Urethral Sphincter ActivityNCT01028014
Medication Effects on Periurethral Sensation,Urethral Sphincter Activity and Pressure Flow Parameters
A study testing Pseudoephedrine, Tamsulosin and Imipramine in people with Urethral Sphincter Activity, run by University of Alabama at Birmingham at 1 site in United States.
Trial summary
Lower urinary tract symptoms such as urinary leakage and overactive bladder affect millions of American women. Women may develop these problems because the innervation of the muscles of the bladder and urethra are injured. Read more about this study
- Who is it for?
- Ages 19 to 51 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Urethral Sphincter Activity
- What is being tested?
- Pseudoephedrine, Tamsulosin and Imipramine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 56 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2010to Apr 2011
- 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 19 to 51 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy Females only
- Ages 19-51 and up including pre-menopausal older women who have had a normal menstrual cycle for the prior 3 months
- Able to take oral medication for 2 weeks
- For women of child bearing potential,willing to use an approved method of birth control during the study
Who cannot join
- Urinary Incontinence or other bladder symptoms
- Known neurologic disease that may impair urethral tone or sensation
- Currently taking a class of medication that is being tested (alpha-antagonists, anticholinergics, sympathomimetics, tricyclic antidepressants, or skeletal muscle relaxants)
- History of QTc prolongation or cardiac arrhythmia
- Pregnant, breastfeeding, or are less than 6 months postpartum
- Known hypersensitivity to or other contraindications to taking any of the study medications
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Alabama at Birmingham, The Kirklin Clinic
Birmingham, Alabama, 35233
About this study
Official title: Medication Effects on Periurethral Sensation, Urethral Sphincter Activity and Pressure Flow Parameters
Lower urinary tract symptoms such as urinary leakage and overactive bladder affect millions of American women. Women may develop these problems because the innervation of the muscles of the bladder and urethra are injured. Most research on treating these problems has focused on the abnormalities of the bladder muscle, but newer studies have shown abnormalities in the innervation and muscle function of the urethra.
Women with these symptoms may benefit from treatment with medications to improve their urethral function. However, to truly understand what types of medications will help women with these symptoms, the investigators wish to study how these medications affect innervation and muscle function in healthy women who do not have lower urinary tract symptoms.
Read the detailed description
Women without urinary incontinence or bladder symptoms (healthy controls)will undergo urethral testing prior to randomization to one of 5 medications or placebo. Participants will take an oral medication for 2 weeks and then return for repeat testing.
- Conditions
- Urethral Sphincter Activity
- Being tested
- Pseudoephedrine, Tamsulosin, Imipramine, Cyclobenzaprine, Lactose capsule
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PseudoephedrineDrug
Pseudoephedrine ER 120 mg by mouth once daily for 2 weeks
TamsulosinDrug
Also called Flomax
Tamsulosin 0.4mg by mouth daily for 2 weeks
ImipramineDrug
Also called Tofranil
Imipramine 25mg daily by mouth for 2 weeks
CyclobenzaprineDrug
Also called Flexeril
Cyclobenzaprine 10mg daily by mouth for 2 weeks
Lactose capsuleDrug
Lactose capsule 1 by mouth daily for 2 weeks
SolifenacinDrug
Also called VESIcare
Solifenacin 5mg by mouth daily for 2 weeks
| Study group | Role | What they receive |
|---|---|---|
| Pseudoephedrine | Active comparator | Pseudoephedrine 120mg extended release tablets Receives: Drug: Pseudoephedrine |
| Solifenacin | Active comparator | Solifenacin 5mg capsule Receives: Drug: Solifenacin |
| Tamsulosin | Active comparator | Tamsulosin 0.4mg capsule Receives: Drug: Tamsulosin |
| Imipramine | Active comparator | Imipramine 25mg tablet Receives: Drug: Imipramine |
| Cyclobenzaprine | Active comparator | Cyclobenzaprine 10mg tablet Receives: Drug: Cyclobenzaprine |
| Lactose capsules | Placebo comparator | Sham Receives: Drug: Lactose capsule |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference (Pre - Post) in Amplitude (Microvolts) of Urethral Sphincter Activity as Measured by Quantitative Concentric Needle EMG
Concentric needle EMG was used to measure urethral sphincter activity at 2-3 sites around the urethral meatus before and after 2 weeks of therapy with one of 6 randomly assigned medications. Two methods of quantitative electromyography were performed on all subjects. (1) Multi-Motor Unit Action Potential (MUP) analysis, which has been shown to be the most sensitive technique in distinguishing neuropathic from control muscles; and (2) interference pattern analysis (IPA) which reflects changes in MUP recruitment from weak effort to maximal contraction.
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2009 (estimated)
- Study startApr 2010
- Primary completionApr 2011
- Study completionApr 2011
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 (1)Papers the sponsor has linked to this study.
- Other trials for Urethral Sphincter ActivityStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe 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 N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Collaborators
- Astellas Pharma Inc
- Responsible party
- Principal investigator, Holly Richter, MD, University of Alabama at Birmingham
- Investigators
- Holly E Richter, PhD, MD, Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01028014
- Sponsor's protocol ID
- VESI-9E03-UAB
- Status last verified
- Jun 2012
- First submitted
- 7 Dec 2009
- Last updated
- 8 Jun 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Greer WJ; Gleason J; Szychowski JM; Goode P; Kenton K; Richter HE. Medication Effects on Urethral Current Perception Thresholds and Pressure Flow Parameters. Fem Pelv Med Recons Surg 2011;17:S33.
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Medication Effects on Periurethral Sensation, Urethral Sphincter Activity and Pressure Flow Parameters
- ClinicalTrials.gov ID
- NCT01028014
- Acronym / sponsor ID
- VESI-9E03-UAB
- Conditions
- Urethral Sphincter Activity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Collaborators
- Astellas Pharma Inc
- Study start
- Apr 2010
- Primary completion
- Apr 2011 (actual)
- Study completion
- Apr 2011 (actual)
- First posted
- 9 Dec 2009 (estimated)
- Results
- Posted 5 Sep 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Lower urinary tract symptoms such as urinary leakage and overactive bladder affect millions of American women. Women may develop these problems because the innervation of the muscles of the bladder and urethra are injured. Most research on treating these problems has focused on the abnormalities of the bladder muscle, but newer studies have shown abnormalities in the innervation and muscle function of the urethra.
Women with these symptoms may benefit from treatment with medications to improve their urethral function. However, to truly understand what types of medications will help women with these symptoms, the investigators wish to study how these medications affect innervation and muscle function in healthy women who do not have lower urinary tract symptoms.
Detailed description
Women without urinary incontinence or bladder symptoms (healthy controls)will undergo urethral testing prior to randomization to one of 5 medications or placebo. Participants will take an oral medication for 2 weeks and then return for repeat testing.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Pseudoephedrine | Active comparator | Drug: PseudoephedrinePseudoephedrine 120mg extended release tablets |
| Solifenacin | Active comparator | Drug: SolifenacinSolifenacin 5mg capsule |
| Tamsulosin | Active comparator | Drug: TamsulosinTamsulosin 0.4mg capsule |
| Imipramine | Active comparator | Drug: ImipramineImipramine 25mg tablet |
| Cyclobenzaprine | Active comparator | Drug: CyclobenzaprineCyclobenzaprine 10mg tablet |
| Lactose capsules | Placebo comparator | Drug: Lactose capsuleSham |
Who may qualify
- Ages
- 19 to 51 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy Females only
- Ages 19-51 and up including pre-menopausal older women who have had a normal menstrual cycle for the prior 3 months
- Able to take oral medication for 2 weeks
- For women of child bearing potential,willing to use an approved method of birth control during the study
Key exclusion criteria (6 listed)
- Urinary Incontinence or other bladder symptoms
- Known neurologic disease that may impair urethral tone or sensation
- Currently taking a class of medication that is being tested (alpha-antagonists, anticholinergics, sympathomimetics, tricyclic antidepressants, or skeletal muscle relaxants)
- History of QTc prolongation or cardiac arrhythmia
- Pregnant, breastfeeding, or are less than 6 months postpartum
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 |
|---|---|---|
| PseudoephedrinePseudoephedrine ER 120 mg by mouth once daily for 2 weeks | Drug | Pseudoephedrine |
| TamsulosinAlso: FlomaxTamsulosin 0.4mg by mouth daily for 2 weeks | Drug | Tamsulosin |
| ImipramineAlso: TofranilImipramine 25mg daily by mouth for 2 weeks | Drug | Imipramine |
| CyclobenzaprineAlso: FlexerilCyclobenzaprine 10mg daily by mouth for 2 weeks | Drug | Cyclobenzaprine |
| Lactose capsuleLactose capsule 1 by mouth daily for 2 weeks | Drug | Lactose capsules |
| SolifenacinAlso: VESIcareSolifenacin 5mg by mouth daily for 2 weeks | Drug | Solifenacin |
Primary outcome
Difference (Pre - Post) in Amplitude (Microvolts) of Urethral Sphincter Activity as Measured by Quantitative Concentric Needle EMG
Time frame: 2 weeks
Concentric needle EMG was used to measure urethral sphincter activity at 2-3 sites around the urethral meatus before and after 2 weeks of therapy with one of 6 randomly assigned medications. Two methods of quantitative electromyography were performed on all subjects. (1) Multi-Motor Unit Action Potential (MUP) analysis, which has been shown to be the most sensitive technique in distinguishing neuropathic from control muscles; and (2) interference pattern analysis (IPA) which reflects changes in MUP recruitment from weak effort to maximal contraction.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publicationGreer WJ; Gleason J; Szychowski JM; Goode P; Kenton K; Richter HE. Medication Effects on Urethral Current Perception Thresholds and Pressure Flow Parameters. Fem Pelv Med Recons Surg 2011;17:S33.
Related trials for Urethral Sphincter Activity
Not yet recruiting
Trial of NASHA Dx Urethral Bulking System
Urinary Incontinence, Urinary Incontinence (UI)
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.
Holly E Richter, PhD, MD principal investigator
University of Alabama at Birmingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pseudoephedrine, Tamsulosin and Imipramine in people with Urethral Sphincter Activity, run by University of Alabama at Birmingham 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 6 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 8 Jun 2012. 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 5 Sep 2011). 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?
Difference (Pre - Post) in Amplitude (Microvolts) of Urethral Sphincter Activity as Measured by Quantitative Concentric Needle EMG (time frame: 2 weeks). 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 NCT01028014, which also lists 1 linked publication.
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 8 Jun 2012.