Clinical trial NCT02529865: Clinical Trial of Autologous Adipose Derived Regenerative Cells for the Treatment of Male Stress Urinary Incontinence
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Urinary Incontinence , Stress
Keywords: Cell Transplantation
Lead sponsor: Nagoya University
Sponsor class: OTHER
First posted: 2015-08-20
Enrollment: 45
Sex: MALE
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* - 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
* 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

Primary outcomes:
measure: Rate of patients with improvement in urine leakage volume as greater than 50% reduction from baseline by 24-hour pad test
timeFrame: Baseline and 52 weeks (LOCF) after intervention
Secondary outcomes:
measure: Rate of patients with improvement in urine leakage volume as greater than 50% reduction from baseline by 24-hour pad test
timeFrame: Baseline, 2, 4, 12, 26, 38 and 52 weeks after intervention
measure: Urine leakage volume by 24-hour pad test
timeFrame: Baseline, 2, 4, 12, 26, 38 and 52 weeks after intervention
measure: Rate of patients with improvement in the number of incontinence episodes per day as greater than 50% reduction from baseline
timeFrame: Baseline, 2, 4, 12, 26, 38 and 52 weeks after intervention
measure: Number of incontinence episodes per day
timeFrame: Baseline, 2, 4, 12, 26, 38 and 52 weeks after intervention
measure: Number of pads used per day
timeFrame: Baseline, 2, 4, 12, 26, 38 and 52 weeks after intervention
measure: QOL score (ICIQ-SF and KHQ)
timeFrame: Baseline, 26 and 52 weeks after intervention
measure: Patient overall satisfaction
timeFrame: Baseline, 26 and 52 weeks after intervention
measure: Urodynamic parameters (MUCP, FPL and ALPP)
timeFrame: Baseline, 2, 4, 12, 26 and 52 weeks after intervention
measure: Blood flow at the injection site measured by transrectal ultrasonography
timeFrame: Baseline,12, 26 and 52 weeks after intervention
measure: Injection site evaluated by pelvis MRI scan
timeFrame: Baseline, 2, 26 and 52 weeks after intervention
Other outcomes:
Locations:
city: Nagoya
country: Japan
facility: Nagoya university Hospital
state: Aichi
city: Kanazawa
country: Japan
facility: Kanazawa University Hospital
state: Ishikawa
city: Matsumoto
country: Japan
facility: Shinshu University Hospital
state: Nagano
city: Shimotsuga-gun
country: Japan
facility: Dokkyo Medical University Hospital
state: Tochigi
Study officials:
affiliation: Department of Urology
name: Momokazu Gotoh, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Hersh WR, Greenes RA. Information retrieval in medicine: state of the art. MD Comput. 1990 Sep-Oct;7(5):302-11.
citation: Shimizu 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.