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:

• Female, aged 55 years or older
• An additive sum of the frequency (question 1) and volume (question 2) items from the International Consultation on Incontinence Questionnaire-Short Form is ≤5
• Negative for demonstrable UI on the standardized Paper Towel Test
• Willing to undergo vaginal/pelvic examination
• Willing and able to be compliant with visit schedule and study procedures for the study duration
• Provide written informed consent form
• Able to understand and read English

Exclusion:

• Non-ambulatory (patient confined to bed or wheelchair)
• Persistent pelvic pain (defined as daily pelvic pain)
• 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)
• Actively taking UI, OAB, or any other bladder control medication.
• 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)
• Participation in another research project that may influence the results of this trial
• Pelvic organ prolapse protruding past the introitus upon straining
• Absolute absence of pelvic floor muscle strength manifested by zero Brink test (Brink et al., 1994 for pressure and displacement 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.
• History of > 2 recurrent UTI's in the past year and no more than one UTI within 6 months
• Post void residual > 150 cc

Inclusion criteria

• Female, aged 55 years or older
• An additive sum of the frequency (question 1) and volume (question 2) items from the International Consultation on Incontinence Questionnaire-Short Form is ≤5
• Negative for demonstrable UI on the standardized Paper Towel Test
• Willing to undergo vaginal/pelvic examination
• Willing and able to be compliant with visit schedule and study procedures for the study duration
• Provide written informed consent form
• Able to understand and read English

Exclusion criteria

• Non-ambulatory (patient confined to bed or wheelchair)
• Persistent pelvic pain (defined as daily pelvic pain)
• 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)
• Actively taking UI, OAB, or any other bladder control medication.
• 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)
• Participation in another research project that may influence the results of this trial
• Pelvic organ prolapse protruding past the introitus upon straining
• Absolute absence of pelvic floor muscle strength manifested by zero Brink test (Brink et al., 1994 for pressure and displacement 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.
• History of > 2 recurrent UTI's in the past year and no more than one UTI within 6 months
• Post void residual > 150 cc