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Comparison of Combination Therapy vs Single Agent Therapy for Treatment of Urge Incontinence. (APP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02176642
Recruitment Status : Terminated
First Posted : June 27, 2014
Results First Posted : January 23, 2018
Last Update Posted : January 23, 2018
Sponsor:
Collaborator:
Society of Urodynamics and Female Pelvic Medicine & Urogenital Reconstruction
Information provided by (Responsible Party):
Duke University

Brief 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).

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.


Condition or disease Intervention/treatment Phase
Urinary Urge Incontinence Drug: Oxybutynin extended release Device: Posterior Tibial Nerve Stimulation Drug: Placebo Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 55 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Study Start Date : August 2014
Actual Primary Completion Date : November 21, 2016
Actual Study Completion Date : November 21, 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Oxybutynin plus PTNS
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.
Drug: Oxybutynin extended release
5mg tablet taken by mouth daily for 6 weeks
Other Name: Ditropan XL

Device: Posterior Tibial Nerve Stimulation
In office therapy administered for 30 minutes once every week for a total of 6 weeks
Other Name: Urgent PC Neuromodulation system

Placebo Comparator: Placebo plus PTNS
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.
Device: Posterior Tibial Nerve Stimulation
In office therapy administered for 30 minutes once every week for a total of 6 weeks
Other Name: Urgent PC Neuromodulation system

Drug: Placebo
Tablet taken by mouth daily for 6 weeks
Other Name: Dextrose powder




Primary Outcome Measures :
  1. 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].


Secondary Outcome Measures :
  1. Change in 24hr Pad Weight [ Time Frame: Baseline, 6 weeks ]
    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.


Other Outcome Measures:
  1. Change in the Patient Global Impression of Improvement (PGI-I) [ Time Frame: Baseline, 6 weeks ]
    The Patient Global Impression of Improvement (PGI-I) is a transition scale that is a single question asking the patient to rate their urinary tract condition now, as compared with how it was prior to before beginning treatment on a scale from 1 (Very much better to) 7 (Very much worse).

  2. Change in the Overactive Bladder Questionnaire Short Form (OABq-SF) Part 1 [ Time Frame: Baseline, 6 weeks ]
    Part 1 of the OABq-SF questionnaire asks about the relative bother a patient experiences with regard to overactive bladder symptoms over the previous 4 weeks. This part of the questionnaire has 6 questions, with scores ranging from 6 (least amount of bother) to 36 (most amount of bother). For this secondary outcome, we are measuring the change in score on the OABq-SF Part 1 from baseline to 6 weeks. Median change in scores were compared between the 2 groups using Wilcoxon Rank Sum test.

  3. Change in the Overactive Bladder Questionnaire Short Form (OABq-SF) Part 2 [ Time Frame: Baseline, 6 weeks ]
    Part 2 of the OABq-SF questionnaire asks about the relative bother a patient experiences with regard to overactive bladder symptoms over the previous 4 weeks. This part of the questionnaire has 13 questions, with scores ranging from 13 (least amount of bother) to 78 (most amount of bother). For this secondary outcome, we are measuring the change in score on the OABq-SF Part 2 from baseline to 6 weeks. Median change in scores were compared between the 2 groups using Wilcoxon Rank Sum test.

  4. Change in the Urinary Distress Inventory (UDI-6) [ Time Frame: Baseline, 6 weeks ]
    The UDI-6 is a 6-question inventory of how frequently and how much bother patients have from overactive bladder symptoms. The scores range from 0 (not at all) to 24 (a great deal of bother). We compared the change in scores from baseline to 6 weeks between the 2 groups using Wilcoxon Rank Sum test.

  5. Change in the Incontinence Impact Questionnaire (IIQ-7) [ Time Frame: Baseline, 6 weeks ]
    The IIQ-7 is a 7-question score assessing how urinary incontinence affects a patient's various activities and feelings. The range of possible scores is from 0 (not at all) to 28 (a great deal). Median change in scores from baseline to 6 weeks were compared between the 2 groups using Wilcoxon Rank Sum test.

  6. Change in Treatment Satisfaction Questionnaire for Medication, Version Two (TSQMvII) - Global Satisfaction Domain [ Time Frame: Baseline, 6 weeks ]
    To compare treatment satisfaction between PTNS plus anticholinergic medication versus PTNS plus placebo using the Treatment Satisfaction Questionnaire for Medication, version two (TSQMvII). Patients completed the questionnaire at baseline and again at 6 weeks. The TSQMvII satisfaction domains at each timepjoint were transformed into a score from 0 (extremely dissatisfied) to 100 (extremely satisfied). Median change in scores from baseline to 6 weeks were compared between the 2 groups using Wilcoxon Rank Sum Test.

  7. Change in Treatment Satisfaction Questionnaire for Medication, Version Two (TSQMvII) - Side Effects Domain [ Time Frame: Baseline, 6 weeks ]
    To compare bother from medication side effects between PTNS plus anticholinergic medication versus PTNS plus placebo using the Treatment Satisfaction Questionnaire for Medication, version two (TSQMvII). The questionnaire was completed at baseline and at 6 weeks. The TSQMvII side effects domain at each time point was transformed into a score from 0 (extremely dissatisfied) to 150 (extremely satisfied). Median change in scores from baseline to 6 weeks were compared between the 2 groups using Wilcoxon Rank Sum Test.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02176642


Locations
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United States, North Carolina
Duke Urogynecology
Durham, North Carolina, United States, 27707
Duke OB/GYN Consultants of Raleigh
Raleigh, North Carolina, United States, 27607
Sponsors and Collaborators
Duke University
Society of Urodynamics and Female Pelvic Medicine & Urogenital Reconstruction
Investigators
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Principal Investigator: Nazema Y Siddiqui, MD, MHS Duke University
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Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT02176642    
Other Study ID Numbers: Pro00052742
First Posted: June 27, 2014    Key Record Dates
Results First Posted: January 23, 2018
Last Update Posted: January 23, 2018
Last Verified: December 2017
Keywords provided by Duke University:
Urinary Urge Incontinence
Posterior Tibial Nerve Stimulation
PTNS
Neuromodulation
Oxybutynin
Anticholinergic Medication
Additional relevant MeSH terms:
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Urinary Incontinence, Urge
Urinary Incontinence
Urination Disorders
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Oxybutynin
Parasympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Urological Agents