Urinary Incontinence by Intrinsic Sphincter DeficiencyIPSMANCT02606201
Peri-sphincter Injection of Autologous Myofibres to Treat of Urinary Incontinence by Sphincter Deficiency
A study testing Peri sphincter injection Autologous myofibers in people with Urinary Incontinence by Intrinsic Sphincter Deficiency, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Urinary Incontinence by Intrinsic Sphincter Deficiency
- What is being tested?
- Peri sphincter injection Autologous myofibers
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteFrance
- Study dates
- 20 Jan 2016to 6 Dec 2021
- Phase
- Interventional
- 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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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 locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Being tested
- Peri sphincter injection Autologous myofibers
- Keywords
- stress urinary incontinence, intrinsic sphincter deficiency, myofiber, autologous, skeletal muscle precursor cells, autologous serum
- 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.
Peri sphincter injection Autologous myofibersOther
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.
| Study group | Role | What they receive |
|---|---|---|
| IPSMA | Experimental | Injection Peri Sphincter Myofibers Autologous Receives: Other: Peri sphincter injection Autologous myofibers |
What is being measured
The primary outcome is the main question the study is designed to answer.
Step 1: Tolerance
- Tolerance: Serious adverse events grade 3 or more related to the procedure according to Data Safety and Monitoring Board (DSMB)
Measured: One year after treatment
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
Measured: One year after treatment
Secondary outcomes (9)
Occurrence of serious and non-serious adverse events
Measured: One year after treatment
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).
Measured: One year after treatment
Improvement of quality of life
Measured: One year after treatment
Response times
Measured: One year after treatment
Urodynamic evaluation
Leak Point Pressure (LPP), maximal urethral closure pressure (MUCP), area under the curve (profilometry), electromyogram (EMG) gives urodynamic evaluation
Measured: One year after treatment
Number of re-intervention required (conventional treatment after 6 months) to treat persistent urinary incontinence after IPSMA
Measured: 6 months after treatment
Patients with a reduction in the 24h pad test <50% at one year will be considered failure.
Measured: One year after treatment
Direct global cost of IPSMA surgery
Measured: One year after treatment
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).
Measured: One year after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2015 (estimated)
- Study start20 Jan 2016
- Primary completion6 Dec 2021
- Study completion6 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Urinary Incontinence by Intrinsic Sphincter DeficiencyStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- René YIOU, MD, PhD, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02606201
- Sponsor's protocol ID
- P130927
- Acronym
- IPSMA
- Status last verified
- May 2023
- First submitted
- 20 Oct 2015
- Last updated
- 19 May 2023
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No: DATAS ARE OWNED BY ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS, PLEASE CONTACT SPONSOR FOR FURTHER INFORMATION
Publications
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.
PubMed 23470219
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Peri-sphincter Injection of Autologous Myofibres to Treat of Urinary Incontinence by Sphincter Deficiency
- ClinicalTrials.gov ID
- NCT02606201
- Acronym / sponsor ID
- IPSMA / P130927
- Keywords
- stress urinary incontinence, intrinsic sphincter deficiency, myofiber, autologous, skeletal muscle precursor cells, autologous serum
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 20 Jan 2016 (actual)
- Primary completion
- 6 Dec 2021 (actual)
- Study completion
- 6 Dec 2021 (actual)
- First posted
- 17 Nov 2015 (estimated)
- 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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| IPSMA | Experimental | Other: Peri sphincter injection Autologous myofibersInjection Peri Sphincter Myofibers Autologous |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (12 listed)
- 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
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 |
|---|---|---|
| Peri sphincter injection Autologous myofibersThe 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. | Other | IPSMA |
Primary outcome
Step 1: Tolerance
Time frame: One year after treatment
- Tolerance: Serious adverse events grade 3 or more related to the procedure according to Data Safety and Monitoring Board (DSMB)
Step 1 and 2: Rate of patients responder at M12 after surgery
Time frame: One year after treatment
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
9 secondary outcomes
Occurrence of serious and non-serious adverse events
Time frame: One year after treatment
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).
Time frame: One year after treatment
Improvement of quality of life
Time frame: One year after treatment
Response times
Time frame: One year after treatment
Urodynamic evaluation
Time frame: One year after treatment
Number of re-intervention required (conventional treatment after 6 months) to treat persistent urinary incontinence after IPSMA
Time frame: 6 months after treatment
Patients with a reduction in the 24h pad test <50% at one year will be considered failure.
Time frame: One year after treatment
Direct global cost of IPSMA surgery
Time frame: One year after treatment
Healing times
Time frame: One year after treatment
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 19 May 2023.
- Results publication: PubMed 23470219Yiou 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.
- Individual participant dataSharing planned: No. DATAS ARE OWNED BY ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS, PLEASE CONTACT SPONSOR FOR FURTHER INFORMATION
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.
René YIOU, MD, PhD principal investigator
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Peri sphincter injection Autologous myofibers in people with Urinary Incontinence by Intrinsic Sphincter Deficiency, run by Assistance Publique - Hôpitaux de Paris at 1 site 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 7 inclusion and 12 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 19 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
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?
Step 1: Tolerance (time frame: One year after treatment). 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?
On the ClinicalTrials.gov record for NCT02606201, which also lists 1 linked publication.
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 19 May 2023.