Clinical trial · Interventional

Improving Urinary Continence and Quality of Life in Prostate Cancer Patients

NCT01365182CI-TRIAL-00061422completedN/AResults postedClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Summary

Brief summary (as posted)

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.

Conditions

Conditions (1)

Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.

Condition (as posted)	Mapped entity	Match	Confidence
Urinary Incontinence	—	UNRESOLVED	—

Interventions

Interventions (2)

Intervention	Type	Mapped drug	Match
BF+PHONE	Behavioral	—	UNRESOLVED
BF+SUPPORT	Behavioral	—	UNRESOLVED

Design

Arms and outcomes

Arms (3)

type
EXPERIMENTAL
label
BF+SUPPORT
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
interventionNames
1. Behavioral: BF+SUPPORT
type
EXPERIMENTAL
label
BF+PHONE
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
interventionNames
1. Behavioral: BF+PHONE
type
NO_INTERVENTION
label
Usual Care

Eligibility

Eligibility (as posted)

Sex: Male
Minimum age: 21 Years

Show eligibility criteria text

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

References

Publications (7)

BACKGROUNDBalch 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. PMID 19917835
BACKGROUNDCharlson 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. doi: 10.1016/0021-9681(87)90171-8. PMID 3558716
RESULTZhang 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 Urol. 2015 Dec;194(6):1675-81. doi: 10.1016/j.juro.2015.07.090. Epub 2015 Jul 29. PMID 26231554
RESULTZhang 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/s11764-016-0557-0. Epub 2016 Jun 24. PMID 27341843
RESULTZhang 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. Epub 2019 Mar 22. PMID 30903368
RESULTZhang 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 2019 Nov 24. PMID 31762400