Pelvic Organ ProlapsePhase 4NCT03939715
Surgical Intervention With DermaPure vs Native Tissue in Pelvic Organ Prolapse
A Phase 4 study testing DermaPure® and native tissue in people with Pelvic Organ Prolapse, run by Colorado Pelvic Floor Consultants at 1 site in United States.
Trial summary
Comparing FDA-approved DermaPure with patient's own native tissue surgically for diagnosis of pelvic organ prolapse. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Pelvic Organ Prolapse
- What is being tested?
- DermaPure® and native tissue
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Apr 2020to 5 May 2022
- 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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject is female
- Subject is at least 18 years of age
- Subject has prolapse of the anterior compartment beyond the hymen
- Subject reports bulge symptoms as defined in question 3 of the PFDI-20 with a response of 2 or higher ("somewhat", "moderately" or "quite a bit")
- Subject is willing and able to provide informed consent
- Subject is willing and able to comply with the follow-up protocol through 36 months
Who cannot join
- Subject is pregnant or intends to become pregnant during the study
- Subject has untreated severe urogenital atrophy
- Subject has an active or chronic systemic infection including any gynecologic infection, untreated urinary tract infection (UTI), or tissue necrosis
- Subject has a history of pelvic organ cancer (e.g. uterine, ovarian, bladder, or cervical)
- Subject has had prior pelvic radiation therapy
- Subject has taken systemic steroids within the last month, or immunosuppressive or immunomodulatory treatment within the last 3 months (list attached)
Show all 17Show fewer
- Subject has a history of poor wound healing with or without a diagnosis of connective tissue disease
- Subject has chronic systemic pain that includes the pelvic area or chronic focal pain that involves the pelvis
- Subject has uncontrolled diabetes mellitus (DM) as defined by a hemoglobin A1C < or = to 8% (Underwood, Ata)
- Subject has a known neurologic or medical condition that may effect of currently affects bladder function
- Subject is seeking obliterative vaginal surgery as treatment for pelvic organ prolapse (colpocleisis)
- Subject is not able to conform to the modified dorsal lithotomy position
- Subject is currently participating in or plans to participate in another pelvic organ prolapse related study during this study
- Subject has had previous prolapse repair with synthetic mesh in the anterior compartment
- Subject is planning to undergo a concomitant prolapse repair in a non-target compartment with anything other than native tissue or DermaPure®
- Subject is unable to be treated in the anterior compartment with DermaPure®
- Subject is desirous of a concomitant hysteropexy
Trial locations and contacts
1 site in 1 country.
United States1 site
Colorado Pelvic Floor Consultants
Englewood, Colorado, 80113
CATHERINE JAY, 303-955-8059
About this study
Official title: Anterior And Multi-Compartment Vaginal Prolapse Repair Augmented With Decellularized Human Dermal Allograft: A Prospactive, Randomized Controlled, Post Market Study
Comparing FDA-approved DermaPure with patient's own native tissue surgically for diagnosis of pelvic organ prolapse.
Read the detailed description
The investigator is comparing FDA-approved DermaPure with patient's own native tissue for the repair of pelvic organ prolapse. Please see below for detailed objectives and endpoints for our measuring parameters:
Objectives
Specific Aim #1:
To determine the relative safety and efficacy of anterior and multi-compartment vaginal wall prolapse repair augmented with decellularized human dermal allograft (DermaPure®) versus anterior and multi-compartment repair employing native tissue.
Specific Aim #2:
To evaluate bulge symptoms, quality of life, sexual function, and patient satisfaction
Our hypothesis is that pelvic organ prolapse repair augmented with DermaPure® will provide superior anatomic outcomes as compared to native tissue controls with a non-inferior safety profile.
Endpoints
Safety Endpoint #1:
The relative proportion of allograft, native tissue, and procedure-related SAE's at 12 months.
Safety Endpoint #2:
The relative proportion of allograft, native tissue, and procedure-related AE's of interest at 12 months, which include:
- Vaginal shortening
- Vaginal scarring or banding
- De novo vaginal bleeding
- Atypical vaginal discharge
- Fistula formation
- De novo dyspareunia
- Pelvic pain
- Peri-operative infection
- Vaginal infection
- UTI
- Neuromuscular disorder
- SUI (worsening or de novo)
- UUI (worsening or de novo)
- Difficulty emptying bladder (worsening or de novo)
- Graft exposure (into vagina)
- Graft erosion (into viscus)
Efficacy Endpoint #1:
The proportion of patients in each group at 36 months with prolapse of the target compartment beyond the hymen.
Efficacy Endpoint #2:
The proportion of patients in each group at 36 months with bulge symptoms attributable to the target compartment as determined by PFDI-20 question number 3 ("Does the participant usually have a bulge or something falling out that the participant can see or feel in the vaginal area") answering "yes" and >= 2 (responses of "somewhat", "moderately", or "quite a bit"). (Barber)
Efficacy Endpoint #3:
The proportion of patients in each group at 36 months requiring re-treatment for recurrent prolapse of the target compartment (to include surgery, physical therapy or pessary insertion).
Efficacy Endpoint #4:
Change in quality of life in each group from baseline to 36 months as measured by the PFDI-20 and the PFIQ-7. (Barber)
Efficacy Endpoint #5:
Change in sexual function in each group from baseline to 36 months as measured by the PISQ-IR. (Rogers)
Efficacy Endpoint #6:
Patient satisfaction in each group at 36 months as measured by the SSQ-8. (Haff)
Efficacy Endpoint #7:
Patient impression in each group at 36 months of postoperative improvement by the PGI-I (Srikrishna)
- Conditions
- Pelvic Organ Prolapse
- Being tested
- DermaPure®, native tissue
- 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.
DermaPure®Biological
Surgical intervention using DermaPure®
native tissueProcedure or surgery
Surgical intervention using native tissue
| Study group | Role | What they receive |
|---|---|---|
| DermaPure | Active comparator | Not described Receives: Biological: DermaPure® |
| Native Tissue | Active comparator | Not described Receives: Procedure: native tissue |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety through AE and SAE assessments and percentage of incidences
The relative proportion of allograft, native tissue, and procedure-related SAE's is assessed at 12 months, 24 months, and 36 months.
The relative proportion of allograft, native tissue, and procedure-related AE's of interest is assessed at 12 months, 24 months, and 36 months which include:
- Vaginal shortening
- Vaginal scarring or banding
- De novo vaginal bleeding
- Atypical vaginal discharge
- Fistula formation
- De novo dyspareunia
- Pelvic pain
- Peri-operative infection
- Vaginal infection
- UTI
- Neuromuscular disorder
- SUI (worsening or de novo)
- UUI (worsening or de novo)
- Difficulty emptying bladder (worsening or de novo)
- Graft exposure (into vagina)
- Graft erosion (into viscus)
Measured: 3 years
Quality of Life through the administration of questionnaires, analyzed at the end of the study as % of patients that are satisfied or above satisfied
The proportion of patients in each group at 36 months with bulge symptoms attributable to the target compartment as determined by PFDI-20 question number 3 ("Do you usually have a bulge or something falling out that you can see or feel in the vaginal area") answering "yes" and >= 2 (responses of "somewhat", "moderately", or "quite a bit"). (Barber) Change in quality of life in each group from baseline to 36 months as measured by the PFDI-20 and the PFIQ-7. (Barber)
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2019
- Study start5 Apr 2020 (estimated)
- Primary completion5 May 2022 (estimated)
- Study completion5 May 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pelvic Organ ProlapseStudies of the same condition, open and under way.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Colorado Pelvic Floor Consultants
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Tissue Regenix Ltd
- Responsible party
- Sponsor
- Investigators
- James Lukban, DO, Principal investigator, Colorado Pelvic Floor Consultants
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03939715
- Sponsor's protocol ID
- 1385925-1
- Status last verified
- Jan 2020
- First submitted
- 30 Apr 2019
- Last updated
- 23 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anterior And Multi-Compartment Vaginal Prolapse Repair Augmented With Decellularized Human Dermal Allograft: A Prospactive, Randomized Controlled, Post Market Study
- ClinicalTrials.gov ID
- NCT03939715
- Acronym / sponsor ID
- 1385925-1
- Conditions
- Pelvic Organ Prolapse
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Colorado Pelvic Floor ConsultantsIndustry (pharma, biotech, devices)
- Collaborators
- Tissue Regenix Ltd
- Study start
- 5 Apr 2020 (estimated)
- Primary completion
- 5 May 2022 (estimated)
- Study completion
- 5 May 2022 (estimated)
- First posted
- 7 May 2019 (actual)
- 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.
Comparing FDA-approved DermaPure with patient's own native tissue surgically for diagnosis of pelvic organ prolapse.
Detailed description
The investigator is comparing FDA-approved DermaPure with patient's own native tissue for the repair of pelvic organ prolapse. Please see below for detailed objectives and endpoints for our measuring parameters:
Objectives
Specific Aim #1:
To determine the relative safety and efficacy of anterior and multi-compartment vaginal wall prolapse repair augmented with decellularized human dermal allograft (DermaPure®) versus anterior and multi-compartment repair employing native tissue.
Specific Aim #2:
To evaluate bulge symptoms, quality of life, sexual function, and patient satisfaction
Our hypothesis is that pelvic organ prolapse repair augmented with DermaPure® will provide superior anatomic outcomes as compared to native tissue controls with a non-inferior safety profile.
Endpoints
Safety Endpoint #1:
The relative proportion of allograft, native tissue, and procedure-related SAE's at 12 months.
Safety Endpoint #2:
The relative proportion of allograft, native tissue, and procedure-related AE's of interest at 12 months, which include:
- Vaginal shortening
- Vaginal scarring or banding
- De novo vaginal bleeding
- Atypical vaginal discharge
- Fistula formation
- De novo dyspareunia
- Pelvic pain
- Peri-operative infection
- Vaginal infection
- UTI
- Neuromuscular disorder
- SUI (worsening or de novo)
- UUI (worsening or de novo)
- Difficulty emptying bladder (worsening or de novo)
- Graft exposure (into vagina)
- Graft erosion (into viscus)
Efficacy Endpoint #1:
The proportion of patients in each group at 36 months with prolapse of the target compartment beyond the hymen.
Efficacy Endpoint #2:
The proportion of patients in each group at 36 months with bulge symptoms attributable to the target compartment as determined by PFDI-20 question number 3 ("Does the participant usually have a bulge or something falling out that the participant can see or feel in the vaginal area") answering "yes" and >= 2 (responses of "somewhat", "moderately", or "quite a bit"). (Barber)
Efficacy Endpoint #3:
The proportion of patients in each group at 36 months requiring re-treatment for recurrent prolapse of the target compartment (to include surgery, physical therapy or pessary insertion).
Efficacy Endpoint #4:
Change in quality of life in each group from baseline to 36 months as measured by the PFDI-20 and the PFIQ-7. (Barber)
Efficacy Endpoint #5:
Change in sexual function in each group from baseline to 36 months as measured by the PISQ-IR. (Rogers)
Efficacy Endpoint #6:
Patient satisfaction in each group at 36 months as measured by the SSQ-8. (Haff)
Efficacy Endpoint #7:
Patient impression in each group at 36 months of postoperative improvement by the PGI-I (Srikrishna)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DermaPure | Active comparator | Biological: DermaPure® |
| Native Tissue | Active comparator | Procedure: native tissue |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Subject is female
- Subject is at least 18 years of age
- Subject has prolapse of the anterior compartment beyond the hymen
- Subject reports bulge symptoms as defined in question 3 of the PFDI-20 with a response of 2 or higher ("somewhat", "moderately" or "quite a bit")
- Subject is willing and able to provide informed consent
Key exclusion criteria (17 listed)
- Subject is pregnant or intends to become pregnant during the study
- Subject has untreated severe urogenital atrophy
- Subject has an active or chronic systemic infection including any gynecologic infection, untreated urinary tract infection (UTI), or tissue necrosis
- Subject has a history of pelvic organ cancer (e.g. uterine, ovarian, bladder, or cervical)
- Subject has had prior pelvic radiation therapy
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 |
|---|---|---|
| DermaPure®Surgical intervention using DermaPure® | Biological | DermaPure |
| native tissueSurgical intervention using native tissue | Procedure or surgery | Native Tissue |
Primary outcome
Safety through AE and SAE assessments and percentage of incidences
Time frame: 3 years
The relative proportion of allograft, native tissue, and procedure-related SAE's is assessed at 12 months, 24 months, and 36 months. The relative proportion of allograft, native tissue, and procedure-related AE's of interest is assessed at 12 months, 24 months, and 36 months which include: * Vaginal shortening * Vaginal scarring or banding * De novo vaginal bleeding * Atypical vaginal discharge * Fistula formation * De novo dyspareunia * Pelvic pain * Peri-operative infection * Vaginal infection * UTI * Neuromuscular disorder * SUI (worsening or de novo) * UUI (worsening or de novo) * Difficulty emptying bladder (worsening or de novo) * Graft exposure (into vagina) * Graft erosion (into viscus)
Quality of Life through the administration of questionnaires, analyzed at the end of the study as % of patients that are satisfied or above satisfied
Time frame: 3 years
The proportion of patients in each group at 36 months with bulge symptoms attributable to the target compartment as determined by PFDI-20 question number 3 ("Do you usually have a bulge or something falling out that you can see or feel in the vaginal area") answering "yes" and >= 2 (responses of "somewhat", "moderately", or "quite a bit"). (Barber) Change in quality of life in each group from baseline to 36 months as measured by the PFDI-20 and the PFIQ-7. (Barber)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2020.
- Individual participant dataSharing planned: Yes
Related trials for Pelvic Organ Prolapse
Active, not recruitingObservational study
Return to Physical Activity After Retropublic Transvaginal Sling and Laparoscopic Sacrocolpopexy
Stress Urinary Incontinence, Pelvic Organ Prolapse
Active, not recruitingObservational study
i-Stitch for Bilateral Sacrospinous Ligament Fixation (SSLF)
Pelvic Organ Prolapse, Genital Prolapse
Recruiting
Safety and Performance of a Pelvic Floor Mesh Implant for Laparoscopic Sacrocolpopexy (ProGYNious)
Pelvic Organ Prolapse (POP), Synthetic Mesh
Recruiting
Pelvic Floor Muscle Training During Pregnancy
Urinary Incontinence, Anal Incontinence
Not yet recruiting
Perineal Protection Device for Reducing Perineal Trauma During Vaginal Delivery in First-time Mothers: a Multicenter Randomized Controlled Trial
Pelvic Floor Dysfunction, Perineal Laceration
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.
James Lukban, DO principal investigator
Colorado Pelvic Floor Consultants
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing DermaPure® and native tissue in people with Pelvic Organ Prolapse, run by Colorado Pelvic Floor Consultants at 1 site in United States.
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 17 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: status not confirmed, as of the sponsor's last update on 23 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact CATHERINE JAY (3039558059, cjay@surgone.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety through AE and SAE assessments and percentage of incidences (time frame: 3 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Jan 2020.