Brain-Centered Therapy Versus Medication for Urgency Urinary Incontinence : Hypnotherapy Or Pharmacotherapy

NCT01829425 | Completed Results DMC

• 2 other identifiers: 09-3141R01AT007171-01A1
• Study Type: interventional
• Target: 165
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Urinary Incontinence, Urge

Keywords

Hypnosis; Mind-Body Therapy; Anticholinergics; Female Urogenital Diseases

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (11)

• Percent Change in Urgency Urinary Incontinence Episodes

  6 months

• Percent Change in Urgency Urinary Incontinence Episodes

  12 months

• Overactive Bladder Questionnaire Short Form Symptom Bother

  2 months

• Overactive Bladder Questionnaire Short Form Symptom Bother

  6 months

• Overactive Bladder Questionnaire Short Form Symptom Bother

  12 months

Study Arms (2)

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.

Drug: Anticholinergic medications

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.

Behavioral: Hypnotherapy

Interventions

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.

Also known as: Tolterodine (Detrol LA or equivalent generic), Oxybutynin (Ditropan Extended Release or equivalent generic)

Anticholinergic medications

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.

Hypnotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Non-pregnant English-speaking women
• yo or older
• Overactive Bladder (OAB) Awareness scores ≥ 8
• UUI episodes/week for ≥ 3 months

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of New Mexico: lead
• National Center for Complementary and Integrative Health (NCCIH): collaborator

Study Sites (1)

University of New Mexico Health Science Center

Albuquerque, New Mexico, 87131, United States

Location

Related Publications (9)

• 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.

  PMID: 21399722 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.

  PMID: 22453228 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.

  PMID: 12206577 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.

  PMID: 10679830 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.

  PMID: 16460875 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.

  PMID: 16418145 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.

  PMID: 9863850 BACKGROUND

• 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.

  PMID: 33122028 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.

  PMID: 31449805 DERIVED

MeSH Terms

Conditions

Urinary Incontinence, Urge; Female Urogenital Diseases

Interventions

Tolterodine Tartrate; oxybutynin; Hypnosis

Condition Hierarchy (Ancestors)

Urinary Incontinence; Urination Disorders; Urologic 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; Mind-Body Therapies; Complementary Therapies; Therapeutics; Psychotherapy; Behavioral Disciplines and Activities

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

Results Point of Contact

• Title: Dr. Yuko Komesu
• Organization: University of New Mexico

ykomesu@salud.unm.edu

5052490726

Study Officials

• Yuko Komesu, MD

  University of New Mexcio Health Science Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: April 8, 2013
• First Posted: April 11, 2013
• Study Start: April 22, 2013
• Primary Completion: October 27, 2017
• Study Completion: October 27, 2017
• Last Updated: April 23, 2019
• Results First Posted: April 1, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: 6 months after manuscript for the primary outcome is accepted for publication. Anticipated time for manuscript acceptance July 2019. Anticipated availability 3-5 years.
• Access Criteria: 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.

Locations

US (1)