Improving Urinary Continence and Quality of Life in Prostate Cancer Patients

A study testing BF+SUPPORT and BF+PHONE in people with Urinary Incontinence, run by Case Western Reserve University.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

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. Read more about this study

Who is it for?: Ages 21 years and older, men only
Conditions the study is for: Urinary Incontinence
What is being tested?: BF+SUPPORT and BF+PHONE
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 279 participants
Where: No sites listed yet
Study dates: Jan 2010to Jun 2014
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 21 years and older
Men only
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

Receiving hormonal treatment.
Urinary tract infection or urinary retention.
Cognitive impairment.
Having an implant

About this study

Read the detailed 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.

Conditions: Urinary Incontinence
Being tested: BF+SUPPORT, BF+PHONE
Keywords: prostate cancer, urinary incontinence, pelvic floor muscle exercise, self-management, behavioral intervention, quality of life
Medical subject headings: Urinary Incontinence, Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

Study groups in NCT01365182
Study group	Role	What they receive
BF+SUPPORT	Experimental	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 Receives: Behavioral: BF+SUPPORT
BF+PHONE	Experimental	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 Receives: Behavioral: BF+PHONE
Usual Care	No intervention	Subjects continued receiving usual care without receiving any intervention training sessions

What is being measured

The primary outcome is the main question the study is designed to answer.

Amount of Urinary Leakage
Amount of leakage measured on 1-hour pad test
Measured: Measured at baseline, 3 months after baseline, and then 6 months after the baseline assessment
Frequency of Daily Urinary Leakage
Average times of daily leakage measured on a 3-day diary
Measured: Measured at baseline, 3 months after baseline, and then 6 months after the baseline assessment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 2010Jun 2014

First posted3 Jun 2011 (estimated)
Study startJan 2010
Primary completionDec 2013
Study completionJun 2014

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (7)Papers the sponsor has linked to this study.
Other trials for Urinary IncontinenceStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Model description: A biobehavioral interveniton was tested
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 279 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01365182
Sponsor's protocol ID: CASE 14807
Other IDs: 1R01CA127493-01A2
Status last verified: Sep 2022
First submitted: 26 May 2011
Last updated: 12 Oct 2022
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

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.
PubMed 19917835
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. doi: 10.1016/0021-9681(87)90171-8.
PubMed 3558716
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 Urol. 2015 Dec;194(6):1675-81. doi: 10.1016/j.juro.2015.07.090. Epub 2015 Jul 29.
PubMed 26231554
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/s11764-016-0557-0. Epub 2016 Jun 24.
PubMed 27341843
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. Epub 2019 Mar 22.
PubMed 30903368
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 2019 Nov 24.
PubMed 31762400
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.
PubMed 25963381

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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Rehabilitation and Sex Therapy to Optimize Recovery After Prostate Cancer Treatment
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All Urinary Incontinence trials

Study at a glance

From the registry record, last updated by the sponsor on 12 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Improving Urinary Continence and Quality of Life in Prostate Cancer Patients
ClinicalTrials.gov ID: NCT01365182
Acronym / sponsor ID: CASE 14807
Conditions: Urinary Incontinence
Keywords: prostate cancer, urinary incontinence, pelvic floor muscle exercise, self-management, behavioral intervention, quality of life
Study type: Interventional
Recruitment status: Completed
Enrolment: 279 participants (actual)
Lead sponsor: Case Western Reserve UniversityUniversity, hospital or other
Collaborators: National Cancer Institute (NCI)
Study start: Jan 2010 (actual)
Primary completion: Dec 2013 (actual)
Study completion: Jun 2014 (actual)
First posted: 3 Jun 2011 (estimated)
Results: Posted 12 Oct 2022

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 3
Model description: A biobehavioral interveniton was tested

Arm	Type	Receives
BF+SUPPORT	Experimental	Behavioral: BF+SUPPORTa 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
BF+PHONE	Experimental	Behavioral: BF+PHONEa 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
Usual Care	No intervention	–Subjects continued receiving usual care without receiving any intervention training sessions

Who may qualify

Ages: 21 years and older
Sex: Male only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

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

Key exclusion criteria (4 listed)

Receiving hormonal treatment.
Urinary tract infection or urinary retention.
Cognitive impairment.
Having an implant

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
BF+SUPPORTA session of biofeedback-assisted pelvic floor muscle exercises (PFME) plus 6 group sessions of the Problem-Solving Therapy (teaching self-management skills).	Behavioural	BF+SUPPORT
BF+PHONEA session of biofeedback-assisted pelvic floor muscle exercises (PFME) plus 6 telephone sessions of the Problem-Solving Therapy (teaching self-management skills).	Behavioural	BF+PHONE

Primary outcome

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

Results and safety

Results posted to the registry on 12 Oct 2022, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
BE+Support	91	81
BF+PHONE	94	81
Usual Care	94	82

Primary outcome: Amount of Urinary Leakage

Time frame: Measured at baseline, 3 months after baseline, and then 6 months after the baseline assessment. Mean (Standard Deviation). Unit: grams

Measure	Usual Care n = 70	BF+Telephone n = 62	BF+Support n = 67
T1 (baseline)	23.2 (48.4)	22.3 (47.6)	31.5 (62.9)
T2 (3 month)	11 (24.2)	23.2 (73.5)	17.9 (43.3)
T3 (6 month)	14.2 (37.1)	7.5 (21.8)	14.9 (40.1)

Population analysed: Data are reported only for those who completed the entire study.

Primary outcome: Frequency of Daily Urinary Leakage

Time frame: Measured at baseline, 3 months after baseline, and then 6 months after the baseline assessment. Mean (Standard Deviation). Unit: Leaks per day

Measure	Usual Care n = 55	BF+Telephone n = 49	BF+Support n = 54
T1 (baseline)	3.2 (3.4)	2.9 (3.0)	2.7 (3.4)
T2 (3 month)	2.8 (3.4)	1.8 (2.5)	1.7 (2.7)
T3 (6 month)	2.5 (3.0)	1.7 (2.7)	1.9 (3.3)

Population analysed: Data are reported only for those who completed this measure at all three assessment points. Subjects that did not complete this measure three times were not included.

Adverse events

Time frame: 7 months (study duration). Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
BF+Support	0 of 81 (0%)	0 of 81 (0%)	0 of 81
BF+PHONE	2 of 81 (2.5%)	0 of 81 (0%)	0 of 81
Usual Care	1 of 82 (1.2%)	0 of 82 (0%)	0 of 82

Limitations and caveats (from the sponsor): Limitations: * The rate of missing data at 6 months was higher for daily leakage frequency than the leakage amount. * The 3-month intervention duration limited our ability to assess intervention sustainability and long-term effect.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 19917835Balch 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.
Background: PubMed 3558716Charlson 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.
Results publication: PubMed 26231554Zhang 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.
Results publication: PubMed 27341843Zhang 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.
Results publication: PubMed 30903368Zhang 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.
Results publication: PubMed 31762400Zhang 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.
Results publication: PubMed 25963381Zhang 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.

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Examining the Effects of Intra-detrusor Botox at Time of HoLEP in Men With Overactive Bladder Symptoms
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Amy Zhang, Ph.D. principal investigator

Case Western Reserve University

Questions about this trial

What is this clinical trial studying?

A study testing BF+SUPPORT and BF+PHONE in people with Urinary Incontinence, run by Case Western Reserve University.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 12 Oct 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Amount of Urinary Leakage (time frame: Measured at baseline, 3 months after baseline, and then 6 months after the baseline assessment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01365182, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Oct 2022.