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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
16
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.
Hôtel-Dieu, CHU de Nantes
Nantes, France
Hôpital de la Pitié-Salpêtrière, Assistance Publique des Hôpitaux de Paris
Paris, France
Hôpital Lyon Sud, Hospices Civils de Lyon
Pierre-Bénite, France
No major signs of incontinence
Use of less than 2 pads a day
Time frame: 6 months
No complication related to investigational product
Evaluation of urinary retention, dysuria, local inflammation, irritation of suture and suspension areas, and other indirect symptoms
Time frame: 6 months
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
Time frame: 15 days, 6 weeks, 3 months, 6 months, 12 months
Decrease of pain and analgesic consumption
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
Progressive recuperation of continence
Continence evaluated by uroflow test and 3-day voiding diary
Time frame: 15 days, 6 weeks, 3 months, 6 months, 12 months
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)
Time frame: 6 weeks, 3 months, 6 months, 12 months
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)
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Time frame: 6 weeks, 3 months, 6 months, 12 months
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)
Time frame: 6 weeks, 3 months, 6 months, 12 months