Study of Cytrix Use in Pelvic Floor Prolapse Treatment | NCT01244165

NCT01244165

Protocol Section

Identification Module

Results Section

No data available

No data is available for this block.

Annotation Section

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No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Status Module

Oversight Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Label	Type	Description	Intervention Names
Cytrix	Other	Observational Study	Device: Cytrix
Control Group	Other	Patients with similar indications who were treated at the same centers using other products	Other: Other treatments for pelvic organ prolapse

Name	Type	Description	Arm Group Labels	Other Names
Cytrix	Device		Cytrix
Other treatments for pelvic organ prolapse

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of patients reporting intra-operative complications		at procedure
number of treated patients reporting post-operative adverse events		6 Months
Patient healing time	length of hospital stay and pain medication	6 Months
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
Patient satisfaction after Pelvic Organ Prolapse surgery using Cytrix	Phone-Patient Questionnaire	3 months
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
Patient satisfaction after Pelvic Organ Prolapse surgery using Cytrix		12 months
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.

Secondary Outcomes

Measure	Description	Time Frame
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

Eligibility Module

Eligibility Criteria

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

ID	Term
D011391	Prolapse
D020763	Pathological Conditions, Anatomical
D013568	Pathological Conditions, Signs and Symptoms