Changes of microRNA Expression in Obstructive and Neurogenic Bladder Dysfunction

NCT02410876 | Completed

• 1 other identifier: 331/2014
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

Patients with obstructive or neurogenic lower urinary tract disease will be invited to participate. Upon agreement they will undergo an assessment of bladder function (questionnaires) and bladder biopsies at 2 time-points. Bladder biopsies will be evaluated for molecular changes in the laboratory and compared to the functional findings.By uncovering the molecular similarities and differences between BLUTD and NLUTD, the investigators will elucidate some of the causative factors in the development of these disorders and highlight the impact of myogenic and neurogenic components postulated to be involved. The project involves close collaboration between clinical and basic research.

Conditions

Disorder of the Lower Urinary Tract

Keywords

Bladder; neurogenic lower urinary tract dysfunction; benign prostatic obstruction

Outcome Measures

Primary Outcomes (1)

• Establishment of mRNA targets and pathways defining a disease state and/or potentially amendable to pharmacological evaluation.

  Next generation sequencing of bladder wall tissue to determine changes in mRNAs and their targets and pathways

  8 years

Study Arms (5)

Controls

No lower urinary tract symptoms undergoing cystoscopy in anesthesia for stone treatment or microhematuria assessment.

Procedure: Bladder biopsy

Spinal cord injury/acontractile

Patients with traumatic spinal cord injury (SCI) with no (neither spontaneous nor provoked) detrusor activity during the filling phase of urodynamics. Bladder biopsy 6 weeks after trauma 6 months later urodynamic study and bladder biopsy

Procedure: Bladder biopsy; Procedure: Urodynamic study

Spinal cord injury/Detrusor overactivity

SCI patients with proven detrusor (urodynamics) overactivity during the filling phase. Bladder biopsy 6 weeks after trauma 6 months later urodynamic study and bladder biopsy

Procedure: Bladder biopsy; Procedure: Urodynamic study

Prostatic obstruction/acontractile

Low flow to no flow, no measurable detrusor activity on urodynamic evaluation, cystoscopy in line with obstruction. Bladder biopsy at TURP (transurethral resection prostate) 3 months later urodynamic study and bladder biopsy

Procedure: Bladder biopsy; Procedure: Urodynamic study

Prostatic obstruction/ obstructed

Obstruction according to Schäfer nomogram on urodynamic evaluation. Bladder biopsy at TURP 3 months later urodynamic study and bladder biopsy

Procedure: Bladder biopsy; Procedure: Urodynamic study

Interventions

Bladder biopsy PROCEDURE

Small biopsy of the bladder is taken with cold-cup tongs.

Controls; Prostatic obstruction/ obstructed; Prostatic obstruction/acontractile; Spinal cord injury/Detrusor overactivity; Spinal cord injury/acontractile

Urodynamic study PROCEDURE

Assessment of bladder function through intravesical and intrabdominal pressure measurements according to International Continence Society standards.

Prostatic obstruction/ obstructed; Prostatic obstruction/acontractile; Spinal cord injury/Detrusor overactivity; Spinal cord injury/acontractile

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Controls: patients with cystoscopy for stone disease or microhematuria without bladder symptoms Patients with spinal cord injury or benign prostatic obstruction.

You may qualify if:

• Planned cystoscopy in anesthesia for upper tract stone treatment or microscopic hematuria evaluation (controls)
• Planned TURP (transurethral prostate resection) (BLUTD)
• Spinal cord injury (in last 6 weeks) (NLUTD)
• Prior urodynamic study
• Informed consent

You may not qualify if:

• Age \< 18 years old
• Pregnancy
• Urinary tract infection
• History of or current genitourinary tuberculosis, bladder malignancy, radiotherapy.

Sponsors & Collaborators

• Insel Gruppe AG, University Hospital Bern: lead
• Swiss National Science Foundation: collaborator
• Balgrist University Hospital: collaborator

Study Sites (1)

University Hospital Inselspital

Bern, 3010, Switzerland

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

cold cup biopsies of the bladder wall

Study Officials

• Fiona C Burkhard, MD

  Insel Gruppe AG, University Hospital Bern

  PRINCIPAL INVESTIGATOR

• Jürgen Pannek, MD

  Swiss paraplegic center Nottwil

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: April 2, 2015
• First Posted: April 8, 2015
• Study Start: June 1, 2015
• Primary Completion: December 1, 2020
• Study Completion: December 31, 2020
• Last Updated: April 29, 2021

Record last verified: 2021-04

Locations

CH (1)