Pelvic Organ Prolapse Clinical Trial
— BioSynIRSOfficial title:
Prospective Randomized Pilot Study on the Use of Biological Mesh Versus Synthetic Mesh in Interdisciplinary Resection Rectopexy With Sacro Colpopexy
The purpose of the pilot study is to demonstrate the safety and efficacy of a biological mesh compared to a standard synthetic mesh for the planned procedure in the above-mentioned clinical picture. Subsequently, a multicentre, randomized intervention study is planned to confirm the results and evaluate the long-term outcomes.
Status | Recruiting |
Enrollment | 28 |
Est. completion date | May 31, 2026 |
Est. primary completion date | December 31, 2025 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 80 Years |
Eligibility | Inclusion Criteria: - clinical diagnosis of obstructed defection syndrome - clinical diagnosis of pelvic organ prolapse pelvic organ prolapse - must be suitable for surgery Exclusion Criteria: - allergy to the components of the mesh - pregnancy |
Country | Name | City | State |
---|---|---|---|
Germany | Evangelisches Klinikum Koeln Weyertal | Cologne | Northrhine Westphalia |
Lead Sponsor | Collaborator |
---|---|
Evangelisches Klinikum Köln Weyertal gGmbH | University of Cologne |
Germany,
Ahmad M, Sileri P, Franceschilli L, Mercer-Jones M. The role of biologics in pelvic floor surgery. Colorectal Dis. 2012 Dec;14 Suppl 3:19-23. doi: 10.1111/codi.12045. — View Citation
Augusto KL, Bezerra LRPS, Murad-Regadas SM, Vasconcelos Neto JA, Vasconcelos CTM, Karbage SAL, Bilhar APM, Regadas FSP. Defecatory dysfunction and fecal incontinence in women with or without posterior vaginal wall prolapse as measured by pelvic organ prolapse quantification (POP-Q). Eur J Obstet Gynecol Reprod Biol. 2017 Jul;214:50-55. doi: 10.1016/j.ejogrb.2017.04.039. Epub 2017 Apr 26. — View Citation
Brunner M, Roth H, Gunther K, Grutzmann R, Matzel KE. Ventral rectopexy with biological mesh: short-term functional results. Int J Colorectal Dis. 2018 Apr;33(4):449-457. doi: 10.1007/s00384-018-2972-3. Epub 2018 Feb 13. — View Citation
Clemons JL, Weinstein M, Guess MK, Alperin M, Moalli P, Gregory WT, Lukacz ES, Sung VW, Chen BH, Bradley CS; AUGS Research Committee. Impact of the 2011 FDA transvaginal mesh safety update on AUGS members' use of synthetic mesh and biologic grafts in pelvic reconstructive surgery. Female Pelvic Med Reconstr Surg. 2013 Jul-Aug;19(4):191-8. doi: 10.1097/SPV.0b013e31829099c1. — View Citation
de Mattos Lourenco TR, Pergialiotis V, Durnea C, Elfituri A, Haddad JM, Betschart C, Falconi G, Doumouchtsis SK; CHORUS: An International Collaboration for Harmonising Outcomes, Research, and Standards in Urogynaecology and Women's Health. A systematic review of reported outcomes and outcome measures in randomized controlled trials on apical prolapse surgery. Int J Gynaecol Obstet. 2019 Apr;145(1):4-11. doi: 10.1002/ijgo.12766. Epub 2019 Feb 22. — View Citation
Dindo 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. — View Citation
Sohlberg EM, Dallas KB, Weeks BT, Elliott CS, Rogo-Gupta L. Reoperation rates for pelvic organ prolapse repairs with biologic and synthetic grafts in a large population-based cohort. Int Urogynecol J. 2020 Feb;31(2):291-301. doi: 10.1007/s00192-019-04035-3. Epub 2019 Jul 12. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | safety of the experimental internvention as measured by surgical outcome | Morbidity and mortality according to the Clavien-Dindo Classification (CDC) at 12 months after surgery (maximum value) | 12 months | |
Secondary | Altomare Score for Obstruct4ed defecation syndrome (ODS) | Improvement in medical condition as measured Altomare score for ODS, min/max points 0-30 point, more points indicate more severe ODS symptoms; a reduction after intervention indicatesmprovement/deterioration (-3 =better, - 6 = much better; +3=worse, +6=much worse) | 12 months | |
Secondary | Pelvic organ prolapse Quantification (POP Q) | Measurement of clinical pelvic organ prolapse by the above score. min/max 0-4, more points are more symptoms. Improvement of the POP-Q is -1= good; -2 = very good; +1 =worse, +2=much worse. | 12 months | |
Secondary | Rectal Toxicity Score for bowel dysfunction | Improvement in medical condition as measured rectal toxicity score for bowel dysfunction, min/max points 0-30 point, more points indicate more severe bowel dysfunction; a reduction after intervention indicates improvement/deterioration (-3 =better, - 6 = much better; +3=worse, +6=much worse) | 12 months | |
Secondary | Wexner Incontinence Score for fecal incontinence | Improvement in medical condition as measured with Wexner Incontinence Score for fecal incontinence, min/max points 0-20 point, more points indicate more severe incontinence symptoms; a reduction after intervention indicates mprovement/deterioration (-3 =better, - 6 = much better; +3=worse, +6=much worse) | 12 months |
Status | Clinical Trial | Phase | |
---|---|---|---|
Active, not recruiting |
NCT05420831 -
Comparison of Vaginal and Laparoscopic Apical Fixation Techniques for Pelvic Organ Prolapse Treatment
|
N/A | |
Active, not recruiting |
NCT05422209 -
The Influence of Simultaneous Posterior Colporrhaphy and Perineoplasty on the Efficiency and Safety of Mesh-augmented Sacrospinal Fixation (Apical Sling) in Advanced POP Repair.
|
N/A | |
Completed |
NCT05493735 -
Lidocaine for Pessary Check Pain Reduction
|
Phase 3 | |
Completed |
NCT06126328 -
Materna Prep Study Phase II
|
Phase 2 | |
Recruiting |
NCT05542836 -
EVeRLAST 2-Year Follow-Up
|
||
Recruiting |
NCT05918367 -
Multicenter Ventral Mesh Rectopexy Registry Collaborative
|
||
Recruiting |
NCT04172272 -
The Influence of TAP Block in the Control of Postoperative Pain After Laparotomy for Gynecological Procedures
|
N/A | |
Recruiting |
NCT04807920 -
BOTOX® at the Time of Prolapse Surgery for OAB
|
Phase 4 | |
Completed |
NCT06268782 -
The Effectiveness of an Online Exercise Program on Well-being of Postpartum Women
|
N/A | |
Recruiting |
NCT02919852 -
Laparoscopic Retrovesical Colpopectinopexia
|
N/A | |
Recruiting |
NCT03146195 -
The 3D Reconstruction Research of Pelvic Organ Prolapse Disease
|
N/A | |
Completed |
NCT02925585 -
Vaginal Tactile Imaging for Pelvic Floor Prolapse
|
||
Not yet recruiting |
NCT02536001 -
Prospective Randomized Study to Compare Results of Pelvic Organ Prolapse Repair With One Versus Two Vaginal Meshes
|
N/A | |
Recruiting |
NCT02113969 -
Conservative Management of Symptomatic Pelvic Organ Prolapse Using Vaginal Pessaries: Generation of a Standardized Management Protocol
|
N/A | |
Completed |
NCT02383199 -
Polypropylene Mesh in Prolapse Surgery
|
N/A | |
Terminated |
NCT01673360 -
Collection of Long Term Patient Outcomes Data Following Implantation of AMS Surgical Devices
|
N/A | |
Withdrawn |
NCT01530191 -
Factors Affecting Perioperative Outcomes
|
N/A | |
Completed |
NCT01842464 -
Sacro-Spinous Ligaments Anterior Apical Anchoring
|
N/A | |
Completed |
NCT01320631 -
Male Sexual Experience and Its Impact on Quality of Life Before and After Their Sexual Partners Undergo Polypropylene Mesh Augmented Pelvic Floor Reconstruction
|
N/A | |
Completed |
NCT00581412 -
Composite Graft Use in Abdominal Sacrocolpopexy Reduces Erosion Rates
|
N/A |