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| ID | Type | Description | Link |
|---|---|---|---|
| 1R01AT007171-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Center for Complementary and Integrative Health (NCCIH) | NIH |
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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.
Study Objectives Primary: To compare change in Urgency Urinary Incontinence (UUI) episodes at 2 month follow-up on voiding diaries between hypnotherapy and pharmacotherapy groups (to determine whether hypnotherapy is at least as effective and durable in treating UUI as pharmacotherapy)
Secondary Analyses:
Randomization will occur using a computer-generated randomization scheme in varying permuted block sizes. Study personnel performing data entry will be masked to participants' treatment. Masking participants to treatment is not feasible. Participants will be followed at 2,6 & 12 months. Measurements will be performed before treatment, following completion of treatment visits (approximately 8 weeks), and at 6 and 12 months. Primary analysis will be intention to treat. Exploratory analyses of secondary outcomes will also be performed.
Study Visits: UUI participant screening: Study information given. Screening questionnaire given. Visit 1 Enrollment: Formal screening for eligibility, voiding diary reviewed, if eligible, written consent obtained with administration of study questionnaires, demographic and past medical history administration forms, Pelvic Organ Prolapse Quantitation (POP-Q) exam & hypnotic susceptibility testing scheduled. Pariticipants undergo hypnotic susceptibility testing prior to randomization. Participants randomized to treatment and contacted, treatments arranged. Hypnotherapy group: undergo weekly treatments over 8 weeks. Pharmacotherapy group: weekly counseling sessions over 8 week: Following hypnotherapy or medication counseling completion, f/u voiding diaries collected & study questionnaires administered. One of two long acting anti-cholinergic medications offered (Long acting Tolterodine or Extended Release Oxybutynin or equivalent generic substitutes).
6 & 12 month follow-up: Pharmacotherapy subjects receive medications for 1 year and Hypnotherapy subjects encouraged to continue self-hypnosis for 1 year with assistance of audio-recordings, with 1 optional hypnotherapy session between 6-12 months..
Participants informed pharmacotherapy & hypnotherapy sessions are audio-recorded and reviewed ensuring manual of procedures are followed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Anticholinergic medications | Active Comparator | Either of two standard, long acting anti-cholinergic medications (Long acting Tolterodine or Extended Release Oxybutynin)will be given. Subjects receive 8 weeks of medication counseling in conjunction with the medications. Medications will be continued for 1 year. |
|
| Hypnotherapy | Active Comparator | Subjects will receive approximately weekly hypnotherapy sessions over 8 weeks and will receive/download digital recordings for home practice. Subjects will be encouraged to practice self-hypnosis +/or listen to their recordings for 1 year. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Anticholinergic medications | Drug | The study will use either of two standard, long acting anti-cholinergic medications and dosages. Pharmacotherapy counseling sessions will also be administered over 8 weeks by trained research personnel. Pharmacotherapy counseling sessions will be audio-recorded and one or more sessions will be reviewed by study personnel to ensure that the medication counselor administers the sessions in a standardized fashion. Pill counts will be performed at the conclusion of the 8 weeks of pharmacotherapy counseling. Subjects will be provided the medication for 1 year. |
| Measure | Description | Time Frame |
|---|---|---|
| Percent Change in Urgency Urinary Incontinence Episodes | Percent change in UUI episodes from baseline to 2 months with comparison made between hypnotherapy & pharmacotherapy | Baseline and 2 month follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| Percent Change in Urgency Urinary Incontinence Episodes | Differences comparing hypnotherapy to pharmacotherapy percent change in median UUI episodes | 6 months |
| Percent Change in Urgency Urinary Incontinence Episodes |
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Inclusion Criteria:(For randomized trial)
Exclusion Criteria: (For Randomized trial)
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| Name | Affiliation | Role |
|---|---|---|
| Yuko Komesu, MD | University of New Mexcio Health Science Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of New Mexico Health Science Center | Albuquerque | New Mexico | 87131 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21399722 | Background | Komesu YM, Ketai LH, Mayer AR, Teshiba TM, Rogers RG. Functional MRI of the Brain in Women with Overactive Bladder: Brain Activation During Urinary Urgency. Female Pelvic Med Reconstr Surg. 2011;17(1):50-54. doi: 10.1097/SPV.0b013e3182065507. | |
| 22453228 | Background | Komesu YM, Sapien RE, Rogers RG, Ketai LH. Hypnotherapy for treatment of overactive bladder: a randomized controlled trial pilot study. Female Pelvic Med Reconstr Surg. 2011 Nov;17(6):308-13. doi: 10.1097/SPV.0b013e31823a08d9. |
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The information will be shared with other researchers upon their request. Our IRB required that we re-consent participants in order to make their data available to others. We can only share the information available on participants who signed these additional consents.
6 months after manuscript for the primary outcome is accepted for publication. Anticipated time for manuscript acceptance July 2019. Anticipated availability 3-5 years.
Dr. Komesu and Dr. Ketai will review requests. Access criteria includes de-identified dataset (including de-identification of dates of visit as this may be interpreted as a potential identifier) of those who consented to have data shared. Data for secondary manuscripts in progress by PIs will be shared only after PIs publish said data 6 months post-publication.
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Patients required to keep 3 day voiding diary to confirm their eligibility for the study prior to randomization. Pts also underwent hypnotic susceptibility testing prior to randomization.
Of those consented, 13 did not go on to randomization: 8 were excluded because they did not meet inclusion criteria and 5 were lost to further followup
Patients recruited March 2013 through October 2016 from the UNMH Urogynecology clinics
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| ID | Title | Description |
|---|---|---|
| FG000 | Anticholinergic Medications | Either of two standard, long acting anti-cholinergic medications (Long acting Tolterodine or Extended Release Oxybutynin)will be given. Subjects receive 8 weeks of medication counseling in conjunction with the medications. Medications will be continued for 1 year. Anticholinergic medications: The study will use either of two standard, long acting anti-cholinergic medications and dosages. Pharmacotherapy counseling sessions will also be administered over 8 weeks by trained research personnel. Pharmacotherapy counseling sessions will be audio-recorded and one or more sessions will be reviewed by study personnel to ensure that the medication counselor administers the sessions in a standardized fashion. Pill counts will be performed at the conclusion of the 8 weeks of pharmacotherapy counseling. Subjects will be provided the medication for 1 year. |
| FG001 | Hypnotherapy | Subjects will receive approximately weekly hypnotherapy sessions over 8 weeks and will receive/download digital recordings for home practice. Subjects will be encouraged to practice self-hypnosis +/or listen to their recordings for 1 year. Hypnotherapy: Hypnotherapy will be administered approximately weekly over 8 weeks by certified, trained clinical hypnotherapists. Sessions will be audio-recorded and one or more sessions will be reviewed by study personnel to ensure that the hypnotherapist administers the hypnotherapy session in a standardized fashion.Subjects will receive or download a digital recording specially prepared for them to for home practice of hypnotherapy sessions.Following the 8 weeks of therapy, subjects will be encouraged to continue to practice self-hypnosis and/or listen to their home practice digital recording and this practice will be tracked for the 1 year duration of the study. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
analysis was performed on baseline of patients with primary outcome data; baseline analysis includes the 70 and 72 patients with 2 month data
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Hypnotherapy | Subjects will receive approximately weekly hypnotherapy sessions over 8 weeks and will receive/download digital recordings for home practice. Subjects will be encouraged to practice self-hypnosis +/or listen to their recordings for 1 year. Hypnotherapy: Hypnotherapy will be administered approximately weekly over 8 weeks by certified, trained clinical hypnotherapists. Sessions will be audio-recorded and one or more sessions will be reviewed by study personnel to ensure that the hypnotherapist administers the hypnotherapy session in a standardized fashion.Subjects will receive or download a digital recording specially prepared for them to for home practice of hypnotherapy sessions.Following the 8 weeks of therapy, subjects will be encouraged to continue to practice self-hypnosis and/or listen to their home practice digital recording and this practice will be tracked for the 1 year duration of the study. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percent Change in Urgency Urinary Incontinence Episodes | Percent change in UUI episodes from baseline to 2 months with comparison made between hypnotherapy & pharmacotherapy | 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 | Posted | Median | 95% Confidence Interval | percentage change in median UUI episodes | Baseline and 2 month follow-up |
|
1 year; from study randomization to study completion
Adverse event collection occurred at all follow-up and by spontaneous participant report
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Hypnotherapy | Subjects will receive approximately weekly hypnotherapy sessions over 8 weeks and will receive/download digital recordings for home practice. Subjects will be encouraged to practice self-hypnosis +/or listen to their recordings for 1 year. Hypnotherapy: Hypnotherapy will be administered approximately weekly over 8 weeks by certified, trained clinical hypnotherapists. Sessions will be audio-recorded and one or more sessions will be reviewed by study personnel to ensure that the hypnotherapist administers the hypnotherapy session in a standardized fashion.Subjects will receive or download a digital recording specially prepared for them to for home practice of hypnotherapy sessions.Following the 8 weeks of therapy, subjects will be encouraged to continue to practice self-hypnosis and/or listen to their home practice digital recording and this practice will be tracked for the 1 year duration of the study. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| 1 inpatient hospitalization | Renal and urinary disorders | Systematic Assessment | admitted with worsening hyperparathyroidism; a pre-existing condition |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Falls | Musculoskeletal and connective tissue disorders | Systematic Assessment | Fell on floor |
Women willing to participate x1 yr in RCT may not represent the general population. Population limited to 1 U.S. southwestern institution
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Yuko Komesu | University of New Mexico | 5052490726 | ykomesu@salud.unm.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 16, 2016 | Dec 7, 2018 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D053202 | Urinary Incontinence, Urge |
| D052776 | Female Urogenital Diseases |
| ID | Term |
|---|---|
| D014549 | Urinary Incontinence |
| D014555 | Urination Disorders |
| D014570 | Urologic Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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Not provided
| ID | Term |
|---|---|
| D000068737 | Tolterodine Tartrate |
| C005419 | oxybutynin |
| D006990 | Hypnosis |
| ID | Term |
|---|---|
| D010665 | Phenylpropanolamine |
| D011412 | Propanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
Not provided
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Not provided
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|
|
| Hypnotherapy | Behavioral | Hypnotherapy will be administered approximately weekly over 8 weeks by certified, trained clinical hypnotherapists. Sessions will be audio-recorded and one or more sessions will be reviewed by study personnel to ensure that the hypnotherapist administers the hypnotherapy session in a standardized fashion.Subjects will receive or download a digital recording specially prepared for them to for home practice of hypnotherapy sessions.Following the 8 weeks of therapy, subjects will be encouraged to continue to practice self-hypnosis and/or listen to their home practice digital recording and this practice will be tracked for the 1 year duration of the study. |
|
Percent change in median UUI episodes from baseline to 12 months with comparison made between hypnotherapy & pharmacotherapy
| 12 months |
| Overactive Bladder Questionnaire Short Form Symptom Bother | 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) | 2 months |
| Overactive Bladder Questionnaire Short Form Symptom Bother | 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) | 6 months |
| Overactive Bladder Questionnaire Short Form Symptom Bother | 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) | 12 months |
| Overactive Bladder Questionnaire Short Form Quality of Life | 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. | 2 months |
| Overactive Bladder Questionnaire Short Form Quality of Life | 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. | 6 months |
| Overactive Bladder Questionnaire Short Form Quality of Life | 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. | 12 months |
| Voids on Bladder Diary | Total Number of voids on 3-day bladder diary. | 2 months |
| Voids on Bladder Diary | number of voids on 3-day bladder diary | 6 months |
| Voids on Bladder Diary | number of voids on 3-day bladder diary | 12 months |
| 12206577 | Background | Coyne K, Revicki D, Hunt T, Corey R, Stewart W, Bentkover J, Kurth H, Abrams P. Psychometric validation of an overactive bladder symptom and health-related quality of life questionnaire: the OAB-q. Qual Life Res. 2002 Sep;11(6):563-74. doi: 10.1023/a:1016370925601. |
| 10679830 | Background | Sandvik H, Seim A, Vanvik A, Hunskaar S. A severity index for epidemiological surveys of female urinary incontinence: comparison with 48-hour pad-weighing tests. Neurourol Urodyn. 2000;19(2):137-45. doi: 10.1002/(sici)1520-6777(2000)19:23.0.co;2-g. |
| 16460875 | Background | Coyne KS, Matza LS, Kopp Z, Abrams P. The validation of the patient perception of bladder condition (PPBC): a single-item global measure for patients with overactive bladder. Eur Urol. 2006 Jun;49(6):1079-86. doi: 10.1016/j.eururo.2006.01.007. Epub 2006 Jan 24. |
| 16418145 | Background | Coyne KS, Zyczynski T, Margolis MK, Elinoff V, Roberts RG. Validation of an overactive bladder awareness tool for use in primary care settings. Adv Ther. 2005 Jul-Aug;22(4):381-94. doi: 10.1007/BF02850085. |
| 9863850 | Background | Burgio KL, Locher JL, Goode PS, Hardin JM, McDowell BJ, Dombrowski M, Candib D. Behavioral vs drug treatment for urge urinary incontinence in older women: a randomized controlled trial. JAMA. 1998 Dec 16;280(23):1995-2000. doi: 10.1001/jama.280.23.1995. |
| 33122028 | Derived | Ketai LH, Komesu YM, Schrader RM, Rogers RG, Sapien RE, Dodd AB, Mayer AR. Mind-body (hypnotherapy) treatment of women with urgency urinary incontinence: changes in brain attentional networks. Am J Obstet Gynecol. 2021 May;224(5):498.e1-498.e10. doi: 10.1016/j.ajog.2020.10.041. Epub 2020 Oct 26. |
| 31449805 | Derived | Komesu YM, Schrader RM, Rogers RG, Sapien RE, Mayer AR, Ketai LH. Hypnotherapy or medications: a randomized noninferiority trial in urgency urinary incontinent women. Am J Obstet Gynecol. 2020 Feb;222(2):159.e1-159.e16. doi: 10.1016/j.ajog.2019.08.025. Epub 2019 Aug 23. |
| BG001 | Anticholinergic Medications | Either of two standard, long acting anti-cholinergic medications (Long acting Tolterodine or Extended Release Oxybutynin)will be given. Subjects receive 8 weeks of medication counseling in conjunction with the medications. Medications will be continued for 1 year. Anticholinergic medications: The study will use either of two standard, long acting anti-cholinergic medications and dosages. Pharmacotherapy counseling sessions will also be administered over 8 weeks by trained research personnel. Pharmacotherapy counseling sessions will be audio-recorded and one or more sessions will be reviewed by study personnel to ensure that the medication counselor administers the sessions in a standardized fashion. Pill counts will be performed at the conclusion of the 8 weeks of pharmacotherapy counseling. Subjects will be provided the medication for 1 year. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Urgency Incontinence episodes on 3 day diary | Median | Inter-Quartile Range | episodes |
|
| Overactive bladder short form (OABq-SF) questionnaires | Lower scores on the bother sub-scale are better (less bother) and Higher scores on the quality of life sub-scale are better (higher quality of life) ; validated questionnaire scores for both Sub-scales range from 0-100. These results are stand-alone; they are not combined | Mean | Standard Deviation | units on a scale |
|
| number of voids on bladder diary | Patients recorded their number of voids (total) on a 3-day bladder diary | Mean | Standard Deviation | episodes |
|
| OG001 | Anticholinergic Medications | Either of two standard, long acting anti-cholinergic medications (Long acting Tolterodine or Extended Release Oxybutynin)will be given. Subjects receive 8 weeks of medication counseling in conjunction with the medications. Medications will be continued for 1 year. Anticholinergic medications: The study will use either of two standard, long acting anti-cholinergic medications and dosages. Pharmacotherapy counseling sessions will also be administered over 8 weeks by trained research personnel. Pharmacotherapy counseling sessions will be audio-recorded and one or more sessions will be reviewed by study personnel to ensure that the medication counselor administers the sessions in a standardized fashion. Pill counts will be performed at the conclusion of the 8 weeks of pharmacotherapy counseling. Subjects will be provided the medication for 1 year. |
|
|
|
| Secondary | Percent Change in Urgency Urinary Incontinence Episodes | Differences comparing hypnotherapy to pharmacotherapy percent change in median UUI episodes | 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 | Posted | Median | 95% Confidence Interval | percentage change in median UUI episodes | 6 months |
|
|
|
|
| Secondary | Percent Change in Urgency Urinary Incontinence Episodes | Percent change in median UUI episodes from baseline to 12 months with comparison made between hypnotherapy & pharmacotherapy | 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. | Posted | Median | 95% Confidence Interval | percentage change in median UUI episodes | 12 months |
|
|
|
| Secondary | Overactive Bladder Questionnaire Short Form Symptom Bother | 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) | 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 | Posted | Least Squares Mean | 95% Confidence Interval | scores on a sub-scale | 2 months |
|
|
|
| Secondary | Overactive Bladder Questionnaire Short Form Symptom Bother | 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) | 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. | Posted | Least Squares Mean | 95% Confidence Interval | sub-scale scores | 6 months |
|
|
|
| Secondary | Overactive Bladder Questionnaire Short Form Symptom Bother | 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) | 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. | Posted | Least Squares Mean | 95% Confidence Interval | sub-scale scores | 12 months |
|
|
|
| Secondary | Overactive Bladder Questionnaire Short Form Quality of Life | 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. | 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. | Posted | Least Squares Mean | 95% Confidence Interval | sub-scale scores | 2 months |
|
|
|
| Secondary | Overactive Bladder Questionnaire Short Form Quality of Life | 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. | 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. | Posted | Least Squares Mean | 95% Confidence Interval | sub-scale scores | 6 months |
|
|
|
| Secondary | Overactive Bladder Questionnaire Short Form Quality of Life | 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. | At 12 months in the hypnotherapy group: 4 had withdrawn, 1 missing diary. In the medication group, 7 had withdrawn. | Posted | Least Squares Mean | 95% Confidence Interval | sub-scale scores | 12 months |
|
|
|
| Secondary | Voids on Bladder Diary | Total Number of voids on 3-day bladder diary. | 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. | Posted | Mean | 95% Confidence Interval | counts | 2 months |
|
|
|
| Secondary | Voids on Bladder Diary | number of voids on 3-day bladder diary | Of the 74 women randomized to hypnotherapy, at 6 months: 4 had withdrawn and 2 were lost and 1 was missing diary information. Of the 78 women randomized to medications, 6 had withdrawn and 1 was lost. | Posted | Mean | 95% Confidence Interval | counts | 6 months |
|
|
|
| Secondary | Voids on Bladder Diary | number of voids on 3-day bladder diary | At 12 months, of the 74 randomized to hypnotherapy: 4 had withdrawn and 1 was missing diary information. Of the 78 women randomized to medications, 7 had withdrawn. | Posted | Mean | 95% Confidence Interval | counts | 12 months |
|
|
|
| 0 |
| 70 |
| 1 |
| 70 |
| 12 |
| 70 |
| EG001 | Anticholinergic Medications | Either of two standard, long acting anti-cholinergic medications (Long acting Tolterodine or Extended Release Oxybutynin)will be given. Subjects receive 8 weeks of medication counseling in conjunction with the medications. Medications will be continued for 1 year. Anticholinergic medications: The study will use either of two standard, long acting anti-cholinergic medications and dosages. Pharmacotherapy counseling sessions will also be administered over 8 weeks by trained research personnel. Pharmacotherapy counseling sessions will be audio-recorded and one or more sessions will be reviewed by study personnel to ensure that the medication counselor administers the sessions in a standardized fashion. Pill counts will be performed at the conclusion of the 8 weeks of pharmacotherapy counseling. Subjects will be provided the medication for 1 year. | 0 | 72 | 3 | 72 | 27 | 72 |
|
| 1 inpatient hospitalization | Musculoskeletal and connective tissue disorders | Systematic Assessment | fell off horse when horse stepped into a hole and incurred trauma to leg. |
|
| 1 inpatient hospitalization for observation | Cardiac disorders | Systematic Assessment | pt had abnormal cardiac stress test with pre-existing cardiac disease. Patient's cardiac work up in the hospital was negative |
|
| 1 in-patient hospitalization | Musculoskeletal and connective tissue disorders | Systematic Assessment | pt had pre-existing chronic back pain. Hospitalized for possible disc disease. Recovered and returned to usual activities with continued follow-up with orthopedic physician. |
|
|
| urinary tract infection | Infections and infestations | Systematic Assessment | treated for urinary tract infection |
|
| back pain | Musculoskeletal and connective tissue disorders | Systematic Assessment | complaint of back pain |
|
| expected adverse events pharmacotherapy | General disorders | Systematic Assessment | dry eyes, dry mouth, constipation, dyspepsia These expected events were not gathered separately and are therefore are listed together |
|
Not provided
Not provided
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D059411 | Lower Urinary Tract Symptoms |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009930 |
| Organic Chemicals |
| D020005 | Propanols |
| D000588 | Amines |
| D001559 | Benzhydryl Compounds |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D003408 | Cresols |
| D010636 | Phenols |
| D026441 | Mind-Body Therapies |
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |