Female Stress IncontinencePhase 2NCT05207189
Biological Sling Allograft (UVT) for the Treatment of Urinary Incontinence in Women Presenting With Synthetic Sling Complications
A Phase 2 study testing UVT in people with Female Stress Incontinence and Stress Urinary Incontinence, run by TBF Genie Tissulaire at 3 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 75 years, women only
- Conditions the study is for
- Female Stress Incontinence, Stress Urinary Incontinence
- What is being tested?
- UVT
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 3 sitesFrance
- Study dates
- 8 Nov 2021to 28 Mar 2024
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
- 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.
Who cannot join
- 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.
Trial locations and contacts
3 sites in 1 country.
France3 sites
Hôtel-Dieu, CHU de Nantes
Nantes, 44000
Hôpital de la Pitié-Salpêtrière, Assistance Publique des Hôpitaux de Paris
Paris, 75013
Hôpital Lyon Sud, Hospices Civils de Lyon
Pierre-Bénite, 69310
About this study
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
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.
Read the 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.
- Being tested
- UVT
- Medical subject headings
- Urinary Incontinence, Stress
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UVTBiological
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.
| Study group | Role | What they receive |
|---|---|---|
| UVT | Experimental | Biological sling used as a replacement of the synthetic sling. Receives: Biological: UVT |
What is being measured
The primary outcome is the main question the study is designed to answer.
No major signs of incontinence
Use of less than 2 pads a day
Measured: 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
Measured: 6 months
Secondary outcomes (6)
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
Measured: 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)
Measured: 15 days, 6 weeks, 3 months, 6 months, 12 months
Progressive recuperation of continence
Continence evaluated by uroflow test and 3-day voiding diary
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 6 weeks, 3 months, 6 months, 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2022
- Study start8 Nov 2021
- Primary completion28 Mar 2024
- Study completion28 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Female Stress IncontinenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- TBF Genie Tissulaire
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05207189
- Sponsor's protocol ID
- UVT-TBF1
- Other IDs
- 2020-A02983-36
- Status last verified
- Jun 2024
- First submitted
- 28 Dec 2021
- Last updated
- 5 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05207189
- Acronym / sponsor ID
- UVT-TBF1
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- TBF Genie TissulaireIndustry (pharma, biotech, devices)
- Study start
- 8 Nov 2021 (actual)
- Primary completion
- 28 Mar 2024 (actual)
- Study completion
- 28 Mar 2024 (actual)
- First posted
- 26 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| UVT | Experimental | Biological: UVTBiological sling used as a replacement of the synthetic sling. |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| UVTChemically-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. | Biological | UVT |
Primary outcome
No major signs of incontinence
Time frame: 6 months
Use of less than 2 pads a day
No complication related to investigational product
Time frame: 6 months
Evaluation of urinary retention, dysuria, local inflammation, irritation of suture and suspension areas, and other indirect symptoms
6 secondary outcomes
Decrease of the signs of complications of the first surgery
Time frame: 15 days, 6 weeks, 3 months, 6 months, 12 months
Decrease of pain and analgesic consumption
Time frame: 15 days, 6 weeks, 3 months, 6 months, 12 months
Progressive recuperation of continence
Time frame: 15 days, 6 weeks, 3 months, 6 months, 12 months
Decrease of Urinary Incontinence (UI) severity
Time frame: 6 weeks, 3 months, 6 months, 12 months
Decrease of distress caused by UI symptoms
Time frame: 6 weeks, 3 months, 6 months, 12 months
Improvement of health-related quality of life
Time frame: 6 weeks, 3 months, 6 months, 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing UVT in people with Female Stress Incontinence and Stress Urinary Incontinence, run by TBF Genie Tissulaire at 3 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
No major signs of incontinence (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jun 2024.