Overactive Bladder SyndromePhase 4NCT00909428

Validation of a Real-time Urodynamic Measure of Urinary Urgency

A Phase 4 study testing Solifenacin Succinate in people with Overactive Bladder Syndrome, run by Loyola University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and older, women only
Conditions the study is for: Overactive Bladder Syndrome
What is being tested?: Solifenacin Succinate
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 51 participants
Where: 1 siteUnited States
Study dates: Jan 2007to Feb 2009
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

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
Women only
No healthy volunteers
Adult, Older adult

Who may be able to join

Have symptoms of urge or mixed incontinence (urge predominant) and desire treatment with anticholinergic medication.
Demonstrated detrusor overactivity with or without incontinence during urodynamic testing.
Are able to consent and fill out study documents, complete repeated urodynamic testing, and follow-up in 4 weeks.

Who cannot join

Have been treated with any anticholinergic medication in the previous month.
Have an elevated post -void residual volume as determined during their routine clinical care.
Have had a urinary tract infection in the last month, as determined by history.
Have untreated narrow angle glaucoma, by patient history.
Have a known allergy or intolerance to solifenacin, as determined by patient history.

Trial locations and contacts

1 site in 1 country.

United States1 site

Loyola University Medical Center
Maywood, Illinois, 60153

Other trials in United States

About this study

Official title: Validation of a Real-time Urodynamic Measure of Urinary Urgency as a Measure of the Success of Drug Treatment

Urinary urgency is a key symptom of overactive bladder syndrome (OAB) and may be more bothersome to a patient than the symptom of urinary frequency. Unfortunately, controversy continues to surround the term 'urgency' and there is no good tool to evaluate the severity of urgency. This fact has constrained the performance of clinical research in this field. The cause of urinary urgency is not fully understood and may vary from patient to patient.

Although clinicians regularly obtain measures of bladder sensation during cystometry, little attention has been paid to the patient experience of urinary urgency. In this study, the researchers will use a non-significant risk device (i.e., an Urgeometer) to measure urinary urgency in women with overactive bladder.

Read the detailed description

At baseline, a small catheter is placed inside the participant's bladder. The bladder is filled with sterile water through the catheter. As the bladder is filled, the participant is asked to rate their urinary urgency using the Urgeometer. The Urgeometer lever marks a continuous scale from 0 'no urge at all' to 100 'maximum urge which you can tolerate'. The testing is stopped once the bladder is filled. To minimize the chance of infection, participants receive one dose of oral antibiotics prior to the bladder testing.

Following completion of the bladder test, participants will take 10mg solifenacin succinate (VesicareR) daily for 30 days. Afterward, participants repeat the bladder test. The change in participants' maximal tolerated cystometric capacity (MCC) will be measured in milliliters and used to evaluate the effectiveness of the drug.

Conditions: Overactive Bladder Syndrome
Being tested: Solifenacin Succinate
Keywords: Bladder, Urinary Urgency, Solifenacin, Vesicare(R)

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Solifenacin SuccinateDrug
Also called Vesicare(R)
Participants take 10mg daily solifenacin succinate for 30 days

Study groups in NCT00909428
Study group	Role	What they receive
Solifenacin Succinate	Experimental	The intervention for this study is 10mg daily solifenacin. Patients with overactive bladder syndrome will take this study drug for 30 days. Receives: Drug: Solifenacin Succinate

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in Maximal Cystometric Capacity (mL)
At baseline, a small catheter is placed inside the participant's bladder. The bladder is filled with sterile water through the catheter and participants' maximal tolerated cystometric capacity (MCC) is measured in milliliters. Following completion of the bladder test, participants take 10mg solifenacin succinate (VesicareR) daily for 30 days. After 30 days of treatment, participants repeat the bladder test. Change in the MCC is used to evaluate the effectiveness of the drug.
Measured: 30 Days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 2007Feb 2009

First posted28 May 2009 (estimated)
Study startJan 2007
Primary completionJul 2008
Study completionFeb 2009

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (5)Papers the sponsor has linked to this study.
Other trials for Overactive Bladder SyndromeStudies 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 4
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 51 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00909428
Sponsor's protocol ID: 109248
Status last verified: Apr 2017
First submitted: 26 May 2009
Last updated: 24 May 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No: Due to restrictions on the availability of individual participant data (IPD), IPD are not publicly available

Publications

Craggs MD. Objective measurement of bladder sensation: use of a new patient-activated device and response to neuromodulation. BJU Int. 2005 Sep;96 Suppl 1:29-36. doi: 10.1111/j.1464-410X.2005.05649.x.
PubMed 16086677
Oliver S, Fowler C, Mundy A, Craggs M. Measuring the sensations of urge and bladder filling during cystometry in urge incontinence and the effects of neuromodulation. Neurourol Urodyn. 2003;22(1):7-16. doi: 10.1002/nau.10082.
PubMed 12478595
Abrams P, Cardozo L, Fall M, Griffiths D, Rosier P, Ulmsten U, Van Kerrebroeck P, Victor A, Wein A; Standardisation Sub-Committee of the International Continence Society. The standardisation of terminology in lower urinary tract function: report from the standardisation sub-committee of the International Continence Society. Urology. 2003 Jan;61(1):37-49. doi: 10.1016/s0090-4295(02)02243-4. No abstract available.
PubMed 12559262
Barber MD, Kuchibhatla MN, Pieper CF, Bump RC. Psychometric evaluation of 2 comprehensive condition-specific quality of life instruments for women with pelvic floor disorders. Am J Obstet Gynecol. 2001 Dec;185(6):1388-95. doi: 10.1067/mob.2001.118659.
PubMed 11744914
Herzog AR, Diokno AC, Fultz NH. Urinary incontinence: medical and psychosocial aspects. Annu Rev Gerontol Geriatr. 1989;9:74-119. doi: 10.1007/978-3-662-40455-3_3.
PubMed 2514773

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruitingPhase 2/3
Examining the Effects of Intra-detrusor Botox at Time of HoLEP in Men With Overactive Bladder Symptoms
Urinary Incontinence, Overactive Bladder Syndrome
Enrolling by invitationObservational study
Migraine Medication Effects on Urinary Symptoms
Overactive Bladder, Bladder Pain Syndrome
Recruiting
Tensi+ for Treating Overactive Bladder
Overactive Bladder (OAB)
Not yet recruitingObservational study
Efficacy and Safety of Peroneal Electric Transcutaneous Neuromodulation in the Real-world Clinical Practice
Overactive Bladder Syndrome
Recruiting
Improving Overactive Bladder Treatment Access and Adherence
Overactive Bladder Syndrome, Urinary Incontinence

All Overactive Bladder Syndrome trials

Study at a glance

From the registry record, last updated by the sponsor on 24 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Validation of a Real-time Urodynamic Measure of Urinary Urgency as a Measure of the Success of Drug Treatment
ClinicalTrials.gov ID: NCT00909428
Acronym / sponsor ID: 109248
Conditions: Overactive Bladder Syndrome
Keywords: Bladder, Urinary Urgency, Solifenacin, Vesicare(R)
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 51 participants (actual)
Lead sponsor: Loyola UniversityUniversity, hospital or other
Collaborators: Astellas Pharma Inc
Study start: Jan 2007 (actual)
Primary completion: Jul 2008 (actual)
Study completion: Feb 2009 (actual)
First posted: 28 May 2009 (estimated)
Results: Posted 24 May 2017

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Solifenacin Succinate	Experimental	Drug: Solifenacin SuccinateThe intervention for this study is 10mg daily solifenacin. Patients with overactive bladder syndrome will take this study drug for 30 days.

Who may qualify

Ages: 18 years and older
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Have symptoms of urge or mixed incontinence (urge predominant) and desire treatment with anticholinergic medication.
Demonstrated detrusor overactivity with or without incontinence during urodynamic testing.
Are able to consent and fill out study documents, complete repeated urodynamic testing, and follow-up in 4 weeks.

Key exclusion criteria (5 listed)

Have been treated with any anticholinergic medication in the previous month.
Have an elevated post -void residual volume as determined during their routine clinical care.
Have had a urinary tract infection in the last month, as determined by history.
Have untreated narrow angle glaucoma, by patient history.
Have a known allergy or intolerance to solifenacin, as determined by patient history.

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
Solifenacin SuccinateAlso: Vesicare(R)Participants take 10mg daily solifenacin succinate for 30 days	Drug	Solifenacin Succinate

Primary outcome

Change in Maximal Cystometric Capacity (mL)
Time frame: 30 Days
At baseline, a small catheter is placed inside the participant's bladder. The bladder is filled with sterile water through the catheter and participants' maximal tolerated cystometric capacity (MCC) is measured in milliliters. Following completion of the bladder test, participants take 10mg solifenacin succinate (VesicareR) daily for 30 days. After 30 days of treatment, participants repeat the bladder test. Change in the MCC is used to evaluate the effectiveness of the drug.

Results and safety

Results posted to the registry on 24 May 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Detrusor Overactivity Incontinence (DOI)	18	5
Urodynamic Stress Incontinence (USI)	15	5
Mixed Incontinence (DOI-USI)	9	0

Primary outcome: Change in Maximal Cystometric Capacity (mL)

Time frame: 30 Days. Median (Inter-Quartile Range). Unit: milliliters (mL)

Measure	Baseline Maximal Cystometric Capacity n = 10	One Month Maximal Cystometric Capacity n = 10
Value	95 (0 to 99.25)	473.50 (416.75 to 549.50)

Baseline Maximal Cystometric Capacity vs One Month Maximal Cystometric Capacity: Z-Score: 2.803, p = .005, Wilcoxon signed rank test

Population analysed: The primary outcome analysis population comprises only women with two valid MCC recordings (i.e., one baseline recording and one recording following 30 days of treatment with daily 10mg solifenacin succinate. The groups DOI and USI were combined for this repeated measures analysis.

Adverse events

Time frame: Adverse event data were collected during the 30 day trial. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Detrusor Overactivity Incontinence (DOI)	0 of 18 (0%)	0 of 18 (0%)	0 of 18
Urodynamic Stress Incontinence (USI)	0 of 15 (0%)	0 of 15 (0%)	0 of 15
Mixed Incontinence (DOI-USI)	0 of 9 (0%)	0 of 9 (0%)	0 of 9

Limitations and caveats (from the sponsor): The trial experienced significant attrition. Otherwise, there are no limitations or caveats to report.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 16086677Craggs MD. Objective measurement of bladder sensation: use of a new patient-activated device and response to neuromodulation. BJU Int. 2005 Sep;96 Suppl 1:29-36. doi: 10.1111/j.1464-410X.2005.05649.x.
Background: PubMed 12478595Oliver S, Fowler C, Mundy A, Craggs M. Measuring the sensations of urge and bladder filling during cystometry in urge incontinence and the effects of neuromodulation. Neurourol Urodyn. 2003;22(1):7-16. doi: 10.1002/nau.10082.
Background: PubMed 12559262Abrams P, Cardozo L, Fall M, Griffiths D, Rosier P, Ulmsten U, Van Kerrebroeck P, Victor A, Wein A; Standardisation Sub-Committee of the International Continence Society. The standardisation of terminology in lower urinary tract function: report from the standardisation sub-committee of the International Continence Society. Urology. 2003 Jan;61(1):37-49. doi: 10.1016/s0090-4295(02)02243-4. No abstract available.
Background: PubMed 11744914Barber MD, Kuchibhatla MN, Pieper CF, Bump RC. Psychometric evaluation of 2 comprehensive condition-specific quality of life instruments for women with pelvic floor disorders. Am J Obstet Gynecol. 2001 Dec;185(6):1388-95. doi: 10.1067/mob.2001.118659.
Background: PubMed 2514773Herzog AR, Diokno AC, Fultz NH. Urinary incontinence: medical and psychosocial aspects. Annu Rev Gerontol Geriatr. 1989;9:74-119. doi: 10.1007/978-3-662-40455-3_3.
Individual participant dataSharing planned: No. Due to restrictions on the availability of individual participant data (IPD), IPD are not publicly available

Related trials for Overactive Bladder Syndrome

Active, not recruitingPhase 2/3
Examining the Effects of Intra-detrusor Botox at Time of HoLEP in Men With Overactive Bladder Symptoms
Urinary Incontinence, Overactive Bladder Syndrome
Enrolling by invitationObservational study
Migraine Medication Effects on Urinary Symptoms
Overactive Bladder, Bladder Pain Syndrome
Recruiting
Tensi+ for Treating Overactive Bladder
Overactive Bladder (OAB)
Not yet recruitingObservational study
Efficacy and Safety of Peroneal Electric Transcutaneous Neuromodulation in the Real-world Clinical Practice
Overactive Bladder Syndrome
Recruiting
Improving Overactive Bladder Treatment Access and Adherence
Overactive Bladder Syndrome, Urinary Incontinence

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.

Mary P FitzGerald, MD principal investigator

Loyola University

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 Solifenacin Succinate in people with Overactive Bladder Syndrome, run by Loyola University at 1 site in United States.

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 3 inclusion and 5 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 24 May 2017. 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 United States. 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 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?

Yes. Results are posted in the registry (first posted 24 May 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Change in Maximal Cystometric Capacity (mL) (time frame: 30 Days). 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 NCT00909428, which also lists 5 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 24 May 2017.