A Phase 2 interventional study of Vaginal hysterectomy plus matrix reinforcement and sacrospinous fixation with Anchorsure® device and Vaginal hysterectomy plus anterior colporrhaphy in Prolapse; Female, Prolapse Genital and Prolapse Uterovaginal, sponsored by Hospital Mutua de Terrassa. Recruiting at 1 site in Spain. Open to female participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2025-01-17.
Sponsored by Hospital Mutua de Terrassa · Phase 2, Interventional, and Treatment
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.
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.
93 studies on the registry are indexed under Prolapse; 9 are open to participants now.
This study's planned enrollment of 90 is above the median of 70 across 65 interventional studies indexed under Prolapse.
Browse Prolapse studies →Hospital Mutua de Terrassa is the lead sponsor of 35 studies on the registry; 12 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Vaginal hysterectomy plus anterior colporrhaphy
Procedure: 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 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
Vaginal hysterectomy plus sacrospinous fixation with Anchorsure® device
Recurrence of anatomical anterior vaginal wall prolapse
Defined as point Ba POP-Q stage ≥II by clinical examination
Time frame: 36 months
Difference between groups in anatomical prolapse
Defined as point C POP-Q stage ≥II by clinical examination
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 36 months
Differences between groups in hospital stay
Evaluated by number of days of hospital stay
Time frame: 36 months
Differences between groups in operative time
Evaluated by minutes of duration of surgery
Time frame: 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
Time frame: 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.
Time frame: 36 months
Plan to share: Yes — All IPD that underlie results in the publication
Supporting information: Study protocol, Statistical analysis plan, Informed consent form
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).
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