Biological OviTex Versus Synthetic Graft in Robotic Prolapse Surgery
ProTex
1 other identifier
interventional
184
1 country
1
Brief Summary
This prospective study aims to assess the efficacy of the OviTex 1S permanent mesh in pelvic floor surgery in comparison with the current standard polypropylene mesh.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Dec 2023
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 6, 2023
CompletedFirst Submitted
Initial submission to the registry
May 2, 2024
CompletedFirst Posted
Study publicly available on registry
May 28, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
July 1, 2027
January 2, 2026
December 1, 2025
3.6 years
May 2, 2024
December 31, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Main study parameter/endpoint phase II: rate of complications
Post-operative complications. The Clavien Dindo Classification is used to rank the severity of a surgical complication
90days postoperative
Main study parameter/endpoint phase ll: number of participants with post-operative morbidity
Post-operative morbidity measured by reoperations, reinterventions, readmissions,
90days postoperative
Main study parameter/endpoint phase Ill: Pelvic Floor Distress lnventory-20 score (PFDl-20)
Constipation, incontinence and urogenital functioning (questionnaire, validated scoring system: Pelvic Floor Distress lnventory-20 (PFDl-20). The Pelvic Floor Distress Inventory-20 (PFDI-20) is a questionnaire used to assess the presence and severity of symptoms related to pelvic floor disorders. The PFDI-20 consists of 20 questions divided into three subscales: the Pelvic Organ Prolapse Distress Inventory (POPDI), the Colorectal-Anal Distress Inventory (CRADI), and the Urinary Distress Inventory (UDI). Scale Details: Minimum Score: 0 Maximum Score: 300 Interpretation: Higher scores indicate a worse outcome, reflecting greater distress or more severe symptoms.
24 months postoperative
Secondary Outcomes (13)
Constipation
24 months postoperative
Incontinence
24 months postoperative
Quality of life (Qol) pre- and postoperatively by the Patient Global Impression of Improvement (PGl-I).
24 months postoperative
Quality of life (Qol) pre- and postoperatively by the Patient Global Impression of Severity (PGl-S).
24 months postoperative
Quality of life (Qol) pre- and postoperatively by the European Quality of Life Five Dimension (EQ-5D).
24 months postoperative
- +8 more secondary outcomes
Study Arms (2)
Polypropylene mesh
ACTIVE COMPARATORPolypropylene mesh (Prolene, PMN3, Ethicon Inc Johnson \& Johnson, Amersfoort, The Netherlands; weight 78 g/m2)
OviTex 1S permanent mesh
EXPERIMENTALOviTex Reinforced BioScaffold, Permanent Polymer composed of ovine (sheep) forestomach extracellular matrix (ECM) and polypropylene.
Interventions
All procedures will be performed with robotic assistance of the da Vinci Si-HD (intuitive Surgical, Inc, Sunnyvale, CA).
All procedures will be performed with robotic assistance of the da Vinci Si-HD (intuitive Surgical, Inc, Sunnyvale, CA).
Eligibility Criteria
You may qualify if:
- Indication for VMR or SCR set by the treating surgeon/gynecologist in accordance to the current guidelines on rectal and pelvic prolapse;
- Counselled for therapeutic options and given informed consent for VMR or SCR;
- Counselled for different types of mesh (OviTex or Prolene) and randomisation;
- Written informed consent for randomisation, OviTex implant or Prolene;
- Written informed consent for observational data collection.
You may not qualify if:
- Mentally incompetent patients (unable to fulfil questionnaires).
- Allergy to ovine rumen.
- A medical history of pelvic radiation therapy.
- Scheduled for a redo-rectopexy.
- A medical history of previously implanted pelvic floor meshes or native tissue.
- Language barrier
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Meander Medical Centerlead
- Health Hollandcollaborator
Study Sites (1)
Meander Medisch Centrum
Amersfoort, Utrecht, 3813TZ, Netherlands
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Esther Consten, Prof.dr
Meander Medisch Centrum
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Clinical Professor
Study Record Dates
First Submitted
May 2, 2024
First Posted
May 28, 2024
Study Start
December 6, 2023
Primary Completion (Estimated)
July 1, 2027
Study Completion (Estimated)
July 1, 2027
Last Updated
January 2, 2026
Record last verified: 2025-12
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL
- Time Frame
- After publication of the primary study results.
De-identified individual participant data will be shared upon reasonable request after publication of the primary study results. Data will be available for academic research purposes, subject to approval of a research proposal and a data sharing agreement. Requests should be addressed to the principal investigator.