Urinary IncontinenceNCT00982098
Prevention of Urinary Incontinence After Prostatectomy
A study testing BioFeedback; Functional Electrical Stimulation; Pelvic Floor Muscle training exercises in people with Urinary Incontinence, run by Azienda Ospedaliero Universitaria Maggiore della Carita at 1 site in Italy.
Trial summary
Urinary incontinence is a frequent complication after radical prostatectomy. Rehabilitative treatments are frequently utilized to reduce incontinence. However, their efficacy has not been completely investigated. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Urinary Incontinence
- What is being tested?
- BioFeedback; Functional Electrical Stimulation; Pelvic Floor Muscle training exercises
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteItaly
- Study dates
- Feb 2007to Nov 2009
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- men who will undergo radical prostatectomy for prostatic cancer
Who cannot join
- previous urinary and/or faecal incontinence
- neurologic bladder
- previous pelvic surgery
Trial locations and contacts
1 site in 1 country.
Italy1 site
SC Medicina Fisica e Riabilitativa AUO "Maggiore della Carità"
Novara, 28100
About this study
Urinary incontinence is a frequent complication after radical prostatectomy. Rehabilitative treatments are frequently utilized to reduce incontinence. However, their efficacy has not been completely investigated. In this study the investigators will compare the effect of an early rehabilitation programme (instruction of the patient, pelvic floor muscle training, electrical stimulation and biofeedback) versus instruction of the patient only.
The investigators hypothesis is that early rehabilitation programme is more effective than patient's instruction alone in preventing urinary incontinence after radical prostatectomy.
- Conditions
- Urinary Incontinence
- Being tested
- BioFeedback; Functional Electrical Stimulation; Pelvic Floor Muscle training exercises
- Keywords
- Prostatectomy, Prostatic cancer, Urinary incontinence, Exercise, Electric stimulation therapy, Counseling
- Medical subject headings
- Urinary Incontinence, Prostatic Neoplasms, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BioFeedback; Functional Electrical Stimulation; Pelvic Floor Muscle training exercisesProcedure or surgery
After surgery: physical therapist's assisted pelvic floor muscle biofeedback (15 min/day for 10 days), followed by patient's instruction for pelvic floor muscle training and home based exercised pelvic floor muscle for 10 days. Then pelvic floor muscle biofeedback (15 min/day for 10 days) and functional electrical stimulation of pelvic floor (30 min/day for 10 days).
| Study group | Role | What they receive |
|---|---|---|
| Early Rehabilitation | Experimental | Before surgery: 15 minutes pelvic floor muscle training and 15 minutes biofeedback, for 4 sessions.
After surgery: physical therapist's assisted pelvic floor muscle biofeedback (15 min/day for 10 days), followed by patient's instruction for pelvic floor muscle training and home based exercised pelvic floor muscle for 10 days. Then pelvic floor muscle biofeedback (15 min/day for 10 days) and functional electrical stimulation of pelvic floor (30 min/day for 10 days).
Patients will be instructed to carry on exercises at home for the following 11 months. Receives: Procedure: BioFeedback; Functional Electrical Stimulation; Pelvic Floor Muscle training exercises |
| Counseling and home-based exercises | No intervention | Before surgery: 15 minutes pelvic floor muscle training and 15 minutes biofeedback, for 4 sessions. After surgery: Patients will be instructed to carry on pelvic floor exercises at home for the year after prostatectomy. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete continence (PAD test 24 hours <10 cc)
Measured: 12 months
Secondary outcomes (1)
PAD test 24 hours
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2009 (estimated)
- Study startFeb 2007
- Primary completionNov 2009 (estimated)
- Study completionNov 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Azienda Ospedaliero Universitaria Maggiore della Carita
- Sponsor type
- University, hospital or other
- Investigators
- Carlo Cisari, prof., Study director, AUO "Maggiore della Carità" - NovaraCarlo Terrone, prof., Study chair, AUO "Maggiore della Carità" - Novara
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00982098
- Sponsor's protocol ID
- NO08974
- Status last verified
- Sep 2009
- First submitted
- 21 Sep 2009
- Last updated
- 22 Sep 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevention of Urinary Incontinence After Prostatectomy
- ClinicalTrials.gov ID
- NCT00982098
- Acronym / sponsor ID
- NO08974
- Conditions
- Urinary Incontinence
- Keywords
- Prostatectomy, Prostatic cancer, Urinary incontinence, Exercise, Electric stimulation therapy, Counseling
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Azienda Ospedaliero Universitaria Maggiore della CaritaUniversity, hospital or other
- Study start
- Feb 2007
- Primary completion
- Nov 2009 (estimated)
- Study completion
- Nov 2009 (estimated)
- First posted
- 22 Sep 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Urinary incontinence is a frequent complication after radical prostatectomy. Rehabilitative treatments are frequently utilized to reduce incontinence. However, their efficacy has not been completely investigated. In this study the investigators will compare the effect of an early rehabilitation programme (instruction of the patient, pelvic floor muscle training, electrical stimulation and biofeedback) versus instruction of the patient only.
The investigators hypothesis is that early rehabilitation programme is more effective than patient's instruction alone in preventing urinary incontinence after radical prostatectomy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Early Rehabilitation | Experimental | Procedure: BioFeedback; Functional Electrical Stimulation; Pelvic Floor Muscle training exercisesBefore surgery: 15 minutes pelvic floor muscle training and 15 minutes biofeedback, for 4 sessions. After surgery: physical therapist's assisted pelvic floor muscle biofeedback (15 min/day for 10 days), followed by patient's instruction for pelvic floor muscle training and home based exercised pelvic floor muscle for 10 days. Then pelvic floor muscle biofeedback (15 min/day for 10 days) and functional electrical stimulation of pelvic floor (30 min/day for 10 days). Patients will be instructed to carry on exercises at home for the following 11 months. |
| Counseling and home-based exercises | No intervention | –Before surgery: 15 minutes pelvic floor muscle training and 15 minutes biofeedback, for 4 sessions. After surgery: Patients will be instructed to carry on pelvic floor exercises at home for the year after prostatectomy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- men who will undergo radical prostatectomy for prostatic cancer
Key exclusion criteria (3 listed)
- previous urinary and/or faecal incontinence
- neurologic bladder
- previous pelvic surgery
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 |
|---|---|---|
| BioFeedback; Functional Electrical Stimulation; Pelvic Floor Muscle training exercisesAfter surgery: physical therapist's assisted pelvic floor muscle biofeedback (15 min/day for 10 days), followed by patient's instruction for pelvic floor muscle training and home based exercised pelvic floor muscle for 10 days. Then pelvic floor muscle biofeedback (15 min/day for 10 days) and functional electrical stimulation of pelvic floor (30 min/day for 10 days). | Procedure or surgery | Early Rehabilitation |
Primary outcome
Complete continence (PAD test 24 hours <10 cc)
Time frame: 12 months
1 secondary outcome
PAD test 24 hours
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2009.
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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.
Carlo Cisari, prof. study director
AUO "Maggiore della Carità" - Novara
Carlo Terrone, prof. study chair
AUO "Maggiore della Carità" - Novara
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BioFeedback; Functional Electrical Stimulation; Pelvic Floor Muscle training exercises in people with Urinary Incontinence, run by Azienda Ospedaliero Universitaria Maggiore della Carita at 1 site in Italy.
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 1 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 22 Sep 2009. 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 Italy. 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. 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?
Results are not available in the source record.
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?
Complete continence (PAD test 24 hours <10 cc) (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Sep 2009.