N/A
N=152
Brain-Centered Therapy Versus Medication for Urgency Urinary Incontinence : Hypnotherapy Or Pharmacotherapy
Urinary Incontinence, Urge
Bottom Line
View on ClinicalTrials.gov: NCT01829425 ↗Enrolled (actual)
152
Serious AEs
2.8%
Results posted
Apr 2019
Primary outcome: Primary: Percent Change in Urgency Urinary Incontinence Episodes — 73; 88.6 percentage change in median UUI episodes — p=<.025
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Anticholinergic medications (Drug); Hypnotherapy (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- University of New Mexico
- Primary completion
- Oct 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent Change in Urgency Urinary Incontinence Episodes |
85.7; 80.0 | — |
| SECONDARY Percent Change in Urgency Urinary Incontinence Episodes |
85.7; 80.0 | — |
| SECONDARY Percent Change in Urgency Urinary Incontinence Episodes |
85.7; 80.0 | — |
| SECONDARY Overactive Bladder Questionnaire Short Form Symptom Bother |
32.27; 30.74 | — |
| SECONDARY Overactive Bladder Questionnaire Short Form Symptom Bother |
32.27; 30.74 | — |
| SECONDARY Overactive Bladder Questionnaire Short Form Symptom Bother |
32.27; 30.74 | — |
| SECONDARY Overactive Bladder Questionnaire Short Form Quality of Life |
75.71; 81.57 | — |
| SECONDARY Overactive Bladder Questionnaire Short Form Quality of Life |
75.71; 81.57 | — |
| SECONDARY Overactive Bladder Questionnaire Short Form Quality of Life |
75.71; 81.57 | — |
| SECONDARY Voids on Bladder Diary |
25.74; 25.37 | — |
| SECONDARY Voids on Bladder Diary |
25.74; 25.37 | — |
| SECONDARY Voids on Bladder Diary |
25.74; 25.37 | — |
Summary
This study is randomized controlled trial in which urgency incontinent women (approximately 150-160) will be randomized to hypnotherapy or pharmacotherapy and evaluated at months 2, 6 &12 Hypotheses: Among patients with urgency urinary incontinence (UUI), hypnotherapy will be non-inferior pharmacotherapy in diminishing UUI episodes. Hypnotherapy may be superior or may not differ from pharmacotherapy in diminishing symptoms or quality of life based on validated questionnaires and/or other diary parameters.
Eligibility Criteria
Inclusion Criteria:(For randomized trial)
- Non-pregnant English-speaking women
- 18 yo or older
- Overactive Bladder (OAB) Awareness scores ≥ 8
- 3 UUI episodes/week for ≥ 3 months
Exclusion Criteria: (For Randomized trial)
- Women with a history of neurologic diseases such as Multiple Sclerosis, Parkinson's disease, stroke, or dementia
- History of schizophrenia or untreated bipolar disorder or current drug or alcohol dependence
- Women who have taken anticholinergic medications for UUI within the last 3 weeks (women who have taken anti-cholinergics for UUI but discontinued them > than 3 weeks ago may participate in the study) or have a sacral neuromodulator in place to treat UUI or have received Onabotulinum toxin A in the last 12 months to treat UUI
- Contraindications to anticholinergic medications (untreated narrow angle glaucoma, significant urinary retention or gastric retention)
- Pregnant women or lactating women, women who plan to become pregnant in the next year, or pre-menopausal women unwilling to use contraception if engaging in sexual relations during the year of study participation (hysterectomy is considered to be a form of contraception)
- Untreated urinary tract infection
- Prolapse which extends past the hymen (POP-Q points of ≥ 1+) which may be responsible for UUI symptoms
- Women who cannot keep the majority of the study therapy appointments or those without reliable contact phone numbers or methods of communication with the study personnel.
Data sourced from ClinicalTrials.gov (NCT01829425). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.