Trial · NCT01829425
Brain-Centered Therapy Versus Medication for Urgency Urinary Incontinence : Hypnotherapy Or Pharmacotherapy
NCT01829425, Not applicable, Completed, University of New Mexico; results first posted 2019-04-01
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Brain-Centered Therapy Versus Medication for Urgency Urinary Incontinence : Hypnotherapy Or Pharmacotherapy. Trials, record NCT01829425. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01829425
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Brain-Centered Therapy Versus Medication for Urgency Urinary Incontinence : Hypnotherapy Or Pharmacotherapy
- NCT number
- NCT01829425
- Status
- Completed
- Phases
- Not applicable
- Enrollment
- 165 participants, actual
- Lead sponsor
- University of New Mexico
- Conditions
- Urinary Incontinence, Urge
- Interventions
- Anticholinergic medications, Hypnotherapy
- First posted
- 2013-04-11
- Last updated
- 2019-04-23
- Results first posted
- 2019-04-01
- Limitations and caveats
- Women willing to participate x1 yr in RCT may not represent the general population. Population limited to 1 U.S. southwestern institution
Source ClinicalTrials.gov
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percent Change in Urgency Urinary Incontinence Episodes | Baseline and 2 month follow-up | Percent change in UUI episodes from baseline to 2 months with comparison made between hypnotherapy \& pharmacotherapy |
| Secondary | Percent Change in Urgency Urinary Incontinence Episodes | 6 months | Differences comparing hypnotherapy to pharmacotherapy percent change in median UUI episodes |
| Secondary | Percent Change in Urgency Urinary Incontinence Episodes | 12 months | Percent change in median UUI episodes from baseline to 12 months with comparison made between hypnotherapy \& pharmacotherapy |
| Secondary | Overactive Bladder Questionnaire Short Form Symptom Bother | 2 months | Overactive Bladder Questionnaire Short Form symptom bother Scale. Sub-Scale range 0-100. Higher numbers are worse (more bother) and lower numbers are better (less bother) |
| Secondary | Overactive Bladder Questionnaire Short Form Symptom Bother | 6 months | Overactive Bladder Questionnaire Short Form symptom bother. Sub-scale range 0-100. Higher numbers are worse (more bother) and lower numbers are better (less bother) |
| Secondary | Overactive Bladder Questionnaire Short Form Symptom Bother | 12 months | Overactive Bladder Questionnaire Short Form symptom bother. Sub-scale range 0-100. Higher numbers are worse (more bother) and lower numbers are better (less bother) |
| Secondary | Overactive Bladder Questionnaire Short Form Quality of Life | 2 months | Overactive Bladder questionnaire-Short Form Quality of Life. Higher scores are better (better quality of life) and lower scores are worse (poorer quality of life). sub-score range 0-100. |
| Secondary | Overactive Bladder Questionnaire Short Form Quality of Life | 6 months | Overactive Bladder questionnaire Short Form Quality of Life. Higher scores are better (better quality of life) and lower scores are worse (poorer quality of life). sub-scale score range 0-100. |
| Secondary | Overactive Bladder Questionnaire Short Form Quality of Life | 12 months | Overactive Bladder questionnaire-Short Form Quality of Life. Higher scores are better (higher quality of life) and lower scores are worse (poorer quality of life). score range 0-100. |
| Secondary | Voids on Bladder Diary | 2 months | Total Number of voids on 3-day bladder diary. |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 registered outcomesOutcomes12
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percent Change in Urgency Urinary Incontinence Episodes | Baseline and 2 month follow-up | Randomized patients with primary outcome (diary information) 2 months. Hypnotherapy: 74 randomized; of those randomized 3 had withdrawn, 1 was lost=70 with primary outcome information for analysis. Medications: 78 randomized-- 4 withdrawn. 2 were missing diary information=72 with primary outcome information for analysis | percentage change in median UUI episodes | MEDIAN |
| SECONDARY | Percent Change in Urgency Urinary Incontinence Episodes | 6 months | At 6 months. Hypnotherapy: 74 women randomized-- 4 withdrawn, 2 lost and 1 missing diary information=67 analyzed with diary data. Medication: 78 randomized, 6 had withdrawn and 1 lost=71 analyzed with diary data | percentage change in median UUI episodes | MEDIAN |
| SECONDARY | Percent Change in Urgency Urinary Incontinence Episodes | 12 months | Pts with diary data at 12 months. For the Hypnotherapy group, of the 74 women randomized, 4 had withdrawn and 1 was missing diary data. For the medication group, of the 78 women randomized, 7 had withdrawn. | percentage change in median UUI episodes | MEDIAN |
| SECONDARY | Overactive Bladder Questionnaire Short Form Symptom Bother | 2 months | Randomized patients with primary outcome (diary information) 2 months. Hypnotherapy: 70 had diary information; of those randomized 3 had withdrawn, 1 was lost=70 with primary outcome information for analysis. Medications: 78 randomized-- 4 withdrawn. 2 were missing diary information=72 with primary outcome information for analysis | scores on a sub-scale | LEAST_SQUARES_MEAN |
| SECONDARY | Overactive Bladder Questionnaire Short Form Symptom Bother | 6 months | At 6 months in the hypnotherapy group, 4 had withdrawn and 2 were lost and 1 missing diary. In the medication group, 6 had withdrawn and 1 was missing. | sub-scale scores | LEAST_SQUARES_MEAN |
| SECONDARY | Overactive Bladder Questionnaire Short Form Symptom Bother | 12 months | 12 months. Hypnotherapy: 74 randomized, 4 withdrawn \& 1 was missing diary=69 analyzed with diary data. Medication: 78 randomized, 7 had withdrawn=71 analyzed with diary data. | sub-scale scores | LEAST_SQUARES_MEAN |
| SECONDARY | Overactive Bladder Questionnaire Short Form Quality of Life | 2 months | Randomized patients with primary outcome (diary information) 2 months. Hypnotherapy: 74 randomized; 3 withdrawn, 1 lost=70 with primary outcome information used for analysis for secondary outcomes. Medications: 78 randomized-- 4 withdrawn, 2 were missing diary information=72 for analysis of secondary outcome. | sub-scale scores | LEAST_SQUARES_MEAN |
| SECONDARY | Overactive Bladder Questionnaire Short Form Quality of Life | 6 months | At 6 months, in the hypnotherapy group: 4 had withdrawn and 2 were lost and 1 missing diary. In the medication group: 6 had withdrawn and 1 was lost. | sub-scale scores | LEAST_SQUARES_MEAN |
| SECONDARY | Overactive Bladder Questionnaire Short Form Quality of Life | 12 months | At 12 months in the hypnotherapy group: 4 had withdrawn, 1 missing diary. In the medication group, 7 had withdrawn. | sub-scale scores | LEAST_SQUARES_MEAN |
| SECONDARY | Voids on Bladder Diary | 2 months | At 2 months in the hypnotherapy group of the 74 randomized, 3 had withdrawn and 1 was lost. In the medication group, of 78 randomized: 4 had withdrawn and 2 were missing diaries. | counts | MEAN |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 outcomesResults by group24
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percent Change in Urgency Urinary Incontinence Episodes | Hypnotherapy | 73 | 95% Confidence Interval 60 to 88.9 | percentage change in median UUI episodes | |
| Percent Change in Urgency Urinary Incontinence Episodes | Anticholinergic Medications | 88.6 | 95% Confidence Interval 78.6 to 100 | percentage change in median UUI episodes | |
| Percent Change in Urgency Urinary Incontinence Episodes | Hypnotherapy | 85.7 | 95% Confidence Interval 75 to 100 | percentage change in median UUI episodes | |
| Percent Change in Urgency Urinary Incontinence Episodes | Anticholinergic Medications | 83.3 | 95% Confidence Interval 64.7 to 100 | percentage change in median UUI episodes | |
| Percent Change in Urgency Urinary Incontinence Episodes | Hypnotherapy | 85.7 | 95% Confidence Interval 66.7 to 94.4 | percentage change in median UUI episodes | |
| Percent Change in Urgency Urinary Incontinence Episodes | Anticholinergic Medications | 80.0 | 95% Confidence Interval 54.5 to 100.0 | percentage change in median UUI episodes | |
| Overactive Bladder Questionnaire Short Form Symptom Bother | Hypnotherapy | 38.17 | 95% Confidence Interval 30.19 to 46.14 | scores on a sub-scale | |
| Overactive Bladder Questionnaire Short Form Symptom Bother | Anticholinergic Medications | 35.33 | 95% Confidence Interval 28.64 to 42.02 | scores on a sub-scale | |
| Overactive Bladder Questionnaire Short Form Symptom Bother | Hypnotherapy | 34.61 | 95% Confidence Interval 26.26 to 42.96 | sub-scale scores | |
| Overactive Bladder Questionnaire Short Form Symptom Bother | Anticholinergic Medications | 27.93 | 95% Confidence Interval 20.66 to 35.20 | sub-scale scores |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Anticholinergic Medications | 78 | |
| Overall Study | STARTED | Hypnotherapy | 74 | |
| Overall Study | COMPLETED | Anticholinergic Medications | 72 | |
| Overall Study | COMPLETED | Hypnotherapy | 70 | |
| Overall Study | NOT COMPLETED | Anticholinergic Medications | 6 | |
| Overall Study | NOT COMPLETED | Hypnotherapy | 4 |
Source ClinicalTrials.gov
Adverse events16
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Falls | Musculoskeletal and connective tissue disorders | Hypnotherapy | 3 | 70 | 3 |
| other | Falls | Musculoskeletal and connective tissue disorders | Anticholinergic Medications | 5 | 72 | 5 |
| other | urinary tract infection | Infections and infestations | Hypnotherapy | 5 | 70 | 5 |
| other | urinary tract infection | Infections and infestations | Anticholinergic Medications | 6 | 72 | 6 |
| other | back pain | Musculoskeletal and connective tissue disorders | Hypnotherapy | 3 | 70 | 3 |
| other | back pain | Musculoskeletal and connective tissue disorders | Anticholinergic Medications | 4 | 72 | 4 |
| other | expected adverse events pharmacotherapy | General disorders | Hypnotherapy | 1 | 70 | 1 |
| other | expected adverse events pharmacotherapy | General disorders | Anticholinergic Medications | 12 | 72 | 12 |
| serious | 1 inpatient hospitalization | Renal and urinary disorders | Hypnotherapy | 1 | 70 | 1 |
| serious | 1 inpatient hospitalization | Renal and urinary disorders | Anticholinergic Medications | 0 | 72 | 0 |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Hypnotherapy | 0 | 70 |
| Total, all-cause mortality | Anticholinergic Medications | 0 | 72 |
| Total, other adverse events | Hypnotherapy | 12 | 70 |
| Total, other adverse events | Anticholinergic Medications | 27 | 72 |
| Total, serious adverse events | Hypnotherapy | 1 | 70 |
| Total, serious adverse events | Anticholinergic Medications | 3 | 72 |
Source ClinicalTrials.gov
Papers9
The papers the trial lists on ClinicalTrials.gov.
Grants1
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| R01AT007171 | Brain-Centered Therapy versus Medication for Urgency Urinary Incontinence_An RCT | KETAI, LOREN HOWARD; KOMESU, YUKO MARGARET | UNIVERSITY OF NEW MEXICO HEALTH SCIS CTR | NATIONAL CENTER FOR COMPLEMENTARY & INTEGRATIVE HEALTH | 2012 to 2016 |
Source NIH RePORTER
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Hypnotherapy vs Anticholinergic Medications: deaths from any cause | Trial comparisons |
| Hypnotherapy vs Anticholinergic Medications: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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