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Study of Cytrix Use in Pelvic Floor Prolapse Treatment

Primary Purpose

Vaginal Vault Prolapse

Status

Completed

Phase

Phase 4

Locations

Study Type

Interventional

Intervention

Cytrix

Other treatments for pelvic organ prolapse

About this trial

This is an interventional treatment trial for Vaginal Vault Prolapse

Eligibility Criteria

30 Years - 85 Years (Adult, Older Adult)FemaleAccepts 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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Arm Label

Cytrix

Control Group

Arm Description

Observational Study

Patients with similar indications who were treated at the same centers using other products

Outcomes

Primary Outcome Measures

Number of patients reporting intra-operative complications

number of treated patients reporting post-operative adverse events

Patient healing time

length of hospital stay and pain medication

Incidence of complication in Cytrix treated patients compared to patients in the historical control group

Patient satisfaction after Pelvic Organ Prolapse surgery using Cytrix

Phone-Patient Questionnaire

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

Patient satisfaction after Pelvic Organ Prolapse surgery using Cytrix

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.

Patient satisfaction after Pelvic Organ Prolapse surgery using Cytrix

Phone-Patient Questionnaire

Patient satisfaction after Pelvic Organ Prolapse surgery using Cytrix

Phone-Patient Questionnaire

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.

Secondary Outcome Measures

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

Full Information

NCT ID

NCT01244165

First Posted

November 17, 2010

Last Updated

November 18, 2010

Sponsor

Boston Scientific Corporation

1. Study Identification

Unique Protocol Identification Number

NCT01244165

Brief Title

Study of Cytrix Use in Pelvic Floor Prolapse Treatment

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2010

Overall Recruitment Status

Completed

Study Start Date

January 2002 (undefined)

Primary Completion Date

October 2006 (Actual)

Study Completion Date

October 2006 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Boston Scientific Corporation

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Vaginal Vault Prolapse

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

45 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Cytrix

Arm Type

Other

Arm Description

Observational Study

Arm Title

Control Group

Arm Type

Other

Arm Description

Patients with similar indications who were treated at the same centers using other products

Intervention Type

Device

Intervention Name(s)

Cytrix

Intervention Type

Other

Intervention Name(s)

Other treatments for pelvic organ prolapse

Intervention Description

Treatments for pelvic organ prolapse using other products (standard of care for treatment of pelvic organ prolapse)

Primary Outcome Measure Information:

Title

Number of patients reporting intra-operative complications

Time Frame

at procedure

Title

number of treated patients reporting post-operative adverse events

Time Frame

6 Months

Title

Patient healing time

Description

length of hospital stay and pain medication

Time Frame

6 Months

Title

Incidence of complication in Cytrix treated patients compared to patients in the historical control group

Description

Incidence of complication in Cytrix treated patients compared to patients in the historical control group

Time Frame

6 months

Title

Patient satisfaction after Pelvic Organ Prolapse surgery using Cytrix

Description

Phone-Patient Questionnaire

Time Frame

3 months

Title

Patient satisfaction after Pelvic Organ Prolapse surgery using Cytrix

Description

Pelvic Floor Distress Inventory (PFDI-SF20) Patient questionnaire, and Pelvic Organ Prolapse Sexual Questionnaire (PISQ-12) Questionnaire

Time Frame

6 months

Title

Patient satisfaction after Pelvic Organ Prolapse surgery using Cytrix

Time Frame

12 months

Title

Comparison of phone patient questionnaire results between Cytrix Group and Control Group

Description

Comparison of phone patient questionnaire results in Cytrix treated patients compared to patients in the retrospective historical control group where available.

Time Frame

6 months

Title

Patient satisfaction after Pelvic Organ Prolapse surgery using Cytrix

Description

Phone-Patient Questionnaire

Time Frame

2 wks

Title

Patient satisfaction after Pelvic Organ Prolapse surgery using Cytrix

Description

Phone-Patient Questionnaire

Time Frame

6 wks

Title

Comparison of Pelvic Floor Distress Inventory (PFDI-SF20) questionnaire results between Cytrix Group and Control Group

Description

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.

Time Frame

6 months

Secondary Outcome Measure Information:

Title

Physician satisfaction in the treatment of patients with pelvic floor prolapse using Cytrix

Description

Time Frame

6 months

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

30 Years

Maximum Age & Unit of Time

85 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Oscar A Aguirre, MD

Organizational Affiliation

Milestone Medical Research

Official's Role

Principal Investigator

12. IPD Sharing Statement

Citations:

PubMed Identifier

21144043

Citation

Goldstein HB, Maccarone J, Naughton MJ, Aguirre OA, Patel RC. A multicenter prospective trial evaluating fetal bovine dermal graft (Xenform(R) Matrix) for pelvic reconstructive surgery. BMC Urol. 2010 Dec 13;10:21. doi: 10.1186/1471-2490-10-21.

Results Reference

derived

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Study of Cytrix Use in Pelvic Floor Prolapse Treatment

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