Back to resultsBiological Sling Allograft (UVT) for the Treatment of Urinary Incontinence in Women Presenting With Synthetic Sling Complications
Primary Purpose
Female Stress Incontinence, Stress Urinary Incontinence
Status
Active
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
UVT
Sponsored by
About this trial
This is an interventional treatment trial for Female Stress Incontinence
Eligibility Criteria
Inclusion Criteria:
- Women over 40 years of age and under 75 years of age.
- Failure of primary surgical technique with synthetic sling requiring its removal due to complications such as vaginal exposure or urinal tract erosion.
- Inclusion more than 3 months after primary surgery.
- Any fistula or abnormality of the urinary tract, any erosion or complication due to the synthetic sling placement must be repaired during surgery. In case of persistence of complication or limited possibility to insert the UVT due to major vesical or urethral lesion, the patient will not be included.
- Patients with controlled urinal tract infections.
- Patients who received the study information and provided consent.
- Patients who are members or the beneficiary of a national health insurance plan.
Exclusion Criteria:
- Breast feeding women or women without effective contraception. In absence of effective contraception, a pregnancy test followed by an effective contraception are mandatories for non-menopausal women.
- Patients with mild cases treated by physiotherapy and pelvic floor exercises for urinary incontinence or without surgical complications.
- Patients with current urinary infection, severe anemia or other pathologies that counter-indicate surgery.
- Cystocele and rectocele not treated during the surgery.
- Persons under guardianship or confined by a judicial or administrative decision.
- Patients unable to have discernment for rehabilitation, unable to perform follow-up or unable to provide their consent.
Sites / Locations
- Hôtel-Dieu, CHU de Nantes
- Hôpital de la Pitié-Salpêtrière, Assistance Publique des Hôpitaux de Paris
- Hôpital Lyon Sud, Hospices Civils de Lyon
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
UVT
Arm Description
Biological sling used as a replacement of the synthetic sling.
Outcomes
Primary Outcome Measures
No major signs of incontinence
Use of less than 2 pads a day
No complication related to investigational product
Evaluation of urinary retention, dysuria, local inflammation, irritation of suture and suspension areas, and other indirect symptoms
Secondary Outcome Measures
Decrease of the signs of complications of the first surgery
Monitoring of urinary retention, dysuria, local inflammation, irritation of suture and suspension areas, and other indirect symptoms
Decrease of pain and analgesic consumption
Pain evaluated from 0: no pain to 10: worst imaginable pain on visual analog scale (VAS)
Progressive recuperation of continence
Continence evaluated by uroflow test and 3-day voiding diary
Decrease of Urinary Incontinence (UI) severity
Decrease in the score of the International Consultation on Incontinence Questionnaire - Urinary Incontinence - Short Form (ICIQ-UI-SF) (0 = no UI, 21 = very severe UI)
Decrease of distress caused by UI symptoms
Decrease of the Urogenital Distress Inventory (UDI-6) score (0 = no distress caused by UI symptoms, 100 = highest possible distress cause by UI symptoms)
Improvement of health-related quality of life
Decrease of the Incontinence Impact Questionnaire (IIQ-7) score (0 = no impact of UI on health-related quality of life, 100 = highest possible impact of UI on health-related quality of life)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05207189
Brief Title
Biological Sling Allograft (UVT) for the Treatment of Urinary Incontinence in Women Presenting With Synthetic Sling Complications
Official Title
Phase II Study Evaluating the Treatment of Women Urinary Incontinence by Suburethral Slings; UVT Allograft; in Patients Presenting With Complication of the Synthetic Sling Treatment
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
November 8, 2021 (Actual)
Primary Completion Date
April 2024 (Anticipated)
Study Completion Date
April 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
TBF Genie Tissulaire
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this open, multi center trial is to evaluate a new biological replacement for synthetic slings in the treatment of female stress urinary incontinence.
Detailed Description
It was estimated that more than 9 million French people are affected by urinary incontinence, of which 1% are treated surgically. Indeed, if medical treatment or rehabilitation fails, surgical treatment must be considered. Sling implantation is a commonly used surgical technique to treat stress urinary incontinence as it allows for a reduction in surgery time and morbidity and can be placed under local anesthesia. However, the risk of complications associated with the use of synthetic products is high and contributes to the recent decline of popularity of synthetic slings. As the demand for incontinence treatment remains high, fascia autograft surgeries are being proposed, even though they require an additional surgical procedure and expose the patient to complications at the donor site of the graft.
The study product aims to address the growing need for a safer but equally effective implant to avoid autografting while keeping the standard surgical technique.
The aim of this exploratory study is to evaluate a biological sling replacement to failed synthetic slings in the treatment of female stress urinary incontinence.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Female Stress Incontinence, Stress Urinary Incontinence
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
16 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
UVT
Arm Type
Experimental
Arm Description
Biological sling used as a replacement of the synthetic sling.
Intervention Type
Biological
Intervention Name(s)
UVT
Intervention Description
Chemically-treated, viro-inactivated, freeze-dried and irradiated umbilical vein allograft placed in replacement of a failed synthetic sling during a surgical act performed by the investigator.
Primary Outcome Measure Information:
Title
No major signs of incontinence
Description
Use of less than 2 pads a day
Time Frame
6 months
Title
No complication related to investigational product
Description
Evaluation of urinary retention, dysuria, local inflammation, irritation of suture and suspension areas, and other indirect symptoms
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Decrease of the signs of complications of the first surgery
Description
Monitoring of urinary retention, dysuria, local inflammation, irritation of suture and suspension areas, and other indirect symptoms
Time Frame
15 days, 6 weeks, 3 months, 6 months, 12 months
Title
Decrease of pain and analgesic consumption
Description
Pain evaluated from 0: no pain to 10: worst imaginable pain on visual analog scale (VAS)
Time Frame
15 days, 6 weeks, 3 months, 6 months, 12 months
Title
Progressive recuperation of continence
Description
Continence evaluated by uroflow test and 3-day voiding diary
Time Frame
15 days, 6 weeks, 3 months, 6 months, 12 months
Title
Decrease of Urinary Incontinence (UI) severity
Description
Decrease in the score of the International Consultation on Incontinence Questionnaire - Urinary Incontinence - Short Form (ICIQ-UI-SF) (0 = no UI, 21 = very severe UI)
Time Frame
6 weeks, 3 months, 6 months, 12 months
Title
Decrease of distress caused by UI symptoms
Description
Decrease of the Urogenital Distress Inventory (UDI-6) score (0 = no distress caused by UI symptoms, 100 = highest possible distress cause by UI symptoms)
Time Frame
6 weeks, 3 months, 6 months, 12 months
Title
Improvement of health-related quality of life
Description
Decrease of the Incontinence Impact Questionnaire (IIQ-7) score (0 = no impact of UI on health-related quality of life, 100 = highest possible impact of UI on health-related quality of life)
Time Frame
6 weeks, 3 months, 6 months, 12 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Women over 40 years of age and under 75 years of age.
Failure of primary surgical technique with synthetic sling requiring its removal due to complications such as vaginal exposure or urinal tract erosion.
Inclusion more than 3 months after primary surgery.
Any fistula or abnormality of the urinary tract, any erosion or complication due to the synthetic sling placement must be repaired during surgery. In case of persistence of complication or limited possibility to insert the UVT due to major vesical or urethral lesion, the patient will not be included.
Patients with controlled urinal tract infections.
Patients who received the study information and provided consent.
Patients who are members or the beneficiary of a national health insurance plan.
Exclusion Criteria:
Breast feeding women or women without effective contraception. In absence of effective contraception, a pregnancy test followed by an effective contraception are mandatories for non-menopausal women.
Patients with mild cases treated by physiotherapy and pelvic floor exercises for urinary incontinence or without surgical complications.
Patients with current urinary infection, severe anemia or other pathologies that counter-indicate surgery.
Cystocele and rectocele not treated during the surgery.
Persons under guardianship or confined by a judicial or administrative decision.
Patients unable to have discernment for rehabilitation, unable to perform follow-up or unable to provide their consent.
Facility Information:
Facility Name
Hôtel-Dieu, CHU de Nantes
City
Nantes
ZIP/Postal Code
44000
Country
France
Facility Name
Hôpital de la Pitié-Salpêtrière, Assistance Publique des Hôpitaux de Paris
City
Paris
ZIP/Postal Code
75013
Country
France
Facility Name
Hôpital Lyon Sud, Hospices Civils de Lyon
City
Pierre-Bénite
ZIP/Postal Code
69310
Country
France
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Biological Sling Allograft (UVT) for the Treatment of Urinary Incontinence in Women Presenting With Synthetic Sling Complications
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