NCT02001714

Brief Summary

This three-site randomized controlled trial compares the effectiveness and cost-effectiveness of a group-administered behavioral treatment program to no treatment. Women with stress, urgency, or mixed urinary incontinence will be recruited and screened centrally, evaluated clinically at each of three study sites, and random assigned to one of two treatment arms: 1. Group behavioral treatment or 2. No treatment. Group treatment modalities have the potential to reach a larger population of older women with urinary incontinence, not only in the traditional medical settings, but also in community settings. The investigators hypothesize that group behavioral treatment will be more effective than no treatment. The investigators hypothesize that the group treatment will be cost-effective compared to no treatment.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
463

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2013

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

November 22, 2013

Completed
13 days until next milestone

First Posted

Study publicly available on registry

December 5, 2013

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
11 months until next milestone

Results Posted

Study results publicly available

October 19, 2017

Completed
Last Updated

October 19, 2017

Status Verified

October 1, 2017

Enrollment Period

3.3 years

First QC Date

November 22, 2013

Results QC Date

July 25, 2017

Last Update Submit

October 18, 2017

Conditions

Urinary Incontinence, StressUrinary Incontinence, Urge

Outcome Measures

Primary Outcomes (1)

  • Group Behavioral Treatment Effectiveness as Shown by Changes From Baseline to 3 Months in Urinary Incontinence Severity.

    The primary outcome is the self-reported urinary incontinence severity as measured by the International Consultation on Incontinence questionnaire-short form (ICI-Q). This short and simple questionnaire is used to screen for incontinence (urine leakage) to obtain a brief yet comprehensive summary of the level, impact and perceived cause of symptoms of incontinence. The ICI-Q consists of four questions and numeric scales: 1. How much do you leak urine? (0-5); never - all the time, 2. How much urine do you usually leak? (0-6); none - large amount, 3. Overall, how much does leaking urine interfere with your everyday life? (0-10); not at all - a great deal, 4. When does urine leak? Multiple choices. The ICI-Q score is the sum of questions 1-3 and ranges from 0-21. The higher the score, the greater severity of incontinence. Baseline data is compared to the 3 month data for the primary outcome.

    Baseline and 3 months

Secondary Outcomes (1)

  • Group Behavioral Treatment Cost-effectiveness

    12 months

Study Arms (2)

Group Behavioral Treatment

EXPERIMENTAL

Participants will attend a group behavioral treatment class and follow-up visits.

Behavioral: Group Behavioral Treatment

No Treatment

NO INTERVENTION

Subjects will not attend group behavioral treatment class.

Interventions

Group Behavioral TreatmentBEHAVIORAL

Group Behavioral Treatment class is a two hour class taught by certified interventionist covering urinary system anatomy, bladder health and self management strategies, pelvic floor training, pelvic floor muscle contracting techniques, and bladder training. Slides and handouts supplement the content of the class.

Group Behavioral Treatment

Eligibility Criteria

Age55 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Female
  • Aged 55 years or older
  • Ability to understand, read and write English
  • Stress, urgency, or mixed urgency and stress urinary incontinence (UI) (by self report)
  • On the International Consultation on Incontinence Modular Questionnaire - Short Form (ICIQ UI-SF), frequency of leakage at least a 1 ("about once a week or less often") on item #1 and volume of urine loss at least a 2 ("a small amount") on item #2.
  • Symptoms of three months duration or longer (on history)
  • Passing score (i.e., categorized as "probably not demented") on the MiniCog Test
  • Timed "Up and Go" Test (TUG) score of 20 seconds or less
  • Willing to undergo vaginal/pelvic examination
  • Signed informed consent form

You may not qualify if:

  • History of renal, bladder, uterine, ovarian, urethral, anal or rectal cancer, radiation therapy to the pelvis for any cancer/malignancy, or any active cancer/malignancy (except skin cancer)
  • Non-ambulatory (participant confined to bed or wheelchair)
  • Persistent pelvic pain (defined as daily pelvic pain \> 3 months)
  • History of neurologic or end-stage diseases (e.g. cerebral vascular accident (CVA), Parkinson's disease, multiple sclerosis, epilepsy, spinal cord tumor or trauma, spina bifida, symptomatic herniated disc)
  • Previous treatment or current participation in a research study for UI, including surgery or formal behavioral treatment (pelvic floor muscle training, biofeedback, pelvic floor electrical stimulation, percutaneous tibial nerve stimulation, sacral neuromodulation, botox or other periurethral injection)
  • Currently taking urinary incontinence or overactive bladder medications
  • History of other urinary conditions or procedures that may affect continence status (e.g. urethral diverticula, previous augmentation cystoplasty or artificial urinary sphincter; implanted nerve stimulators for urinary symptoms)
  • Participation in any drug/device research study.
  • Pelvic organ prolapse protruding past the introitus (at rest or persisting after strain)
  • Evidence of urinary tract infection (UTI) by urine dipstick (leukocytes +1 or greater, nitrites +1 or greater, leukocytes alone (w/o nitrites) +2 or greater, or presence of hematuria \> +1). Participants may be re-screened after treatment with antibiotics or if hematuria work-up is negative.
  • History of 2 or more recurrent UTI's within the past year; more than one UTI within past 6 months
  • Post void residual urine volume 150 cc or more.
  • Unstable medical condition (as determined by site PI)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Birmingham VA Medical Cnter

Birmingham, Alabama, 35233, United States

Location

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

William Beaumont Hospital

Royal Oak, Michigan, 48073, United States

Location

University of Pennsylvania Health System, Urology

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (2)

  • Funada S, Yoshioka T, Luo Y, Sato A, Akamatsu S, Watanabe N. Bladder training for treating overactive bladder in adults. Cochrane Database Syst Rev. 2023 Oct 9;10(10):CD013571. doi: 10.1002/14651858.CD013571.pub2.

    PMID: 37811598DERIVED

  • Diokno AC, Newman DK, Low LK, Griebling TL, Maddens ME, Goode PS, Raghunathan TE, Subak LL, Sampselle CM, Boura JA, Robinson AE, McIntyre D, Burgio KL. Effect of Group-Administered Behavioral Treatment on Urinary Incontinence in Older Women: A Randomized Clinical Trial. JAMA Intern Med. 2018 Oct 1;178(10):1333-1341. doi: 10.1001/jamainternmed.2018.3766.

    PMID: 30193294DERIVED

MeSH Terms

Conditions

Urinary Incontinence, StressUrinary Incontinence, Urge

Condition Hierarchy (Ancestors)

Urinary IncontinenceUrination DisordersUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesLower Urinary Tract SymptomsUrological ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Ananias C. Diokno, MD
Organization
Beaumont Health
ananias.diokno@beaumont.edu

Study Officials

  • Ananias C Diokno, MD

    Corewell Health East

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
The randomization schedule will be concealed so that investigators and staff at the sites will not be able to anticipate experimental group assignments. Evaluators at each site will be blind to group assignment throughout all assessments.
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 22, 2013

First Posted

December 5, 2013

Study Start

September 1, 2013

Primary Completion

December 1, 2016

Study Completion

December 1, 2016

Last Updated

October 19, 2017

Results First Posted

October 19, 2017

Record last verified: 2017-10

Data Sharing

IPD Sharing
Will not share

Locations

US(4)