Urinary Urge IncontinencePhase 4APPNCT02176642
Comparison of Combination Therapy vs Single Agent Therapy for Treatment of Urge Incontinence.
A Phase 4 study testing Oxybutynin extended release and Posterior Tibial Nerve Stimulation in people with Urinary Urge Incontinence, run by Duke University at 2 sites in United States.
Trial summary
This is a randomized double-blind placebo-controlled clinical trial of posterior tibial nerve stimulation (PTNS) plus extended release oxybutynin versus PTNS alone (placebo pills) in women undergoing treatment of urgency urinary incontinence (UUI). Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Urinary Urge Incontinence
- What is being tested?
- Oxybutynin extended release and Posterior Tibial Nerve Stimulation
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 55 participants
- Where
- 2 sitesUnited States
- Study dates
- Aug 2014to 21 Nov 2016
- 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
- Female patients
- > 18 years of age
- > 3 UUI episodes on a 3-day bladder diary
- Urge predominant ( > 50% of total incontinence episodes) urinary incontinence based on a three-day bladder diary
- Existing insurance coverage of PTNS therapy.
- Ability to undergo weekly PTNS treatments in clinic for 6 week period of time and complete all study related items
- Not on an anticholinergic or beta agonist medication or, if they are, willing to undergone a three week washout period prior to randomization
Who cannot join
- Any previous PTNS therapy, intra-detrusor botulinum toxin injections, or implanted sacral neuromodulation
- Contraindication to anticholinergic therapy (narrow-angle glaucoma or gastric retention) or PTNS therapy (implanted pacemaker/defibrillator or peripheral neuropathy)
- Symptomatic urinary tract infection that has not resolved prior to randomization
- Surgical treatment for stress urinary incontinence or pelvic organ prolapse recommended or planned at time of enrollment
- Surgically altered detrusor muscle
- Known diagnosis or history of neurogenic bladder, post void residual volume >150ml, bladder malignancy, interstitial cystitis/painful bladder syndrome, or pelvic radiation
- Surgery for pelvic organ prolapse or stress urinary incontinence within the previous 3 months
- Pregnancy, lactation, or planned pregnancy during study period
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Duke Urogynecology
Durham, North Carolina, 27707
Duke OB/GYN Consultants of Raleigh
Raleigh, North Carolina, 27607
About this study
Official title: Double-Blind Randomized Controlled Trial of Extended Release Oxybutynin Versus Placebo in Women Receiving Posterior Tibial Nerve Stimulation for Treatment of Urgency Urinary Incontinence
This is a randomized double-blind placebo-controlled clinical trial of posterior tibial nerve stimulation (PTNS) plus extended release oxybutynin versus PTNS alone (placebo pills) in women undergoing treatment of urgency urinary incontinence (UUI).
The investigators hypothesize that combination therapy with PTNS and anticholinergic medication will result in a significant incremental improvement in UUI symptoms over that achieved with PTNS alone. In addition, the investigators hypothesize that the addition of anticholinergics to PTNS will result in a greater improvement in patients' perception of treatment response, symptom distress, and quality of life than PTNS alone.
Read more
Specific Aim 1: To compare the change, from baseline, in mean number of UUI episodes per day using a 3-day bladder diary between PTNS plus anticholinergic medication versus PTNS plus placebo in women undergoing treatment for UUI.
Specific Aim 2: To compare the change, from baseline, in a 24hr pad weight between PTNS plus anticholinergic medication versus PTNS plus placebo.
Specific Aim 3: To compare subjective treatment response, symptoms distress, and quality of life between PTNS plus anticholinergic medication versus PTNS plus placebo utilizing the Patient Global Impression of Improvement (PGI-I) and the Overactive Bladder Questionnaire Short Form (OABq-SF).
An interim analysis will be conducted by an independent entity after 50 participants have completed the study protocol. A Data Safety Monitoring Board is not utilized because the study utilizes FDA approved treatments for urgency urinary incontinence.
- Conditions
- Urinary Urge Incontinence
- Being tested
- Oxybutynin extended release, Posterior Tibial Nerve Stimulation, Placebo
- Keywords
- Urinary Urge Incontinence, Posterior Tibial Nerve Stimulation, PTNS, Neuromodulation, Oxybutynin, Anticholinergic Medication
- Medical subject headings
- Urinary Incontinence, Urge
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oxybutynin extended releaseDrug
Also called Ditropan XL
5mg tablet taken by mouth daily for 6 weeks
Posterior Tibial Nerve StimulationDevice
Also called Urgent PC Neuromodulation system
In office therapy administered for 30 minutes once every week for a total of 6 weeks
PlaceboDrug
Also called Dextrose powder
Tablet taken by mouth daily for 6 weeks
| Study group | Role | What they receive |
|---|---|---|
| Oxybutynin plus PTNS | Active comparator | Oxybutynin extended release (blinded tablet) 5mg by mouth daily for 6 weeks, Posterior Tibial Nerve Stimulation utilizing the Urgent PC neuromodulation system administered weekly in the office setting for a total of 6 weeks. Receives: Drug: Oxybutynin extended release; Device: Posterior Tibial Nerve Stimulation |
| Placebo plus PTNS | Placebo comparator | Placebo (blinded tablet) taken daily for 6 weeks. Posterior Tibial Nerve Stimulation utilizing the Urgent PC neuromodulation system administered weekly in the office setting for a total of 6 weeks. Receives: Device: Posterior Tibial Nerve Stimulation; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Median Number of UUI Episodes Per Day
To compare the change, from baseline, in median number of UUI episodes per day using a 3-day bladder diary between PTNS plus anticholinergic medication versus PTNS plus placebo in women undergoing treatment for UUI. UUI change score will be calculated [post-treatment UUI/day minus pre-treatment UUI/day].
Measured: Baseline, 6 weeks
Secondary outcomes (1)
Change in 24hr Pad Weight
To compare the change, from baseline, in 24h pad weight between PTNS plus anticholinergic medication versus PTNS plus placebo. Change in median 24h pad weight from baseline to 6 weeks was compared between the 2 groups using Wilcoxon Rank Sum test.
Measured: Baseline, 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2014 (estimated)
- Study startAug 2014
- Primary completion21 Nov 2016
- Study completion21 Nov 2016
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 Urinary Urge IncontinenceStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- Society of Urodynamics, Female Pelvic Medicine & Urogenital Reconstruction
- Responsible party
- Sponsor
- Investigators
- Nazema Y Siddiqui, MD, MHS, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02176642
- Sponsor's protocol ID
- Pro00052742
- Acronym
- APP
- Status last verified
- Dec 2017
- First submitted
- 25 Jun 2014
- Last updated
- 23 Jan 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double-Blind Randomized Controlled Trial of Extended Release Oxybutynin Versus Placebo in Women Receiving Posterior Tibial Nerve Stimulation for Treatment of Urgency Urinary Incontinence
- ClinicalTrials.gov ID
- NCT02176642
- Acronym / sponsor ID
- APP / Pro00052742
- Conditions
- Urinary Urge Incontinence
- Keywords
- Urinary Urge Incontinence, Posterior Tibial Nerve Stimulation, PTNS, Neuromodulation, Oxybutynin, Anticholinergic Medication
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- Society of Urodynamics, Female Pelvic Medicine & Urogenital Reconstruction
- Study start
- Aug 2014
- Primary completion
- 21 Nov 2016 (actual)
- Study completion
- 21 Nov 2016 (actual)
- First posted
- 27 Jun 2014 (estimated)
- Results
- Posted 23 Jan 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a randomized double-blind placebo-controlled clinical trial of posterior tibial nerve stimulation (PTNS) plus extended release oxybutynin versus PTNS alone (placebo pills) in women undergoing treatment of urgency urinary incontinence (UUI).
The investigators hypothesize that combination therapy with PTNS and anticholinergic medication will result in a significant incremental improvement in UUI symptoms over that achieved with PTNS alone. In addition, the investigators hypothesize that the addition of anticholinergics to PTNS will result in a greater improvement in patients' perception of treatment response, symptom distress, and quality of life than PTNS alone.
Specific Aim 1: To compare the change, from baseline, in mean number of UUI episodes per day using a 3-day bladder diary between PTNS plus anticholinergic medication versus PTNS plus placebo in women undergoing treatment for UUI.
Specific Aim 2: To compare the change, from baseline, in a 24hr pad weight between PTNS plus anticholinergic medication versus PTNS plus placebo.
Specific Aim 3: To compare subjective treatment response, symptoms distress, and quality of life between PTNS plus anticholinergic medication versus PTNS plus placebo utilizing the Patient Global Impression of Improvement (PGI-I) and the Overactive Bladder Questionnaire Short Form (OABq-SF).
An interim analysis will be conducted by an independent entity after 50 participants have completed the study protocol. A Data Safety Monitoring Board is not utilized because the study utilizes FDA approved treatments for urgency urinary incontinence.
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 |
|---|---|---|
| Oxybutynin plus PTNS | Active comparator | Drug: Oxybutynin extended release, Device: Posterior Tibial Nerve StimulationOxybutynin extended release (blinded tablet) 5mg by mouth daily for 6 weeks, Posterior Tibial Nerve Stimulation utilizing the Urgent PC neuromodulation system administered weekly in the office setting for a total of 6 weeks. |
| Placebo plus PTNS | Placebo comparator | Device: Posterior Tibial Nerve Stimulation, Drug: PlaceboPlacebo (blinded tablet) taken daily for 6 weeks. Posterior Tibial Nerve Stimulation utilizing the Urgent PC neuromodulation system administered weekly in the office setting for a total of 6 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Female patients
- > 18 years of age
- > 3 UUI episodes on a 3-day bladder diary
- Urge predominant ( > 50% of total incontinence episodes) urinary incontinence based on a three-day bladder diary
- Existing insurance coverage of PTNS therapy.
Key exclusion criteria (8 listed)
- Any previous PTNS therapy, intra-detrusor botulinum toxin injections, or implanted sacral neuromodulation
- Contraindication to anticholinergic therapy (narrow-angle glaucoma or gastric retention) or PTNS therapy (implanted pacemaker/defibrillator or peripheral neuropathy)
- Symptomatic urinary tract infection that has not resolved prior to randomization
- Surgical treatment for stress urinary incontinence or pelvic organ prolapse recommended or planned at time of enrollment
- Surgically altered detrusor muscle
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 |
|---|---|---|
| Oxybutynin extended releaseAlso: Ditropan XL5mg tablet taken by mouth daily for 6 weeks | Drug | Oxybutynin plus PTNS |
| Posterior Tibial Nerve StimulationAlso: Urgent PC Neuromodulation systemIn office therapy administered for 30 minutes once every week for a total of 6 weeks | Device | Oxybutynin plus PTNS, Placebo plus PTNS |
| PlaceboAlso: Dextrose powderTablet taken by mouth daily for 6 weeks | Drug | Placebo plus PTNS |
Primary outcome
Change in Median Number of UUI Episodes Per Day
Time frame: Baseline, 6 weeks
To compare the change, from baseline, in median number of UUI episodes per day using a 3-day bladder diary between PTNS plus anticholinergic medication versus PTNS plus placebo in women undergoing treatment for UUI. UUI change score will be calculated [post-treatment UUI/day minus pre-treatment UUI/day].
1 secondary outcome
Change in 24hr Pad Weight
Time frame: Baseline, 6 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Nazema Y Siddiqui, MD, MHS principal investigator
Duke University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Oxybutynin extended release and Posterior Tibial Nerve Stimulation in people with Urinary Urge Incontinence, run by Duke University at 2 sites 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 7 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 23 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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.
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 23 Jan 2018). 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 Median Number of UUI Episodes Per Day (time frame: Baseline, 6 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 23 Jan 2018.