Vaginal Wall ProlapseNCT05355623
Surgical Repair of Vaginal Wall Prolapse Using Gamma Irradiated Amniotic Membrane as a Scaffold
A study testing Vaginal Repair in people with Vaginal Wall Prolapse, run by Egymedicalpedia at 1 site in Egypt.
Trial summary
The surgical repair of vaginal wall prolapse continues to remain one of the most difficult challenges in female pelvic floor reconstruction. The recurrence rate after standard colporrhaphy ranges from 40-60 %. Read more about this study
- Who is it for?
- Ages 20 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Vaginal Wall Prolapse
- What is being tested?
- Vaginal Repair
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 22 Apr 2022to 30 Oct 2022
- Phase
- Interventional
- 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 20 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 1 - Parity: from Para 1 to Para 5. 2-BMI: from 25 to 35 KG/M².
Who cannot join
- Chronic debilitating diseases.
- Conditions that lead to increase intra-abdominal pressure
Trial locations and contacts
1 site in 1 country.
About this study
The surgical repair of vaginal wall prolapse continues to remain one of the most difficult challenges in female pelvic floor reconstruction. The recurrence rate after standard colporrhaphy ranges from 40-60 %. This high recurrence rate creates the necessity for developing new surgical techniques and better long-term solutions. Surgeons have been investigating the use of synthetic and biological grafts in vaginal wall prolapse repairs
Read the detailed description
The surgical repair of vaginal wall prolapse continues to remain one of the most difficult challenges in female pelvic floor reconstruction. The recurrence rate after standard colporrhaphy ranges from 40-60 %. This high recurrence rate creates the necessity for developing new surgical techniques and better long-term solutions. Surgeons have been investigating the use of synthetic and biological grafts in vaginal wall prolapse repairs. The use of an absorbable polyglactin 910 mesh (Vicryl) has shown little benefit in its use to correct vaginal wall prolapse (42%), and the use of a synthetic permanent polypropylene mesh for vaginal repair shows a mesh erosion rate of 18%, de novo urgency rate of 20%, and dyspareunia 22% postoperatively. The mesh erosion rate or infection rate increased four-fold when the mesh was introduced vaginally as compared to the abdominal route in pelvic floor reconstruction cases.
Many pelvic surgeons are now using biological grafts for vaginal prolapse surgery, such as cadaveric fascia lata, cadaveric dermis, porcine small intestine, porcine dermis, or bovine pericardium, which are not used in the Middle East for cultural reasons. A new skin tissue-generated matrix has given some hope but is expensive. The use of Amniotic Membrane came to our attention as a possible biological graft material, since it is non-immunogenic, it will not be rejected, and as of protein nature, will be integrated and absorbed by the body after attracting fibrin and collagen, giving necessary support.
Human amniotic membrane is a tough membrane derived from the fetal membranes. Human amniotic membrane is believed to be non-immunogenic, Antibodies or cell-mediated immune response to the amniotic membrane have not been demonstrated, suggesting low antigenicity and hence the recipient will not reject it. Therefore, the use of systemic immunosuppressive drugs is not required.
Some surgeons have described the use of fresh human amniotic membrane for transplantation, but it is not without the risk of infection.
Another important aspect that makes human amniotic epithelial cells (hAECs) and fetal membrane-derived stromal cells attractive for potential stem cell-based therapies is their low antigenicity. The hAECs also release several anti-inflammatory factors that lead to a significant reduction in HLA class II antigen-presenting cells found at sites of injury that prevent apoptosis, enhance wound healing and host cell proliferation, and suppress profibrotic transforming growth factor-beta isoforms and type II transforming growth factor-beta receptors in myofibroblast cells that deposit collagen, which leads to fibrosis. Amniotic membrane has diverse properties against bacterial and viral infections, stores antibiotics, and releases them over the course of a few days, and recently has been shown to produce potent natural antimicrobials. Clinical studies suggest that the amniotic membrane as a biologic dressing has 2 primary favorable effects in addition to being an anatomical barrier as it facilitates epithelialization by acting as a basement membrane substrate, facilitates migration of epithelial cells, reinforces adhesion of the basal epithelium, promotes cellular differentiation, and prevents cellular apoptosis, and it inhibits inflammation and fibrosis. Amnion graft, either fresh or dried, is a promising adjunctive procedure for decreasing the recurrence of adhesions and encouraging endometrial regeneration. Both grafts seem to be equally effective; however, dried amnion graft holds some advantages easy availability, prevention of cross-infection, and easier surgical application. The use of non sterilized amniotic membrane is supposed to increase the risk of fungal, bacterial, or viral diseases transmission from donors. The amniotic membrane graft is a natural human protein, attracting collagen formation, fibrinogen, and causing mild fibrosis, without being rejected, it will adhere to, and integrate with the local pubo-cervical fascia providing a fibrotic sheath, necessary for supporting and augmentation of the weak local fascia, and will be completely absorbed by the body
- Conditions
- Vaginal Wall Prolapse
- Being tested
- Vaginal Repair
- Medical subject headings
- Uterine Prolapse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vaginal RepairProcedure or surgery
Vaginal Repair will be done either by application of sterilized (gamma irradiated) amniotic membrane or by Classical repair
| Study group | Role | What they receive |
|---|---|---|
| amniotic membrane graft | Active comparator | patients in which the surgical vaginal repair will be done with the application of a sterilized (gamma irradiated) amniotic membrane. Receives: Procedure: Vaginal Repair |
| surgical vaginal repair | Active comparator | patients in which the surgical vaginal repair will be done without any graft. Receives: Procedure: Vaginal Repair |
What is being measured
The primary outcome is the main question the study is designed to answer.
Awareness of prolapse and repair
Significant improvement of dyspareunia postoperative in patients with surgical repair of vaginal wall prolapse using Gamma Irradiated Amniotic Membrane
Measured: From baseline to 3 months after the repair of vaginal prolapse operration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2022
- Study start22 Apr 2022
- Primary completion20 Oct 2022
- Study completion30 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vaginal Wall 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- compare between the usage of Gamma irradiated sterilized amniotic membrane as a graft versus conventional classical repair in terms of: Effectiveness, symptoms relief, healing, and infection rate.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Egymedicalpedia
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05355623
- Sponsor's protocol ID
- AMGAD SAMEEH
- Status last verified
- Oct 2023
- First submitted
- 19 Apr 2022
- Last updated
- 19 Oct 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Surgical Repair of Vaginal Wall Prolapse Using Gamma Irradiated Amniotic Membrane as a Scaffold
- ClinicalTrials.gov ID
- NCT05355623
- Acronym / sponsor ID
- AMGAD SAMEEH
- Conditions
- Vaginal Wall Prolapse
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- EgymedicalpediaIndustry (pharma, biotech, devices)
- Study start
- 22 Apr 2022 (actual)
- Primary completion
- 20 Oct 2022 (actual)
- Study completion
- 30 Oct 2022 (actual)
- First posted
- 2 May 2022 (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.
The surgical repair of vaginal wall prolapse continues to remain one of the most difficult challenges in female pelvic floor reconstruction. The recurrence rate after standard colporrhaphy ranges from 40-60 %. This high recurrence rate creates the necessity for developing new surgical techniques and better long-term solutions. Surgeons have been investigating the use of synthetic and biological grafts in vaginal wall prolapse repairs
Detailed description
The surgical repair of vaginal wall prolapse continues to remain one of the most difficult challenges in female pelvic floor reconstruction. The recurrence rate after standard colporrhaphy ranges from 40-60 %. This high recurrence rate creates the necessity for developing new surgical techniques and better long-term solutions. Surgeons have been investigating the use of synthetic and biological grafts in vaginal wall prolapse repairs. The use of an absorbable polyglactin 910 mesh (Vicryl) has shown little benefit in its use to correct vaginal wall prolapse (42%), and the use of a synthetic permanent polypropylene mesh for vaginal repair shows a mesh erosion rate of 18%, de novo urgency rate of 20%, and dyspareunia 22% postoperatively. The mesh erosion rate or infection rate increased four-fold when the mesh was introduced vaginally as compared to the abdominal route in pelvic floor reconstruction cases.
Many pelvic surgeons are now using biological grafts for vaginal prolapse surgery, such as cadaveric fascia lata, cadaveric dermis, porcine small intestine, porcine dermis, or bovine pericardium, which are not used in the Middle East for cultural reasons. A new skin tissue-generated matrix has given some hope but is expensive. The use of Amniotic Membrane came to our attention as a possible biological graft material, since it is non-immunogenic, it will not be rejected, and as of protein nature, will be integrated and absorbed by the body after attracting fibrin and collagen, giving necessary support.
Human amniotic membrane is a tough membrane derived from the fetal membranes. Human amniotic membrane is believed to be non-immunogenic, Antibodies or cell-mediated immune response to the amniotic membrane have not been demonstrated, suggesting low antigenicity and hence the recipient will not reject it. Therefore, the use of systemic immunosuppressive drugs is not required.
Some surgeons have described the use of fresh human amniotic membrane for transplantation, but it is not without the risk of infection.
Another important aspect that makes human amniotic epithelial cells (hAECs) and fetal membrane-derived stromal cells attractive for potential stem cell-based therapies is their low antigenicity. The hAECs also release several anti-inflammatory factors that lead to a significant reduction in HLA class II antigen-presenting cells found at sites of injury that prevent apoptosis, enhance wound healing and host cell proliferation, and suppress profibrotic transforming growth factor-beta isoforms and type II transforming growth factor-beta receptors in myofibroblast cells that deposit collagen, which leads to fibrosis. Amniotic membrane has diverse properties against bacterial and viral infections, stores antibiotics, and releases them over the course of a few days, and recently has been shown to produce potent natural antimicrobials. Clinical studies suggest that the amniotic membrane as a biologic dressing has 2 primary favorable effects in addition to being an anatomical barrier as it facilitates epithelialization by acting as a basement membrane substrate, facilitates migration of epithelial cells, reinforces adhesion of the basal epithelium, promotes cellular differentiation, and prevents cellular apoptosis, and it inhibits inflammation and fibrosis. Amnion graft, either fresh or dried, is a promising adjunctive procedure for decreasing the recurrence of adhesions and encouraging endometrial regeneration. Both grafts seem to be equally effective; however, dried amnion graft holds some advantages easy availability, prevention of cross-infection, and easier surgical application. The use of non sterilized amniotic membrane is supposed to increase the risk of fungal, bacterial, or viral diseases transmission from donors. The amniotic membrane graft is a natural human protein, attracting collagen formation, fibrinogen, and causing mild fibrosis, without being rejected, it will adhere to, and integrate with the local pubo-cervical fascia providing a fibrotic sheath, necessary for supporting and augmentation of the weak local fascia, and will be completely absorbed by the body
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- compare between the usage of Gamma irradiated sterilized amniotic membrane as a graft versus conventional classical repair in terms of: Effectiveness, symptoms relief, healing, and infection rate.
| Arm | Type | Receives |
|---|---|---|
| amniotic membrane graft | Active comparator | Procedure: Vaginal Repairpatients in which the surgical vaginal repair will be done with the application of a sterilized (gamma irradiated) amniotic membrane. |
| surgical vaginal repair | Active comparator | Procedure: Vaginal Repairpatients in which the surgical vaginal repair will be done without any graft. |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 1 - Parity: from Para 1 to Para 5. 2-BMI: from 25 to 35 KG/M².
Key exclusion criteria (2 listed)
- Chronic debilitating diseases.
- Conditions that lead to increase intra-abdominal pressure
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 |
|---|---|---|
| Vaginal RepairVaginal Repair will be done either by application of sterilized (gamma irradiated) amniotic membrane or by Classical repair | Procedure or surgery | amniotic membrane graft, surgical vaginal repair |
Primary outcome
Awareness of prolapse and repair
Time frame: From baseline to 3 months after the repair of vaginal prolapse operration
Significant improvement of dyspareunia postoperative in patients with surgical repair of vaginal wall prolapse using Gamma Irradiated Amniotic Membrane
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 Oct 2023.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vaginal Repair in people with Vaginal Wall Prolapse, run by Egymedicalpedia at 1 site in Egypt.
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 1 inclusion and 2 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 Oct 2023. 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 Egypt. 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.
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?
Awareness of prolapse and repair (time frame: From baseline to 3 months after the repair of vaginal prolapse operration). 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 19 Oct 2023.