Genital ProlapseNCT05691543
Modified Technique in Sacrospinous Fixation for Treatment of Apical Genital Prolapse
An observational study of Genital Prolapse, run by Assiut University.
Trial summary
Pelvic organ prolapse is one of the most common benign gynecological disorders and affects approximately 40% of women over 50 years of age. The causes of utero vaginal prolapse are pregnancy, labor, obesity, increased intra-abdominal pressure, and weak pelvic floor structures Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Genital Prolapse
- What is being tested?
- sacrospinous fixation Using Posterior Vaginal wall flap
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 15 participants
- Where
- No sites listed yet
- Study dates
- Feb 2023to Dec 2025
- Phase
- Observational
- 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Study population: patients with symptomatic Stage II , III and Stage IV Apical Prolapse (diagnosed by pop Q test)
Who may be able to join
- 1- Symptomatic Stage II , III and Stage IV Apical Prolapse (diagnosed by pop Q test ) .
Who cannot join
- Patients with medical disorders that may interfere with surgical interventions ( Like severe chest and heart diseases , renal and liver cell failure , bleeding tendency ) .
- Patients with urinary incontinence ( excluded by history , examination \& Urodynamics)
Trial locations and contacts
No sites are listed yet.
About this study
Official title: A Modified Technique in Sacrospinous Fixation Using Posterior Vaginal Wall Flap for Treatment of Apical Genital Prolapse
Pelvic organ prolapse is one of the most common benign gynecological disorders and affects approximately 40% of women over 50 years of age. The causes of utero vaginal prolapse are pregnancy, labor, obesity, increased intra-abdominal pressure, and weak pelvic floor structures
- Conditions
- Genital Prolapse
- Being tested
- sacrospinous fixation Using Posterior Vaginal wall flap
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sacrospinous fixation Using Posterior Vaginal wall flapProcedure or surgery
- Identification of the sacro spinous ligament.
- Insertion of the sacrospinous stitch. Using a long - handled needle holder, a J - shaped Ethibond suture is placed 2 - 3 cm medial to the right ischial spine. Using posterior vaginal wall flap (rectangular flap )will be incised and retracted Superior to the right , the stitch of sacro spinous ligament will be attached to the flap not the vault after adjusting its size , then the sit . The stitch should be placed through and not around the ligament. The application of firm traction to the suture length will test the correctness of its placement. A second suture is inserted for additional support. We may do it directly or by using an alternative surgical instruments for placement of the suture include the knee scorpion. Per rectum examination should be undertaken to check for misplaced sutures.
- Attachment of the sutures to the vaginal flap . The two sutures are then secured to the upper posterior aspect of the vaginal flap ,
| Study group | Role | What they receive |
|---|---|---|
| study group | patients with symptomatic Stage II , III and Stage IV Apical Prolapse (diagnosed by pop Q test) Receives: Procedure: sacrospinous fixation Using Posterior Vaginal wall flap |
What is being measured
The primary outcome is the main question the study is designed to answer.
The difference of quality life score
this will be assessed before and after the surgery using
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2023
- Study startFeb 2023 (estimated)
- Primary completionFeb 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Genital ProlapseStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Mohamed Abbas, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05691543
- Sponsor's protocol ID
- SSF
- Status last verified
- Jan 2023
- First submitted
- 14 Dec 2022
- Last updated
- 20 Jan 2023
- 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 20 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Modified Technique in Sacrospinous Fixation Using Posterior Vaginal Wall Flap for Treatment of Apical Genital Prolapse
- ClinicalTrials.gov ID
- NCT05691543
- Acronym / sponsor ID
- SSF
- Conditions
- Genital Prolapse
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Feb 2023 (estimated)
- Primary completion
- Feb 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 20 Jan 2023 (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.
Pelvic organ prolapse is one of the most common benign gynecological disorders and affects approximately 40% of women over 50 years of age. The causes of utero vaginal prolapse are pregnancy, labor, obesity, increased intra-abdominal pressure, and weak pelvic floor structures
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| study group | – | Procedure: sacrospinous fixation Using Posterior Vaginal wall flappatients with symptomatic Stage II , III and Stage IV Apical Prolapse (diagnosed by pop Q test) |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- patients with symptomatic Stage II , III and Stage IV Apical Prolapse (diagnosed by pop Q test)
Key inclusion criteria (1 listed)
- 1- Symptomatic Stage II , III and Stage IV Apical Prolapse (diagnosed by pop Q test ) .
Key exclusion criteria (2 listed)
- Patients with medical disorders that may interfere with surgical interventions ( Like severe chest and heart diseases , renal and liver cell failure , bleeding tendency ) .
- Patients with urinary incontinence ( excluded by history , examination \& Urodynamics)
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 fixation Using Posterior Vaginal wall flap* Identification of the sacro spinous ligament. * Insertion of the sacrospinous stitch. Using a long - handled needle holder, a J - shaped Ethibond suture is placed 2 - 3 cm medial to the right ischial spine. Using posterior vaginal wall flap (rectangular flap )will be incised and retracted Superior to the right , the stitch of sacro spinous ligament will be attached to the flap not the vault after adjusting its size , then the sit . The stitch should be placed through and not around the ligament. The application of firm traction to the suture length will test the correctness of its placement. A second suture is inserted for additional support. We may do it directly or by using an alternative surgical instruments for placement of the suture include the knee scorpion. Per rectum examination should be undertaken to check for misplaced sutures. * Attachment of the sutures to the vaginal flap . The two sutures are then secured to the upper posterior aspect of the vaginal flap , | Procedure or surgery | study group |
Primary outcome
The difference of quality life score
Time frame: 6 months
this will be assessed before and after the surgery using
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2023.
- Individual participant dataSharing planned: No
Related trials for Genital Prolapse
Active, not recruitingObservational study
i-Stitch for Bilateral Sacrospinous Ligament Fixation (SSLF)
Pelvic Organ Prolapse, Genital Prolapse
Recruiting
Pelvic Floor Muscle Training During Pregnancy
Urinary Incontinence, Anal Incontinence
Not yet recruiting
Perineal Protection Device for Reducing Perineal Trauma During Vaginal Delivery in First-time Mothers: a Multicenter Randomized Controlled Trial
Pelvic Floor Dysfunction, Perineal Laceration
Active, not recruiting
Patient-Centered Outcomes in the Surgical Treatment of Uterovaginal Prolapse
Uterine Prolapse
Recruiting
Functional Links Between the Temporomandibular Joint and the Pelvis in Gynecology
Prolapse; Female, Endometriosis-related Pain
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.
Questions about this trial
What is this clinical trial studying?
An observational study of Genital Prolapse, run by Assiut University.
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: status not confirmed, as of the sponsor's last update on 20 Jan 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Gehad Zaky, MSc (00201018561298, gehadzaky@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The difference of quality life score (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 20 Jan 2023.