Urinary IncontinenceNCT00212264
Conservative Treatment of Postprostatectomy Incontinence
A study testing Behavioral Therapy, Pelvic Floor Electrical Stimulation and Biofeedback in people with Urinary Incontinence, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) at 1 site in United States.
Trial summary
The primary purpose of this study is to test the effectiveness, impact on quality of life, and durability of non-surgical therapies for incontinence persisting at least one year after surgery. Read more about this study
- Who is it for?
- Any age, men onlyHealthy volunteers can take part
- Conditions the study is for
- Urinary Incontinence
- What is being tested?
- Behavioral Therapy, Pelvic Floor Electrical Stimulation and Biofeedback
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 208 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2003to Aug 2011
- 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 Any age
- Men only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Involuntary loss of urine that started immediately after radical prostatectomy and has persisted for at least one year.
- One-week bladder diary with interpretable data and at least two incontinence episodes
Who cannot join
- Any unstable medical condition, particularly decompensated congestive heart failure, history of malignant arrhythmias, or unstable angina
- Cardiac pacemaker or implanted cardiac defibrillator
- Current use of anticholinergic agents for detrusor instability
- Folstein's Mini-Mental State Exam score below 24 (impaired mental status)
- One-week bladder diary with continual leakage - defined as always being damp or wet or unable to quantitate individual accidents.
- Poorly controlled diabetes, defined as (glycosylated hemoglobin > 9 within last 3 months).
- Hematuria on microscopic examination. Enrollment will be permitted after urologic evaluation.
- Urodynamic evaluation: Post-void residual volume greater than 200 mL
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Alabama at Birmingham
Birmingham, Alabama, 35294
About this study
The primary purpose of this study is to test the effectiveness, impact on quality of life, and durability of non-surgical therapies for incontinence persisting at least one year after surgery. The study is a a prospective, controlled, randomized trial comparing an 8-week, multi-component behavioral training program (pelvic floor muscle exercises, self-monitoring with bladder diaries, regular office visits, bladder control techniques, and fluid management) to the same program with the addition of biofeedback and pelvic muscle electrical stimulation.
Read the detailed description
The primary purpose of this project is to test the effectiveness, impact on quality of life, and durability of conservative therapies for persistent post-prostatectomy urinary incontinence in a prospective, controlled, randomized trial comparing an 8-week, multi-component behavioral training program (pelvic floor muscle exercises, self-monitoring with bladder diaries, regular office visits, bladder control techniques, and fluid management) to the same program with the addition of biofeedback and pelvic muscle electrical stimulation.
The second purpose of the study is to examine and compare the cost-effectiveness of the 8-week, multi-component behavioral training program to the same program with the addition of biofeedback and pelvic floor electrical stimulation.
Prostate cancer is the most common internal cancer in men in the United States. The most common treatment for early disease is radical prostatectomy, the removal of the prostate gland. The two most common sequelae of prostatectomy are incontinence and erectile dysfunction. The incontinence improves and often resolves in the first year after prostatectomy, but surveys of patients show that 40% of men have incontinence severe enough to require pads 1 and 2 years after their surgery. There are currently no randomized, controlled studies of non-surgical treatments for persistent post-prostatectomy incontinence.
- Conditions
- Urinary Incontinence
- Being tested
- Behavioral Therapy, Pelvic Floor Electrical Stimulation, Biofeedback, No Treatment
- Keywords
- urinary incontinence, therapy, prostatectomy, prostate cancer
- 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.
Behavioral TherapyBehavioural
Pelvic Floor Muscle Exercises and Bladder control strategies
Pelvic Floor Electrical StimulationDevice
Pelvic Floor Electrical Stimulation daily for 8 weeks
BiofeedbackBehavioural
Pelvic Floor Muscle training via biofeedback
No TreatmentOther
No treatment
| Study group | Role | What they receive |
|---|---|---|
| Behavioral Therapy | Experimental | Behavioral Therapy (Pelvic floor muscle training, bladder control strategies) Receives: Behavioral: Behavioral Therapy |
| Behavioral Therapy Plus Technologies | Experimental | Behavioral therapy plus technologies (home pelvic floor electrical stimulation and biofeedback) Receives: Behavioral: Behavioral Therapy; Device: Pelvic Floor Electrical Stimulation; Behavioral: Biofeedback |
| Placebo Comparator | Placebo comparator | No treatment control Receives: Other: No Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent Change in Incontinence Episodes on Bladder Diary
[(Baseline incontinence episodes minus 2-month incontinence episodes)/baseline incontinence episodes] x 100%
Measured: 2 months
Percent Change in Incontinence Episodes Per Week on Bladder Diary
[(Baseline incontinence episodes minus 12-month incontinence episodes)/baseline incontinence episodes] x 100%
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2005 (estimated)
- Study startAug 2003
- Primary completionSep 2008
- Study completionAug 2011
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 (2)Papers the sponsor has linked to this study.
- Other trials for Urinary IncontinenceStudies of the same condition, open and under way.
- More trials run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)The sponsor's other registered studies.
- 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
- Masking
- None (open label)
- Enrolment
- 208 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Principal investigator, Patricia Goode, MD, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Investigators
- Patricia S Goode, MD, Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00212264
- Sponsor's protocol ID
- DK60044 (completed)
- Status last verified
- Mar 2016
- First submitted
- 13 Sep 2005
- Last updated
- 11 Apr 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Goode PS, Burgio KL, Johnson TM 2nd, Clay OJ, Roth DL, Markland AD, Burkhardt JH, Issa MM, Lloyd LK. Behavioral therapy with or without biofeedback and pelvic floor electrical stimulation for persistent postprostatectomy incontinence: a randomized controlled trial. JAMA. 2011 Jan 12;305(2):151-9. doi: 10.1001/jama.2010.1972.
PubMed 21224456Johnson EE, Mamoulakis C, Stoniute A, Omar MI, Sinha S. Conservative interventions for managing urinary incontinence after prostate surgery. Cochrane Database Syst Rev. 2023 Apr 18;4(4):CD014799. doi: 10.1002/14651858.CD014799.pub2.
PubMed 37070660
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Conservative Treatment of Postprostatectomy Incontinence
- ClinicalTrials.gov ID
- NCT00212264
- Acronym / sponsor ID
- DK60044 (completed)
- Conditions
- Urinary Incontinence
- Keywords
- urinary incontinence, therapy, prostatectomy, prostate cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 208 participants (actual)
- Lead sponsor
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)US National Institutes of Health
- Study start
- Aug 2003
- Primary completion
- Sep 2008 (actual)
- Study completion
- Aug 2011 (actual)
- First posted
- 21 Sep 2005 (estimated)
- Results
- Posted 11 Apr 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary purpose of this study is to test the effectiveness, impact on quality of life, and durability of non-surgical therapies for incontinence persisting at least one year after surgery. The study is a a prospective, controlled, randomized trial comparing an 8-week, multi-component behavioral training program (pelvic floor muscle exercises, self-monitoring with bladder diaries, regular office visits, bladder control techniques, and fluid management) to the same program with the addition of biofeedback and pelvic muscle electrical stimulation.
Detailed description
The primary purpose of this project is to test the effectiveness, impact on quality of life, and durability of conservative therapies for persistent post-prostatectomy urinary incontinence in a prospective, controlled, randomized trial comparing an 8-week, multi-component behavioral training program (pelvic floor muscle exercises, self-monitoring with bladder diaries, regular office visits, bladder control techniques, and fluid management) to the same program with the addition of biofeedback and pelvic muscle electrical stimulation.
The second purpose of the study is to examine and compare the cost-effectiveness of the 8-week, multi-component behavioral training program to the same program with the addition of biofeedback and pelvic floor electrical stimulation.
Prostate cancer is the most common internal cancer in men in the United States. The most common treatment for early disease is radical prostatectomy, the removal of the prostate gland. The two most common sequelae of prostatectomy are incontinence and erectile dysfunction. The incontinence improves and often resolves in the first year after prostatectomy, but surveys of patients show that 40% of men have incontinence severe enough to require pads 1 and 2 years after their surgery. There are currently no randomized, controlled studies of non-surgical treatments for persistent post-prostatectomy incontinence.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Behavioral Therapy | Experimental | Behavioral: Behavioral TherapyBehavioral Therapy (Pelvic floor muscle training, bladder control strategies) |
| Behavioral Therapy Plus Technologies | Experimental | Behavioral: Behavioral Therapy, Device: Pelvic Floor Electrical Stimulation, Behavioral: BiofeedbackBehavioral therapy plus technologies (home pelvic floor electrical stimulation and biofeedback) |
| Placebo Comparator | Placebo comparator | Other: No TreatmentNo treatment control |
Who may qualify
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Involuntary loss of urine that started immediately after radical prostatectomy and has persisted for at least one year.
- One-week bladder diary with interpretable data and at least two incontinence episodes
Key exclusion criteria (8 listed)
- Any unstable medical condition, particularly decompensated congestive heart failure, history of malignant arrhythmias, or unstable angina
- Cardiac pacemaker or implanted cardiac defibrillator
- Current use of anticholinergic agents for detrusor instability
- Folstein's Mini-Mental State Exam score below 24 (impaired mental status)
- One-week bladder diary with continual leakage - defined as always being damp or wet or unable to quantitate individual accidents.
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 |
|---|---|---|
| Behavioral TherapyPelvic Floor Muscle Exercises and Bladder control strategies | Behavioural | Behavioral Therapy, Behavioral Therapy Plus Technologies |
| Pelvic Floor Electrical StimulationPelvic Floor Electrical Stimulation daily for 8 weeks | Device | Behavioral Therapy Plus Technologies |
| BiofeedbackPelvic Floor Muscle training via biofeedback | Behavioural | Behavioral Therapy Plus Technologies |
| No TreatmentNo treatment | Other | Placebo Comparator |
Primary outcome
Percent Change in Incontinence Episodes on Bladder Diary
Time frame: 2 months
[(Baseline incontinence episodes minus 2-month incontinence episodes)/baseline incontinence episodes] x 100%
Percent Change in Incontinence Episodes Per Week on Bladder Diary
Time frame: 1 year
[(Baseline incontinence episodes minus 12-month incontinence episodes)/baseline incontinence episodes] x 100%
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 21224456Goode PS, Burgio KL, Johnson TM 2nd, Clay OJ, Roth DL, Markland AD, Burkhardt JH, Issa MM, Lloyd LK. Behavioral therapy with or without biofeedback and pelvic floor electrical stimulation for persistent postprostatectomy incontinence: a randomized controlled trial. JAMA. 2011 Jan 12;305(2):151-9. doi: 10.1001/jama.2010.1972.
- Derived from this study: PubMed 37070660Johnson EE, Mamoulakis C, Stoniute A, Omar MI, Sinha S. Conservative interventions for managing urinary incontinence after prostate surgery. Cochrane Database Syst Rev. 2023 Apr 18;4(4):CD014799. doi: 10.1002/14651858.CD014799.pub2.
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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.
Patricia S Goode, MD principal investigator
University of Alabama at Birmingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Behavioral Therapy, Pelvic Floor Electrical Stimulation and Biofeedback in people with Urinary Incontinence, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) at 1 site in United States.
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 2 inclusion and 8 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 11 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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 11 Apr 2016). 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?
Percent Change in Incontinence Episodes on Bladder Diary (time frame: 2 months). 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 NCT00212264, which also lists 2 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 11 Apr 2016.