Uterine ProlapseNCT06524700
Pectopexy Autologous Vs Mesh
A study testing pectopexy mesh and pectopexy autologous in people with Uterine Prolapse and Vault Prolapse, Vaginal, run by Ain Shams Maternity Hospital at 2 sites in 2 countries.
Trial summary
prospective comparative study describing using autologous graft for uterine- vault - cervical suspension vs mesh in treatment of apical prolapse Read more about this study
- Who is it for?
- Ages 20 to 60 years, women only
- Conditions the study is for
- Uterine Prolapse, Vault Prolapse, Vaginal
- What is being tested?
- pectopexy mesh and pectopexy autologous
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 1 Aug 2024to 1 Oct 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 60 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- uterine - vault prolapse
- -
Who cannot join
- previous vaginal repair for uterine or vaginal prolapse previous suspension procedures for apical prolapse
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
Saudi Arabia1 site
Armed forces Hospital Wadi Aldwaser
Riyadh, Wadi Aldwaser
About this study
prospective comparative study describing using autologous graft for uterine- vault - cervical suspension vs mesh in treatment of apical prolapse
- Conditions
- Uterine Prolapse, Vault Prolapse, Vaginal
- Being tested
- pectopexy mesh, pectopexy autologous
- Keywords
- vault, uterine, prolapse
- Medical subject headings
- Uterine Prolapse, Pelvic Organ Prolapse, Prolapse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pectopexy meshProcedure or surgery
pectopexy with mesh
pectopexy autologousProcedure or surgery
pectopexy using autologous graft
| Study group | Role | What they receive |
|---|---|---|
| A | Active comparator | Not described Receives: Procedure: pectopexy mesh |
| B | Active comparator | Not described Receives: Procedure: pectopexy autologous |
What is being measured
The primary outcome is the main question the study is designed to answer.
POP-Q
assesment of degree of prolapse correction after surgery
Measured: 3 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2024
- Study start1 Aug 2024
- Primary completion1 Sep 2025 (estimated)
- Study completion1 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Uterine 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
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams Maternity Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Armed forces hospital wadi aldwaser
- Responsible party
- Principal investigator, Hamdy Ahmed Saaid, Ain Shams Maternity Hospital
- Investigators
- Hamdy Saaid, Study chair, UROGYNECOLOGY UNIT
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06524700
- Sponsor's protocol ID
- PAGVM
- Status last verified
- Nov 2024
- First submitted
- 24 Jul 2024
- Last updated
- 6 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pectopexy Autologous Vs Mesh
- ClinicalTrials.gov ID
- NCT06524700
- Acronym / sponsor ID
- PAGVM
- Conditions
- Uterine Prolapse, Vault Prolapse, Vaginal
- Keywords
- vault, uterine, prolapse
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Ain Shams Maternity HospitalUniversity, hospital or other
- Collaborators
- Armed forces hospital wadi aldwaser
- Study start
- 1 Aug 2024 (actual)
- Primary completion
- 1 Sep 2025 (estimated)
- Study completion
- 1 Oct 2025 (estimated)
- First posted
- 29 Jul 2024 (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.
prospective comparative study describing using autologous graft for uterine- vault - cervical suspension vs mesh in treatment of apical prolapse
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Active comparator | Procedure: pectopexy mesh |
| B | Active comparator | Procedure: pectopexy autologous |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- uterine - vault prolapse
- -
Key exclusion criteria (1 listed)
- previous vaginal repair for uterine or vaginal prolapse previous suspension procedures for apical prolapse
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 |
|---|---|---|
| pectopexy meshpectopexy with mesh | Procedure or surgery | A |
| pectopexy autologouspectopexy using autologous graft | Procedure or surgery | B |
Primary outcome
POP-Q
Time frame: 3 month
assesment of degree of prolapse correction after surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2024.
Related trials for Uterine Prolapse
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Patient-Centered Outcomes in the Surgical Treatment of Uterovaginal Prolapse
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Apical Suspension Repair for Vault Prolapse In a Three-Arm Randomized Trial Design
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Deep Neuromuscular Blockade and a Low-Residue Diet for the Surgical Field in vNOTES Hysterectomy
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Safety and Performance of a Pelvic Floor Mesh Implant (LatGYNious)
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Combined Effects of Pelvic Floor Retraining and Hypopressive Exercises in Uterine Prolapse Outcomes
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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.
Hamdy Saaid study chair
UROGYNECOLOGY UNIT
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing pectopexy mesh and pectopexy autologous in people with Uterine Prolapse and Vault Prolapse, Vaginal, run by Ain Shams Maternity Hospital at 2 sites in 2 countries.
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 2 inclusion and 1 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: under way, not looking for participants, as of the sponsor's last update on 6 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Egypt, Saudi Arabia. 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?
This study is still under way. Results are not available in the source record yet.
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?
POP-Q (time frame: 3 month). 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 6 Nov 2024.