Prolapse; FemalePhase 2NCT06404931
Transvaginal Human Acellular Dermal Matrix for Prolapse Treatment
A Phase 2 study testing Vaginal hysterectomy plus matrix reinforcement and sacrospinous fixation with Anchorsure® device, Vaginal hysterectomy plus anterior colporrhaphy and Vaginal hysterectomy plus sacrospinous fixation with Anchorsure® device in people with Prolapse; Female and Prolapse Genital, run by Hospital Mutua de Terrassa at 1 site in Spain.
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. Read more about this study
- Who is it for?
- Ages 18 to 100 years, women only
- Conditions the study is for
- Prolapse; Female, Prolapse Genital, Prolapse Uterovaginal
- What is being tested?
- Vaginal hysterectomy plus matrix reinforcement and sacrospinous fixation with Anchorsure® device, Vaginal hysterectomy plus anterior colporrhaphy and Vaginal hysterectomy plus sacrospinous fixation with Anchorsure® device
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteSpain
- Study dates
- 1 Jul 2024to 1 Jan 2026
- Phase
- Phase 2
- 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 to 100 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Gerard Molina contact
Pilar Arcusa contact
Spain1 site, 1 recruiting
- Recruiting
Hospital Mutua de Terrassa
Terrassa, 08221
Gerard Molina, 937365050
About this study
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
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.
Read the detailed 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.
- Conditions
- Prolapse; Female, Prolapse Genital, Prolapse Uterovaginal
- Being tested
- Vaginal hysterectomy plus matrix reinforcement and sacrospinous fixation with Anchorsure® device, Vaginal hysterectomy plus anterior colporrhaphy, Vaginal hysterectomy plus sacrospinous fixation with Anchorsure® device
- Medical subject headings
- Prolapse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vaginal hysterectomy plus matrix reinforcement and sacrospinous fixation with Anchorsure® deviceProcedure or surgery
Vaginal hysterectomy plus matrix reinforcement and sacrospinous fixation with Anchorsure® device
Vaginal hysterectomy plus anterior colporrhaphyProcedure or surgery
Vaginal hysterectomy plus anterior colporrhaphy
Vaginal hysterectomy plus sacrospinous fixation with Anchorsure® deviceProcedure or surgery
Vaginal hysterectomy plus sacrospinous fixation with Anchorsure® device
| Study group | Role | What they receive |
|---|---|---|
| Vaginal hysterectomy plus anterior colporrhaphy | Sham comparator | Vaginal hysterectomy plus anterior colporrhaphy Receives: Procedure: Vaginal hysterectomy plus anterior colporrhaphy |
| Vaginal hysterectomy plus sacrospinous fixation with Anchorsure® device | Sham comparator | Vaginal hysterectomy plus sacrospinous fixation with Anchorsure® device Receives: 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 Receives: Procedure: Vaginal hysterectomy plus matrix reinforcement and sacrospinous fixation with Anchorsure® device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrence of anatomical anterior vaginal wall prolapse
Defined as point Ba POP-Q stage ≥II by clinical examination
Measured: 36 months
Secondary outcomes (8)
Difference between groups in anatomical prolapse
Defined as point C POP-Q stage ≥II by clinical examination
Measured: 36 moths
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
Measured: 36 months
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
Measured: 36 months
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
Measured: 36 months
Differences between groups in hospital stay
Evaluated by number of days of hospital stay
Measured: 36 months
Differences between groups in operative time
Evaluated by minutes of duration of surgery
Measured: 36 months
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
Measured: 36 months
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.
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2024
- Study start1 Jul 2024
- Primary completion1 Jan 2025
- Study completion1 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (22)Papers the sponsor has linked to this study.
- Other trials for Prolapse; FemaleStudies of the same condition, open and under way.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Mutua de Terrassa
- Sponsor type
- University, hospital or other
- Collaborators
- Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau, Germans Trias i Pujol Hospital, Hospital Arnau de Vilanova
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06404931
- Sponsor's protocol ID
- Mesh in prolapse treatment
- Status last verified
- Jan 2025
- First submitted
- 8 Mar 2024
- Last updated
- 17 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All IPD that underlie results in the publication
Publications
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.
PubMed 12072658Unger 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.
PubMed 26512439NHS Improvement, NHS England. Letter to Acute Trust CEOs and Medical Directors. 2018;(July 2017). Available from: www.england.nhs.uk
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.
PubMed 16799299Guo 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.
PubMed 28232031Menon 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.
PubMed 12792544Salzberg 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.
PubMed 21285756Griffey 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.
PubMed 11152992Botros 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.
PubMed 19533005Clemons 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.
PubMed 14710083Ward 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.
PubMed 18060976Chung 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.
PubMed 11927309Miklos 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.
PubMed 11999206Kohli 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.
PubMed 12851761Perez 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.
PubMed 34119882
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06404931
- Acronym / sponsor ID
- Mesh in prolapse treatment
- Conditions
- Prolapse; Female, Prolapse Genital, Prolapse Uterovaginal
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Hospital Mutua de TerrassaUniversity, hospital or other
- Collaborators
- Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau, Germans Trias i Pujol Hospital, Hospital Arnau de Vilanova
- Study start
- 1 Jul 2024 (actual)
- Primary completion
- 1 Jan 2025 (actual)
- Study completion
- 1 Jan 2026 (estimated)
- First posted
- 8 May 2024 (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 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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Vaginal hysterectomy plus anterior colporrhaphy | Sham comparator | Procedure: Vaginal hysterectomy plus anterior colporrhaphyVaginal hysterectomy plus anterior colporrhaphy |
| Vaginal hysterectomy plus sacrospinous fixation with Anchorsure® device | Sham comparator | Procedure: Vaginal hysterectomy plus sacrospinous fixation with Anchorsure® deviceVaginal hysterectomy plus sacrospinous fixation with Anchorsure® device |
| Vaginal hysterectomy plus matrix reinforcement and sacrospinous fixation with Anchorsure® device | Experimental | Procedure: Vaginal hysterectomy plus matrix reinforcement and sacrospinous fixation with Anchorsure® deviceVaginal hysterectomy plus matrix reinforcement and sacrospinous fixation with Anchorsure® device |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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
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 hysterectomy plus matrix reinforcement and sacrospinous fixation with Anchorsure® deviceVaginal hysterectomy plus matrix reinforcement and sacrospinous fixation with Anchorsure® device | Procedure or surgery | Vaginal hysterectomy plus matrix reinforcement and sacrospinous fixation with Anchorsure® device |
| Vaginal hysterectomy plus anterior colporrhaphyVaginal hysterectomy plus anterior colporrhaphy | Procedure or surgery | Vaginal hysterectomy plus anterior colporrhaphy |
| Vaginal hysterectomy plus sacrospinous fixation with Anchorsure® deviceVaginal hysterectomy plus sacrospinous fixation with Anchorsure® device | Procedure or surgery | Vaginal hysterectomy plus sacrospinous fixation with Anchorsure® device |
Primary outcome
Recurrence of anatomical anterior vaginal wall prolapse
Time frame: 36 months
Defined as point Ba POP-Q stage ≥II by clinical examination
8 secondary outcomes
Difference between groups in anatomical prolapse
Time frame: 36 moths
Differences between groups in symptomatic recurrence
Time frame: 36 months
Differences between groups in quality of Life
Time frame: 36 months
Differences between groups in sexual functioning.
Time frame: 36 months
Differences between groups in hospital stay
Time frame: 36 months
Differences between groups in operative time
Time frame: 36 months
Differences between groups in surgical complication rate.
Time frame: 36 months
Differences between groups in reintervention rate
Time frame: 36 months
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 17 Jan 2025.
- Background: PubMed 12072658Flynn 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.
- Background: PubMed 26512439Unger 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.
- BackgroundNHS Improvement, NHS England. Letter to Acute Trust CEOs and Medical Directors. 2018;(July 2017). Available from: www.england.nhs.uk
- Background: PubMed 16799299Salzberg 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.
- Background: PubMed 28232031Guo 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.
- Background: PubMed 12792544Menon 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.
- Background: PubMed 21285756Salzberg 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.
- Background: PubMed 11152992Griffey 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.
- Background: PubMed 19533005Botros 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.
- Background: PubMed 14710083Clemons 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.
- Background: PubMed 18060976Ward 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.
- Background: PubMed 11927309Chung 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.
- Individual participant dataSharing planned: Yes. All IPD that underlie results in the publication
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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.
Gerard Molina contact
Pilar Arcusa contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Vaginal hysterectomy plus matrix reinforcement and sacrospinous fixation with Anchorsure® device, Vaginal hysterectomy plus anterior colporrhaphy and Vaginal hysterectomy plus sacrospinous fixation with Anchorsure® device in people with Prolapse; Female and Prolapse Genital, run by Hospital Mutua de Terrassa at 1 site 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 5 inclusion and 5 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 17 Jan 2025. 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 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Gerard Molina (+34937365050), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recurrence of anatomical anterior vaginal wall prolapse (time frame: 36 months). 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 NCT06404931, which also lists 22 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 17 Jan 2025.