An interventional study of lateral laparoscopic suspension (LLS) and Sacropexy without posterior mesh fixation on the puborrectalis muscle in Pelvic Floor Disorders, sponsored by Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia. Recruiting at 1 site in Spain. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-02-07.
Sponsored by Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia · Not applicable, Interventional, and Treatment
Among 29 studies in Pelvic Floor Disorders with a site in Spain — 9 open to participants now, 10 under way, none of them phase 3. Pelvic Floor Disorders · Spain.
Among the 29 studies in Pelvic Floor Disorders with a site in Spain, this one is the 3rd largest by planned enrollment of the 26 interventional ones, is one of 5 that started in 2023, is one of 25 with no phase, and was the 25th registered.
212 studies on the registry are indexed under Pelvic Floor Disorders; 46 are open to participants now.
This study's planned enrollment of 181 is above the median of 63 across 148 interventional studies indexed under Pelvic Floor Disorders.
Browse Pelvic Floor Disorders studies →9 of the 29 studies in Pelvic Floor Disorders with a site in Spain are open now, in 1 country. Each count lists the studies.
Of the 27 Pelvic Floor Disorders studies recruiting now, 17 (63%) set no upper age limit and 10 (37%) stop at 75 or younger; 0 take children under 18; 9 take healthy volunteers.
This study: 18 Years and older · female · no healthy volunteers.
The full table on the hub →29 studies; the count open now beside each. This study's row is marked.
First in 2013; this study’s year is marked. 5 started in 2023.
Median enrollment 68 across the 26 interventional studies, 105 across the 3 observational. Of the 16 that completed or were terminated, 0 (0%) have results posted.
None of the 29 has an industry lead sponsor. The 10 most frequent:
Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia is the lead sponsor of 43 studies on the registry; 10 are open to participants now.
Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia has 1 study filed under Pelvic Floor Disorders — fewer than ten, so there is no comparison to draw.
3 of the studies in Pelvic Floor Disorders with a site in Spain that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07757633Universidad de GranadaPelvic Floor Muscle Training and Neuromuscular Performance in Women's Rugby | 2026-12 |
| NCT06359249Fundacio d'Investigacio en Atencio Primaria Jordi Gol i GurinaDo the Symptoms of Chronic Constipation Improve With a Primary Care Programme Based on Behavioural Re-education and Abdominal Massage? | 2026-12-28 |
| NCT07906431SERGIO MONTERO NAVARRORadiofrequency and Pelvic Floor-Core Exercise for Chronic Low Back Pain in Women With Pelvic Floor Dysfunction | 2027-03-31 |
Among the 29 studies in Pelvic Floor Disorders with a site in Spain, from their registry updates:
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.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Procedure: lateral laparoscopic suspension (LLS)
Procedure: Sacropexy without posterior mesh fixation on the puborrectalis muscle
lateral laparoscopic suspension (LLS)
Sacropexy without posterior mesh fixation on the puborrectalis muscle
Pelvic Organ Prolapse Distress Inventory
Pelvic Organ Prolapse Distress Inventory (POPDI-6) Scores range between 0 and 24 for the POPDI-6
Time frame: up to 12 months
Colorectal-Anal Distress Inventory
Colorectal-Anal Distress Inventory (CRADI-8) Scores between 0 and 32 for the CRADI-8
Time frame: up to 12 months
Urinary Distress Inventory
Urinary Distress Inventory (UDI-6) Scores between 0 and 24 for the UDI-6.
Time frame: 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?"
Time frame: up to 12 months
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.
Time frame: 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
Time frame: up to 12 months
Plan to share: No
No publications or documents are linked to this record.
Started Oct 2023 (actual). Primary completion is estimated for Apr 2025, 18 months after the start.
Of 101 non-industry interventional studies with no phase under Pelvic Floor Disorders, half reached primary completion within 16 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 31. This study's planned 18 months is above that.
Counting every sponsor, half of 107 studies reached it within 16 months; a quarter within 7 and three quarters within 31.
How these figures are worked out, and which studies are left out of them.
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Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia