Improving Urinary Continence and Quality of Life in Prostate Cancer Patients

Case Western Reserve University

Status: Completed

Conditions: Urinary Incontinence

Treatments: Behavioral: BF+SUPPORT; Behavioral: BF+PHONE

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT01365182

1R01CA127493-01A2 (U.S. NIH Grant/Contract)

CASE 14807

Details and patient eligibility

About

This intervention program combines biofeedback PFME with a telephone or support group intervention to treat persistent urinary incontinence (UI). The study's primary aims are to improve continence, quality of life, and mood through enhancing adherence to PFME and self-management of incontinence symptoms. The secondary aims are to examine the physiological effects and cost effectiveness of the proposed interventions.

Full description

This is a randomized, controlled longitudinal study. Patients with early-stage prostate cancer and UI for more than six months were randomly assigned to one of three study arms: (1) biofeedback PFME plus a support group (BF+SUPPORT); (2) biofeedback PFME plus telephone (BF+PHONE); and (3) usual care (UC). The BF+SUPPORT and BF+PHONE participants learned PFME through computerized biofeedback. Thereafter, the BF+SUPPORT participants attended six group meetings and the BF+PHONE participants had six phone contacts every other week for three months. The UC participants did not receive biofeedback PFME or telephone/group intervention but continued receiving usual medical care. All subjects were assessed blind at baseline, 3 months (post intervention) and 6 months (follow-up). In addition, 49 moderately to severely incontinent patients were recruited from the three study groups to undergo urodynamic testing at baseline and 3 months for the evaluation of physiological changes. Data of the costs for the interventions and the participants' medical care were collected for a cost-effectiveness analysis.

Enrollment: 279 patients

Sex: Male

Ages: 21+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Have been diagnosed with early stage (I-III) prostate cancer.
2. Have completed cancer treatments six months prior.
3. Presence of incontinence symptoms

Exclusion criteria

1. Receiving hormonal treatment.
2. Urinary tract infection or urinary retention.
3. Cognitive impairment.
4. Having an implant

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

279 participants in 3 patient groups

BF+SUPPORT

Experimental group

Description:

a 60-minute session of biofeedback (BF) training in pelvic floor muscle exercises plus 6 biweekly peer support group sessions during 3 months to learn symptom self- management skills

Treatment:

Behavioral: BF+SUPPORT

BF+PHONE

Experimental group

Description:

a 60-minute session of biofeedback (BF) training in pelvic floor muscle exercises plus 6 biweekly individual telephone contact with a therapist during 3 months to learn symptom self- management skills

Treatment:

Behavioral: BF+PHONE

Usual Care

No Intervention group

Description:

Subjects continued receiving usual care without receiving any intervention training sessions