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

Information source: Duke University
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Urinary Urge Incontinence

Intervention: Oxybutynin extended release (Drug); Posterior Tibial Nerve Stimulation (Device); Placebo (Drug)

Phase: Phase 4

Status: Recruiting

Sponsored by: Duke University

Official(s) and/or principal investigator(s):
Nazema Y Siddiqui, MD, MHS, Principal Investigator, Affiliation: Duke University

Overall contact:
Michael R Polin, MD, Phone: 919-401-1000, Email: michael.polin@duke.edu

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).

Clinical Details

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 design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Change in mean number of UUI episodes per day

Secondary outcome: Change in 24hr pad weight

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Female.

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

Locations and Contacts

Michael R Polin, MD, Phone: 919-401-1000, Email: michael.polin@duke.edu

Duke Urogynecology, Durham, North Carolina 27707, United States; Recruiting
Erica Chambers, RN, MSN, CPN, Phone: 919-419-5211, Email: erica.chambers@duke.edu
Nazema Y Siddiqui, MD, MHS, Principal Investigator
Anthony G Visco, MD, Sub-Investigator
Alison C Weidner, MD, Sub-Investigator
Cindy L Amundsen, MD, Sub-Investigator
Michael R Polin, MD, Sub-Investigator

Duke OB/GYN Consultants of Raleigh, Raleigh, North Carolina 27607, United States; Recruiting
Kimberlee Adcock, RN, Phone: 919-419-5215, Email: kim.adcock@duke.edu
Nazema Y Siddiqui, MD, MHS, Principal Investigator
Anthony G Visco, MD, Sub-Investigator
Alison C Weidner, MD, Sub-Investigator
Cindy L Amundsen, MD, Sub-Investigator
Michael R Polin, MD, Sub-Investigator

Additional Information

Starting date: August 2014
Last updated: July 8, 2015

Page last updated: August 23, 2015

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