CystoceleNCT03489902
Transvaginal Versus Transobturator Paravaginal Repair
A study testing Transobturator Paravaginal Repair and traditional transvaginal Paravaginal Repair in people with Cystocele, run by Ain Shams Maternity Hospital.
Trial summary
Clinical trial comparing the new technique for paravaginal repair versus the traditional technique Read more about this study
- Who is it for?
- Ages 20 to 50 years, women only
- Conditions the study is for
- Cystocele
- What is being tested?
- Transobturator Paravaginal Repair and traditional transvaginal Paravaginal Repair
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2017to 1 Mar 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
- No healthy volunteers
- Adult
Who may be able to join
- paravaginal defect cystocele
- midline and paravaginal defect cystocele
Who cannot join
- uterine descent previous cystocele surgery
About this study
Official title: Transvaginal Versus Transobturator Paravaginal Repair Trial
Clinical trial comparing the new technique for paravaginal repair versus the traditional technique
Read the detailed description
trial comparing the transobturator paravaginal repair versus the traditional technique
- Conditions
- Cystocele
- Being tested
- Transobturator Paravaginal Repair, traditional transvaginal 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 Paravaginal RepairProcedure or surgery
Transobturator application of sutures to the white line in cases needing paravaginal repair
traditional transvaginal Paravaginal RepairProcedure or surgery
traditional transvaginal application of sutures to the white line
| Study group | Role | What they receive |
|---|---|---|
| Transobturator arm | Experimental | Transobturator Paravaginal Repair Receives: Procedure: Transobturator Paravaginal Repair |
| Transvaginal arm | Experimental | traditional transvaginal Paravaginal Repair Receives: Procedure: traditional transvaginal Paravaginal Repair |
What is being measured
The primary outcome is the main question the study is designed to answer.
Operative data
Operative time
Measured: 1 day
Secondary outcomes (2)
Pelvic organ prolapse quantification system
Evaluation of the postoperative degree of anterior vaginal wall descent
Measured: 3 month
Operative Details
blood loss
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2018
- Study start1 Jan 2017
- Primary completion31 Dec 2017
- Study completion1 Mar 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 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
- Hamdy HA Saaid, MD, Principal investigator, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03489902
- Sponsor's protocol ID
- TVTOPVR
- Status last verified
- Apr 2018
- First submitted
- 28 Mar 2018
- Last updated
- 9 Apr 2018
- Results posted
- No
- Data monitoring committee
- Yes
- 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 9 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transvaginal Versus Transobturator Paravaginal Repair Trial
- ClinicalTrials.gov ID
- NCT03489902
- Acronym / sponsor ID
- TVTOPVR
- Conditions
- Cystocele
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Ain Shams Maternity HospitalUniversity, hospital or other
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 31 Dec 2017 (actual)
- Study completion
- 1 Mar 2018 (actual)
- First posted
- 6 Apr 2018 (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.
Clinical trial comparing the new technique for paravaginal repair versus the traditional technique
Detailed description
trial comparing the transobturator paravaginal repair versus the traditional technique
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Transobturator arm | Experimental | Procedure: Transobturator Paravaginal RepairTransobturator Paravaginal Repair |
| Transvaginal arm | Experimental | Procedure: traditional transvaginal Paravaginal Repairtraditional transvaginal Paravaginal Repair |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- paravaginal defect cystocele
- midline and paravaginal defect cystocele
Key exclusion criteria (1 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 Paravaginal RepairTransobturator application of sutures to the white line in cases needing paravaginal repair | Procedure or surgery | Transobturator arm |
| traditional transvaginal Paravaginal Repairtraditional transvaginal application of sutures to the white line | Procedure or surgery | Transvaginal arm |
Primary outcome
Operative data
Time frame: 1 day
Operative time
2 secondary outcomes
Pelvic organ prolapse quantification system
Time frame: 3 month
Operative Details
Time frame: 1 day
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 9 Apr 2018.
- Individual participant dataSharing planned: No
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RecruitingObservational study
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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 HA Saaid, MD principal investigator
Ain Shams University
Questions about this trial
What is this clinical trial studying?
A study testing Transobturator Paravaginal Repair and traditional transvaginal Paravaginal Repair in people with Cystocele, run by Ain Shams Maternity Hospital.
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: finished, as of the sponsor's last update on 9 Apr 2018. 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.
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?
Operative data (time frame: 1 day). 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 9 Apr 2018.