Uterovaginal and Vaginal Vault ProlapseNCT03487328
A New Technique for Sacrospinous-Sacrotuberous Fixation for the Treatment of Uterovaginal and Vaginal Vault Prolapse
A study testing Sacrospinous-Sacrotuberous fixation in people with Uterovaginal and Vaginal Vault Prolapse, run by Ain Shams University at 1 site in Egypt.
Trial summary
This prospective interventional randomized controlled trial is conducted to compare a new technique for Sacrospinous-Sacrotuberous fixation with the traditional sacrospinous ligament fixation technique for treatment of uterovaginal and vaginal vault prolapse. Read more about this study
- Who is it for?
- Ages 40 to 60 years, women only
- Conditions the study is for
- Uterovaginal and Vaginal Vault Prolapse
- What is being tested?
- Sacrospinous-Sacrotuberous fixation
- 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
- 21 Mar 2018to 1 May 2020
- 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 40 to 60 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Age from 40 to 60 years.
- POP Q stage III \& IV
- Uterovaginal prolapse.
- Vaginal vault prolapse.
- BMI >35.
Who cannot join
- Age > 40 years or < 60 years.
- POP Q stage I or II.
- BMI < 35.
- Previous repair of uterovaginal or vaginal vault prolapse.
- Comorbidity with Stress Urinary Incontinence.
- Presence of persistent risk factor increasing intra-abdominal pressure e.g. chronic chest conditions.
- Any significant comorbidity or psychiatric disorder that would compromise patient's consent.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A New Technique for Sacrospinous-Sacrotuberous Fixation for the Treatment of Uterovaginal and Vaginal Vault Prolapse: A Randomized Controlled Trial
This prospective interventional randomized controlled trial is conducted to compare a new technique for Sacrospinous-Sacrotuberous fixation with the traditional sacrospinous ligament fixation technique for treatment of uterovaginal and vaginal vault prolapse.
- Conditions
- Uterovaginal and Vaginal Vault Prolapse
- Being tested
- Sacrospinous-Sacrotuberous fixation
- Keywords
- treatment
- 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.
Sacrospinous-Sacrotuberous fixationProcedure or surgery
Sacrospinous-Sacrotuberous fixation
| Study group | Role | What they receive |
|---|---|---|
| Modified technique for Sacrospinous-Sacrotuberous Fixation | Active comparator | Modified technique for Sacrospinous-Sacrotuberous Fixation Receives: Procedure: Sacrospinous-Sacrotuberous fixation |
| Conventional technique for Sacrospinous-Sacrotuberous Fixation | Active comparator | Modified technique for Sacrospinous-Sacrotuberous Fixation Receives: Procedure: Sacrospinous-Sacrotuberous fixation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with recurrence of uterovaginal and vaginal vault prolapse
Measured: 1 year
Secondary outcomes (3)
blood loss
Measured: intraoperative
Injury to surrounding structures
Number of participants that experience injury of important surrounding structure intraoperative
Measured: intraoperative
operative time
Measured: intraoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2018
- Study start21 Mar 2018
- Primary completion1 May 2020
- Study completion1 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Uterovaginal and Vaginal Vault 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
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed S Sweed, MD, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03487328
- Sponsor's protocol ID
- AS1729
- Status last verified
- Jul 2020
- First submitted
- 21 Mar 2018
- Last updated
- 8 Jul 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A New Technique for Sacrospinous-Sacrotuberous Fixation for the Treatment of Uterovaginal and Vaginal Vault Prolapse: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03487328
- Acronym / sponsor ID
- AS1729
- Conditions
- Uterovaginal and Vaginal Vault Prolapse
- Keywords
- treatment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 21 Mar 2018 (actual)
- Primary completion
- 1 May 2020 (actual)
- Study completion
- 1 May 2020 (actual)
- First posted
- 4 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.
This prospective interventional randomized controlled trial is conducted to compare a new technique for Sacrospinous-Sacrotuberous fixation with the traditional sacrospinous ligament fixation technique for treatment of uterovaginal and vaginal vault prolapse.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Modified technique for Sacrospinous-Sacrotuberous Fixation | Active comparator | Procedure: Sacrospinous-Sacrotuberous fixationModified technique for Sacrospinous-Sacrotuberous Fixation |
| Conventional technique for Sacrospinous-Sacrotuberous Fixation | Active comparator | Procedure: Sacrospinous-Sacrotuberous fixationModified technique for Sacrospinous-Sacrotuberous Fixation |
Who may qualify
- Ages
- 40 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Age from 40 to 60 years.
- POP Q stage III \& IV
- Uterovaginal prolapse.
- Vaginal vault prolapse.
- BMI >35.
Key exclusion criteria (7 listed)
- Age > 40 years or < 60 years.
- POP Q stage I or II.
- BMI < 35.
- Previous repair of uterovaginal or vaginal vault prolapse.
- Comorbidity with Stress Urinary Incontinence.
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 |
|---|---|---|
| Sacrospinous-Sacrotuberous fixationSacrospinous-Sacrotuberous fixation | Procedure or surgery | Conventional technique for Sacrospinous-Sacrotuberous Fixation, Modified technique for Sacrospinous-Sacrotuberous Fixation |
Primary outcome
Number of participants with recurrence of uterovaginal and vaginal vault prolapse
Time frame: 1 year
3 secondary outcomes
blood loss
Time frame: intraoperative
Injury to surrounding structures
Time frame: intraoperative
operative time
Time frame: intraoperative
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 Jul 2020.
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 Sacrospinous-Sacrotuberous fixation in people with Uterovaginal and Vaginal Vault Prolapse, run by Ain Shams University 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 5 inclusion and 7 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 Jul 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 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?
Number of participants with recurrence of uterovaginal and vaginal vault prolapse (time frame: 1 year). 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 Jul 2020.