Improving Urinary Continence and Quality of Life in Prostate Cancer Patients

Urinary Incontinence Clinical Trial

Official title:

Improving Urinary Continence and Quality of Life in Prostate Cancer Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01365182
• Other study ID #: CASE 14807
• Secondary ID: 1R01CA127493-01A
• Status: Completed
• Phase: N/A
• Start date: January 2010
• Est. completion date: June 2014

Study information

• Verified date: September 2022
• Source: Case Western Reserve University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 279
• Est. completion date: June 2014
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 21 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Enuresis
• Prostatic Neoplasms
• Urinary Incontinence

Intervention

Behavioral:
• BF+SUPPORT
A session of biofeedback-assisted pelvic floor muscle exercises (PFME) plus 6 group sessions of the Problem-Solving Therapy (teaching self-management skills).
• BF+PHONE
A session of biofeedback-assisted pelvic floor muscle exercises (PFME) plus 6 telephone sessions of the Problem-Solving Therapy (teaching self-management skills).

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Case Western Reserve University	National Cancer Institute (NCI)

References & Publications (7)

Balch CM, Gershenwald JE, Soong SJ, Thompson JF, Atkins MB, Byrd DR, Buzaid AC, Cochran AJ, Coit DG, Ding S, Eggermont AM, Flaherty KT, Gimotty PA, Kirkwood JM, McMasters KM, Mihm MC Jr, Morton DL, Ross MI, Sober AJ, Sondak VK. Final version of 2009 AJCC melanoma staging and classification. J Clin Oncol. 2009 Dec 20;27(36):6199-206. doi: 10.1200/JCO.2009.23.4799. Epub 2009 Nov 16. — View Citation

Charlson ME, Pompei P, Ales KL, MacKenzie CR. A new method of classifying prognostic comorbidity in longitudinal studies: development and validation. J Chronic Dis. 1987;40(5):373-83. — View Citation

Zhang AY, Bodner DR, Fu AZ, Gunzler DD, Klein E, Kresevic D, Moore S, Ponsky L, Purdum M, Strauss G, Zhu H. Effects of Patient Centered Interventions on Persistent Urinary Incontinence after Prostate Cancer Treatment: A Randomized, Controlled Trial. J Uro — View Citation

Zhang AY, Burant C, Fu AZ, Strauss G, Bodner DR, Ponsky L. Psychosocial mechanisms of a behavioral treatment for urinary incontinence of prostate cancer survivors. J Psychosoc Oncol. 2020 Mar-Apr;38(2):210-227. doi: 10.1080/07347332.2019.1678547. Epub 201 — View Citation

Zhang AY, Fu AZ, Moore S, Zhu H, Strauss G, Kresevic D, Klein E, Ponsky L, Bodner DR. Is a behavioral treatment for urinary incontinence beneficial to prostate cancer survivors as a follow-up care? J Cancer Surviv. 2017 Feb;11(1):24-31. doi: 10.1007/s1176 — View Citation

Zhang AY, Fu AZ. Cost-effectiveness of a behavioral intervention for persistent urinary incontinence in prostate cancer patients. Psychooncology. 2016 Apr;25(4):421-7. doi: 10.1002/pon.3849. Epub 2015 May 12. — View Citation

Zhang AY, Ganocy S, Fu AZ, Kresevic D, Ponsky L, Strauss G, Bodner DR, Zhu H. Mood outcomes of a behavioral treatment for urinary incontinence in prostate cancer survivors. Support Care Cancer. 2019 Dec;27(12):4461-4467. doi: 10.1007/s00520-019-04745-w. E — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Amount of Urinary Leakage	Amount of leakage measured on 1-hour pad test	Measured at baseline, 3 months after baseline, and then 6 months after the baseline assessment
Primary	Frequency of Daily Urinary Leakage	Average times of daily leakage measured on a 3-day diary	Measured at baseline, 3 months after baseline, and then 6 months after the baseline assessment