Transvaginal Human Acellular Dermal Matrix for Prolapse Treatment

Prolapse; Female Clinical Trial

Official title:

Transvaginal Human Acellular Dermal Matrix and Sacrospinous Fixation for Anterior and Apical Prolapse Treatment in Patients With Hiatal Ballooning or Levator Ani Injury: a Randomized Pilot Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06404931
• Other study ID #: Mesh in prolapse treatment
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: May 1, 2024
• Est. completion date: January 1, 2026

Study information

• Verified date: May 2024
• Source: Hospital Mutua de Terrassa
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Eligible patients will be women with symptomatic anterior and apical prolapse with hiatal ballooning or levator ani injury eligible for vaginal surgical treatment.

At the time of the indication for surgery, anatomical severity of the prolapse (according to the Pelvic Organ Prolapse Quantification System (POP-Q) scale) and the symptoms of prolapse and sexual function, as well as their impact on the quality of life of the patient, are evaluated using validated questionnaires "Pelvic Floor Impact Questionnaire (PFIQ)", "Pelvic organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-12)"and "European Quality of Life-5 Dimensions Questionnaire (EQ5D)". Anatomical severity of the prolapse will be also evaluated by ecography described as follows.

Three-dimensional 3D/4D transperineal ultrasound (TPS) will be performed using a GE Voluson® ultrasound system (GE Medical Systems) with a RAB 8-4-MHz transducer at an acquisition angle of 85°.

TPS will be performed with the probe covered with a powder-free glove and applied in the midsagittal plane to the introitus using moderate pressure. Volumes are acquired at rest, on maximum pelvic floor muscle contractility and during maximal Valsalva maneuver. Patients perform Valsalva for at least 5 s, and the best of three volumes is used for analysis. Using visual biofeedback, an attempt is made to correct for levator co-activation by requesting the women observe the narrowing and widening of the levator hiatus during the maneuvers.

3D volumes are measured offline using GE 4 Dimension View (GE Medical Systems). Using the best Valsalva maneuver, pelvic organ descent measurements are obtained relative to a horizontal line from the inferior margin of the pubic symphysis. Levator hiatal area is assessed in the plane of minimal hiatal dimensions.

Surgical indication will be determined by gynaecologists and the decision will be clearly dissociated from the decision of study inclusion. Therefore, the performance of the study should not modify the habits of surgical indication by the doctors.

The study will be a single-blinded study, as it is impossible to blind the health care workers involved for the surgical procedure to which the woman is randomized. The physician evaluating the patients during the follow-up will be blinded about the group the patients were randomized to.

Women will be randomly assigned after consenting for participation in the study, by means of an interactive response technology system in a 1:1:1 ratio to receive surgical treatment with vaginal hysterectomy followed by hADM anterior reinforcement and sacrospinous fixation with Anchorsure® device (NeomedicTM International, Spain), vaginal hysterectomy followed by sacrospinous fixation with Anchorsure® alone or classic vaginal hysterectomy with anterior colporrhaphy. A sacrospinous fixation-alone group was included to assess the impact of this technique in the principal surgery group. Patients will be followed-up at 4 weeks, 6 months, 12 months and annually till 36 months.

Anatomical results will be evaluated by a member of the team blinded to the surgery performed during follow-up visits after surgery and by 3D ultrasound of the pelvic floor. Functional results are evaluated using the validated questionnaires performed prior to surgery done by the patients during follow-up visits after surgery.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 90
• Est. completion date: January 1, 2026
• Est. primary completion date: January 1, 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 100 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Prolapse
• Prolapse Genital
• Prolapse; Female

Intervention

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
Vaginal hysterectomy plus anterior colporrhaphy
• Vaginal hysterectomy plus sacrospinous fixation with Anchorsure® device
Vaginal hysterectomy plus sacrospinous fixation with Anchorsure® device

Locations

Country	Name	City	State
n/a

Sponsors (4)

Lead Sponsor	Collaborator
Hospital Mutua de Terrassa	Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau, Germans Trias i Pujol Hospital, Hospital Arnau de Vilanova

References & Publications (22)

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. Erratum In: N Engl J Med. 2013 Jan 24;368(4):394. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. Erratum In: Ann Plast Surg. 2003 Aug;51(2):228. — View Citation

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. — View Citation

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

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 22 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recurrence of anatomical anterior vaginal wall prolapse	Defined as point Ba POP-Q stage =II by clinical examination	36 months
Secondary	Difference between groups in anatomical prolapse	Defined as point C POP-Q stage =II by clinical examination	36 moths
Secondary	Differences between groups in symptomatic recurrence	Evaluated by Pelvic Floor Impact Questionnaire. Minimum value: 0. Maximum value: 300. The higher the value worse is the outcome	36 months
Secondary	Differences between groups in quality of Life	Evaluated by European Quality of Life-5 Dimensions Questionnaire. Minimum value: 0. Maximum value: 1. The higher the value the worse is the outcome	36 months
Secondary	Differences between groups in sexual functioning.	Evaluated by Pelvic organ Prolapse/Urinary Incontinence Sexual Questionnaire. Minimum value: 0. Maximum value: 100. The higher the value the worse is the outcome	36 months
Secondary	Differences between groups in hospital stay	Evaluated by number of days of hospital stay	36 months
Secondary	Differences between groups in operative time	Evaluated by minutes of duration of surgery	36 months
Secondary	Differences between groups in surgical complication rate.	Monitoring of development of hematoma, urologic lesion, need for blood transfusion, suture dehiscence, pain, infection and mesh extrusion	36 months
Secondary	Differences between groups in reintervention rate	Reintervention will be done in cases of symptomatic recurrence of the compartment previously treated or development of another prolapse.	36 months