Study of Cytrix Use in Pelvic Floor Prolapse Treatment

NCT01244165 | Completed Phase 4

• 1 other identifier: WH-2004-01
• Study Type: interventional
• Target: 45
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Vaginal Vault Prolapse

Outcome Measures

Primary Outcomes (11)

• 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.

  6 months

• Patient satisfaction after Pelvic Organ Prolapse surgery using Cytrix

  Phone-Patient Questionnaire

  2 wks

• Patient satisfaction after Pelvic Organ Prolapse surgery using Cytrix

  Phone-Patient Questionnaire

  6 wks

• 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

Secondary Outcomes (1)

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

  6 months

Study Arms (2)

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

Interventions

Cytrix DEVICE

Cytrix

Other treatments for pelvic organ prolapse OTHER

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

Control Group

Eligibility Criteria

• Age: 30 Years - 85 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Boston Scientific Corporation: lead

Related Publications (1)

• 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.

  PMID: 21144043 DERIVED

MeSH Terms

Conditions

Pelvic Organ Prolapse

Condition Hierarchy (Ancestors)

Prolapse; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Oscar A Aguirre, MD

  Milestone Medical Research

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: November 17, 2010
• First Posted: November 19, 2010
• Study Start: January 1, 2002
• Primary Completion: October 1, 2006
• Study Completion: October 1, 2006
• Last Updated: November 19, 2010

Record last verified: 2010-11