Disorder of the Lower Urinary TractMoVeNCT02410876
Changes of microRNA Expression in Obstructive and Neurogenic Bladder Dysfunction
An observational study of Disorder of the Lower Urinary Tract, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Disorder of the Lower Urinary Tract
- What is being tested?
- Bladder biopsy and Urodynamic study
- Type of treatment
- Surgery or procedure
- How many people
- 50 participants
- Where
- 1 siteSwitzerland
- Study dates
- Jun 2015to 31 Dec 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Controls: patients with cystoscopy for stone disease or microhematuria without bladder symptoms Patients with spinal cord injury or benign prostatic obstruction.
Who may be able to join
- 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
Who cannot join
- Age < 18 years old
- Pregnancy
- Urinary tract infection
- History of or current genitourinary tuberculosis, bladder malignancy, radiotherapy.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Changes of microRNA Expression in Obstructive and Neurogenic Bladder Dysfunction Reveal Common Signalling Pathways Relevant for Disease Progression and Recovery
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.
Read the detailed description
Lower urinary tract dysfunction (LUTD) has multiple causes including bladder outlet obstruction (BOO) as a result of benign prostatic hyperplasia (BPH) and neurological diseases including spinal cord injury (SCI). Manifestations of LUTD include storage symptoms such as increased daytime frequency, nocturia, urgency and urinary incontinence and voiding symptoms such as slow stream, hesitancy and incomplete emptying. The consequences of both BOO-induced (BLUTD) and neurogenic LUTD (NLUTD), leading to functional entities including the low compliance high pressure bladder as well as the acontractile high volume low pressure bladder, are believed to share some pathogenetic mechanisms.
In a previous project, the investigators have established micro ribonucleic acid (miRNA) and messenger ribonucleic acid (mRNA) expression profiles of several urodynamically defined states of BLUTD. In this follow-up project, the investigators propose to extend these studies, undertaking a comparative miRNA and RNA profiling of BLUTD and NLUTD, and investigate the dynamic alteration of microRNA expression in different functional manifestations of disease. The investigators propose to validate primary gene targets of miRNAs differentially expressed in urodynamically defined states of BLUTD and identify signaling pathways, activated during the progression from hypertrophy to decompensation. Monitoring the reversal of changes in miRNA expression after relief of obstruction and restoration of normal bladder function will help delineate the key BOO-induced miRNAs with regulatory potential. Similarly, the dynamics of miRNA alteration, observed in SCI patients during the development and management of NLUTD should reveal the role of miRNA in gene expression regulation during neurogenic-induced organ remodelling.
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, and combines the analysis of human biopsy material with in vitro cell-based assays, creating a comprehensive platform for the dissection of molecular mechanisms of LUTD. This project will keep the momentum of the investigators' previous research and contribute to the basic and applied studies into bladder remodeling. It is a logical continuation of their on-going studies of the role of miRNAs in LUT disorders but represents a novel direction of research and has high diagnostic and therapeutic potential.
- Conditions
- Disorder of the Lower Urinary Tract
- Being tested
- Bladder biopsy, Urodynamic study
- Keywords
- Bladder, neurogenic lower urinary tract dysfunction, benign prostatic obstruction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bladder biopsyProcedure or surgery
Small biopsy of the bladder is taken with cold-cup tongs.
Urodynamic studyProcedure or surgery
Assessment of bladder function through intravesical and intrabdominal pressure measurements according to International Continence Society standards.
| Study group | Role | What they receive |
|---|---|---|
| Controls | No lower urinary tract symptoms undergoing cystoscopy in anesthesia for stone treatment or microhematuria assessment. Receives: 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 Receives: 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 Receives: 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 Receives: 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 Receives: Procedure: Bladder biopsy; Procedure: Urodynamic study |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 8 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2015 (estimated)
- Study startJun 2015
- Primary completionDec 2020
- Study completion31 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Disorder of the Lower Urinary TractStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Insel Gruppe AG, University Hospital Bern
- Sponsor type
- University, hospital or other
- Collaborators
- Swiss National Science Foundation, Balgrist University Hospital
- Responsible party
- Sponsor
- Investigators
- Fiona C Burkhard, MD, Principal investigator, Insel Gruppe AG, University Hospital BernJürgen Pannek, MD, Principal investigator, Swiss paraplegic center Nottwil
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02410876
- Sponsor's protocol ID
- 331/2014
- Acronym
- MoVe
- Status last verified
- Apr 2021
- First submitted
- 2 Apr 2015
- Last updated
- 29 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Changes of microRNA Expression in Obstructive and Neurogenic Bladder Dysfunction Reveal Common Signalling Pathways Relevant for Disease Progression and Recovery
- ClinicalTrials.gov ID
- NCT02410876
- Acronym / sponsor ID
- MoVe / 331/2014
- Conditions
- Disorder of the Lower Urinary Tract
- Keywords
- Bladder, neurogenic lower urinary tract dysfunction, benign prostatic obstruction
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Insel Gruppe AG, University Hospital BernUniversity, hospital or other
- Collaborators
- Swiss National Science Foundation, Balgrist University Hospital
- Study start
- Jun 2015
- Primary completion
- Dec 2020 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 8 Apr 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Lower urinary tract dysfunction (LUTD) has multiple causes including bladder outlet obstruction (BOO) as a result of benign prostatic hyperplasia (BPH) and neurological diseases including spinal cord injury (SCI). Manifestations of LUTD include storage symptoms such as increased daytime frequency, nocturia, urgency and urinary incontinence and voiding symptoms such as slow stream, hesitancy and incomplete emptying. The consequences of both BOO-induced (BLUTD) and neurogenic LUTD (NLUTD), leading to functional entities including the low compliance high pressure bladder as well as the acontractile high volume low pressure bladder, are believed to share some pathogenetic mechanisms.
In a previous project, the investigators have established micro ribonucleic acid (miRNA) and messenger ribonucleic acid (mRNA) expression profiles of several urodynamically defined states of BLUTD. In this follow-up project, the investigators propose to extend these studies, undertaking a comparative miRNA and RNA profiling of BLUTD and NLUTD, and investigate the dynamic alteration of microRNA expression in different functional manifestations of disease. The investigators propose to validate primary gene targets of miRNAs differentially expressed in urodynamically defined states of BLUTD and identify signaling pathways, activated during the progression from hypertrophy to decompensation. Monitoring the reversal of changes in miRNA expression after relief of obstruction and restoration of normal bladder function will help delineate the key BOO-induced miRNAs with regulatory potential. Similarly, the dynamics of miRNA alteration, observed in SCI patients during the development and management of NLUTD should reveal the role of miRNA in gene expression regulation during neurogenic-induced organ remodelling.
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, and combines the analysis of human biopsy material with in vitro cell-based assays, creating a comprehensive platform for the dissection of molecular mechanisms of LUTD. This project will keep the momentum of the investigators' previous research and contribute to the basic and applied studies into bladder remodeling. It is a logical continuation of their on-going studies of the role of miRNAs in LUT disorders but represents a novel direction of research and has high diagnostic and therapeutic potential.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Controls | – | Procedure: Bladder biopsyNo lower urinary tract symptoms undergoing cystoscopy in anesthesia for stone treatment or microhematuria assessment. |
| Spinal cord injury/acontractile | – | Procedure: Bladder biopsy, Procedure: Urodynamic studyPatients 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 |
| Spinal cord injury/Detrusor overactivity | – | Procedure: Bladder biopsy, Procedure: Urodynamic studySCI patients with proven detrusor (urodynamics) overactivity during the filling phase. Bladder biopsy 6 weeks after trauma 6 months later urodynamic study and bladder biopsy |
| Prostatic obstruction/acontractile | – | Procedure: Bladder biopsy, Procedure: Urodynamic studyLow 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 |
| Prostatic obstruction/ obstructed | – | Procedure: Bladder biopsy, Procedure: Urodynamic studyObstruction according to Schäfer nomogram on urodynamic evaluation. Bladder biopsy at TURP 3 months later urodynamic study and bladder biopsy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Controls: patients with cystoscopy for stone disease or microhematuria without bladder symptoms Patients with spinal cord injury or benign prostatic obstruction.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- Age < 18 years old
- Pregnancy
- Urinary tract infection
- History of or current genitourinary tuberculosis, bladder malignancy, radiotherapy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bladder biopsySmall biopsy of the bladder is taken with cold-cup tongs. | Procedure or surgery | Controls, Prostatic obstruction/ obstructed, Prostatic obstruction/acontractile, Spinal cord injury/Detrusor overactivity, Spinal cord injury/acontractile |
| Urodynamic studyAssessment of bladder function through intravesical and intrabdominal pressure measurements according to International Continence Society standards. | Procedure or surgery | Prostatic obstruction/ obstructed, Prostatic obstruction/acontractile, Spinal cord injury/Detrusor overactivity, Spinal cord injury/acontractile |
Primary outcome
Establishment of mRNA targets and pathways defining a disease state and/or potentially amendable to pharmacological evaluation.
Time frame: 8 years
Next generation sequencing of bladder wall tissue to determine changes in mRNAs and their targets and pathways
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fiona C Burkhard, MD principal investigator
Insel Gruppe AG, University Hospital Bern
Jürgen Pannek, MD principal investigator
Swiss paraplegic center Nottwil
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Disorder of the Lower Urinary Tract, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Establishment of mRNA targets and pathways defining a disease state and/or potentially amendable to pharmacological evaluation. (time frame: 8 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2021.