Urinary Incontinence by Intrinsic Sphincter Deficiency Clinical Trial
— IPSMAOfficial title:
Peri-sphincter Injection of Autologous Myofibres to Treat of Urinary Incontinence by Sphincter Deficiency
| Verified date | May 2023 |
| Source | Assistance Publique - Hôpitaux de Paris |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
Stress urinary incontinence related to intrinsic sphincter deficiency (ISD) is a severe form of incontinence that may have a major impact on the quality of life. The main treatment is surgical and consists in the implantation of medical devices such as the artificial urinary sphincter, adjustable continence therapy, compressive sling, or injection of bulking agent. The investigator has developed a new therapeutic strategy for ISD that consist to implant myofibers with their attached satellite cells (the main source of muscle progenitor cells) at the vicinity of the striated urethral sphincter. The principle of this method relies on the in vivo activation of satellite cells leading to the formation of regenerated myofibers (myotubes) generating a distinct and tonic muscular activity . The proof of concept was investigated in a Phase I clinical trial: Investigator found that the periurethral implantation of myofiber strips around the urethra generated an electromyographic activity improving urethral closure pressure in women with severe urinary incontinence associated to ISD. In this previous study, the technique of myofiber implantation was invasive, as it required a surgical approach and dissection of the urethra to place the myofiber. For the clinical trial IPSMA, the investigator sought to optimize the myofiber transplantation process using a method injection of myofibers core obtained by hydro-dissection. The injection technique is performed percutaneously under fluoroscopic and endoscopic control and does not require a surgical approach of the urethra. This clinical trial is prospective, open-label, non-randomized, uncontrolled, single-center for the first stage and multicenter for the second stage, of 13 months for each patient aims to assess the efficacy and safety of IPSMA in the treatment of urinary incontinence in women with ISD.
| Status | Completed |
| Enrollment | 11 |
| Est. completion date | December 6, 2021 |
| Est. primary completion date | December 6, 2021 |
| Accepts healthy volunteers | No |
| Gender | Female |
| Age group | 18 Years and older |
| Eligibility | Inclusion Criteria: - Female. - Age> or = 18 years. - Patients with stress urinary incontinence by ISD for at least 6 months Failure of Pelvic ?oor muscle training (at least 20 sessions). - Fixed urethra : a negative Ulmsten test / Qtip test <30 ° - 24h Pad test >50 g - Urodynamic criteria: LPP (leak points pressure) <100 cm H20 and MUCP <50 cm H2O replaced by Urodynamic criteria: MUCP <50 cm H2O (amendment n°3) - Collection of informed written consent Exclusion Criteria: - Not affiliated to a social security scheme - Trouble hemostasis known - Untreated urinary tract infection - Muscle disease genetically determined or acquired - Patients with urinary incontinence by vesica-urethral hypermobility - Incomplete bladder emptying: post void residual> 20% of the volume voided during urination> 150cc - Maximum urinary flow rate <12 ml / sec replaced by maximum urinary flow rate <12 ml / sec for volume urinated during urination > 150cc (amendment n°3) - overactive bladder - Bladder capacity (B3) <200 cc (deleted in amendment n°3) - Urethral stricture - Anticoagulant therapy that cannot be replaced by a low molecular weight heparin - Pregnant or intend to become pregnant during the study period or breastfeeding informed by the patient during the consultation. |
| Country | Name | City | State |
|---|---|---|---|
| France | Henri Mondor Hospital | Creteil |
| Lead Sponsor | Collaborator |
|---|---|
| Assistance Publique - Hôpitaux de Paris |
France,
Yiou R, Hogrel JY, Loche CM, Authier FJ, Lecorvoisier P, Jouany P, Roudot-Thoraval F, Lefaucheur JP. Periurethral skeletal myofibre implantation in patients with urinary incontinence and intrinsic sphincter deficiency: a phase I clinical trial. BJU Int. 2 — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Step 1: Tolerance | - Tolerance: Serious adverse events grade 3 or more related to the procedure according to Data Safety and Monitoring Board (DSMB) | One year after treatment | |
| Primary | Step 1 and 2: Rate of patients responder at M12 after surgery | Efficiency: Response is defined by an improvement in 24h pad weight as greater than 50% reduction from baseline and improvement in the number of incontinence episodes per day as greater than 50% reduction from baseline | One year after treatment | |
| Secondary | Occurrence of serious and non-serious adverse events | One year after treatment | ||
| Secondary | Proportion of patients cured at M12. patients are considered as cured if: - The absence of pad use, a 24h pad test <2g AND - The absence of urinary leakage reported in the voiding diary (3 consecutive days). | One year after treatment | ||
| Secondary | Improvement of quality of life | One year after treatment | ||
| Secondary | Response times | One year after treatment | ||
| Secondary | Urodynamic evaluation | Leak Point Pressure (LPP), maximal urethral closure pressure (MUCP), area under the curve (profilometry), electromyogram (EMG) gives urodynamic evaluation | One year after treatment | |
| Secondary | Number of re-intervention required (conventional treatment after 6 months) to treat persistent urinary incontinence after IPSMA | 6 months after treatment | ||
| Secondary | Patients with a reduction in the 24h pad test <50% at one year will be considered failure. | One year after treatment | ||
| Secondary | Direct global cost of IPSMA surgery | One year after treatment | ||
| Secondary | Healing times | Defined by :
The absence of pad use, a 24h pad test <2g AND The absence of urinary leakage reported in the voiding diary (3 consecutive days). |
One year after treatment |