Transvaginal Human Acellular Dermal Matrix for Prolapse Treatment

NCT06404931 | Recruiting Phase 2

• 1 other identifier: Mesh in prolapse treatment
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

This is a randomised study in which we compare the effectiveness of three different procedures in mending symptomatic anterior and apical prolapse in patients who are candidates to receive surgery. They will be randomly assigned in a ratio 1:1:1 to three different groups who will have assigned three different kinds of surgery. In the patients of the first group a classic vaginal hysterectomy with anterior colporrhaphy will be practised. Patients who belong to group two will undergo a vaginal hysterectomy followed by placement of an acellular dermal matrix from cadaveric donors (hADM) for anterior reinforcement and sacrospinous fixation with Anchorsure® device (Neomedic trade mark (TM) International, Spain). Finally, patients from group three will have vaginal hysterectomy followed by sacrospinous fixation with Anchorsure® alone . Patients will be followed-up at 4 weeks, 6 months, 12 months and annually till 36 months to evaluate relapses and possible complications.

Conditions

Prolapse; Female; Prolapse Genital; Prolapse Uterovaginal

Outcome Measures

Primary Outcomes (1)

• Recurrence of anatomical anterior vaginal wall prolapse

  Defined as point Ba POP-Q stage ≥II by clinical examination

  36 months

Secondary Outcomes (8)

• Difference between groups in anatomical prolapse

  36 moths

• Differences between groups in symptomatic recurrence

  36 months

• Differences between groups in quality of Life

  36 months

• Differences between groups in sexual functioning.

  36 months

• Differences between groups in hospital stay

  36 months

Study Arms (3)

Vaginal hysterectomy plus anterior colporrhaphy

SHAM COMPARATOR

Vaginal hysterectomy plus anterior colporrhaphy

Procedure: Vaginal hysterectomy plus anterior colporrhaphy

Vaginal hysterectomy plus sacrospinous fixation with Anchorsure® device

SHAM COMPARATOR

Vaginal hysterectomy plus sacrospinous fixation with Anchorsure® device

Procedure: Vaginal hysterectomy plus sacrospinous fixation with Anchorsure® device

Vaginal hysterectomy plus matrix reinforcement and sacrospinous fixation with Anchorsure® device

EXPERIMENTAL

Vaginal hysterectomy plus matrix reinforcement and sacrospinous fixation with Anchorsure® device

Procedure: Vaginal hysterectomy plus matrix reinforcement and sacrospinous fixation with Anchorsure® device

Interventions

Vaginal hysterectomy plus matrix reinforcement and sacrospinous fixation with Anchorsure® device PROCEDURE

Vaginal hysterectomy plus matrix reinforcement and sacrospinous fixation with Anchorsure® device

Vaginal hysterectomy plus matrix reinforcement and sacrospinous fixation with Anchorsure® device

Vaginal hysterectomy plus anterior colporrhaphy PROCEDURE

Vaginal hysterectomy plus anterior colporrhaphy

Vaginal hysterectomy plus anterior colporrhaphy

Vaginal hysterectomy plus sacrospinous fixation with Anchorsure® device PROCEDURE

Vaginal hysterectomy plus sacrospinous fixation with Anchorsure® device

Vaginal hysterectomy plus sacrospinous fixation with Anchorsure® device

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Women with symptomatic POP with indication of vaginal surgery.
• Women with hiatal ballooning or levator ani injury evaluated by 3D pelvic floor ultrasound.
• Women ≥18 years old.
• Women wishing to complete a 36-month follow-up.
• Understand and accept the study procedures and sign the informed consent.

You may not qualify if:

• Women with previous pelvic floor or prolapse surgery
• Women with POP grade IV
• Women with chronic pelvic pain.
• Not being able to understand the nature of the study and/or the procedures to be followed.
• Not signing the informed consent

Sponsors & Collaborators

• Hospital Mutua de Terrassa: lead
• Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau: collaborator
• Germans Trias i Pujol Hospital: collaborator
• Hospital Arnau de Vilanova: collaborator

Study Sites (1)

Hospital Mutua de Terrassa

Terrassa, 08221, Spain

RECRUITING

Related Publications (22)

• Flynn BJ, Webster GD. Surgical management of the apical vaginal defect. Curr Opin Urol. 2002 Jul;12(4):353-8. doi: 10.1097/00042307-200207000-00015.

  PMID: 12072658 BACKGROUND

• Unger CA, Barber MD. Vaginal Mesh in Pelvic Reconstructive Surgery: Controversies, Current Use, and Complications. Clin Obstet Gynecol. 2015 Dec;58(4):740-53. doi: 10.1097/GRF.0000000000000148.

  PMID: 26512439 BACKGROUND

• NHS Improvement, NHS England. Letter to Acute Trust CEOs and Medical Directors. 2018;(July 2017). Available from: www.england.nhs.uk

  BACKGROUND

• Salzberg CA. Nonexpansive immediate breast reconstruction using human acellular tissue matrix graft (AlloDerm). Ann Plast Surg. 2006 Jul;57(1):1-5. doi: 10.1097/01.sap.0000214873.13102.9f.

  PMID: 16799299 BACKGROUND

• Guo X, Mu D, Gao F. Efficacy and safety of acellular dermal matrix in diabetic foot ulcer treatment: A systematic review and meta-analysis. Int J Surg. 2017 Apr;40:1-7. doi: 10.1016/j.ijsu.2017.02.008. Epub 2017 Feb 14.

  PMID: 28232031 BACKGROUND

• Menon NG, Rodriguez ED, Byrnes CK, Girotto JA, Goldberg NH, Silverman RP. Revascularization of human acellular dermis in full-thickness abdominal wall reconstruction in the rabbit model. Ann Plast Surg. 2003 May;50(5):523-7. doi: 10.1097/01.SAP.0000044252.76804.6B.

  PMID: 12792544 BACKGROUND

• Salzberg CA, Ashikari AY, Koch RM, Chabner-Thompson E. An 8-year experience of direct-to-implant immediate breast reconstruction using human acellular dermal matrix (AlloDerm). Plast Reconstr Surg. 2011 Feb;127(2):514-524. doi: 10.1097/PRS.0b013e318200a961.

  PMID: 21285756 BACKGROUND

• Griffey S, Schwade ND, Wright CG. Particulate dermal matrix as an injectable soft tissue replacement material. J Biomed Mater Res. 2001;58(1):10-5. doi: 10.1002/1097-4636(2001)58:13.0.co;2-e.

  PMID: 11152992 BACKGROUND

• Botros SM, Sand PK, Beaumont JL, Abramov Y, Miller JJ, Goldberg RP. Arcus-anchored acellular dermal graft compared to anterior colporrhaphy for stage II cystoceles and beyond. Int Urogynecol J Pelvic Floor Dysfunct. 2009 Oct;20(10):1265-71. doi: 10.1007/s00192-009-0933-7. Epub 2009 Jun 17.

  PMID: 19533005 BACKGROUND

• Clemons JL, Myers DL, Aguilar VC, Arya LA. Vaginal paravaginal repair with an AlloDerm graft. Am J Obstet Gynecol. 2003 Dec;189(6):1612-8; discussion 1618-9. doi: 10.1016/s0002-9378(03)00929-3.

  PMID: 14710083 BACKGROUND

• Ward RM, Sung VW, Clemons JL, Myers DL. Vaginal paravaginal repair with an AlloDerm graft: Long-term outcomes. Am J Obstet Gynecol. 2007 Dec;197(6):670.e1-5. doi: 10.1016/j.ajog.2007.08.067.

  PMID: 18060976 BACKGROUND

• Chung SY, Franks M, Smith CP, Lee JY, Lu SH, Chancellor M. Technique of combined pubovaginal sling and cystocele repair using a single piece of cadaveric dermal graft. Urology. 2002 Apr;59(4):538-41. doi: 10.1016/s0090-4295(01)01611-9.

  PMID: 11927309 BACKGROUND

• Miklos JR, Kohli N, Moore R. Levatorplasty release and reconstruction of rectovaginal septum using allogenic dermal graft. Int Urogynecol J Pelvic Floor Dysfunct. 2002;13(1):44-6. doi: 10.1007/s001920200009.

  PMID: 11999206 BACKGROUND

• Kohli N, Miklos JR. Dermal graft-augmented rectocele repair. Int Urogynecol J Pelvic Floor Dysfunct. 2003 Jun;14(2):146-9. doi: 10.1007/s00192-002-1013-4. Epub 2003 Feb 13.

  PMID: 12851761 BACKGROUND

• Perez ML, Castells-Sala C, Lopez-Chicon P, Nieto-Nicolau N, Aiti A, Farinas O, Casaroli-Marano RP, Porta O, Vilarrodona A. Fast protocol for the processing of split-thickness skin into decellularized human dermal matrix. Tissue Cell. 2021 Oct;72:101572. doi: 10.1016/j.tice.2021.101572. Epub 2021 Jun 4.

  PMID: 34119882 BACKGROUND

• Pero M, Casani L, Castells-Sala C, Perez ML, Moga Naranjo E, Juan-Babot O, Alserawan De Lamo L, Lopez-Chicon P, Vilarrodona Serrat A, Badimon L, Porta Roda O. Rabbit as an animal model for the study of biological grafts in pelvic floor dysfunctions. Sci Rep. 2021 May 18;11(1):10545. doi: 10.1038/s41598-021-89698-z.

  PMID: 34006889 BACKGROUND

• Curtiss N, Duckett J. A long-term cohort study of surgery for recurrent prolapse comparing mesh augmented anterior repairs to anterior colporrhaphy. Gynecol Surg. 2018;15(1):1. doi: 10.1186/s10397-017-1035-z. Epub 2018 Jan 10.

  PMID: 29375283 BACKGROUND

• Altman D, Vayrynen T, Engh ME, Axelsen S, Falconer C; Nordic Transvaginal Mesh Group. Anterior colporrhaphy versus transvaginal mesh for pelvic-organ prolapse. N Engl J Med. 2011 May 12;364(19):1826-36. doi: 10.1056/NEJMoa1009521.

  PMID: 21561348 BACKGROUND

• Wong NKL, Cheung RYK, Lee LL, Wan OYK, Choy KW, Chan SSC. Women with advanced pelvic organ prolapse and levator ani muscle avulsion would significantly benefit from mesh repair surgery. Ultrasound Obstet Gynecol. 2021 Apr;57(4):631-638. doi: 10.1002/uog.23109.

  PMID: 32898286 BACKGROUND

• Rodrigo N, Wong V, Shek KL, Martin A, Dietz HP. The use of 3-dimensional ultrasound of the pelvic floor to predict recurrence risk after pelvic reconstructive surgery. Aust N Z J Obstet Gynaecol. 2014 Jun;54(3):206-11. doi: 10.1111/ajo.12171. Epub 2014 Feb 18.

  PMID: 24576013 BACKGROUND

• Vollebregt A, Fischer K, Gietelink D, van der Vaart CH. Primary surgical repair of anterior vaginal prolapse: a randomised trial comparing anatomical and functional outcome between anterior colporrhaphy and trocar-guided transobturator anterior mesh. BJOG. 2011 Nov;118(12):1518-27. doi: 10.1111/j.1471-0528.2011.03082.x. Epub 2011 Aug 22.

  PMID: 21864325 BACKGROUND

• Dietz HP. Ultrasound imaging of the pelvic floor. Part II: three-dimensional or volume imaging. Ultrasound Obstet Gynecol. 2004 Jun;23(6):615-25. doi: 10.1002/uog.1072.

  PMID: 15170808 BACKGROUND

MeSH Terms

Conditions

Prolapse

Interventions

Hysterectomy, Vaginal

Condition Hierarchy (Ancestors)

Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Hysterectomy; Gynecologic Surgical Procedures; Urogenital Surgical Procedures; Surgical Procedures, Operative

Central Study Contacts

Gerard Molina

CONTACT

+34937365050

Pilar Arcusa

CONTACT

+34937365050

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 8, 2024
• First Posted: May 8, 2024
• Study Start: July 1, 2024
• Primary Completion: January 1, 2025
• Study Completion: January 1, 2026
• Last Updated: January 17, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Data requests can be submitted starting 9 months after article publication and the data will be made accessible for up to 24 months. Extensions will be considered on a case-by-case basis
• Access Criteria: Access to trial IPD can be requested by qualified researchers engaging in independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA).

Locations

ES (1)