Improving Continence and Quality of Life in Prostate Cancer Patients (StayDry)

• Urinary incontinence [ Time Frame: Change from baseline in urinary incontinence at 6 months ] [ Designated as safety issue: No ]
  Urinary incontinence is measured in the amount and frequency of urinary leakage
• Quality of life [ Time Frame: Change from baseline in quality of life at 6 months ] [ Designated as safety issue: No ]
  Quality of life is measured by standard instrument (SF36 etc.) as an continuous variable
• Mood [ Time Frame: Change from baseline in mood at 6 months ] [ Designated as safety issue: No ]
  Mood is measured by POMS as a continuous variable

• Physiological changes in muscle condition [ Time Frame: Change from baseline in physiological condition at 3 months ] [ Designated as safety issue: No ]
• Cost-effectiveness [ Time Frame: Change from baseline in the cost-effective ratio at 6 months ] [ Designated as safety issue: No ]

This is a randomized, controlled longitudinal study of 312 early-stage prostate cancer patients that experience urinary incontinence six months after the completion of cancer treatment. This "STAY DRY" research program uses biofeedback to teach pelvic floor muscle exercises (PFME) and combines it with a telephone or support group intervention to treat persistent urinary incontinence. The study's primary aims are to improve continence, quality of life, and mood through enhancing adherence to PFME and self-management of bladder control. The secondary aims are to examine the physiological effects and cost effectiveness of the proposed interventions. The study hypothesizes that the proposed intervention will improve continence, quality of life and mood of prostate cancer patients and reduce the cost.

Study participants will be randomly assigned to one of three study arms: (1) biofeedback PFME plus a support group (BF+GROUP); (2) biofeedback PFME plus telephone (BF+PHONE); and (3) usual care (UC). The BF+GROUP and BF+PHONE participants will learn PFME through computerized biofeedback. Thereafter, the BF+GROUP participants will attend six group meetings and the BF+PHONE participants will have six phone contacts every other week for three months. The interventions use a Problem-Solving Therapy (PST) framework to treat UI. The UC participants will not receive biofeedback PFME or telephone/group intervention but will continue receiving usual medical care. In addition, 51 moderately to severely incontinent patients will be recruited from the three study groups, with 17 per group, to undergo urodynamic testing at T1 and T2. Data of the costs for the interventions and the participants' medical care will be collected for a cost-effectiveness analysis.

• Urinary Incontinence
• Mood

• Experimental: BF+GROUP
  BF+GROUP entails biofeedback-based pelvic floor muscle exercise plus behavioral intervention that is delivered through a support group
  Intervention: Behavioral: BF+GROUP; BF+PHONE
• Active Comparator: BF+PHONE
  BF+PHONE entails biofeedback-based pelvic floor muscle exercise plus behavioral intervention that is delivered through telephone contacts
  Intervention: Behavioral: BF+GROUP; BF+PHONE
• No Intervention: UC
  UC refers to the "usual care." This is an observational group without any intervention
  Intervention: Behavioral: BF+GROUP; BF+PHONE

Inclusion Criteria:

1. stage I, II and III prostate cancer;
2. having completed treatment (surgery or radiation) at least six months prior;
3. presence of UI symptoms.

Exclusion Criteria:

1. receiving hormonal treatment
2. urinary tract infection or urinary retention
3. cognitive impairment.