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OpenTrials
Completed

NCT Number: NCT01799694

Stem Cells Treatment for the Local Urinary Incontinence After a Radical Prostate Cancer Surgery (HULPURO)

The purpose of this study is to evaluate the feasibility and security of the autologous e-ASC for the urinary incontinence after a radical prostate cancer surgery

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Signed informed consent
  • Men over 18 years old. Good general state of health according to the findings of the clinical history and the physical examination
  • Prostate cancer diagnosed subjects via a biopsy and having had a radical surgery with a healing purpose in the previous 18 months
  • Having urinary incontinence after the surgery
  • Failure in any previous conservative treatment

Exclusion criteria

  • Having had an adjuvant treatment
  • Having a PSA ≥ 0,2 after surgery
  • Having any sign or symptom that suggest the investigator the non-healing of the adenocarcinoma
  • Active urine infection
  • Alcohol or other addictive substances abuse antecedents in the previous 6 months to the inclusion
  • Cardiopulmonary illness that, in the investigator opinion, could be unstable or could be serious enough to drop the patient from the study
  • Any kind of medical or psychiatric illness that, in the investigator opinion, could be a reason to exclude the patient from the study
  • Subjects with congenital or acquired immunodeficiencies, B and/or C Hepatitis, Tuberculose or Treponema diagnosed at the moment of inclusion
  • Anesthetic allergy
  • Major surgery or severe trauma in the previous 6 months
  • Administration of any drug under experimentation in the present or in the previous 3 months before recruitment

Treatment and study plan

Inject of Autologous Adipose-derived stem cells

Drug

Inject in muscle of autologous adipose derived stem cells

Other names: Autologuos eASC

Primary outcomes

  1. Evaluate the feasibility and security of the autologous e-ASC for the urinary incontinence after a radical prostate cancer surgery

    Time frame: 16 weeks

    Possibility of inject ASc by cystoscope

Secondary outcomes

  1. Quality of life assessment using the SF-12 Questionnaire

    Time frame: 1, 4, 16, 24 weeks

    SF-12 questionnaire

  2. Adverse events

    Time frame: 1, 4, 16, 24 weeks

    Data collected

Sponsors and collaborators

Lead sponsor

Instituto de Investigación Hospital Universitario La Paz

Other

Registry information

Official study title

Phase II Clinical Trial to Study the Feasibility and Safety of the Expanded Autologous Stem Cells Use Derived From Adipose Tissue (e-ASC) for the Local Urinary Incontinence After a Radical Prostate Cancer Surgery

Acronym: FLPURO

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Feb 27, 2013
Registry last updated
Mar 8, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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