Improving Continence and Quality of Life in Prostate Cancer Patients
| Status: | Completed |
|---|---|
| Conditions: | Prostate Cancer, Overactive Bladder, Urology |
| Therapuetic Areas: | Gastroenterology, Nephrology / Urology, Oncology |
| Healthy: | No |
| Age Range: | 21 - Any |
| Updated: | 2/8/2015 |
| Start Date: | January 2009 |
| End Date: | December 2012 |
| Contact: | Amy Zhang, Ph.D. |
| Email: | Amy.Zhang@case.edu |
| Phone: | 2163680968 |
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.
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.
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.
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.
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