Comparison of Combination Therapy vs Single Agent Therapy for Treatment of Urge Incontinence.
| Status: | Terminated |
|---|---|
| Conditions: | Urology |
| Therapuetic Areas: | Nephrology / Urology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 1/25/2018 |
| Start Date: | August 2014 |
| End Date: | November 21, 2016 |
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.
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.
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.
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
We found this trial at
2
sites
Durham, North Carolina 27707
Principal Investigator: Nazema Y Siddiqui, MD, MHS
Phone: 919-419-5211
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Raleigh, North Carolina 27607
Principal Investigator: Nazema Y Siddiqui, MD, MHS
Phone: 919-419-5215
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