Translating Unique Learning for Incontinence Prevention

The study will attempt to accomplish 3 aims:

Aim 1: Compare outcomes of the two-hour BH Class with the condensed DVD version.

To accomplish this aim we will conduct a comparative effectiveness trial of 600 women 55
years and older randomized to BH Class or DVD. Women will be followed for 24 months
post-intervention in order to assess long-term outcomes and sustainability.

Aim 2: Conduct an economic analysis comparing the two-hour BH Class with the DVD version.
Describing the costs, quality of life, and analyzing the willingness to pay and employment/
productivity data will be the primary economic focus of this study.

Aim 3: Conduct a qualitative analysis to gain insight into elements of the intervention that
contribute to sustainability.

Inclusion/Exclusion Criteria

Inclusion:

1. Female, aged 55 years or older

2. An additive sum of the frequency (question 1) and volume (question 2) items from the
International Consultation on Incontinence Questionnaire-Short Form is ≤5

3. Negative for demonstrable UI on the standardized Paper Towel Test

4. Willing to undergo vaginal/pelvic examination

5. Willing and able to be compliant with visit schedule and study procedures for the study
duration

6. Provide written informed consent form

7. Able to understand and read English

Exclusion:

1. Non-ambulatory (patient confined to bed or wheelchair)

2. Persistent pelvic pain (defined as daily pelvic pain)

3. History of neurologic diseases (e.g. Cerebral Vasular Accident, Parkinson's disease,
Multiple sclerosis, Epilepsy, Spinal cord tumor or trauma, spina bifida, current
symptomatic herniated disc)

4. Actively taking UI, OAB, or any other bladder control medication.

5. Other urinary conditions or procedures that may affect continence status (e.g. history
of bladder cancer, urethral diverticula, previous augmentation cystoplasty or
artificial sphincter; implanted nerve stimulators for urinary symptoms, history of
sling surgery for UI or prolapse)

6. Participation in another research project that may influence the results of this trial

7. Pelvic organ prolapse protruding past the introitus upon straining

8. Absolute absence of pelvic floor muscle strength manifested by zero Brink test (Brink
et al., 1994 for pressure and displacement 9

9. Evidence of UTI or hematuria - Urine dipstick positive for red blood cells will exclude
the participant from enrollment in the study until a microscopic urinalysis is
negative. Urine dipstick positive for leukocytes plus nitrates will exclude the
participant from enrollment in the study and require further evaluation for UTI.

10. History of > 2 recurrent UTI's in the past year and no more than one UTI within 6
months

11. Post void residual > 150 cc

Inclusion Criteria:

1. Female, aged 55 years or older

2. An additive sum of the frequency (question 1) and volume (question 2) items from the
International Consultation on Incontinence Questionnaire-Short Form is ≤5

3. Negative for demonstrable UI on the standardized Paper Towel Test

4. Willing to undergo vaginal/pelvic examination

5. Willing and able to be compliant with visit schedule and study procedures for the
study duration

6. Provide written informed consent form

7. Able to understand and read English

Exclusion Criteria:

1. Non-ambulatory (patient confined to bed or wheelchair)

2. Persistent pelvic pain (defined as daily pelvic pain)

3. History of neurologic diseases (e.g. Cerebral Vasular Accident, Parkinson's disease,
Multiple sclerosis, Epilepsy, Spinal cord tumor or trauma, spina bifida, current
symptomatic herniated disc)

4. Actively taking UI, OAB, or any other bladder control medication.

5. Other urinary conditions or procedures that may affect continence status (e.g.
history of bladder cancer, urethral diverticula, previous augmentation cystoplasty or
artificial sphincter; implanted nerve stimulators for urinary symptoms, history of
sling surgery for UI or prolapse)

6. Participation in another research project that may influence the results of this
trial

7. Pelvic organ prolapse protruding past the introitus upon straining

8. Absolute absence of pelvic floor muscle strength manifested by zero Brink test (Brink
et al., 1994 for pressure and displacement 9

9. Evidence of UTI or hematuria - Urine dipstick positive for red blood cells will
exclude the participant from enrollment in the study until a microscopic urinalysis
is negative. Urine dipstick positive for leukocytes plus nitrates will exclude the
participant from enrollment in the study and require further evaluation for UTI.

10. History of > 2 recurrent UTI's in the past year and no more than one UTI within 6
months

11. Post void residual > 150 cc