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

NCT02176642 | Terminated Phase 4 Results

• 1 other identifier: Pro00052742
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 2

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.

Conditions

Urinary Urge Incontinence

Keywords

Urinary Urge Incontinence; Posterior Tibial Nerve Stimulation; PTNS; Neuromodulation; Oxybutynin; Anticholinergic Medication

Outcome Measures

Primary Outcomes (1)

• 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 \[post-treatment UUI/day minus pre-treatment UUI/day\].

  Baseline, 6 weeks

Secondary Outcomes (1)

• Change in 24hr Pad Weight

  Baseline, 6 weeks

Other Outcomes (7)

• Change in the Patient Global Impression of Improvement (PGI-I)

  Baseline, 6 weeks

• Change in the Overactive Bladder Questionnaire Short Form (OABq-SF) Part 1

  Baseline, 6 weeks

• Change in the Overactive Bladder Questionnaire Short Form (OABq-SF) Part 2

  Baseline, 6 weeks

Study Arms (2)

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.

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.

Device: Posterior Tibial Nerve Stimulation; Drug: Placebo

Interventions

Oxybutynin extended release DRUG

5mg tablet taken by mouth daily for 6 weeks

Also known as: Ditropan XL

Oxybutynin plus PTNS

Posterior Tibial Nerve Stimulation DEVICE

In office therapy administered for 30 minutes once every week for a total of 6 weeks

Also known as: Urgent PC Neuromodulation system

Oxybutynin plus PTNS; Placebo plus PTNS

Placebo DRUG

Tablet taken by mouth daily for 6 weeks

Also known as: Dextrose powder

Placebo plus PTNS

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Duke University: lead
• Society of Urodynamics, Female Pelvic Medicine & Urogenital Reconstruction: collaborator

Study Sites (2)

Duke Urogynecology

Durham, North Carolina, 27707, United States

Location

Duke OB/GYN Consultants of Raleigh

Raleigh, North Carolina, 27607, United States

Location

MeSH Terms

Conditions

Urinary Incontinence, Urge

Interventions

Tolterodine Tartrate

Condition Hierarchy (Ancestors)

Urinary Incontinence; Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Phenylpropanolamine; Propanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Propanols; Amines; Benzhydryl Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Cresols; Phenols

Results Point of Contact

• Title: Nazema Siddiqui MD
• Organization: Duke University

nazema.siddiqui@duke.edu

Study Officials

• Nazema Y Siddiqui, MD, MHS

  Duke University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 25, 2014
• First Posted: June 27, 2014
• Study Start: August 1, 2014
• Primary Completion: November 21, 2016
• Study Completion: November 21, 2016
• Last Updated: January 23, 2018
• Results First Posted: January 23, 2018

Record last verified: 2017-12

Locations

US (2)