Urinary Incontinence , StressPhase 3ADRESUNCT02529865
Clinical Trial of Autologous Adipose Derived Regenerative Cells for the Treatment of Male Stress Urinary Incontinence
A Phase 3 study testing Periurethral injection of autologous ADRCs and adipose tissue in people with Urinary Incontinence , Stress, run by Nagoya University at 4 sites in Japan.
Trial summary
The purpose of this study is to evaluate the efficacy and safety of periurethral injection of autologous Adipose Derived Regenerative Cells (ADRCs) in male stress urinary incontinence. Read more about this study
- Who is it for?
- Ages 20 years and older, men only
- Conditions the study is for
- Urinary Incontinence , Stress
- What is being tested?
- Periurethral injection of autologous ADRCs and adipose tissue
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 4 sitesJapan
- Study dates
- 29 Jul 2015to 7 Mar 2019
- Phase
- Phase 3
- 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 20 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males with stress urinary incontinence with insufficient effect by behavioral therapy or pharmacotherapy persisting more than 1 year after either of the following surgical procedure:
- Patients with symptoms after radical prostatectomy for localized prostate cancer and currently without relapse/metastasis, and PSA level less than 0.1 ng/mL for over 1 year
- Patients with symptoms after transurethral prostatectomy or laser prostatectomy for prostatic hyperplasia, and PSA level less than 4.0 ng/mL over 1 year
- Age of 20 or above
- Mild to moderate urinary incontinence on the 24-hour pad test
- Patients who can keep a bladder diary in a satisfactory manner
- Patients who are willing and able to give signed consent
Who cannot join
- - Concurrent with any other types of urinary incontinence
- History of urinary or reproductive surgery within 6 months
- History of behavioral therapy or pharmacotherapy within 3 months
- Concurrent with diabetes insipidus
- History of radiotherapy in the lower urinary tract
- History of ADRCs treatment for stress urinary incontinence
Show all 14Show fewer
- History of any type of cell therapy within 6 months
- Participation in any other clinical trial within 3 months
- Concurrent with lower urinary tract obstruction
- Concurrent with urolithiasis, urinary tract infection or interstitial cystitis
- History of recurrent urinary tract infection
- History of malignant neoplasm within 5 years or a suspicion of it
- Life expectancy of less than 1 year
- Any other patients whom the trial investigator deemed ineligible to this study
Trial locations and contacts
4 sites in 1 country.
Japan4 sites
Kanazawa University Hospital
Kanazawa, Ishikawa-ken, 920-8641
Shinshu University Hospital
Matsumoto, Nagano, 390-8621
Nagoya university Hospital
Nagoya, Aichi-ken, 466-8560
Dokkyo Medical University Hospital
Shimotsuga-gun, Tochigi, 321-0293
About this study
Official title: Open-label, Multi-center, Single Arm Study to Evaluate the Efficacy and Safety of Periurethral Injection of Autologous Adipose Derived Regenerative Cells (ADRCs) for the Treatment of Male Stress Urinary Incontinence
The purpose of this study is to evaluate the efficacy and safety of periurethral injection of autologous Adipose Derived Regenerative Cells (ADRCs) in male stress urinary incontinence.
- Conditions
- Urinary Incontinence , Stress
- Being tested
- Periurethral injection of autologous ADRCs and adipose tissue
- Keywords
- Cell Transplantation
- 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.
Periurethral injection of autologous ADRCs and adipose tissueBiological
1 mL of the isolated ADRC is injected into the region of the external urethral sphincter, and another 4 mL of the ADRC and 16mL autologous adipose cells is injected under the urethral mucosa.
| Study group | Role | What they receive |
|---|---|---|
| ADRCs and Adipose tissue | Experimental | Periurethral injection of autologous adipose derived regenerative cells and adipose tissue Receives: Biological: Periurethral injection of autologous ADRCs and adipose tissue |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of patients with improvement in urine leakage volume as greater than 50% reduction from baseline by 24-hour pad test
Measured: Baseline and 52 weeks (LOCF) after intervention
Secondary outcomes (10)
Rate of patients with improvement in urine leakage volume as greater than 50% reduction from baseline by 24-hour pad test
Measured: Baseline, 2, 4, 12, 26, 38 and 52 weeks after intervention
Urine leakage volume by 24-hour pad test
Measured: Baseline, 2, 4, 12, 26, 38 and 52 weeks after intervention
Rate of patients with improvement in the number of incontinence episodes per day as greater than 50% reduction from baseline
Measured: Baseline, 2, 4, 12, 26, 38 and 52 weeks after intervention
Number of incontinence episodes per day
Measured: Baseline, 2, 4, 12, 26, 38 and 52 weeks after intervention
Number of pads used per day
Measured: Baseline, 2, 4, 12, 26, 38 and 52 weeks after intervention
QOL score (ICIQ-SF and KHQ)
Measured: Baseline, 26 and 52 weeks after intervention
Patient overall satisfaction
Measured: Baseline, 26 and 52 weeks after intervention
Urodynamic parameters (MUCP, FPL and ALPP)
Measured: Baseline, 2, 4, 12, 26 and 52 weeks after intervention
Blood flow at the injection site measured by transrectal ultrasonography
Measured: Baseline,12, 26 and 52 weeks after intervention
Injection site evaluated by pelvis MRI scan
Measured: Baseline, 2, 26 and 52 weeks after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2015 (estimated)
- Study start29 Jul 2015
- Primary completion7 Mar 2019
- Study completion7 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Urinary Incontinence , StressStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nagoya University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Momokazu Gotoh, Nagoya University
- Investigators
- Momokazu Gotoh, M.D., Ph.D., Principal investigator, Department of Urology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02529865
- Sponsor's protocol ID
- CAMCR-005
- Other IDs
- UMIN000017901
- Acronym
- ADRESU
- Status last verified
- Nov 2019
- First submitted
- 18 Aug 2015
- Last updated
- 14 Nov 2019
- Results posted
- No
Publications
Shaw CF 3rd, Isab AA, Coffer MT, Mirabelli CK. Gold(I) efflux from auranofin-treated red blood cells. Evidence for a glutathione-gold-albumin metabolite. Biochem Pharmacol. 1990 Sep 15;40(6):1227-34. doi: 10.1016/0006-2952(90)90387-z.
PubMed 2403377Hersh WR, Greenes RA. Information retrieval in medicine: state of the art. MD Comput. 1990 Sep-Oct;7(5):302-11.
PubMed 2243546Shimizu S, Yamamoto T, Nakayama S, Hirakawa A, Kuwatsuka Y, Funahashi Y, Matsukawa Y, Takanari K, Toriyama K, Kamei Y, Narimoto K, Yamanishi T, Ishizuka O, Mizuno M, Gotoh M. Design of a single-arm clinical trial of regenerative therapy by periurethral injection of adipose-derived regenerative cells for male stress urinary incontinence in Japan: the ADRESU study protocol. BMC Urol. 2017 Sep 25;17(1):89. doi: 10.1186/s12894-017-0282-7.
PubMed 28946874
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open-label, Multi-center, Single Arm Study to Evaluate the Efficacy and Safety of Periurethral Injection of Autologous Adipose Derived Regenerative Cells (ADRCs) for the Treatment of Male Stress Urinary Incontinence
- ClinicalTrials.gov ID
- NCT02529865
- Acronym / sponsor ID
- ADRESU / CAMCR-005
- Conditions
- Urinary Incontinence , Stress
- Keywords
- Cell Transplantation
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Nagoya UniversityUniversity, hospital or other
- Study start
- 29 Jul 2015 (actual)
- Primary completion
- 7 Mar 2019 (actual)
- Study completion
- 7 Mar 2019 (actual)
- First posted
- 20 Aug 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.
The purpose of this study is to evaluate the efficacy and safety of periurethral injection of autologous Adipose Derived Regenerative Cells (ADRCs) in male stress urinary incontinence.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ADRCs and Adipose tissue | Experimental | Biological: Periurethral injection of autologous ADRCs and adipose tissuePeriurethral injection of autologous adipose derived regenerative cells and adipose tissue |
Who may qualify
- Ages
- 20 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Males with stress urinary incontinence with insufficient effect by behavioral therapy or pharmacotherapy persisting more than 1 year after either of the following surgical procedure:
- Age of 20 or above
- Mild to moderate urinary incontinence on the 24-hour pad test
- Patients who can keep a bladder diary in a satisfactory manner
- Patients who are willing and able to give signed consent
Key exclusion criteria (14 listed)
- - Concurrent with any other types of urinary incontinence
- History of urinary or reproductive surgery within 6 months
- History of behavioral therapy or pharmacotherapy within 3 months
- Concurrent with diabetes insipidus
- History of radiotherapy in the lower urinary tract
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 |
|---|---|---|
| Periurethral injection of autologous ADRCs and adipose tissue1 mL of the isolated ADRC is injected into the region of the external urethral sphincter, and another 4 mL of the ADRC and 16mL autologous adipose cells is injected under the urethral mucosa. | Biological | ADRCs and Adipose tissue |
Primary outcome
Rate of patients with improvement in urine leakage volume as greater than 50% reduction from baseline by 24-hour pad test
Time frame: Baseline and 52 weeks (LOCF) after intervention
10 secondary outcomes
Rate of patients with improvement in urine leakage volume as greater than 50% reduction from baseline by 24-hour pad test
Time frame: Baseline, 2, 4, 12, 26, 38 and 52 weeks after intervention
Urine leakage volume by 24-hour pad test
Time frame: Baseline, 2, 4, 12, 26, 38 and 52 weeks after intervention
Rate of patients with improvement in the number of incontinence episodes per day as greater than 50% reduction from baseline
Time frame: Baseline, 2, 4, 12, 26, 38 and 52 weeks after intervention
Number of incontinence episodes per day
Time frame: Baseline, 2, 4, 12, 26, 38 and 52 weeks after intervention
Number of pads used per day
Time frame: Baseline, 2, 4, 12, 26, 38 and 52 weeks after intervention
QOL score (ICIQ-SF and KHQ)
Time frame: Baseline, 26 and 52 weeks after intervention
Patient overall satisfaction
Time frame: Baseline, 26 and 52 weeks after intervention
Urodynamic parameters (MUCP, FPL and ALPP)
Time frame: Baseline, 2, 4, 12, 26 and 52 weeks after intervention
Blood flow at the injection site measured by transrectal ultrasonography
Time frame: Baseline,12, 26 and 52 weeks after intervention
Injection site evaluated by pelvis MRI scan
Time frame: Baseline, 2, 26 and 52 weeks after intervention
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 14 Nov 2019.
- Background: PubMed 2403377Shaw CF 3rd, Isab AA, Coffer MT, Mirabelli CK. Gold(I) efflux from auranofin-treated red blood cells. Evidence for a glutathione-gold-albumin metabolite. Biochem Pharmacol. 1990 Sep 15;40(6):1227-34. doi: 10.1016/0006-2952(90)90387-z.
- Background: PubMed 2243546Hersh WR, Greenes RA. Information retrieval in medicine: state of the art. MD Comput. 1990 Sep-Oct;7(5):302-11.
- Derived from this study: PubMed 28946874Shimizu S, Yamamoto T, Nakayama S, Hirakawa A, Kuwatsuka Y, Funahashi Y, Matsukawa Y, Takanari K, Toriyama K, Kamei Y, Narimoto K, Yamanishi T, Ishizuka O, Mizuno M, Gotoh M. Design of a single-arm clinical trial of regenerative therapy by periurethral injection of adipose-derived regenerative cells for male stress urinary incontinence in Japan: the ADRESU study protocol. BMC Urol. 2017 Sep 25;17(1):89. doi: 10.1186/s12894-017-0282-7.
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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.
Momokazu Gotoh, M.D., Ph.D. principal investigator
Department of Urology
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Periurethral injection of autologous ADRCs and adipose tissue in people with Urinary Incontinence , Stress, run by Nagoya University at 4 sites in Japan.
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 14 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 14 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Japan. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Rate of patients with improvement in urine leakage volume as greater than 50% reduction from baseline by 24-hour pad test (time frame: Baseline and 52 weeks (LOCF) after intervention). 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 NCT02529865, which also lists 3 linked publications.
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 14 Nov 2019.