CystoceleNCT02735772
Transobturator Approach for Paravaginal Repair
A study testing transobturator approach for paravaginal repair in people with Cystocele, run by Ain Shams Maternity Hospital at 1 site in Egypt.
Trial summary
A new technique for Applying sutures to the white line in paravaginal repair. Read more about this study
- Who is it for?
- Ages 20 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cystocele
- What is being tested?
- transobturator approach for paravaginal repair
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteEgypt
- Study dates
- 25 Apr 2017to 1 Dec 2018
- 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 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- paravaginal defect cystocele
- midline and paravaginal defect cystocele
Who cannot join
- uterine descent
- previous cystocele surgery
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Transobturator Approach for Paravaginal Repair a New Approach
A new technique for Applying sutures to the white line in paravaginal repair.
Read the detailed description
A new trial for transobturator repair of the paravaginal defect.
- Conditions
- Cystocele
- Being tested
- transobturator approach for paravaginal repair
- Medical subject headings
- Cystocele
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
transobturator approach for paravaginal repairProcedure or surgery
using TOT needle to apply suturs to white line
| Study group | Role | What they receive |
|---|---|---|
| cystocele | Other | Arm: Patients with paravaginal defect cystocele
Intervention: transobturator approach for paravaginal repair Receives: Procedure: transobturator approach for paravaginal repair |
What is being measured
The primary outcome is the main question the study is designed to answer.
success rate
Evaluation of the postoperative degree of anterior vaginal wall descent using pelvic organ prolapse quantitative system
Measured: 6 months
Secondary outcomes (4)
lateral vaginal fornices elevation
test is negative means success
Measured: 3 month
Operative time
Operative time
Measured: 1 day
Intraoperative blood loss
Blood loss during the operative procedure
Measured: 1 day
Complications rate
Intraoperative and postoperative complications
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2016 (estimated)
- Study start25 Apr 2017
- Primary completion1 Nov 2018
- Study completion1 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CystoceleStudies 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
- Not applicable
- Intervention model
- Single group
- Model description
- All Patients included in the study will undergo repair of paravaginal defect using tge new technique described in this study
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams Maternity Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hamdy Ahmed Saaid, Ain Shams Maternity Hospital
- Investigators
- Hazem SH Samoor, Professor, Study chair, Ain Shams Universty
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02735772
- Sponsor's protocol ID
- PVRNA
- Status last verified
- Oct 2019
- First submitted
- 31 Mar 2016
- Last updated
- 8 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transobturator Approach for Paravaginal Repair a New Approach
- ClinicalTrials.gov ID
- NCT02735772
- Acronym / sponsor ID
- PVRNA
- Conditions
- Cystocele
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Ain Shams Maternity HospitalUniversity, hospital or other
- Study start
- 25 Apr 2017 (actual)
- Primary completion
- 1 Nov 2018 (actual)
- Study completion
- 1 Dec 2018 (actual)
- First posted
- 13 Apr 2016 (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.
A new technique for Applying sutures to the white line in paravaginal repair.
Detailed description
A new trial for transobturator repair of the paravaginal defect.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All Patients included in the study will undergo repair of paravaginal defect using tge new technique described in this study
| Arm | Type | Receives |
|---|---|---|
| cystocele | Other | Procedure: transobturator approach for paravaginal repairArm: Patients with paravaginal defect cystocele Intervention: transobturator approach for paravaginal repair |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- paravaginal defect cystocele
- midline and paravaginal defect cystocele
Key exclusion criteria (2 listed)
- uterine descent
- previous cystocele surgery
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 |
|---|---|---|
| transobturator approach for paravaginal repairusing TOT needle to apply suturs to white line | Procedure or surgery | cystocele |
Primary outcome
success rate
Time frame: 6 months
Evaluation of the postoperative degree of anterior vaginal wall descent using pelvic organ prolapse quantitative system
4 secondary outcomes
lateral vaginal fornices elevation
Time frame: 3 month
Operative time
Time frame: 1 day
Intraoperative blood loss
Time frame: 1 day
Complications rate
Time frame: 1 week
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 8 Oct 2019.
- Individual participant dataSharing planned: No
Related trials for Cystocele
Active, not recruiting
Apical Suspension Repair for Vault Prolapse In a Three-Arm Randomized Trial Design
Visceral Prolapse
Recruiting
Poly-L-Lactic Acid for Vulvovaginal Tissue Regeneration
Pelvic Organ Prolapse (POP), Cystocele
RecruitingObservational study
Long Term Follow Up Of Transvaginal Cystocele Repair Using Four Armed Collagen Coated Polyester Mesh
Long Term Follow-Up, Transvaginal Cystocele Repair
Recruiting
Study Comparing Transobturator Cystocele vs. Anterior Vaginal RepairS
Pelvic Organ Prolapse, Cystocele
Recruiting
Biological OviTex Versus Synthetic Graft in Robotic Prolapse Surgery
Colorectal Disorders, Prolapse
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.
Hazem SH Samoor, Professor study chair
Ain Shams Universty
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing transobturator approach for paravaginal repair in people with Cystocele, run by Ain Shams Maternity Hospital 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 2 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 8 Oct 2019. 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?
success rate (time frame: 6 months). 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 8 Oct 2019.