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

NCT ID: NCT02606201

Last Updated: 2023-05-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 11 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-01-20
• Study Completion Date: 2021-12-06

Brief Summary

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.

Detailed 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.

Conditions

Urinary Incontinence by Intrinsic Sphincter Deficiency

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

IPSMA

Injection Peri Sphincter Myofibers Autologous

Group Type: EXPERIMENTAL

Peri sphincter injection Autologous myofibers

Intervention Type: OTHER

The first step of the procedure consists to harvest a muscle fragment from the lower part of the rectus abdominis muscle of the abdomen approached by a short incision. Injectable myofiber cores will be prepared by hydrodissection of the muscle biopsy.

All myofibers cores will be suspended in autologous serum prepared by centrifugation before the incision.

During the second step of the procedure, the myofibers will be injected percutaneously into the peri-sphincter region under endoscopic and radiographic control.

Interventions

Peri sphincter injection Autologous myofibers

The first step of the procedure consists to harvest a muscle fragment from the lower part of the rectus abdominis muscle of the abdomen approached by a short incision. Injectable myofiber cores will be prepared by hydrodissection of the muscle biopsy.

All myofibers cores will be suspended in autologous serum prepared by centrifugation before the incision.

During the second step of the procedure, the myofibers will be injected percutaneously into the peri-sphincter region under endoscopic and radiographic control.

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

René YIOU, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Assistance Publique - Hôpitaux de Paris

Locations

Henri Mondor Hospital

Créteil, , France

Countries

France

References

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. 2013 Jun;111(7):1105-16. doi: 10.1111/j.1464-410X.2012.11682.x. Epub 2013 Mar 7.

Reference Type: RESULT

PMID: 23470219 (View on PubMed)

Other Identifiers

P130927

Identifier Type: -

Identifier Source: org_study_id