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A New Therapeutic Strategy for Urethral Sphincter Insufficiency

Primary Purpose

Stress Urinary Incontinence, Urethral Intrinsic Sphincter Deficiency

Status
Completed
Phase
Phase 1
Locations
France
Study Type
Interventional
Intervention
transplantation of the squeletic muscular cells
Sponsored by
Assistance Publique - Hôpitaux de Paris
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stress Urinary Incontinence focused on measuring Stress Urinary Incontinence, striated urethral sphincter insufficiency, myofibers, satellite cells, myotubes, urethral, Muscle fibres

Eligibility Criteria

40 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Men or women from 40 to 75 years old, suffering from urinary incontinence since at least 6 months and candidate for a surgical treatment (artificial urinary sphincter, synthetic compressive tapes or adjustable balloons).

The myofiber implantation procedure will be proposed after failure of pelvic floor exercises.

  • The observation of urine leakage during cough in consultation or during urodynamic (with absence of abnormal vesical contraction) and a score MHU > 2 (domain of stress urinary incontinence) will be considered as the main diagnostic criteria.
  • An urethral closure pressure lower than 40 cm H20 will be the main urodynamic diagnostic criterion

  • For women: a negative BONNEY test, and Qtip test<40° (c.f. annex) demonstrating the absence of vesica-urethral hypermobility.

    24 hours Pad test > 20g.

Exclusion Criteria:

  • Incapacity to answer the questionnaires of evaluation.
  • History of pelvic radiotherapy.
  • Disorder of hemostasis.
  • Untreated urinary infection.
  • Genetically determined or acquired muscular disease.
  • Neurological disorder (Parkinson's disease, multiple sclerosis, spina BIFIDA, medullary traumatism).
  • The patients suffering from stress urinary incontinence due to vesica-urethral hypermobility (positive BONNEY test and Qtip test >40°) will not be included in the study because the referenced treatment is the implantation of a vaginal tape supporting the urethra.
  • Incomplete vesical emptying. Residual volume > 20% of the urinated volume with a micturition >150cc.
  • Dysuria: maximum urinary flow < 12 ml/sec, IPSS score>7 or score (men) or MHU dysuria domain none equal to 0 at woman.
  • Vesical instability (bladder contraction > 10 cm H20 during the vesical filling of the cysto-manometry). bladder capacity (B3) < 300 DC.
  • Urethral Stenosis (ureterocystoscopy).
  • Previous surgeries for urinary incontinence do not constitute a criterion of exclusion.
  • Pregnancy or intention of pregnancy throughout study. A test of pregnancy will be carried out with the visit of inclusion.
  • Urethral diverticulum.

Sites / Locations

  • Hopital Henri Mondor service Urologie

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

A

Arm Description

transplantation of the squeletic muscular cells

Outcomes

Primary Outcome Measures

Clinical tolerance and feasibility of a new therapeutic strategy for stress urinary incontinence based on intra urethral myofiber implantation of autologous myofibers with their satellite cells

Secondary Outcome Measures

Effects of this treatment on urinary continence in order to consider a phase II later on.

Full Information

First Posted
May 10, 2007
Last Updated
May 4, 2011
Sponsor
Assistance Publique - Hôpitaux de Paris
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1. Study Identification

Unique Protocol Identification Number
NCT00472069
Brief Title
A New Therapeutic Strategy for Urethral Sphincter Insufficiency
Official Title
EVALUATION Of A NEW THERAPEUTIC STRATEGY FOR URETHRAL SPHINCTER INSUFFICIENCY BASED ON THE INTRA-URETHRAL IMPLANTATION OF AUTOLOGOUS MYOFIBERS WITH THEIR SATELLITE CELLS
Study Type
Interventional

2. Study Status

Record Verification Date
September 2007
Overall Recruitment Status
Completed
Study Start Date
April 2007 (undefined)
Primary Completion Date
February 2009 (Actual)
Study Completion Date
February 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Assistance Publique - Hôpitaux de Paris

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Stress urinary incontinence is a frequent condition that can be caused by urethral sphincter insufficiency and results in a dramatic deterioration of the quality of life. We developed a new therapeutic strategy for stress urinary incontinence based on the implantation myofibers with their satellite cells in the urethra. The aim of this procedure is to generate functional tissue acting like a new sphincter in the urethra
Detailed Description
stress urinary incontinence is a frequent condition that can be caused by urethral sphincter insufficiency and results in a dramatic deterioration of the quality of life. We developed a new therapeutic strategy for stress urinary incontinence based on the implantation myofibers with their satellite cells. The principle of this procedure relies on the activation in vivo of the satellite cells present around each myofibers. Satellite cell activation is concomitant with myofiber death that occurs after their implantation. Activated satellite proliferate and fuse to form myotubes replacing the parental myofibers thus leading to the reconstitution of the muscle mass that was initially implanted. Preliminary studies in the pig showed the regenerated muscle tissue in the urethra was innervated by urethral nerves and developed tonic contractions acting like a new sphincter. This procedure does not include a phase of satellite cell amplification ex vivo, as standard methods of satellite cell transfer, and rather relies on the natural myogenic capacities of these cells. Thus, the procedure of cell transfer into the urethra is considerably simplified and can be performed in one step in the operating room.This therapeutic strategy could represent an alternative to the artificial urinary sphincter.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stress Urinary Incontinence, Urethral Intrinsic Sphincter Deficiency
Keywords
Stress Urinary Incontinence, striated urethral sphincter insufficiency, myofibers, satellite cells, myotubes, urethral, Muscle fibres

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
A
Arm Type
Experimental
Arm Description
transplantation of the squeletic muscular cells
Intervention Type
Procedure
Intervention Name(s)
transplantation of the squeletic muscular cells
Intervention Description
transplantation of the squeletic muscular cells
Primary Outcome Measure Information:
Title
Clinical tolerance and feasibility of a new therapeutic strategy for stress urinary incontinence based on intra urethral myofiber implantation of autologous myofibers with their satellite cells
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Effects of this treatment on urinary continence in order to consider a phase II later on.
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Men or women from 40 to 75 years old, suffering from urinary incontinence since at least 6 months and candidate for a surgical treatment (artificial urinary sphincter, synthetic compressive tapes or adjustable balloons). The myofiber implantation procedure will be proposed after failure of pelvic floor exercises. The observation of urine leakage during cough in consultation or during urodynamic (with absence of abnormal vesical contraction) and a score MHU > 2 (domain of stress urinary incontinence) will be considered as the main diagnostic criteria. An urethral closure pressure lower than 40 cm H20 will be the main urodynamic diagnostic criterion For women: a negative BONNEY test, and Qtip test<40° (c.f. annex) demonstrating the absence of vesica-urethral hypermobility. 24 hours Pad test > 20g. Exclusion Criteria: Incapacity to answer the questionnaires of evaluation. History of pelvic radiotherapy. Disorder of hemostasis. Untreated urinary infection. Genetically determined or acquired muscular disease. Neurological disorder (Parkinson's disease, multiple sclerosis, spina BIFIDA, medullary traumatism). The patients suffering from stress urinary incontinence due to vesica-urethral hypermobility (positive BONNEY test and Qtip test >40°) will not be included in the study because the referenced treatment is the implantation of a vaginal tape supporting the urethra. Incomplete vesical emptying. Residual volume > 20% of the urinated volume with a micturition >150cc. Dysuria: maximum urinary flow < 12 ml/sec, IPSS score>7 or score (men) or MHU dysuria domain none equal to 0 at woman. Vesical instability (bladder contraction > 10 cm H20 during the vesical filling of the cysto-manometry). bladder capacity (B3) < 300 DC. Urethral Stenosis (ureterocystoscopy). Previous surgeries for urinary incontinence do not constitute a criterion of exclusion. Pregnancy or intention of pregnancy throughout study. A test of pregnancy will be carried out with the visit of inclusion. Urethral diverticulum.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
René YIOU, MD,PhD
Organizational Affiliation
Assistance Publique - Hôpitaux de Paris
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hopital Henri Mondor service Urologie
City
Creteil
ZIP/Postal Code
94010
Country
France

12. IPD Sharing Statement

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A New Therapeutic Strategy for Urethral Sphincter Insufficiency

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