Vaginal Vault ProlapsePhase 4NCT01244165
Study of Cytrix Use in Pelvic Floor Prolapse Treatment
A Phase 4 study testing Cytrix and Other treatments for pelvic organ prolapse in people with Vaginal Vault Prolapse, run by Boston Scientific Corporation.
Trial summary
To evaluate safety and effectiveness of using the fetal bovine dermis (Cytrix) in the treatment of pelvic organ prolapse. Read more about this study
- Who is it for?
- Ages 30 to 85 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Vaginal Vault Prolapse
- What is being tested?
- Cytrix and Other treatments for pelvic organ prolapse
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- No sites listed yet
- Study dates
- Jan 2002to Oct 2006
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 85 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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)
Show all 18Show fewer
- 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
About this study
Official title: Clinical Investigation of Fetal Bovine Dermis Material (Cytrix) for Use in the Treatment of Pelvic Floor Prolapse
To evaluate safety and effectiveness of using the fetal bovine dermis (Cytrix) in the treatment of pelvic organ prolapse.
- Conditions
- Vaginal Vault Prolapse
- Being tested
- Cytrix, Other treatments for pelvic organ prolapse
- Medical subject headings
- Pelvic Organ Prolapse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CytrixDevice
Other treatments for pelvic organ prolapseOther
Treatments for pelvic organ prolapse using other products (standard of care for treatment of pelvic organ prolapse)
| Study group | Role | What they receive |
|---|---|---|
| Cytrix | Other | Observational Study Receives: Device: Cytrix |
| Control Group | Other | Patients with similar indications who were treated at the same centers using other products Receives: Other: Other treatments for pelvic organ prolapse |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients reporting intra-operative complications
Measured: at procedure
number of treated patients reporting post-operative adverse events
Measured: 6 Months
Patient healing time
length of hospital stay and pain medication
Measured: 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
Measured: 6 months
Patient satisfaction after Pelvic Organ Prolapse surgery using Cytrix
Phone-Patient Questionnaire
Measured: 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
Measured: 6 months
Patient satisfaction after Pelvic Organ Prolapse surgery using Cytrix
Measured: 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.
Measured: 6 months
Patient satisfaction after Pelvic Organ Prolapse surgery using Cytrix
Phone-Patient Questionnaire
Measured: 2 wks
Patient satisfaction after Pelvic Organ Prolapse surgery using Cytrix
Phone-Patient Questionnaire
Measured: 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.
Measured: 6 months
Secondary outcomes (1)
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
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2010 (estimated)
- Study startJan 2002
- Primary completionOct 2006
- Study completionOct 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Vaginal Vault ProlapseStudies of the same condition, open and under way.
- More trials run by Boston Scientific CorporationThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Scientific Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Oscar A Aguirre, MD, Principal investigator, Milestone Medical Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01244165
- Sponsor's protocol ID
- WH-2004-01
- Status last verified
- Nov 2010
- First submitted
- 17 Nov 2010
- Last updated
- 19 Nov 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 21144043
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Investigation of Fetal Bovine Dermis Material (Cytrix) for Use in the Treatment of Pelvic Floor Prolapse
- ClinicalTrials.gov ID
- NCT01244165
- Acronym / sponsor ID
- WH-2004-01
- Conditions
- Vaginal Vault Prolapse
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Boston Scientific CorporationIndustry (pharma, biotech, devices)
- Study start
- Jan 2002
- Primary completion
- Oct 2006 (actual)
- Study completion
- Oct 2006 (actual)
- First posted
- 19 Nov 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To evaluate safety and effectiveness of using the fetal bovine dermis (Cytrix) in the treatment of pelvic organ prolapse.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cytrix | Other | Device: CytrixObservational Study |
| Control Group | Other | Other: Other treatments for pelvic organ prolapsePatients with similar indications who were treated at the same centers using other products |
Who may qualify
- Ages
- 30 to 85 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (18 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cytrix | Device | Cytrix |
| Other treatments for pelvic organ prolapseTreatments for pelvic organ prolapse using other products (standard of care for treatment of pelvic organ prolapse) | Other | Control Group |
Primary outcome
Number of patients reporting intra-operative complications
Time frame: at procedure
number of treated patients reporting post-operative adverse events
Time frame: 6 Months
Patient healing time
Time frame: 6 Months
length of hospital stay and pain medication
Incidence of complication in Cytrix treated patients compared to patients in the historical control group
Time frame: 6 months
Incidence of complication in Cytrix treated patients compared to patients in the historical control group
Patient satisfaction after Pelvic Organ Prolapse surgery using Cytrix
Time frame: 3 months
Phone-Patient Questionnaire
Patient satisfaction after Pelvic Organ Prolapse surgery using Cytrix
Time frame: 6 months
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
Time frame: 12 months
Comparison of phone patient questionnaire results between Cytrix Group and Control Group
Time frame: 6 months
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
Time frame: 2 wks
Phone-Patient Questionnaire
Patient satisfaction after Pelvic Organ Prolapse surgery using Cytrix
Time frame: 6 wks
Phone-Patient Questionnaire
Comparison of Pelvic Floor Distress Inventory (PFDI-SF20) questionnaire results between Cytrix Group and Control Group
Time frame: 6 months
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.
1 secondary outcome
Physician satisfaction in the treatment of patients with pelvic floor prolapse using Cytrix
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2010.
- Derived from this study: PubMed 21144043Goldstein 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.
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Vaginal Vault Native Tissue Suspension
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Vaginal Mesh Surgery Versus Robotic-assisted Abdominal Mesh Surgery in the Treatment of Apical Prolapse - Prospective Randomized Non-inferiority Study
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Transvaginal Mesh vs. Laparoscopic Colposacropexy- Study
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Post-Hysterectomy Vaginal Length: Horizontal vs. Vertical Closure
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Oscar A Aguirre, MD principal investigator
Milestone Medical Research
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Cytrix and Other treatments for pelvic organ prolapse in people with Vaginal Vault Prolapse, run by Boston Scientific Corporation.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Nov 2010. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients reporting intra-operative complications (time frame: at procedure). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01244165, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Nov 2010.