Stress Urine IncontinencyPhase 2NCT02156934
Paraurethral Transplantation of Autologous Muscle Derived Stem Cells for Treatment of Stress Incontinency
A Phase 2 study testing paraurethral injection in people with Stress Urine Incontinency, run by Royan Institute at 1 site in Iran.
Trial summary
This study was designed to provide confirmation of efficacy of muscle derived stem cells (MDCs) for the treatment of SUI in women. Read more about this study
- Who is it for?
- Ages 40 to 60 years, women only
- Conditions the study is for
- Stress Urine Incontinency
- What is being tested?
- paraurethral injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteIran
- Study dates
- Jan 2014to Dec 2015
- Phase
- Phase 2
- 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 40 to 60 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Female
- Stress Urinary Incontinence symptoms
- Urodynamic stress incontinence confirmed with multichannel urodynamic testing
- positive cough stress test
- urgency score < stress score
- Patient's age between 40 - 65 years
- Desire to surgical correction of stress urinary incontinence or inadequate response to conservative treatment of SUI
Who cannot join
- Post-void residual volume >100cc
- Detrusor overactivity on preoperative multichannel urodynamic testing
- History of previous synthetic, biologic or fascial sub-urethral sling or any other surgery on external genitalia, bladder neck, bladder or urethra
- Desires future childbearing
- Chronic inguinal or vulvar abscess or history of Hidradenitis Suppurative
- History of bleeding diathesis or current anti-coagulation therapy
Show all 15Show fewer
- Inguinal lymphadenopathy or inguinal/vulvar mass
- Current genitourinary fistula or urethral diverticulum
- Current sever cystocele or rectocele
- Active urinary infection
- Non-treated urge incontinency or any significant voiding dysfunction
- Neuromuscular disorders
- Uncontrolled Diabetes
- Reversible cause of incontinence (i.e. drug effect)
- Contraindications for surgery
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation the Effect of Autologous Muscle Derived Stem Cells Injection Into the Paraurethral Tissues for Treatment of Stress Urinary Incontinency,The Randomized Clinical Trial Phase II
This study was designed to provide confirmation of efficacy of muscle derived stem cells (MDCs) for the treatment of SUI in women.
Read the detailed description
The investigators will be assessed the 12-month potential efficacy of autologous muscle derived cells as therapy for stress urinary incontinence. A total of 20 women in whom stress urinary incontinence had not improved underwent intra-sphincter injection of low doses 50×106 of autologous muscle derived cells, which will be derived from biopsies of their deltoid muscle. Assessments will be made at 1, 3, 6 and 12 months after cell injection. Changes in stress urinary incontinence severity were evaluated by pad test, diary of incontinence episodes and quality of life surveys.
- Conditions
- Stress Urine Incontinency
- Being tested
- paraurethral injection
- Keywords
- autologous stress urinary incontinence muscle derived cells
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
paraurethral injectionBiological
Paraurethral injection of muscle derived stem cell in patients with stress urine incontinency.
| Study group | Role | What they receive |
|---|---|---|
| Muscle derived stem cell | Experimental | Paraurethral injection of muscle derived stem cell in patients with stress urine incontinency. Receives: Biological: paraurethral injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
24hr voiding diary reduction
Evaluation the 24hr voiding diary reduction by patient questionnaire 2hr pad test and cystourethroscopy and urodynamic.
Measured: 1 month
Secondary outcomes (1)
incontinence quality of life (I-Qol)
Evaluation the increasing of incontinence quality of life (I-Qol) by questionnaire form.
Measured: 1month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2014 (estimated)
- Study startJan 2014
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stress Urine IncontinencyStudies of the same condition, open and under way.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Royan Institute
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Hamid Gourabi, PhD, Study chair, Head of Royan InstituteNasser Aghdami, MD,PhD, Study director, Head of Department of Regenerative Medicine & Cell therapy center of Royan InstituteFarzaneh Sharifiaghdas, MD, Study director, Urology and Nephrology Research Center, Shahid Beheshti University of Medical SciencesFarshad Zohrabi, MD, Principal investigator, Urology and Nephrology Research Center, Shahid Beheshti University of Medical SciencesReza Moghadasali, PhD, Principal investigator, Department of Regenerative Medicine And Royan Cell Therapy Center Royan Institute For stem Cell Biology and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02156934
- Sponsor's protocol ID
- Royan-Kidney-002
- Status last verified
- Oct 2013
- First submitted
- 2 Jun 2014
- Last updated
- 4 Dec 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation the Effect of Autologous Muscle Derived Stem Cells Injection Into the Paraurethral Tissues for Treatment of Stress Urinary Incontinency,The Randomized Clinical Trial Phase II
- ClinicalTrials.gov ID
- NCT02156934
- Acronym / sponsor ID
- Royan-Kidney-002
- Conditions
- Stress Urine Incontinency
- Keywords
- autologous stress urinary incontinence muscle derived cells
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Royan InstituteOther government
- Study start
- Jan 2014
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 5 Jun 2014 (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.
This study was designed to provide confirmation of efficacy of muscle derived stem cells (MDCs) for the treatment of SUI in women.
Detailed description
The investigators will be assessed the 12-month potential efficacy of autologous muscle derived cells as therapy for stress urinary incontinence. A total of 20 women in whom stress urinary incontinence had not improved underwent intra-sphincter injection of low doses 50×106 of autologous muscle derived cells, which will be derived from biopsies of their deltoid muscle. Assessments will be made at 1, 3, 6 and 12 months after cell injection. Changes in stress urinary incontinence severity were evaluated by pad test, diary of incontinence episodes and quality of life surveys.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Muscle derived stem cell | Experimental | Biological: paraurethral injectionParaurethral injection of muscle derived stem cell in patients with stress urine incontinency. |
Who may qualify
- Ages
- 40 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Female
- Stress Urinary Incontinence symptoms
- Urodynamic stress incontinence confirmed with multichannel urodynamic testing
- positive cough stress test
- urgency score < stress score
Key exclusion criteria (15 listed)
- Post-void residual volume >100cc
- Detrusor overactivity on preoperative multichannel urodynamic testing
- History of previous synthetic, biologic or fascial sub-urethral sling or any other surgery on external genitalia, bladder neck, bladder or urethra
- Desires future childbearing
- Chronic inguinal or vulvar abscess or history of Hidradenitis Suppurative
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 |
|---|---|---|
| paraurethral injectionParaurethral injection of muscle derived stem cell in patients with stress urine incontinency. | Biological | Muscle derived stem cell |
Primary outcome
24hr voiding diary reduction
Time frame: 1 month
Evaluation the 24hr voiding diary reduction by patient questionnaire 2hr pad test and cystourethroscopy and urodynamic.
1 secondary outcome
incontinence quality of life (I-Qol)
Time frame: 1month
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 4 Dec 2015.
- Related InfoLink provided by the sponsor.
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.
Hamid Gourabi, PhD study chair
Head of Royan Institute
Nasser Aghdami, MD,PhD study director
Head of Department of Regenerative Medicine & Cell therapy center of Royan Institute
Farzaneh Sharifiaghdas, MD study director
Urology and Nephrology Research Center, Shahid Beheshti University of Medical Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing paraurethral injection in people with Stress Urine Incontinency, run by Royan Institute at 1 site in Iran.
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 15 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 4 Dec 2015. 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 Iran. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
24hr voiding diary reduction (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Dec 2015.