Overactive BladderNCT00852696
Over Active Bladder Patients Having Sling Surgery
A study testing Solifenacin in people with Overactive Bladder, run by Cleveland Clinic Florida at 1 site in United States.
Trial summary
The purpose of this study is to determine whether treatment with anti-muscarinic medications following sub-urethral sling procedures improves overall subjective and objective outcomes in women with mixed incontinence with primary stress symptoms. Read more about this study
- Who is it for?
- Ages 18 to 100 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Overactive Bladder
- What is being tested?
- Solifenacin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2008to Feb 2010
- Phase
- Interventional
- 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 to 100 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age >/= 18
- Patient is appropriate for sub-urethral sling procedure
- Mixed urinary incontinence
- No antimuscarinic therapy for previous 30 days
Who cannot join
- Uncontrolled narrow angle glaucoma
- Acute cystitis
- Unevaluated hematuria
- Currently using anti-muscarinic therapy
- Unable to complete pre-operative urodynamics
- Contraindication to anti-cholinergic therapy
- Unable or unwilling to complete diaries or quality of life questionaire
- Significant (exteriorized) Pelvic Organ Prolapse
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Double Blind, Randomized Placebo Controlled Trial of the Perioperative Use of Solifenacin in the Management of Postoperative Overactive Bladder Symptoms in Patients With Mixed Incontinence Undergoing Suburethral Sling Procedures.
The purpose of this study is to determine whether treatment with anti-muscarinic medications following sub-urethral sling procedures improves overall subjective and objective outcomes in women with mixed incontinence with primary stress symptoms.
Read the detailed description
Women with mixed incontinence with primary stress symptoms undergoing Sub-Urethral Sling Procedures will be randomized to peri-operative placebo or solifenacin. Subjects in the placebo group will take orally once daily for 9 weeks. Subjects in the Solifenacin group will take orally once daily for 9 weeks.
- Conditions
- Overactive Bladder
- Being tested
- Solifenacin, Placebo
- Keywords
- Overactive Bladder, Incontinence, Solifenacin, Women, Postoperative
- 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.
SolifenacinDrug
Also called Tolterodine Tartrate
Solifenacin is used to treat overactive bladder. It works by relaxing the bladder muscles to prevent urgent, frequent, or uncontrolled urination. Take orally once daily for 9 weeks.
PlaceboOther
Take orally once daily for 9 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Placebo Group | Placebo comparator | Placebo Orally 9 weeks once daily. Receives: Other: Placebo |
| Solifenacin Group | Experimental | Solifenacin Orally 9 weeks once daily. Receives: Drug: Solifenacin |
What is being measured
The primary outcome is the main question the study is designed to answer.
To Determine Whether Treatment With Anti-muscarinic Medications Following Sub-urethral Sling Procedures Improves Overall Subjective and Objective Outcomes in Women With Mixed Incontinence With Primary Stress Symptoms.
Women with mixed incontinence with primary stress symptoms undergoing Sub-Urethral Sling Procedures will be randomized to peri-operative placebo or solifenacin. Subjects in the placebo group will take orally once daily for 9 weeks. Subjects in the Solifenacin group will take orally once daily for 9 weeks.
Measured: 9 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2009 (estimated)
- Study startFeb 2008
- Primary completionJul 2009
- Study completionFeb 2010
Why it stopped: Investigator left Cleveland Clinic and absolutely no data is available.
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.
- Other trials for Overactive BladderStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cleveland Clinic Florida
- Sponsor type
- University, hospital or other
- Collaborators
- Astellas Pharma US, Inc.
- Responsible party
- Principal investigator, Eric Hurtado, The Cleveland Clinic
- Investigators
- G W Davila, MD, Principal investigator, Cleeland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00852696
- Sponsor's protocol ID
- 8867
- Status last verified
- Jun 2022
- First submitted
- 26 Feb 2009
- Last updated
- 1 Jul 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double Blind, Randomized Placebo Controlled Trial of the Perioperative Use of Solifenacin in the Management of Postoperative Overactive Bladder Symptoms in Patients With Mixed Incontinence Undergoing Suburethral Sling Procedures.
- ClinicalTrials.gov ID
- NCT00852696
- Acronym / sponsor ID
- 8867
- Conditions
- Overactive Bladder
- Keywords
- Overactive Bladder, Incontinence, Solifenacin, Women, Postoperative
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Investigator left Cleveland Clinic and absolutely no data is available.
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Cleveland Clinic FloridaUniversity, hospital or other
- Collaborators
- Astellas Pharma US, Inc.
- Study start
- Feb 2008
- Primary completion
- Jul 2009 (actual)
- Study completion
- Feb 2010 (actual)
- First posted
- 27 Feb 2009 (estimated)
- Results
- Posted 1 Jul 2022
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 study is to determine whether treatment with anti-muscarinic medications following sub-urethral sling procedures improves overall subjective and objective outcomes in women with mixed incontinence with primary stress symptoms.
Detailed description
Women with mixed incontinence with primary stress symptoms undergoing Sub-Urethral Sling Procedures will be randomized to peri-operative placebo or solifenacin. Subjects in the placebo group will take orally once daily for 9 weeks. Subjects in the Solifenacin group will take orally once daily for 9 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo Group | Placebo comparator | Other: PlaceboPlacebo Orally 9 weeks once daily. |
| Solifenacin Group | Experimental | Drug: SolifenacinSolifenacin Orally 9 weeks once daily. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age >/= 18
- Patient is appropriate for sub-urethral sling procedure
- Mixed urinary incontinence
- No antimuscarinic therapy for previous 30 days
Key exclusion criteria (8 listed)
- Uncontrolled narrow angle glaucoma
- Acute cystitis
- Unevaluated hematuria
- Currently using anti-muscarinic therapy
- Unable to complete pre-operative urodynamics
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 |
|---|---|---|
| SolifenacinAlso: Tolterodine TartrateSolifenacin is used to treat overactive bladder. It works by relaxing the bladder muscles to prevent urgent, frequent, or uncontrolled urination. Take orally once daily for 9 weeks. | Drug | Solifenacin Group |
| PlaceboTake orally once daily for 9 weeks. | Other | Placebo Group |
Primary outcome
To Determine Whether Treatment With Anti-muscarinic Medications Following Sub-urethral Sling Procedures Improves Overall Subjective and Objective Outcomes in Women With Mixed Incontinence With Primary Stress Symptoms.
Time frame: 9 weeks
Women with mixed incontinence with primary stress symptoms undergoing Sub-Urethral Sling Procedures will be randomized to peri-operative placebo or solifenacin. Subjects in the placebo group will take orally once daily for 9 weeks. Subjects in the Solifenacin group will take orally once daily for 9 weeks.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
G W Davila, MD principal investigator
Cleeland Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Solifenacin in people with Overactive Bladder, run by Cleveland Clinic Florida 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 4 inclusion and 8 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: stopped early, as of the sponsor's last update on 1 Jul 2022. 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. 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 1 Jul 2022). 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?
To Determine Whether Treatment With Anti-muscarinic Medications Following Sub-urethral Sling Procedures Improves Overall Subjective and Objective Outcomes in Women With Mixed Incontinence With Primary Stress Symptoms. (time frame: 9 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 1 Jul 2022.