Status:
COMPLETED
Biological Sling Allograft (UVT) for the Treatment of Urinary Incontinence in Women Presenting With Synthetic Sling Complications
Lead Sponsor:
TBF Genie Tissulaire
Conditions:
Female Stress Incontinence
Stress Urinary Incontinence
Eligibility:
FEMALE
40-75 years
Phase:
PHASE2
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 treatme...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 8 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 28 2024
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT05207189
Start Date
November 8 2021
End Date
March 28 2024
Last Update
June 5 2024
Active Locations (3)
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1
Hôtel-Dieu, CHU de Nantes
Nantes, France, 44000
2
Hôpital de la Pitié-Salpêtrière, Assistance Publique des Hôpitaux de Paris
Paris, France, 75013
3
Hôpital Lyon Sud, Hospices Civils de Lyon
Pierre-Bénite, France, 69310