
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

To evaluate safety and effectiveness of using the fetal bovine dermis (Cytrix) in the treatment of pelvic organ prolapse.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: October 2006
• Est. primary completion date: October 2006
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 30 Years to 85 Years

Eligibility

Inclusion Criteria:

• Female >30 years of age

• Willing and able to comply w/ the study procedures and provide written informed consent to participate in the study.

• Diagnosed with pelvic organ prolapse with or without pelvis floor dysfunction

• Patient is willing to complete PFDI-SF20 and PISQ-12 questionnaires at 6 and 12 months post-operatively

• Patient is willing to answer phone questionnaires at 2 weeks, 6 weeks, and 3 months

• Patients with a history of pelvic surgery (cystocele/anterior repair, hysterectomy, vault suspension, etc) prior to this procedure are allowed to participate in the study except if the patient had a dermal graft implanted.

Exclusion Criteria:

• Patients who, in the clinical judgment of the investigator, are not suitable for this study

• Patients who are, in the Investigators opinion, mentally or legally incapacitated preventing informed consent or unable to read or understand written material.

• Patients who have participated in an investigational study within 30 days of study entry that may impact analysis of this device or have previously participated in the current trial

• Patient whose pelvic organ prolapse is Stage I

• Patient with Diabetes Mellitus type I or II

• Patient with morbid obesity (weight parameters determined by physician)

• Patient with undiagnosed pelvic mass outside of the uterus (not expected to be functional in nature)

• Patient with unexplained abnormal menstrual bleeding

• Patient with any acute or chronic infection (kidney, bladder, lung, etc)

• Patient with coagulopathy

• Patient participating in other investigational device or drug study

• Patients must not be pregnant

• Patients with life expectancy less than 2 years

• Patients with known or suspected hypersensitivity to collagen or bovine products

• Patients with preexisting local or systemic infection

• Patients with a history of soft tissue pathology where the implant is to be placed

• Patients with any pathology that would limit the blood supply and compromise healing

• Patient diagnosed with autoimmune connective tissue disease

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pelvic Organ Prolapse
• Prolapse
• Vaginal Vault Prolapse

Intervention

Device:
• Cytrix

Other:
• Other treatments for pelvic organ prolapse
Treatments for pelvic organ prolapse using other products (standard of care for treatment of pelvic organ prolapse)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Boston Scientific Corporation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of patients reporting intra-operative complications		at procedure	Yes
Primary	number of treated patients reporting post-operative adverse events		6 Months	Yes
Primary	Patient healing time	length of hospital stay and pain medication	6 Months	Yes
Primary	Incidence of complication in Cytrix treated patients compared to patients in the historical control group	Incidence of complication in Cytrix treated patients compared to patients in the historical control group	6 months	Yes
Primary	Patient satisfaction after Pelvic Organ Prolapse surgery using Cytrix	Phone-Patient Questionnaire	3 months	No
Primary	Patient satisfaction after Pelvic Organ Prolapse surgery using Cytrix	Pelvic Floor Distress Inventory (PFDI-SF20) Patient questionnaire, and Pelvic Organ Prolapse Sexual Questionnaire (PISQ-12) Questionnaire	6 months	No
Primary	Patient satisfaction after Pelvic Organ Prolapse surgery using Cytrix		12 months	No
Primary	Comparison of phone patient questionnaire results between Cytrix Group and Control Group	Comparison of phone patient questionnaire results in Cytrix treated patients compared to patients in the retrospective historical control group where available.	6 months	No
Primary	Patient satisfaction after Pelvic Organ Prolapse surgery using Cytrix	Phone-Patient Questionnaire	2 wks	No
Primary	Patient satisfaction after Pelvic Organ Prolapse surgery using Cytrix	Phone-Patient Questionnaire	6 wks	No
Primary	Comparison of Pelvic Floor Distress Inventory (PFDI-SF20) questionnaire results between Cytrix Group and Control Group	Comparison of Pelvic Floor Distress Inventory (PFDI-SF20) questionnaire results in Cytrix treated patients compared to patients in the retrospective historical control group where available.	6 months	No
Secondary	Physician satisfaction in the treatment of patients with pelvic floor prolapse using Cytrix	Physician satisfaction in the treatment of patients with pelvic floor prolapse using Cytrix versus any other product currently being the standard method of care; handling characteristics; conformity to the surgical site; ease of suture; procedure length of time	6 months	No