Clinical Trial of Autologous Adipose Derived Regenerative Cells for the Treatment of Male Stress Urinary Incontinence

NCT02529865 | Completed Phase 3

• 2 other identifiers: CAMCR-005UMIN000017901
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 4

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.

Conditions

Urinary Incontinence , Stress

Keywords

Cell Transplantation

Outcome Measures

Primary Outcomes (1)

• Rate of patients with improvement in urine leakage volume as greater than 50% reduction from baseline by 24-hour pad test

  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

  Baseline, 2, 4, 12, 26, 38 and 52 weeks after intervention

• Urine leakage volume by 24-hour pad test

  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

  Baseline, 2, 4, 12, 26, 38 and 52 weeks after intervention

• Number of incontinence episodes per day

  Baseline, 2, 4, 12, 26, 38 and 52 weeks after intervention

• Number of pads used per day

  Baseline, 2, 4, 12, 26, 38 and 52 weeks after intervention

Study Arms (1)

ADRCs and Adipose tissue

EXPERIMENTAL

Periurethral injection of autologous adipose derived regenerative cells and adipose tissue

Biological: Periurethral injection of autologous ADRCs and adipose tissue

Interventions

Periurethral injection of autologous ADRCs and adipose tissue BIOLOGICAL

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.

ADRCs and Adipose tissue

Eligibility Criteria

• Age: 20 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• \- 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

Sponsors & Collaborators

• Nagoya University: lead

Study Sites (4)

Nagoya university Hospital

Nagoya, Aichi-ken, 466-8560, Japan

Location

Kanazawa University Hospital

Kanazawa, Ishikawa-ken, 920-8641, Japan

Location

Shinshu University Hospital

Matsumoto, Nagano, 390-8621, Japan

Location

Dokkyo Medical University Hospital

Shimotsuga-gun, Tochigi, 321-0293, Japan

Location

Related Publications (3)

• 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.

  PMID: 2403377 BACKGROUND

• Hersh WR, Greenes RA. Information retrieval in medicine: state of the art. MD Comput. 1990 Sep-Oct;7(5):302-11.

  PMID: 2243546 BACKGROUND

• 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.

  PMID: 28946874 DERIVED

MeSH Terms

Conditions

Urinary Incontinence, Stress

Condition Hierarchy (Ancestors)

Urinary Incontinence; Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Momokazu Gotoh, M.D., Ph.D.

  Department of Urology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD, Professor at Department of Urology, Nagoya University Hospital

Study Record Dates

• First Submitted: August 18, 2015
• First Posted: August 20, 2015
• Study Start: July 29, 2015
• Primary Completion: March 7, 2019
• Study Completion: March 7, 2019
• Last Updated: November 14, 2019

Record last verified: 2019-11

Locations

JP (4)