Study of Cytrix Use in Pelvic Floor Prolapse Treatment

Boston Scientific

Status and phase

Completed

Phase 4

Conditions

Vaginal Vault Prolapse

Treatments

Device: Cytrix

Other: Other treatments for pelvic organ prolapse

Study type

Interventional

Funder types

Industry

Identifiers

WH-2004-01

Details and patient eligibility

About

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

Enrollment

45 patients

Sex

Female

Ages

30 to 85 years old

Volunteers

Accepts Healthy Volunteers

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