Overactive BladderPhase 4NCT00903045
Urinary Urgency Outcomes Following Propiverine Treatment for an Overactive Bladder
A Phase 4 study testing Propiverine hydrochloride in people with Overactive Bladder, run by Samsung Medical Center at 1 site in South Korea.
Trial summary
Overactive bladder (OAB) is defined as "urgency, with or without urge incontinence, usually with frequency and nocturia" in the absence of local pathological or endocrine factors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Overactive Bladder
- What is being tested?
- Propiverine hydrochloride
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 264 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jan 2005to Aug 2006
- Phase
- Phase 4
- 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
Who may be able to join
- age ≥ 18 years
- Overactive bladder for at least 3 months
- 3 day- voiding diary
- average urinary frequency ≥ 10 voids/24hrs
- urgency ≥ 2 episodes/24hrs
- "moderate to severe" in the Indevus Urgency Severity Scale (IUSS)
Who cannot join
- clinically significant stress urinary incontinence
- polyuria of more than 3000 ml/24 hrs
- severe hepatic or renal diseases
- contraindications to the use of antimuscarinic drugs
- genitourinary conditions that could cause OAB symptoms such as urinary tract infection, genitourinary malignancy or interstitial cystitis
- uninvestigated hematuria
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- clinically significant bladder outlet obstruction
- clinically significant pelvic organ prolapse
- being on a bladder-training program or having been on electrostimulation therapy two weeks before randomization or intention to start
- unstable dosages of drugs with anticholinergic side effects
- any other investigational drug taken up to 2 months prior to randomization
- pregnancy or breastfeeding
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Urinary Urgency Outcomes Following Propiverine Treatment for an Overactive Bladder: PRopiverine Study on Overactive Bladder Including Urgency Data (PROUD)
Overactive bladder (OAB) is defined as "urgency, with or without urge incontinence, usually with frequency and nocturia" in the absence of local pathological or endocrine factors. Urgency is defined as "the complaint of a sudden compelling desire to pass urine that is difficult to defer" and an abnormal sensation that is distinctly different from the normal physiologic feeling of 'urge to void' that occurs during typical bladder-filling cycles.
Because up to 50% of patients with OAB experience urgency without incontinence, and because urgency is the most bothersome symptom that drives behavioral adaptations such as frequent voiding because of the very fear of urgency, this is the cornerstone symptom of OAB that indicates the diagnosis of OAB.
Read more
Even though any effective treatment for OAB must reduce the patient's sense of urgency, its subjective nature makes it difficult to measure. Therefore, the clinical efficacy of OAB treatment was traditionally measured in terms of objective surrogate parameters instead of urgency itself: for example, change in urinary frequency, incontinent episodes, number of pads and urodynamically proven detrusor overactivity, which could be measured easily and quantifiably.
Recently, several methods that measure urgency have been developed and used in clinical practice. However, the analysis questioned the clinical significance of the results; a possible reason for this being the lack of data based on urinary urgency and the use of sensitive patient-driven criteria.
Propiverine hydrochloride (1-methyl-4-piperidyl diphenylpropoxyacetate hydrochloride) is a drug with combined antimuscarinic and calcium antagonistic actions. Previous trials on the clinical efficacy and safety of propiverine for treating patients with OAB have reported improvements in urinary frequency and incontinence, but not in urgency.
The aim of this study was to explore the efficacy of a daily regimen of propiverine at 20 mg (immediate release formulation) in improving urgency from baseline to 12 weeks of treatment in patients with OAB.
Read the detailed description
12-week multi-center, prospective, parallel, double-blind, placebo-controlled trial
- Conditions
- Overactive Bladder
- Being tested
- Propiverine hydrochloride, Placebo
- Keywords
- Overactive bladder, Propiverin
- Medical subject headings
- Urinary Bladder, Overactive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Propiverine hydrochlorideDrug
Also called BUP-4
Propiverine hydrochloride 20mg twice a day
PlaceboDrug
Identical placebo twice a day
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: Propiverine hydrochloride |
| 2 | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent change in mean number of urgency episode
Measured: 12 weeks of treatment
Secondary outcomes (4)
Change in the patients' perception of urgency
Measured: 12 weeks of treatment
Change in urgency severity/voids
Measured: 12 weeks of treatment
Change in sum of urgency severity/24 hours
Measured: 12 weeks of treatment
Changes in voiding frequency/24hrs, daytime and nocturnal voiding frequency/24 hours
Measured: 12 weeks of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2009 (estimated)
- Study startJan 2005
- Primary completionAug 2006
- Study completionAug 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Overactive BladderStudies of the same condition, open and under way.
- More trials run by Samsung Medical CenterThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 264 participants (actual)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Investigators
- Kyu-Sung Lee, Ph.D, Principal investigator, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00903045
- Sponsor's protocol ID
- 2005-01-08
- Status last verified
- May 2009
- First submitted
- 14 May 2009
- Last updated
- 15 May 2009
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Stoniute A, Madhuvrata P, Still M, Barron-Millar E, Nabi G, Omar MI. Oral anticholinergic drugs versus placebo or no treatment for managing overactive bladder syndrome in adults. Cochrane Database Syst Rev. 2023 May 9;5(5):CD003781. doi: 10.1002/14651858.CD003781.pub3.
PubMed 37160401Lee KS, Lee HW, Choo MS, Paick JS, Lee JG, Seo JT, Lee JZ, Lee YS, Yoon H, Park CH, Na YG, Jeong YB, Lee JB, Park WH. Urinary urgency outcomes after propiverine treatment for an overactive bladder: the 'Propiverine study on overactive bladder including urgency data'. BJU Int. 2010 Jun;105(11):1565-70. doi: 10.1111/j.1464-410X.2009.09050.x. Epub 2009 Nov 12.
PubMed 19912183
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Urinary Urgency Outcomes Following Propiverine Treatment for an Overactive Bladder: PRopiverine Study on Overactive Bladder Including Urgency Data (PROUD)
- ClinicalTrials.gov ID
- NCT00903045
- Acronym / sponsor ID
- 2005-01-08
- Conditions
- Overactive Bladder
- Keywords
- Overactive bladder, Propiverin
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 264 participants (actual)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- Jan 2005
- Primary completion
- Aug 2006 (actual)
- Study completion
- Aug 2006 (actual)
- First posted
- 15 May 2009 (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.
Overactive bladder (OAB) is defined as "urgency, with or without urge incontinence, usually with frequency and nocturia" in the absence of local pathological or endocrine factors. Urgency is defined as "the complaint of a sudden compelling desire to pass urine that is difficult to defer" and an abnormal sensation that is distinctly different from the normal physiologic feeling of 'urge to void' that occurs during typical bladder-filling cycles.
Because up to 50% of patients with OAB experience urgency without incontinence, and because urgency is the most bothersome symptom that drives behavioral adaptations such as frequent voiding because of the very fear of urgency, this is the cornerstone symptom of OAB that indicates the diagnosis of OAB.
Even though any effective treatment for OAB must reduce the patient's sense of urgency, its subjective nature makes it difficult to measure. Therefore, the clinical efficacy of OAB treatment was traditionally measured in terms of objective surrogate parameters instead of urgency itself: for example, change in urinary frequency, incontinent episodes, number of pads and urodynamically proven detrusor overactivity, which could be measured easily and quantifiably.
Recently, several methods that measure urgency have been developed and used in clinical practice. However, the analysis questioned the clinical significance of the results; a possible reason for this being the lack of data based on urinary urgency and the use of sensitive patient-driven criteria.
Propiverine hydrochloride (1-methyl-4-piperidyl diphenylpropoxyacetate hydrochloride) is a drug with combined antimuscarinic and calcium antagonistic actions. Previous trials on the clinical efficacy and safety of propiverine for treating patients with OAB have reported improvements in urinary frequency and incontinence, but not in urgency.
The aim of this study was to explore the efficacy of a daily regimen of propiverine at 20 mg (immediate release formulation) in improving urgency from baseline to 12 weeks of treatment in patients with OAB.
Detailed description
12-week multi-center, prospective, parallel, double-blind, placebo-controlled trial
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Propiverine hydrochloride |
| 2 | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- age ≥ 18 years
- Overactive bladder for at least 3 months
- 3 day- voiding diary
- "moderate to severe" in the Indevus Urgency Severity Scale (IUSS)
Key exclusion criteria (12 listed)
- clinically significant stress urinary incontinence
- polyuria of more than 3000 ml/24 hrs
- severe hepatic or renal diseases
- contraindications to the use of antimuscarinic drugs
- genitourinary conditions that could cause OAB symptoms such as urinary tract infection, genitourinary malignancy or interstitial cystitis
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 hydrochlorideAlso: BUP-4Propiverine hydrochloride 20mg twice a day | Drug | 1 |
| PlaceboIdentical placebo twice a day | Drug | 2 |
Primary outcome
Percent change in mean number of urgency episode
Time frame: 12 weeks of treatment
4 secondary outcomes
Change in the patients' perception of urgency
Time frame: 12 weeks of treatment
Change in urgency severity/voids
Time frame: 12 weeks of treatment
Change in sum of urgency severity/24 hours
Time frame: 12 weeks of treatment
Changes in voiding frequency/24hrs, daytime and nocturnal voiding frequency/24 hours
Time frame: 12 weeks of treatment
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 15 May 2009.
- Derived from this study: PubMed 37160401Stoniute A, Madhuvrata P, Still M, Barron-Millar E, Nabi G, Omar MI. Oral anticholinergic drugs versus placebo or no treatment for managing overactive bladder syndrome in adults. Cochrane Database Syst Rev. 2023 May 9;5(5):CD003781. doi: 10.1002/14651858.CD003781.pub3.
- Derived from this study: PubMed 19912183Lee KS, Lee HW, Choo MS, Paick JS, Lee JG, Seo JT, Lee JZ, Lee YS, Yoon H, Park CH, Na YG, Jeong YB, Lee JB, Park WH. Urinary urgency outcomes after propiverine treatment for an overactive bladder: the 'Propiverine study on overactive bladder including urgency data'. BJU Int. 2010 Jun;105(11):1565-70. doi: 10.1111/j.1464-410X.2009.09050.x. Epub 2009 Nov 12.
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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.
Kyu-Sung Lee, Ph.D principal investigator
Samsung Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Propiverine hydrochloride in people with Overactive Bladder, run by Samsung Medical Center at 1 site in South Korea.
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 6 inclusion and 12 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 15 May 2009. 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 South Korea. 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. Some participants in this study may receive a placebo. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Percent change in mean number of urgency episode (time frame: 12 weeks of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00903045, which also lists 2 linked publications.
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 15 May 2009.