Neurogenic Urinary Bladder DisorderPhase 3NCT01530620
Efficacy and Tolerability of Propiverine Hydrochloride in Patients With Neurogenic Detrusor Overactivity
A Phase 3 study testing Propiverine hydrochloride ER (extended release) and Propiverine hydrochloride IR (immediate release) in people with Neurogenic Urinary Bladder Disorder and Urinary Bladder, Neurogenic, run by APOGEPHA Arzneimittel GmbH at 3 sites in 3 countries.
Trial summary
The purpose of this clinical study is to compare efficacy and safety of propiverine hydrochloride extended and immediate release formulations in patients suffering from neurogenic detrusor overactivity. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Neurogenic Urinary Bladder Disorder, Urinary Bladder, Neurogenic, Bladder Disorder, Neurogenic
- What is being tested?
- Propiverine hydrochloride ER (extended release) and Propiverine hydrochloride IR (immediate release)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 3 sitesin 3 countries
- Study dates
- Dec 2004to Jul 2006
- Phase
- Phase 3
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female Caucasian patients aged ≥18 and ≤70 years
- Voluntarily signed informed consent
- Neurogenic detrusor overactivity with occurrence of reflex detrusor contractions
- Reflex volume of ≤250 mL
- Intact reflex arcs in the area of segments S2-S4
Who cannot join
- Patients suffering from multiple sclerosis under unstable conditions
- Augmented reflex bladder
- Patients with increased residual urine (≥20 % of the maximum bladder capacity), in whom catheterization is not possible
- Acute urinary tract infection
- Electrostimulation therapy (within 4 weeks propir to Visit 1)
- Anomalies of the lower genitourinary tract (e.g. ectopic ureters, fistulas, urethral stenosis)
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- Radiation bladder, interstitial cystitis, bladder calculi, bladder carcinoma
- Surgery of the lower genitourinary tract within the last 6 months (e.g. prostatectomy, hysterectomy, tumor surgery)
- Pre-existing medical contraindications for anticholinergics
- Cardiac insufficiency (NYHA stage III/ IV)
- Therapy with botulinum toxin within the last 12 months
- Evidence of severe renal, hepatic or metabolic disorders
- History of drug or alcohol abuse
- Concomitant medication known to have a potential to interfere with the trial medication
- Known hypersensitivity to Propiverine hydrochloride or excipients contained in the trial medication, respectively
- Pregnant or breast-feeding women, or women of childbearing potential without using any reliable contraceptive method
- Patients with impaired co-operation or who are unable to understand the nature, scope and possible consequences of the study
Trial locations and contacts
3 sites in 3 countries.
3 sites in 3 countries
About this study
Official title: Efficacy and Tolerability of Propiverine Hydrochloride Extended Release (ER) Compared to Immediate Release (IR) in Patients With Neurogenic Detrusor Overactivity. A Randomized, Double Blind, Parallel Group, Multicenter Clinical Trial
The purpose of this clinical study is to compare efficacy and safety of propiverine hydrochloride extended and immediate release formulations in patients suffering from neurogenic detrusor overactivity.
- Conditions
- Neurogenic Urinary Bladder Disorder, Urinary Bladder, Neurogenic, Bladder Disorder, Neurogenic, Urinary Bladder Disorder, Neurogenic, Neurogenic Bladder Disorder, Urinary Bladder Neurogenic Dysfunction
- Being tested
- Propiverine hydrochloride ER (extended release), Propiverine hydrochloride IR (immediate release)
- Keywords
- Antimuscarinics, Neurogenic bladder, Propiverine, Urodynamics
- Medical subject headings
- Urinary Bladder, Neurogenic, Urologic Diseases, Urinary Bladder, Overactive, Urinary Incontinence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Propiverine hydrochloride ER (extended release)Drug
Also called Mictonorm UNO 45, Detrunorm XL 45
45 mg capsule (1x1/d)
Propiverine hydrochloride IR (immediate release)Drug
Also called Mictonorm, Detrunorm
15 mg tablet (3x1/d)
| Study group | Role | What they receive |
|---|---|---|
| Propiverine hydrochloride ER | Experimental | 45 mg Receives: Drug: Propiverine hydrochloride ER (extended release) |
| Propiverine hydrochloride IR | Active comparator | 15 mg Receives: Drug: Propiverine hydrochloride IR (immediate release) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reflex volume (cystometry)
Change in reflex volume compared to baseline and compared between the two treatment arms
Measured: three weeks
Secondary outcomes (9)
Leak point pressure
Change in LPP compared to baseline and compared between the two treatment arms
Measured: three weeks
Leak point volume
Change in LPV compared to baseline and compared between the two treatment arms
Measured: three weeks
Maximum detrusor pressure
Change in maximum p det compared to baseline and compared between the two treatment arms
Measured: three weeks
Maximum cystometric capacity
Change in maximum cystometric capacity compared to baseline and compared between the two treatment arms
Measured: three weeks
Bladder compliance
Change in compliance compared to baseline and compared between the two treatment arms
Measured: three weeks
Change in number of incontinence episodes
Change of incontinence episodes compared to baseline and compared between the two treatment arms
Measured: three weeks
State of Well-Being Questionnaire
Change of well-beeing compared to baseline and compared between the two treatment arms
Measured: three weeks
Post void residual volume
Change in PVR compared to baseline and compared between the two treatment arms
Measured: three weeks
Incidence and severity of adverse events
occurrences and intensity of adverse events or withdrawals over the whole treatment period
Measured: three weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2012 (estimated)
- Study startDec 2004
- Primary completionJun 2005
- Study completionJul 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neurogenic Urinary Bladder DisorderStudies 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- APOGEPHA Arzneimittel GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01530620
- Sponsor's protocol ID
- 8405010
- Status last verified
- Feb 2012
- First submitted
- 2 Feb 2012
- Last updated
- 10 Feb 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Tolerability of Propiverine Hydrochloride Extended Release (ER) Compared to Immediate Release (IR) in Patients With Neurogenic Detrusor Overactivity. A Randomized, Double Blind, Parallel Group, Multicenter Clinical Trial
- ClinicalTrials.gov ID
- NCT01530620
- Acronym / sponsor ID
- 8405010
- Conditions
- Neurogenic Urinary Bladder Disorder, Urinary Bladder, Neurogenic, Bladder Disorder, Neurogenic, Urinary Bladder Disorder, Neurogenic, Neurogenic Bladder Disorder, Urinary Bladder Neurogenic Dysfunction
- Keywords
- Antimuscarinics, Neurogenic bladder, Propiverine, Urodynamics
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- APOGEPHA Arzneimittel GmbHIndustry (pharma, biotech, devices)
- Study start
- Dec 2004
- Primary completion
- Jun 2005 (actual)
- Study completion
- Jul 2006 (actual)
- First posted
- 10 Feb 2012 (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.
The purpose of this clinical study is to compare efficacy and safety of propiverine hydrochloride extended and immediate release formulations in patients suffering from neurogenic detrusor overactivity.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Propiverine hydrochloride ER | Experimental | Drug: Propiverine hydrochloride ER (extended release)45 mg |
| Propiverine hydrochloride IR | Active comparator | Drug: Propiverine hydrochloride IR (immediate release)15 mg |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male or female Caucasian patients aged ≥18 and ≤70 years
- Voluntarily signed informed consent
- Neurogenic detrusor overactivity with occurrence of reflex detrusor contractions
- Reflex volume of ≤250 mL
- Intact reflex arcs in the area of segments S2-S4
Key exclusion criteria (17 listed)
- Patients suffering from multiple sclerosis under unstable conditions
- Augmented reflex bladder
- Patients with increased residual urine (≥20 % of the maximum bladder capacity), in whom catheterization is not possible
- Acute urinary tract infection
- Electrostimulation therapy (within 4 weeks propir to Visit 1)
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 |
|---|---|---|
| Propiverine hydrochloride ER (extended release)Also: Mictonorm UNO 45, Detrunorm XL 4545 mg capsule (1x1/d) | Drug | Propiverine hydrochloride ER |
| Propiverine hydrochloride IR (immediate release)Also: Mictonorm, Detrunorm15 mg tablet (3x1/d) | Drug | Propiverine hydrochloride IR |
Primary outcome
Reflex volume (cystometry)
Time frame: three weeks
Change in reflex volume compared to baseline and compared between the two treatment arms
9 secondary outcomes
Leak point pressure
Time frame: three weeks
Leak point volume
Time frame: three weeks
Maximum detrusor pressure
Time frame: three weeks
Maximum cystometric capacity
Time frame: three weeks
Bladder compliance
Time frame: three weeks
Change in number of incontinence episodes
Time frame: three weeks
State of Well-Being Questionnaire
Time frame: three weeks
Post void residual volume
Time frame: three weeks
Incidence and severity of adverse events
Time frame: three weeks
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 10 Feb 2012.
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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.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Propiverine hydrochloride ER (extended release) and Propiverine hydrochloride IR (immediate release) in people with Neurogenic Urinary Bladder Disorder and Urinary Bladder, Neurogenic, run by APOGEPHA Arzneimittel GmbH at 3 sites in 3 countries.
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 17 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 10 Feb 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Austria, Germany, Romania. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Reflex volume (cystometry) (time frame: three weeks). 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 10 Feb 2012.