Prolapse GenitalFIMEANCT07194343
Posterior Mesh Fixation at the Levator Ani Level in Apical Pelvic Organ Prolapse
A study testing Laparoscopic colposacropexy with levator ani muscle mesh fixation and Simplified modification of laparoscopic colposacropexy in people with Prolapse Genital and Prolapse Uterovaginal, run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau at 6 sites in Spain.
Trial summary
This is a prospective, randomized, multicenter, non-inferiority trial including women with stage II-IV apical pelvic organ prolapse (POP), classified according to the POP-Q system. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Prolapse Genital, Prolapse Uterovaginal, Prolapse; Female
- What is being tested?
- Laparoscopic colposacropexy with levator ani muscle mesh fixation and Simplified modification of laparoscopic colposacropexy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 190 participants
- Where
- 6 sitesSpain
- Study dates
- 6 Oct 2022to 31 Oct 2025
- 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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women with primary or recurrent apical prolapse (uterine or vaginal vault) stage II-IV according to the POP-Q classification.
- Women with symptomatic POP with indication of reconstructive POP surgery.
- Agreement to comply with all scheduled visits and assessments through 12 months post-surgery.
- Understand and accept the study procedures and sign the informed consent.
Who cannot join
- History of abdominal reconstructive surgery for pelvic organ prolapse.
- History of vaginal reconstructive surgery for prolapse using mesh.
- Stage I prolapse according to the POP-Q classification, or asymptomatic prolapse.
- Medical contraindication to general anesthesia.
- Patient preference for vaginal surgical treatment.
- Declines participation in the study.
- Patients with disabilities or unable to understand the terms of the study.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Spain6 sites
Hospital de la Santa Creu i Sant Pau
Barcelona, Barcelona
Hospital Universitari Dexeus
Barcelona, Barcelona
Hospital Universitari d'Igualada
Igualada, Barcelona
Hospital Clinico Universitario Virgen de la Arrixaca
Murcia
Hospital Universitario Infanta Sofia
San Sebastián de los Reyes, Madrid
Hospital General Universitario de Valencia
Valencia, Valencia
About this study
Official title: Multicenter Study on Levator Ani Muscle Fixation in Laparoscopic Colposacropexy (FIMEA Multicenter Study)
This is a prospective, randomized, multicenter, non-inferiority trial including women with stage II-IV apical pelvic organ prolapse (POP), classified according to the POP-Q system. Participants will be randomized into two groups:
Group A: laparoscopic colposacropexy with posterior mesh fixation to the levator ani muscle.
Read more
Group B: laparoscopic colposacropexy with posterior mesh fixation to the vaginal cuff/cervix, without dissection of the rectovaginal space.
The objective of the study is to determine whether a simplified colposacropexy technique is non-inferior to the standard procedure in terms of anatomical and functional outcomes.
The primary outcome is anatomical success, defined as a postoperative POP-Q stage 0-I. Secondary outcomes include functional status and sexual function, evaluated using the PFDI-20 and PISQ-12 questionnaires. Data on prolapse anatomy, related symptoms, and sexual function will be collected at baseline and during follow-up visits at 1, 6, and 12 months after surgery.
This study is supported by a national health research grant from the Instituto de Salud Carlos III (ISCIII), Ministry of Science and Innovation, Spain.
Read the detailed description
This study is a multicenter, randomized, controlled, evaluator-blinded, non-inferiority clinical trial. The null hypothesis is that colposacropexy with posterior mesh fixation to the vaginal vault (without rectovaginal dissection) is associated with an anatomical and/or functional failure rate that is equal to or more than 15% higher than colposacropexy with posterior mesh fixation to the levator ani muscle (deep rectovaginal dissection). A non-inferiority margin of 15% has been selected because smaller differences are not considered clinically relevant.
With this project, the investigators aim to evaluate the outcomes of a simplified colposacropexy technique that avoids dissection of the rectovaginal space and deep pelvic mesh fixation. Demonstrating non-inferiority would imply rejecting the null hypothesis.
The procedure is indicated for women with stage II-IV uterine or vault prolapse according to the POP-Q classification, with or without associated anterior and/or posterior vaginal wall defects. The decision to perform surgery will be made by the gynecologists, independent of trial participation, to ensure that study enrollment does not influence standard surgical indications. Exclusion criteria include previous abdominal or vaginal mesh prolapse reconstructive surgery or POP-Q stage I or asymptomatic prolapse.
Sample size calculations assume a 91% success rate for the standardized procedure (Lee 2014), a non-inferiority margin of 15%, a 95% confidence interval, and 80% statistical power. A total of 166 patients (83 per group) are required, accounting for a 10% dropout rate.
DESCRIPTION OF THE SURGICAL TECHNIQUE
The vesicovaginal dissection and exposure of the sacral promontory will be performed identically in both groups. A predesigned polypropylene mesh will be used, consisting of:
- an apical end for fixation to the sacral promontory,
- two lateral arms shaped like "butterfly wings" to cover and support the anterior and lateral vaginal walls,
- and two lower arms designed for fixation to the levator ani muscle.
Fixation of the mesh to the vagina, sacral promontory, and (when applicable) the levator ani muscle will be performed using nitinol helical mechanical sutures (Spire'it). At the vesicovaginal space, the mesh will be anchored at the anatomical depth corresponding to the vesical neck level in both groups.
The only difference between groups involves the posterior compartment dissection and mesh fixation:
- Group A (standard technique): the posterior arms of the mesh are anchored bilaterally to the levator ani muscle with mechanical sutures.
- Group B (simplified technique): the posterior arms are removed, and the mesh is anchored only to the vaginal vault or cervix with mechanical sutures, without rectovaginal dissection.
- Conditions
- Prolapse Genital, Prolapse Uterovaginal, Prolapse; Female
- Being tested
- Laparoscopic colposacropexy with levator ani muscle mesh fixation, Simplified modification of laparoscopic colposacropexy
- Keywords
- pelvic organ prolapse, apical prolapse, laparoscopic colposacropexy, mesh fixation, levator ani muscle, surgical outcomes, functional outcomes, anatomical outcomes, sexual function
- Medical subject headings
- Prolapse, Pelvic Organ Prolapse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laparoscopic colposacropexy with levator ani muscle mesh fixationProcedure or surgery
The standard technique includes dissection of the rectovaginal space and bilateral mesh fixation to the levator ani muscle at the deep limit of the pararectal fossae dissection.
Simplified modification of laparoscopic colposacropexyProcedure or surgery
Rectovaginal dissection is avoided, and the mesh is anchored to the posterior aspect of the cervix or vaginal vault rather than to the levator ani muscle, representing the specific modification from the standard technique.
| Study group | Role | What they receive |
|---|---|---|
| Group A: Standard laparoscopic colposacropexy | Active comparator | The procedure is based on the laparoscopic colposacropexy technique described by Wattiez in 2001 (Clermont-Ferrand group).
The standard technique includes dissection of the sacral promontory, the vesicovaginal space, and the rectovaginal space with bilateral pararectal fossae.
In the vesicovaginal space, the mesh is anchored deeply at the level of the vesical neck, and posteriorly, in the rectovaginal and pararectal spaces, at the level of the levator ani muscle. Receives: Procedure: Laparoscopic colposacropexy with levator ani muscle mesh fixation |
| Group B: Simplified laparoscopic colposacropexy | Experimental | The simplified technique includes dissection of the sacral promontory and the vesicovaginal space, but does not involve dissection of the rectovaginal space or the pararectal fossae. In this technique, the posterior mesh is anchored to the posterior aspect of the vaginal vault or cervix. Mesh fixation at the sacral promontory and in the vesicovaginal space is performed within the same anatomical boundaries as in the standard technique. Receives: Procedure: Simplified modification of laparoscopic colposacropexy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in anatomical success rate between simplified (Group B) and standard (Group A) laparoscopic colposacropexy.
Proportion of participants achieving anatomical success, defined as postoperative POP-Q stage 0-I. The primary analysis will test non-inferiority of the simplified technique (Group B) versus the standard technique (Group A). Non-inferiority will be concluded if the lower bound of the two-sided 95% confidence interval for (Success_B - Success_A) is greater than 15% (non-inferiority margin = 15%). POP-Q assessment will be performed using standardized technique by an evaluator blinded to surgical assignment.
Measured: 12 months after surgery
Secondary outcomes (2)
Difference in functional outcomes between simplified (Group B) and standard (Group A) laparoscopic colposacropexy.
Functional outcomes will be assessed by validated questionnaire: Pelvic Floor Distress Inventory-20 (PFDI-20). Scores will be compared between groups to evaluate whether the simplified technique results in inferior functional outcomes compared with the standard technique in women with stage II-IV apical prolapse.
PFDI-20 consists of 20 items divided into three subdomains:
- Pelvic Organ Prolapse Distress Inventory (POPDI-6): Score range: 0 to 24.
- Colorectal-Anal Distress Inventory (CRADI-8): Score range: 0 to 32.
- Urinary Distress Inventory (UDI-6): Score range: 0 to 24. Each item is scored from 0 (no distress) to 4 (quite a bit of distress). Subdomain scores are calculated by summing the responses within each section. The total PFDI-20 score is the sum of all three subdomains, with a possible global score ranging from 0 to 80. Higher scores indicate greater symptom severity and higher levels of distress caused by pelvic floor disorders.
Measured: 12 months after surgery
Difference in sexual outcomes between simplified (Group B) and standard (Group A) laparoscopic colposacropexy.
Sexual outcomes will be assessed by validated questionnaire: Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire-12 (PISQ-12). Scores will be compared between groups to evaluate whether the simplified technique results in inferior sexual outcomes compared with the standard technique in women with stage II-IV apical prolapse.
The PISQ-12 is a validated, condition-specific questionnaire used to assess sexual function in women with pelvic organ prolapse and urinary incontinence. It consists of 12 items covering three domains:
- Behavioral-Emotional Domain
- Physical Domain
- Partner-Related Domain Each item is scored on a scale from 0 to 4 and the total PISQ-12 score ranges from 0 to 48. A higher total score reflects better sexual function and quality of sexual life, while lower scores indicate greater sexual dysfunction related to pelvic floor disorders.
Measured: 12 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2025
- Study start6 Oct 2022
- Primary completion31 Oct 2025
- Study completion31 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Prolapse GenitalStudies of the same condition, open and under way.
- More trials run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant PauThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Group A: Laparoscopic colposacropexy with posterior mesh fixation to the levator ani muscle (standard technique). Group B: Laparoscopic colposacropexy with posterior mesh fixation to the vaginal cuff or cervix, without rectovaginal space dissection (simplified technique).
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 190 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Carlos III Health Institute, Ministry of Science and Innovation, Spain
- Responsible party
- Principal investigator, IRENE MORA HERVAS, Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07194343
- Sponsor's protocol ID
- PI21/00852
- Acronym
- FIMEA
- Status last verified
- Nov 2025
- First submitted
- 12 Sep 2025
- Last updated
- 10 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There are no current plans to share individual participant data (IPD). Data use is restricted to the investigators involved in this project, according to the informed consent provided by participants and ethical committee approval.
Publications
Kuroda K, Hamamoto K, Kawamura K, Masunaga A, Horiguchi A, Ito K. Device Selection Contributes to Operative Time Reduction in Laparoscopic Sacrocolpopexy. Gynecol Minim Invasive Ther. 2025 Mar 15;14(2):157-164. doi: 10.4103/gmit.gmit_155_23. eCollection 2025 Apr-Jun.
PubMed 40521574Schaub M, Lecointre L, Faller E, Boisrame T, Baldauf JJ, Wattiez A, Akladios CY. Laparoscopic Sacral Colpopexy: The "6-Points" Technique. J Minim Invasive Gynecol. 2017 Nov-Dec;24(7):1081-1082. doi: 10.1016/j.jmig.2017.04.003. Epub 2017 Apr 18.
PubMed 28435129Bataller E, Ros C, Angles S, Gallego M, Espuna-Pons M, Carmona F. Anatomical outcomes 1 year after pelvic organ prolapse surgery in patients with and without a uterus at a high risk of recurrence: a randomised controlled trial comparing laparoscopic sacrocolpopexy/cervicopexy and anterior vaginal mesh. Int Urogynecol J. 2019 Apr;30(4):545-555. doi: 10.1007/s00192-018-3702-7. Epub 2018 Jul 9.
PubMed 29987345Habib N, Centini G, Pizzoferrato AC, Bui C, Argay I, Bader G. Laparoscopic promontofixation: Where to stop the anterior dissection? Med Hypotheses. 2019 Mar;124:60-63. doi: 10.1016/j.mehy.2019.02.006. Epub 2019 Feb 2.
PubMed 30798918Cosma S, Petruzzelli P, Chiado Fiorio Tin M, Parisi S, Olearo E, Fassio F, Zizzo R, Danese S, Benedetto C. Simplified laparoscopic sacropexy avoiding deep vaginal dissection. Int J Gynaecol Obstet. 2018 Nov;143(2):239-245. doi: 10.1002/ijgo.12632. Epub 2018 Aug 24.
PubMed 30076597Moroni RM, Juliato CRT, Cosson M, Giraudet G, Brito LGO. Does sacrocolpopexy present heterogeneity in its surgical technique? A systematic review. Neurourol Urodyn. 2018 Nov;37(8):2335-2345. doi: 10.1002/nau.23764. Epub 2018 Jul 19.
PubMed 30024069Gluck O, Blaganje M, Veit-Rubin N, Phillips C, Deprest J, O'reilly B, But I, Moore R, Jeffery S, Haddad JM, Deval B. Laparoscopic sacrocolpopexy: A comprehensive literature review on current practice. Eur J Obstet Gynecol Reprod Biol. 2020 Feb;245:94-101. doi: 10.1016/j.ejogrb.2019.12.029. Epub 2019 Dec 26.
PubMed 31891897Costantini E, Brubaker L, Cervigni M, Matthews CA, O'Reilly BA, Rizk D, Giannitsas K, Maher CF. Sacrocolpopexy for pelvic organ prolapse: evidence-based review and recommendations. Eur J Obstet Gynecol Reprod Biol. 2016 Oct;205:60-5. doi: 10.1016/j.ejogrb.2016.07.503. Epub 2016 Aug 3.
PubMed 27566224Maher C, Yeung E, Haya N, Christmann-Schmid C, Mowat A, Chen Z, Baessler K. Surgery for women with apical vaginal prolapse. Cochrane Database Syst Rev. 2023 Jul 26;7(7):CD012376. doi: 10.1002/14651858.CD012376.pub2.
PubMed 37493538
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter Study on Levator Ani Muscle Fixation in Laparoscopic Colposacropexy (FIMEA Multicenter Study)
- ClinicalTrials.gov ID
- NCT07194343
- Acronym / sponsor ID
- FIMEA / PI21/00852
- Conditions
- Prolapse Genital, Prolapse Uterovaginal, Prolapse; Female
- Keywords
- pelvic organ prolapse, apical prolapse, laparoscopic colposacropexy, mesh fixation, levator ani muscle, surgical outcomes, functional outcomes, anatomical outcomes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 190 participants (actual)
- Lead sponsor
- Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant PauUniversity, hospital or other
- Collaborators
- Carlos III Health Institute, Ministry of Science and Innovation, Spain
- Study start
- 6 Oct 2022 (actual)
- Primary completion
- 31 Oct 2025 (actual)
- Study completion
- 31 Oct 2025 (actual)
- First posted
- 26 Sep 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.
This is a prospective, randomized, multicenter, non-inferiority trial including women with stage II-IV apical pelvic organ prolapse (POP), classified according to the POP-Q system. Participants will be randomized into two groups:
Group A: laparoscopic colposacropexy with posterior mesh fixation to the levator ani muscle.
Group B: laparoscopic colposacropexy with posterior mesh fixation to the vaginal cuff/cervix, without dissection of the rectovaginal space.
The objective of the study is to determine whether a simplified colposacropexy technique is non-inferior to the standard procedure in terms of anatomical and functional outcomes.
The primary outcome is anatomical success, defined as a postoperative POP-Q stage 0-I. Secondary outcomes include functional status and sexual function, evaluated using the PFDI-20 and PISQ-12 questionnaires. Data on prolapse anatomy, related symptoms, and sexual function will be collected at baseline and during follow-up visits at 1, 6, and 12 months after surgery.
This study is supported by a national health research grant from the Instituto de Salud Carlos III (ISCIII), Ministry of Science and Innovation, Spain.
Detailed description
This study is a multicenter, randomized, controlled, evaluator-blinded, non-inferiority clinical trial. The null hypothesis is that colposacropexy with posterior mesh fixation to the vaginal vault (without rectovaginal dissection) is associated with an anatomical and/or functional failure rate that is equal to or more than 15% higher than colposacropexy with posterior mesh fixation to the levator ani muscle (deep rectovaginal dissection). A non-inferiority margin of 15% has been selected because smaller differences are not considered clinically relevant.
With this project, the investigators aim to evaluate the outcomes of a simplified colposacropexy technique that avoids dissection of the rectovaginal space and deep pelvic mesh fixation. Demonstrating non-inferiority would imply rejecting the null hypothesis.
The procedure is indicated for women with stage II-IV uterine or vault prolapse according to the POP-Q classification, with or without associated anterior and/or posterior vaginal wall defects. The decision to perform surgery will be made by the gynecologists, independent of trial participation, to ensure that study enrollment does not influence standard surgical indications. Exclusion criteria include previous abdominal or vaginal mesh prolapse reconstructive surgery or POP-Q stage I or asymptomatic prolapse.
Sample size calculations assume a 91% success rate for the standardized procedure (Lee 2014), a non-inferiority margin of 15%, a 95% confidence interval, and 80% statistical power. A total of 166 patients (83 per group) are required, accounting for a 10% dropout rate.
DESCRIPTION OF THE SURGICAL TECHNIQUE
The vesicovaginal dissection and exposure of the sacral promontory will be performed identically in both groups. A predesigned polypropylene mesh will be used, consisting of:
- an apical end for fixation to the sacral promontory,
- two lateral arms shaped like "butterfly wings" to cover and support the anterior and lateral vaginal walls,
- and two lower arms designed for fixation to the levator ani muscle.
Fixation of the mesh to the vagina, sacral promontory, and (when applicable) the levator ani muscle will be performed using nitinol helical mechanical sutures (Spire'it). At the vesicovaginal space, the mesh will be anchored at the anatomical depth corresponding to the vesical neck level in both groups.
The only difference between groups involves the posterior compartment dissection and mesh fixation:
- Group A (standard technique): the posterior arms of the mesh are anchored bilaterally to the levator ani muscle with mechanical sutures.
- Group B (simplified technique): the posterior arms are removed, and the mesh is anchored only to the vaginal vault or cervix with mechanical sutures, without rectovaginal dissection.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Group A: Laparoscopic colposacropexy with posterior mesh fixation to the levator ani muscle (standard technique). Group B: Laparoscopic colposacropexy with posterior mesh fixation to the vaginal cuff or cervix, without rectovaginal space dissection (simplified technique).
| Arm | Type | Receives |
|---|---|---|
| Group A: Standard laparoscopic colposacropexy | Active comparator | Procedure: Laparoscopic colposacropexy with levator ani muscle mesh fixationThe procedure is based on the laparoscopic colposacropexy technique described by Wattiez in 2001 (Clermont-Ferrand group). The standard technique includes dissection of the sacral promontory, the vesicovaginal space, and the rectovaginal space with bilateral pararectal fossae. In the vesicovaginal space, the mesh is anchored deeply at the level of the vesical neck, and posteriorly, in the rectovaginal and pararectal spaces, at the level of the levator ani muscle. |
| Group B: Simplified laparoscopic colposacropexy | Experimental | Procedure: Simplified modification of laparoscopic colposacropexyThe simplified technique includes dissection of the sacral promontory and the vesicovaginal space, but does not involve dissection of the rectovaginal space or the pararectal fossae. In this technique, the posterior mesh is anchored to the posterior aspect of the vaginal vault or cervix. Mesh fixation at the sacral promontory and in the vesicovaginal space is performed within the same anatomical boundaries as in the standard technique. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Women with primary or recurrent apical prolapse (uterine or vaginal vault) stage II-IV according to the POP-Q classification.
- Women with symptomatic POP with indication of reconstructive POP surgery.
- Agreement to comply with all scheduled visits and assessments through 12 months post-surgery.
- Understand and accept the study procedures and sign the informed consent.
Key exclusion criteria (7 listed)
- History of abdominal reconstructive surgery for pelvic organ prolapse.
- History of vaginal reconstructive surgery for prolapse using mesh.
- Stage I prolapse according to the POP-Q classification, or asymptomatic prolapse.
- Medical contraindication to general anesthesia.
- 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 |
|---|---|---|
| Laparoscopic colposacropexy with levator ani muscle mesh fixationThe standard technique includes dissection of the rectovaginal space and bilateral mesh fixation to the levator ani muscle at the deep limit of the pararectal fossae dissection. | Procedure or surgery | Group A: Standard laparoscopic colposacropexy |
| Simplified modification of laparoscopic colposacropexyRectovaginal dissection is avoided, and the mesh is anchored to the posterior aspect of the cervix or vaginal vault rather than to the levator ani muscle, representing the specific modification from the standard technique. | Procedure or surgery | Group B: Simplified laparoscopic colposacropexy |
Primary outcome
Difference in anatomical success rate between simplified (Group B) and standard (Group A) laparoscopic colposacropexy.
Time frame: 12 months after surgery
Proportion of participants achieving anatomical success, defined as postoperative POP-Q stage 0-I. The primary analysis will test non-inferiority of the simplified technique (Group B) versus the standard technique (Group A). Non-inferiority will be concluded if the lower bound of the two-sided 95% confidence interval for (Success_B - Success_A) is greater than 15% (non-inferiority margin = 15%). POP-Q assessment will be performed using standardized technique by an evaluator blinded to surgical assignment.
2 secondary outcomes
Difference in functional outcomes between simplified (Group B) and standard (Group A) laparoscopic colposacropexy.
Time frame: 12 months after surgery
Difference in sexual outcomes between simplified (Group B) and standard (Group A) laparoscopic colposacropexy.
Time frame: 12 months after surgery
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 10 Feb 2026.
- Background: PubMed 40521574Kuroda K, Hamamoto K, Kawamura K, Masunaga A, Horiguchi A, Ito K. Device Selection Contributes to Operative Time Reduction in Laparoscopic Sacrocolpopexy. Gynecol Minim Invasive Ther. 2025 Mar 15;14(2):157-164. doi: 10.4103/gmit.gmit_155_23. eCollection 2025 Apr-Jun.
- Background: PubMed 28435129Schaub M, Lecointre L, Faller E, Boisrame T, Baldauf JJ, Wattiez A, Akladios CY. Laparoscopic Sacral Colpopexy: The "6-Points" Technique. J Minim Invasive Gynecol. 2017 Nov-Dec;24(7):1081-1082. doi: 10.1016/j.jmig.2017.04.003. Epub 2017 Apr 18.
- Background: PubMed 29987345Bataller E, Ros C, Angles S, Gallego M, Espuna-Pons M, Carmona F. Anatomical outcomes 1 year after pelvic organ prolapse surgery in patients with and without a uterus at a high risk of recurrence: a randomised controlled trial comparing laparoscopic sacrocolpopexy/cervicopexy and anterior vaginal mesh. Int Urogynecol J. 2019 Apr;30(4):545-555. doi: 10.1007/s00192-018-3702-7. Epub 2018 Jul 9.
- Background: PubMed 30798918Habib N, Centini G, Pizzoferrato AC, Bui C, Argay I, Bader G. Laparoscopic promontofixation: Where to stop the anterior dissection? Med Hypotheses. 2019 Mar;124:60-63. doi: 10.1016/j.mehy.2019.02.006. Epub 2019 Feb 2.
- Background: PubMed 30076597Cosma S, Petruzzelli P, Chiado Fiorio Tin M, Parisi S, Olearo E, Fassio F, Zizzo R, Danese S, Benedetto C. Simplified laparoscopic sacropexy avoiding deep vaginal dissection. Int J Gynaecol Obstet. 2018 Nov;143(2):239-245. doi: 10.1002/ijgo.12632. Epub 2018 Aug 24.
- Background: PubMed 30024069Moroni RM, Juliato CRT, Cosson M, Giraudet G, Brito LGO. Does sacrocolpopexy present heterogeneity in its surgical technique? A systematic review. Neurourol Urodyn. 2018 Nov;37(8):2335-2345. doi: 10.1002/nau.23764. Epub 2018 Jul 19.
- Background: PubMed 31891897Gluck O, Blaganje M, Veit-Rubin N, Phillips C, Deprest J, O'reilly B, But I, Moore R, Jeffery S, Haddad JM, Deval B. Laparoscopic sacrocolpopexy: A comprehensive literature review on current practice. Eur J Obstet Gynecol Reprod Biol. 2020 Feb;245:94-101. doi: 10.1016/j.ejogrb.2019.12.029. Epub 2019 Dec 26.
- Background: PubMed 27566224Costantini E, Brubaker L, Cervigni M, Matthews CA, O'Reilly BA, Rizk D, Giannitsas K, Maher CF. Sacrocolpopexy for pelvic organ prolapse: evidence-based review and recommendations. Eur J Obstet Gynecol Reprod Biol. 2016 Oct;205:60-5. doi: 10.1016/j.ejogrb.2016.07.503. Epub 2016 Aug 3.
- Background: PubMed 37493538Maher C, Yeung E, Haya N, Christmann-Schmid C, Mowat A, Chen Z, Baessler K. Surgery for women with apical vaginal prolapse. Cochrane Database Syst Rev. 2023 Jul 26;7(7):CD012376. doi: 10.1002/14651858.CD012376.pub2.
- Individual participant dataSharing planned: No. There are no current plans to share individual participant data (IPD). Data use is restricted to the investigators involved in this project, according to the informed consent provided by participants and ethical committee approval.
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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.
The record lists no contact. Use the official record to reach the sponsor.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Laparoscopic colposacropexy with levator ani muscle mesh fixation and Simplified modification of laparoscopic colposacropexy in people with Prolapse Genital and Prolapse Uterovaginal, run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau at 6 sites 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 4 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 10 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites 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?
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?
Difference in anatomical success rate between simplified (Group B) and standard (Group A) laparoscopic colposacropexy. (time frame: 12 months after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07194343, which also lists 9 linked publications.
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 10 Feb 2026.