Urothelium Tissue Engineering Using Biopsies From Transurethral Resection of Prostate

NCT03698721 | Not Yet Recruiting

• 1 other identifier: PSS2017/IMOPU-BERTE/MS
• Study Type: observational
• Target: 365
• Locations: 0 countries
• Sites: N/A

Brief Summary

Different clinical conditions can require urinary bladder augmentation or replacement. Tissue engineered bladder has been clinically evaluated but is not recommended due to diverse side effects. Thus, there is a real interest for the development of regenerative approach with innovative scaffolds and cell transplantation. The investigators propose the use of urothelial cells obtained by Trans-Urethral Resection of Prostate or bladder (TURP) to obtain a tissue engineered urothelium in association with different scaffolds.

Conditions

Spina Bifida; Urothelial Neoplasm; Bladder, Neurogenic; Bladder Exstrophy; Hypospadias

Keywords

Tissue engineering; Collagen scaffold; Alginate scaffold; Urothelial cells

Outcome Measures

Primary Outcomes (1)

• Histological analysis of biopsy.

  Histological analysis with standard coloration will assess the viability of urothelium. Signs of necrosis (ulcerations, destructions of urothelium structure) will be noted.

  6 month

Secondary Outcomes (16)

• Immunohistological analysis of biopsy.

  6 month

• RT-qPCR analysis of biopsy.

  6 month

• Digestion of the biopsy and culture with adapted medium. Optimization of culture conditions.

  12 months

• Histological analysis of the cultured cells.

  12 months

• Immunocytological analysis of the cultured cells.

  12 months

Interventions

Transurethral Resection of Prostate PROCEDURE

Transurethral resection of the prostate is a urological operation used to treat benign prostatic hyperplasia (BPH). It is performed by visualising the prostate through the urethra and removing tissue by electrocautery or sharp dissection with a resectoscope. This is considered the most effective treatment for BPH. This procedure is done with spinal or general anaesthetic. A triple lumen catheter is inserted through the urethra to irrigate and drain the bladder after the surgical procedure is complete. Outcome is considered excellent for 80-90% of BPH patients.

Also known as: TURP, TURPs, TUPR

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Only male patients have prostate
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Male patient requiring TURP for Benign Prostatic Hyperplasia with prostate weight evaluated preoperatively greater than or equal to 30 grams

You may qualify if:

• Patient needing a Transurethral Resection of Prostate (TURP)
• Weight of prostate (evaluated by ultrasonography)greater than or equal to 30 grams
• Affiliation to a social security system
• Patient over the age of majority
• Patient receiving complete information on research organization without opposition to the use of biological specimen

You may not qualify if:

• Patient for whom no TURP is realized during endoscopic procedure
• Patient for whom no resection is realized on the bladder neck
• Patient with prostate weight estimated under 30 grams
• Patient who opposed to the realization of the study

Sponsors & Collaborators

• Central Hospital, Nancy, France: lead

Related Publications (4)

• Adamowicz J, Kowalczyk T, Drewa T. Tissue engineering of urinary bladder - current state of art and future perspectives. Cent European J Urol. 2013;66(2):202-6. doi: 10.5173/ceju.2013.02.art23. Epub 2013 Aug 13.

  PMID: 24579029 BACKGROUND

• Lam Van Ba O, Aharony S, Loutochin O, Corcos J. Bladder tissue engineering: a literature review. Adv Drug Deliv Rev. 2015 Mar;82-83:31-7. doi: 10.1016/j.addr.2014.11.013. Epub 2014 Nov 14.

  PMID: 25446136 BACKGROUND

• Garthwaite M, Hinley J, Cross W, Warwick RM, Ambrose A, Hardaker H, Eardley I, Southgate J. Use of donor bladder tissues for in vitro research. BJU Int. 2014 Jan;113(1):160-6. doi: 10.1111/bju.12285.

  PMID: 24053725 BACKGROUND

• Baker SC, Shabir S, Southgate J. Biomimetic urothelial tissue models for the in vitro evaluation of barrier physiology and bladder drug efficacy. Mol Pharm. 2014 Jul 7;11(7):1964-70. doi: 10.1021/mp500065m. Epub 2014 Apr 17.

  PMID: 24697150 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Bladder biopsy obtained from the bladder neck during Transurethral Resection of Prostate. Maximum 3 biopsies measuring about 0.5\*0.3\*0.2 cm.

MeSH Terms

Conditions

Spinal Dysraphism; Urinary Bladder, Neurogenic; Bladder Exstrophy; Hypospadias

Interventions

Transurethral Resection of Prostate

Condition Hierarchy (Ancestors)

Neural Tube Defects; Nervous System Malformations; Nervous System Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Neurologic Manifestations; Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Urogenital Abnormalities; Penile Diseases; Genital Diseases, Male; Genital Diseases

Intervention Hierarchy (Ancestors)

Prostatectomy; Urologic Surgical Procedures, Male; Urologic Surgical Procedures; Urogenital Surgical Procedures; Surgical Procedures, Operative

Central Study Contacts

Nicolas Berte, Dr

CONTACT

00333673004195; n.berte@chru-nancy.fr

Jean-Louis Lemelle, PHD

CONTACT

0033383154729; jl.lemelle@chru-nancy.fr

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 17, 2018
• First Posted: October 9, 2018
• Study Start: October 1, 2018
• Primary Completion: October 1, 2024
• Study Completion (Estimated): October 1, 2026
• Last Updated: October 9, 2018

Record last verified: 2018-09

Data Sharing

• IPD Sharing: Will not share