Pelvic Floor DisordersNCT06815731
Multicenter Study on the Correction of Prolapse Via Laparoscopy
A study testing lateral laparoscopic suspension (LLS) and Sacropexy without posterior mesh fixation on the puborrectalis muscle in people with Pelvic Floor Disorders, run by Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia at 1 site in Spain.
Trial summary
In the laparoscopic lateral suspension (LLS) technique, the fixation of the mesh as a prosthetic element for correcting anterior apical vaginal prolapse at the level of the dome or uterus can offer anatomical and functional results that are not inferior to those of the conventional surgical technique, minimize… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Pelvic Floor Disorders
- What is being tested?
- lateral laparoscopic suspension (LLS) and Sacropexy without posterior mesh fixation on the puborrectalis muscle
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 181 participants
- Where
- 1 siteSpain
- Study dates
- 1 Oct 2023to 30 May 2026
- 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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with Stage II- IV primary or recurrent prolapse affecting the anterior or middle vaginal compartment with or without minimal posterior defect (Stage I) according to the POP-Q.
Who cannot join
- History of abdominal prolapse reconstructive surgery.
- History of prolapse reconstructive surgery with vaginal meshes.
- Stage I according to the POP-Q classification or asymptomatic prolapse.
- Medical contraindication for general anaesthesia.
- Patient preference for vaginal surgical treatment.
- Patient does not wish to participate in the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site, 1 recruiting
- Recruiting
HCUVA
Murcia, 30120
Maria Luisa Sanchez Ferrer, MD, marisasanchezferrer1@gmail.com
About this study
In the laparoscopic lateral suspension (LLS) technique, the fixation of the mesh as a prosthetic element for correcting anterior apical vaginal prolapse at the level of the dome or uterus can offer anatomical and functional results that are not inferior to those of the conventional surgical technique, minimize possible intraoperative complications and facilitate the specific learning curve of sacropexy.
Read the detailed description
In the laparoscopic lateral suspension (LLS) technique, the fixation of the mesh as a prosthetic element for correcting anterior apical vaginal prolapse at the level of the dome or uterus can offer anatomical and functional results that are not inferior to those of the conventional surgical technique, minimize possible intraoperative complications and facilitate the specific learning curve of sacropexy.
- Conditions
- Pelvic Floor Disorders
- Being tested
- lateral laparoscopic suspension (LLS), Sacropexy without posterior mesh fixation on the puborrectalis muscle
- Medical subject headings
- Pelvic Floor Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lateral laparoscopic suspension (LLS)Procedure or surgery
lateral laparoscopic suspension (LLS)
Sacropexy without posterior mesh fixation on the puborrectalis muscleProcedure or surgery
Sacropexy without posterior mesh fixation on the puborrectalis muscle
| Study group | Role | What they receive |
|---|---|---|
| lateral laparoscopic suspension (LLS) | Experimental | Not described Receives: Procedure: lateral laparoscopic suspension (LLS) |
| Sacropexy without posterior mesh fixation on the puborrectalis muscle | Active comparator | Not described Receives: Procedure: Sacropexy without posterior mesh fixation on the puborrectalis muscle |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pelvic Organ Prolapse Distress Inventory
Pelvic Organ Prolapse Distress Inventory (POPDI-6) Scores range between 0 and 24 for the POPDI-6
Measured: up to 12 months
Colorectal-Anal Distress Inventory
Colorectal-Anal Distress Inventory (CRADI-8) Scores between 0 and 32 for the CRADI-8
Measured: up to 12 months
Urinary Distress Inventory
Urinary Distress Inventory (UDI-6) Scores between 0 and 24 for the UDI-6.
Measured: up to 12 months
Number of patients with symptomatic failure
Number of patients with symptomatic failure , defined as a positive response (accompanied by any degree of discomfort) to the following question on the validated questionnaire regarding prolapse symptoms (PFDI-20): "Do you usually have a bulge or something falling out that you can see or feel in your vaginal area?"
Measured: up to 12 months
Secondary outcomes (2)
Intestinal and pain symptoms
Subjective or functional success is defined as an improvement of ≥15 points per domain (the minimally important difference) or a decrease in the total score of 45 points (the minimally important difference). The PISQ-2 questionnaire has a score range between 0 and 48, and a difference ≥ 6 points is considered a minimally important difference.
Measured: up to 12 months
Anatomical result
Anatomical results are defined as any POP-Q measurement below the hymen.
Anatomical variables of prolapse: POPQ classification :
- Anterior compartment: Aa, Ba
- Middle compartment: C or D
- Posterior compartment: Ap, Bp
Measured: up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2025
- Study start1 Oct 2023
- Primary completion30 Apr 2025 (estimated)
- Study completion30 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pelvic Floor DisordersStudies 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
- 181 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06815731
- Sponsor's protocol ID
- 2022-3-8-HCUVA
- Status last verified
- Feb 2025
- First submitted
- 30 Jan 2025
- Last updated
- 7 Feb 2025
- 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 7 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter Study on the Correction of Prolapse Via Laparoscopy
- ClinicalTrials.gov ID
- NCT06815731
- Acronym / sponsor ID
- 2022-3-8-HCUVA
- Conditions
- Pelvic Floor Disorders
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 181 participants (estimated)
- Lead sponsor
- Fundacion para la Formacion e Investigacion Sanitarias de la Region de MurciaUniversity, hospital or other
- Study start
- 1 Oct 2023 (actual)
- Primary completion
- 30 Apr 2025 (estimated)
- Study completion
- 30 May 2026 (estimated)
- First posted
- 7 Feb 2025 (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.
In the laparoscopic lateral suspension (LLS) technique, the fixation of the mesh as a prosthetic element for correcting anterior apical vaginal prolapse at the level of the dome or uterus can offer anatomical and functional results that are not inferior to those of the conventional surgical technique, minimize possible intraoperative complications and facilitate the specific learning curve of sacropexy.
Detailed description
In the laparoscopic lateral suspension (LLS) technique, the fixation of the mesh as a prosthetic element for correcting anterior apical vaginal prolapse at the level of the dome or uterus can offer anatomical and functional results that are not inferior to those of the conventional surgical technique, minimize possible intraoperative complications and facilitate the specific learning curve of sacropexy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| lateral laparoscopic suspension (LLS) | Experimental | Procedure: lateral laparoscopic suspension (LLS) |
| Sacropexy without posterior mesh fixation on the puborrectalis muscle | Active comparator | Procedure: Sacropexy without posterior mesh fixation on the puborrectalis muscle |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with Stage II- IV primary or recurrent prolapse affecting the anterior or middle vaginal compartment with or without minimal posterior defect (Stage I) according to the POP-Q.
Key exclusion criteria (6 listed)
- History of abdominal prolapse reconstructive surgery.
- History of prolapse reconstructive surgery with vaginal meshes.
- Stage I according to the POP-Q classification or asymptomatic prolapse.
- Medical contraindication for general anaesthesia.
- Patient preference for vaginal surgical treatment.
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 |
|---|---|---|
| lateral laparoscopic suspension (LLS)lateral laparoscopic suspension (LLS) | Procedure or surgery | lateral laparoscopic suspension (LLS) |
| Sacropexy without posterior mesh fixation on the puborrectalis muscleSacropexy without posterior mesh fixation on the puborrectalis muscle | Procedure or surgery | Sacropexy without posterior mesh fixation on the puborrectalis muscle |
Primary outcome
Pelvic Organ Prolapse Distress Inventory
Time frame: up to 12 months
Pelvic Organ Prolapse Distress Inventory (POPDI-6) Scores range between 0 and 24 for the POPDI-6
Colorectal-Anal Distress Inventory
Time frame: up to 12 months
Colorectal-Anal Distress Inventory (CRADI-8) Scores between 0 and 32 for the CRADI-8
Urinary Distress Inventory
Time frame: up to 12 months
Urinary Distress Inventory (UDI-6) Scores between 0 and 24 for the UDI-6.
Number of patients with symptomatic failure
Time frame: up to 12 months
Number of patients with symptomatic failure , defined as a positive response (accompanied by any degree of discomfort) to the following question on the validated questionnaire regarding prolapse symptoms (PFDI-20): "Do you usually have a bulge or something falling out that you can see or feel in your vaginal area?"
2 secondary outcomes
Intestinal and pain symptoms
Time frame: up to 12 months
Anatomical result
Time frame: up to 12 months
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 7 Feb 2025.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing lateral laparoscopic suspension (LLS) and Sacropexy without posterior mesh fixation on the puborrectalis muscle in people with Pelvic Floor Disorders, run by Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia at 1 site in Spain.
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 6 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: looking for participants now, as of the sponsor's last update on 7 Feb 2025. 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 Spain. 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?
Contact María Luisa Sánchez Ferrer, MD (968369500, marisasanchezferrer1@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pelvic Organ Prolapse Distress Inventory (time frame: up to 12 months). The study lists 4 primary outcomes in all. 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 7 Feb 2025.