Peri-sphincter Injection of Autologous Myofibres to Treat of Urinary Incontinence by Sphincter Deficiency (IPSMA)

Assistance Publique - Hôpitaux de Paris

Status: Completed

Conditions: Urinary Incontinence by Intrinsic Sphincter Deficiency

Treatments: Other: Peri sphincter injection Autologous myofibers

Study type: Interventional

Funder types: Other

Identifiers

NCT02606201

P130927

Details and patient eligibility

About

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.

Full description

The investigator chose an assessment method in 2 stages according to the Simon plane . A total of 38 patients are needed. Assuming a ratio of 10% of lost patients or for which the primary endpoint was not evaluable, 4 additional patients will be included totaling 42 patients will be included.

This trial is single-center for the first stage and multicenter for the second stage.

11 patients will be included in the first stage and 31 patients in the second stage.

Enrollment: 11 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Female.
• Age> or = 18 years.
• Patients with stress urinary incontinence by ISD for at least 6 months Failure of Pelvic floor 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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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11 participants in 1 patient group

IPSMA

Experimental group

Description:

Injection Peri Sphincter Myofibers Autologous

Treatment:

Other: Peri sphincter injection Autologous myofibers