Pelvic Organ Prolapse (POP)NCT07359755
Vaginal Mesh Surgery Versus Robotic-assisted Abdominal Mesh Surgery in the Treatment of Apical Prolapse - Prospective Randomized Non-inferiority Study
A study testing Vaginal mesh surgery for apical prolapse and Robotic-assisted abdominal mesh surgery with Upsylon device (Boston Scientific - USA) for vaginal apical prolapse in people with Pelvic Organ Prolapse (POP) and Pelvic Organ Prolapse Vaginal Surgery, run by University of Sao Paulo General Hospital at 1 site in Brazil.
Trial summary
The goal of this study is to compare vaginal mesh surgery with abdominal robotic-assisted mesh surgery for the treatment of genital prolapse in women. The main questions it seeks to answer are: Is the objective cure rate for vaginal mesh surgery non-inferior to that of the abdominal approach? Is the use of vaginal… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Pelvic Organ Prolapse (POP), Pelvic Organ Prolapse Vaginal Surgery, Mesh Reinforcement
- What is being tested?
- Vaginal mesh surgery for apical prolapse and Robotic-assisted abdominal mesh surgery with Upsylon device (Boston Scientific - USA) for vaginal apical prolapse
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 86 participants
- Where
- 1 siteBrazil
- Study dates
- 15 Sep 2025to Jun 2030
- 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
- The study will include patients diagnosed with apical compartment genital prolapse of stage II or higher, who have an indication for surgical correction.
Who cannot join
- The following exclusion criteria will apply: patients who are unable or unwilling to complete validated outcome assessment instruments; those requiring concomitant surgical procedures (e.g., hysterectomy or any other intervention that may alter pelvic floor anatomy);
- individuals with a prior history of pelvic radiotherapy;
- patients with congenital or acquired anomalies of the urogenital or gastrointestinal systems;
- and those with medical conditions that constitute a contraindication to elective surgical intervention.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Brazil1 site, 1 recruiting
- Recruiting
Hospital das Clinicas da Faculdade de Medicina de Sao Paulo
São Paulo, São Paulo, 05403000
Marcelo Hisano, MD PhD, 551126618080, secretariauro.ichc@hc.fm.usp.br
Cristiano Mendes Gomes, MD Professor, 551126618080, secretariauro.ichc@hc.fm.usp.br
About this study
Official title: A Comparative Analysis of Vaginal Mesh Surgery Versus Robotic-assisted Abdominal Mesh Surgery in the Treatment of Apical Genital Prolapse: a Prospective Randomized Non-inferiority Study.
The goal of this study is to compare vaginal mesh surgery with abdominal robotic-assisted mesh surgery for the treatment of genital prolapse in women. The main questions it seeks to answer are:
- Is the objective cure rate for vaginal mesh surgery non-inferior to that of the abdominal approach?
- Is the use of vaginal mesh as safe as abdominal mesh?
Read the detailed description
This is a prospective, randomized non-inferiority study designed to compare the objective outcomes of treating apical compartment pelvic organ prolapse (POP) using robot-assisted abdominal mesh surgery versus vaginal mesh surgery. Additionally, clinical parameters such as mesh erosion, pain, and symptom-specific quality of life will be assessed utilizing an internationally validated instrument adapted for Portuguese-speaking populations.
Patients diagnosed with stage II or higher apical compartment pelvic organ prolapse (POP), with or without a uterus, who require surgical intervention and provide informed consent will be randomized through REDCap® software to determine the surgical approach.
The interventions under investigation include: vaginal prolapse repair with placement of the Splentis® mesh (Promedon®, Córdoba, Argentina) - not FDA approved, comprising anterior colporrhaphy combined with suspension of the cervix or vaginal vault, with bilateral anchoring of the mesh to the sacrospinous ligaments; and robot-assisted laparoscopic abdominal repair employing the Upsylon® mesh (Boston Scientific®, USA) - FDA approved - via colpocervicopexy, involving mesh fixation to the anterior and superior vaginal walls as well as the sacral promontory.
The sample size was calculated to assess the non-inferiority of the vaginal approach compared with the abdominal approach. Assuming an objective cure rate (stage 0 or I) of 90% for the abdominal group and 80% for the vaginal group, with a two-sided significance level of p < 0.05 and an anticipated loss to follow-up of up to 10% in each group, a minimum of 43 participants per arm (total of 86 patients) was required. The calculation was based on detecting a non-inferiority margin considered clinically acceptable for the primary outcome.
- Conditions
- Pelvic Organ Prolapse (POP), Pelvic Organ Prolapse Vaginal Surgery, Mesh Reinforcement, Vaginal Apex/Uterine Prolapse
- Being tested
- Vaginal mesh surgery for apical prolapse, Robotic-assisted abdominal mesh surgery with Upsylon device (Boston Scientific - USA) for vaginal apical prolapse
- Keywords
- Pelvic organ prolapse, Vaginal prolapse, Vaginal mesh, Robotic-assisted sacrocolpopexy, Sacrocolpopexy, Uterine prolapse
- Medical subject headings
- Pelvic Organ Prolapse, Uterine Prolapse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vaginal mesh surgery for apical prolapseProcedure or surgery
Cirurgia com tela vaginal para prolapso apical.
Robotic-assisted abdominal mesh surgery with Upsylon device (Boston Scientific - USA) for vaginal apical prolapseProcedure or surgery
Cirurgia robótica assistida por tela abdominal com dispositivo Upsylon (Boston Scientific - EUA) para prolapso apical vaginal.
| Study group | Role | What they receive |
|---|---|---|
| Vaginal mesh surgery | Experimental | Vaginal mesh surgery for apical prolapse Receives: Procedure: Vaginal mesh surgery for apical prolapse |
| Robotic-assited abdominal sacrocolpopexy | Active comparator | Robotic-assisted abdominal mesh surgery with Upsylon device (Boston Scientific - USA) for vaginal apical prolapse Receives: Procedure: Robotic-assisted abdominal mesh surgery with Upsylon device (Boston Scientific - USA) for vaginal apical prolapse |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Cure Rate
The criteria for objective cure will be defined according to the Pelvic Organ Prolapse Quantification (POP-Q) system, with point C positioned at -6 cm or higher (proximal), corresponding to stage 0 or I genital prolapse.
Measured: Patients will undergo evaluations at 1 month postoperatively and subsequently at 6-month intervals from the date of surgery, continuing until 24 months of follow-up have been completed.
Secondary outcomes (1)
Surgical complication
Complications will be evaluated in the perioperative period and during follow-up, encompassing surgical complications, long-term adverse events such as mesh erosion, and complications necessitating corrective interventions. These complications will be categorized according to the Clavien-Dindo classification system.
Measured: Patients will undergo evaluations at 1 month postoperatively and subsequently at 6-month intervals from the date of surgery, continuing until 24 months of follow-up have been completed.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2026
- Study start15 Sep 2025
- Primary completionOct 2027 (estimated)
- Study completionJun 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (18)Papers the sponsor has linked to this study.
- Other trials for Pelvic Organ Prolapse (POP)Studies of the same condition, open and under way.
- More trials run by University of Sao Paulo General HospitalThe 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
- Sequential
- Model description
- This prospective, randomized trial is designed to evaluate the treatment of apical vaginal prolapse, with the objective of demonstrating the non-inferiority of vaginal mesh repair compared to robotic-assisted abdominal sacral colpopexy. The assessment will focus on objective cure rates as well as secondary outcomes, including clinical complications, mesh erosion, and patient-reported clinical improvements measured through validated questionnaires.
- Masking
- None (open label)
- Enrolment
- 86 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marcelo Hisano, University of Sao Paulo General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07359755
- Sponsor's protocol ID
- 7.815.545
- Other IDs
- 86242424.1.0000.0068
- Status last verified
- Jan 2026
- First submitted
- 30 Nov 2025
- Last updated
- 22 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Study Protocol; Statistical Analysis Plan (SAP)
Publications
Bataller 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 29987345Lee RK, Mottrie A, Payne CK, Waltregny D. A review of the current status of laparoscopic and robot-assisted sacrocolpopexy for pelvic organ prolapse. Eur Urol. 2014 Jun;65(6):1128-37. doi: 10.1016/j.eururo.2013.12.064. Epub 2014 Jan 8.
PubMed 24433811Coolen AWM, Bui BN, Dietz V, Wang R, van Montfoort APA, Mol BWJ, Roovers JWR, Bongers MY. The treatment of post-hysterectomy vaginal vault prolapse: a systematic review and meta-analysis. Int Urogynecol J. 2017 Dec;28(12):1767-1783. doi: 10.1007/s00192-017-3493-2. Epub 2017 Oct 16.
PubMed 29038834Maher CF, Feiner B, DeCuyper EM, Nichlos CJ, Hickey KV, O'Rourke P. Laparoscopic sacral colpopexy versus total vaginal mesh for vaginal vault prolapse: a randomized trial. Am J Obstet Gynecol. 2011 Apr;204(4):360.e1-7. doi: 10.1016/j.ajog.2010.11.016.
PubMed 21306698Hudson CO, Northington GM, Lyles RH, Karp DR. Outcomes of robotic sacrocolpopexy: a systematic review and meta-analysis. Female Pelvic Med Reconstr Surg. 2014 Sep-Oct;20(5):252-60. doi: 10.1097/SPV.0000000000000070.
PubMed 25181374Rovner E, Chermansky C, Costantini E, Dmochowski R, Enemchukwu E, Ginsberg DA, Heesakkers J, Menefee S, Nadeau G, Rardin C, Zimmern P. Recommendations of the SUFU/AUGS/ICS Female Stress Urinary Incontinence Surgical Publication Working Group: A common standard minimum data set for the literature. Neurourol Urodyn. 2024 Nov;43(8):1753-1764. doi: 10.1002/nau.25445. Epub 2024 Jun 5.
PubMed 38837735Peterson TV, Pinto RA, Davila GW, Nahas SC, Baracat EC, Haddad JM. Validation of the Brazilian Portuguese version of the pelvic floor bother questionnaire. Int Urogynecol J. 2019 Jan;30(1):81-88. doi: 10.1007/s00192-018-3627-1. Epub 2018 Mar 16.
PubMed 29549393Angelo PH, de Queiroz NA, Leitao ACR, Marini G, Micussi MT. Validation of the international consultation on incontinence modular questionnaire - female lower urinary tract symptoms (ICIQ-FLUTS) into brazilian portuguese. Int Braz J Urol. 2020 Jan-Feb;46(1):53-59. doi: 10.1590/S1677-5538.IBJU.2019.0234.
PubMed 31851458Dindo D, Demartines N, Clavien PA. Classification of surgical complications: a new proposal with evaluation in a cohort of 6336 patients and results of a survey. Ann Surg. 2004 Aug;240(2):205-13. doi: 10.1097/01.sla.0000133083.54934.ae.
PubMed 15273542Kisby CK, Occhino JA, Bews KA, Habermann EB, Linder BJ. Perioperative Complications in Minimally Invasive Sacrocolpopexy Versus Transvaginal Mesh in the Management of Pelvic Organ Prolapse: Analysis of a National Multi-institutional Dataset. Female Pelvic Med Reconstr Surg. 2021 Feb 1;27(2):72-77. doi: 10.1097/SPV.0000000000000738.
PubMed 31094716Maher CF, Baessler KK, Barber MD, Cheong C, Consten ECJ, Cooper KG, Deffieux X, Dietz V, Gutman RE, van Iersel JJ, Nager CW, Sung VW, de Tayrac R. Surgical management of pelvic organ prolapse. Climacteric. 2019 Jun;22(3):229-235. doi: 10.1080/13697137.2018.1551348. Epub 2018 Dec 21.
PubMed 30572743Haylen BT, Maher CF, Barber MD, Camargo S, Dandolu V, Digesu A, Goldman HB, Huser M, Milani AL, Moran PA, Schaer GN, Withagen MI. An International Urogynecological Association (IUGA) / International Continence Society (ICS) Joint Report on the Terminology for Female Pelvic Organ Prolapse (POP). Neurourol Urodyn. 2016 Feb;35(2):137-68. doi: 10.1002/nau.22922. Epub 2016 Jan 7.
PubMed 26749391Maher 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 37493538Zhang CY, Sun ZJ, Yang J, Xu T, Zhu L, Lang JH. Sacrocolpopexy compared with transvaginal mesh surgery: a systematic review and meta-analysis. BJOG. 2021 Jan;128(1):14-23. doi: 10.1111/1471-0528.16324. Epub 2020 Jun 15.
PubMed 32426903Nygaard I, Bradley C, Brandt D; Women's Health Initiative. Pelvic organ prolapse in older women: prevalence and risk factors. Obstet Gynecol. 2004 Sep;104(3):489-97. doi: 10.1097/01.AOG.0000136100.10818.d8.
PubMed 15339758
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparative Analysis of Vaginal Mesh Surgery Versus Robotic-assisted Abdominal Mesh Surgery in the Treatment of Apical Genital Prolapse: a Prospective Randomized Non-inferiority Study.
- ClinicalTrials.gov ID
- NCT07359755
- Acronym / sponsor ID
- 7.815.545
- Conditions
- Pelvic Organ Prolapse (POP), Pelvic Organ Prolapse Vaginal Surgery, Mesh Reinforcement, Vaginal Apex/Uterine Prolapse
- Keywords
- Pelvic organ prolapse, Vaginal prolapse, Vaginal mesh, Robotic-assisted sacrocolpopexy, Sacrocolpopexy, Uterine prolapse
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 86 participants (estimated)
- Lead sponsor
- University of Sao Paulo General HospitalUniversity, hospital or other
- Study start
- 15 Sep 2025 (actual)
- Primary completion
- Oct 2027 (estimated)
- Study completion
- Jun 2030 (estimated)
- First posted
- 22 Jan 2026 (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.
The goal of this study is to compare vaginal mesh surgery with abdominal robotic-assisted mesh surgery for the treatment of genital prolapse in women. The main questions it seeks to answer are:
- Is the objective cure rate for vaginal mesh surgery non-inferior to that of the abdominal approach?
- Is the use of vaginal mesh as safe as abdominal mesh?
Detailed description
This is a prospective, randomized non-inferiority study designed to compare the objective outcomes of treating apical compartment pelvic organ prolapse (POP) using robot-assisted abdominal mesh surgery versus vaginal mesh surgery. Additionally, clinical parameters such as mesh erosion, pain, and symptom-specific quality of life will be assessed utilizing an internationally validated instrument adapted for Portuguese-speaking populations.
Patients diagnosed with stage II or higher apical compartment pelvic organ prolapse (POP), with or without a uterus, who require surgical intervention and provide informed consent will be randomized through REDCap® software to determine the surgical approach.
The interventions under investigation include: vaginal prolapse repair with placement of the Splentis® mesh (Promedon®, Córdoba, Argentina) - not FDA approved, comprising anterior colporrhaphy combined with suspension of the cervix or vaginal vault, with bilateral anchoring of the mesh to the sacrospinous ligaments; and robot-assisted laparoscopic abdominal repair employing the Upsylon® mesh (Boston Scientific®, USA) - FDA approved - via colpocervicopexy, involving mesh fixation to the anterior and superior vaginal walls as well as the sacral promontory.
The sample size was calculated to assess the non-inferiority of the vaginal approach compared with the abdominal approach. Assuming an objective cure rate (stage 0 or I) of 90% for the abdominal group and 80% for the vaginal group, with a two-sided significance level of p < 0.05 and an anticipated loss to follow-up of up to 10% in each group, a minimum of 43 participants per arm (total of 86 patients) was required. The calculation was based on detecting a non-inferiority margin considered clinically acceptable for the primary outcome.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This prospective, randomized trial is designed to evaluate the treatment of apical vaginal prolapse, with the objective of demonstrating the non-inferiority of vaginal mesh repair compared to robotic-assisted abdominal sacral colpopexy. The assessment will focus on objective cure rates as well as secondary outcomes, including clinical complications, mesh erosion, and patient-reported clinical improvements measured through validated questionnaires.
| Arm | Type | Receives |
|---|---|---|
| Vaginal mesh surgery | Experimental | Procedure: Vaginal mesh surgery for apical prolapseVaginal mesh surgery for apical prolapse |
| Robotic-assited abdominal sacrocolpopexy | Active comparator | Procedure: Robotic-assisted abdominal mesh surgery with Upsylon device (Boston Scientific - USA) for vaginal apical prolapseRobotic-assisted abdominal mesh surgery with Upsylon device (Boston Scientific - USA) for vaginal apical prolapse |
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)
- The study will include patients diagnosed with apical compartment genital prolapse of stage II or higher, who have an indication for surgical correction.
Key exclusion criteria (4 listed)
- The following exclusion criteria will apply: patients who are unable or unwilling to complete validated outcome assessment instruments; those requiring concomitant surgical procedures (e.g., hysterectomy or any other intervention that may alter pelvic floor anatomy);
- individuals with a prior history of pelvic radiotherapy;
- patients with congenital or acquired anomalies of the urogenital or gastrointestinal systems;
- and those with medical conditions that constitute a contraindication to elective surgical intervention.
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 |
|---|---|---|
| Vaginal mesh surgery for apical prolapseCirurgia com tela vaginal para prolapso apical. | Procedure or surgery | Vaginal mesh surgery |
| Robotic-assisted abdominal mesh surgery with Upsylon device (Boston Scientific - USA) for vaginal apical prolapseCirurgia robótica assistida por tela abdominal com dispositivo Upsylon (Boston Scientific - EUA) para prolapso apical vaginal. | Procedure or surgery | Robotic-assited abdominal sacrocolpopexy |
Primary outcome
Objective Cure Rate
Time frame: Patients will undergo evaluations at 1 month postoperatively and subsequently at 6-month intervals from the date of surgery, continuing until 24 months of follow-up have been completed.
The criteria for objective cure will be defined according to the Pelvic Organ Prolapse Quantification (POP-Q) system, with point C positioned at -6 cm or higher (proximal), corresponding to stage 0 or I genital prolapse.
1 secondary outcome
Surgical complication
Time frame: Patients will undergo evaluations at 1 month postoperatively and subsequently at 6-month intervals from the date of surgery, continuing until 24 months of follow-up have been completed.
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 22 Jan 2026.
- 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 24433811Lee RK, Mottrie A, Payne CK, Waltregny D. A review of the current status of laparoscopic and robot-assisted sacrocolpopexy for pelvic organ prolapse. Eur Urol. 2014 Jun;65(6):1128-37. doi: 10.1016/j.eururo.2013.12.064. Epub 2014 Jan 8.
- Background: PubMed 29038834Coolen AWM, Bui BN, Dietz V, Wang R, van Montfoort APA, Mol BWJ, Roovers JWR, Bongers MY. The treatment of post-hysterectomy vaginal vault prolapse: a systematic review and meta-analysis. Int Urogynecol J. 2017 Dec;28(12):1767-1783. doi: 10.1007/s00192-017-3493-2. Epub 2017 Oct 16.
- Background: PubMed 21306698Maher CF, Feiner B, DeCuyper EM, Nichlos CJ, Hickey KV, O'Rourke P. Laparoscopic sacral colpopexy versus total vaginal mesh for vaginal vault prolapse: a randomized trial. Am J Obstet Gynecol. 2011 Apr;204(4):360.e1-7. doi: 10.1016/j.ajog.2010.11.016.
- Background: PubMed 25181374Hudson CO, Northington GM, Lyles RH, Karp DR. Outcomes of robotic sacrocolpopexy: a systematic review and meta-analysis. Female Pelvic Med Reconstr Surg. 2014 Sep-Oct;20(5):252-60. doi: 10.1097/SPV.0000000000000070.
- Background: PubMed 38837735Rovner E, Chermansky C, Costantini E, Dmochowski R, Enemchukwu E, Ginsberg DA, Heesakkers J, Menefee S, Nadeau G, Rardin C, Zimmern P. Recommendations of the SUFU/AUGS/ICS Female Stress Urinary Incontinence Surgical Publication Working Group: A common standard minimum data set for the literature. Neurourol Urodyn. 2024 Nov;43(8):1753-1764. doi: 10.1002/nau.25445. Epub 2024 Jun 5.
- Background: PubMed 29549393Peterson TV, Pinto RA, Davila GW, Nahas SC, Baracat EC, Haddad JM. Validation of the Brazilian Portuguese version of the pelvic floor bother questionnaire. Int Urogynecol J. 2019 Jan;30(1):81-88. doi: 10.1007/s00192-018-3627-1. Epub 2018 Mar 16.
- Background: PubMed 31851458Angelo PH, de Queiroz NA, Leitao ACR, Marini G, Micussi MT. Validation of the international consultation on incontinence modular questionnaire - female lower urinary tract symptoms (ICIQ-FLUTS) into brazilian portuguese. Int Braz J Urol. 2020 Jan-Feb;46(1):53-59. doi: 10.1590/S1677-5538.IBJU.2019.0234.
- Background: PubMed 15273542Dindo D, Demartines N, Clavien PA. Classification of surgical complications: a new proposal with evaluation in a cohort of 6336 patients and results of a survey. Ann Surg. 2004 Aug;240(2):205-13. doi: 10.1097/01.sla.0000133083.54934.ae.
- Background: PubMed 31094716Kisby CK, Occhino JA, Bews KA, Habermann EB, Linder BJ. Perioperative Complications in Minimally Invasive Sacrocolpopexy Versus Transvaginal Mesh in the Management of Pelvic Organ Prolapse: Analysis of a National Multi-institutional Dataset. Female Pelvic Med Reconstr Surg. 2021 Feb 1;27(2):72-77. doi: 10.1097/SPV.0000000000000738.
- Background: PubMed 30572743Maher CF, Baessler KK, Barber MD, Cheong C, Consten ECJ, Cooper KG, Deffieux X, Dietz V, Gutman RE, van Iersel JJ, Nager CW, Sung VW, de Tayrac R. Surgical management of pelvic organ prolapse. Climacteric. 2019 Jun;22(3):229-235. doi: 10.1080/13697137.2018.1551348. Epub 2018 Dec 21.
- Background: PubMed 26749391Haylen BT, Maher CF, Barber MD, Camargo S, Dandolu V, Digesu A, Goldman HB, Huser M, Milani AL, Moran PA, Schaer GN, Withagen MI. An International Urogynecological Association (IUGA) / International Continence Society (ICS) Joint Report on the Terminology for Female Pelvic Organ Prolapse (POP). Neurourol Urodyn. 2016 Feb;35(2):137-68. doi: 10.1002/nau.22922. Epub 2016 Jan 7.
- Individual participant dataSharing planned: Yes. Study Protocol; Statistical Analysis Plan (SAP)
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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 Vaginal mesh surgery for apical prolapse and Robotic-assisted abdominal mesh surgery with Upsylon device (Boston Scientific - USA) for vaginal apical prolapse in people with Pelvic Organ Prolapse (POP) and Pelvic Organ Prolapse Vaginal Surgery, run by University of Sao Paulo General Hospital at 1 site in Brazil.
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 4 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 22 Jan 2026. 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 Brazil. 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 Marcelo Hisano, MD PhD (551126618080, m.hisano@hc.fm.usp.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective Cure Rate (time frame: Patients will undergo evaluations at 1 month postoperatively and subsequently at 6-month intervals from the date of surgery, continuing until 24 months of follow-up have been completed.). 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 NCT07359755, which also lists 18 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 22 Jan 2026.