Urinary IncontinenceNCT04628351
Bladder Training in Radical Prostatectomy
A study testing Bladder Training in people with Urinary Incontinence and Quality of Life, run by Saglik Bilimleri Universitesi at 1 site in Turkey (Türkiye).
Trial summary
Radical prostatectomy is the gold standard in the treatment of patients with localized prostate cancer. Urinary incontinence, which is common after surgery, can affect the quality of life of men negatively. Read more about this study
- Who is it for?
- Ages 40 to 85 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Urinary Incontinence, Quality of Life, Lower Urinary Tract Symptoms
- What is being tested?
- Bladder Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Oct 2019to 7 Nov 2020
- 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 40 to 85 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Being over the age of 40 years
- Being male
- Being with localized prostate cancer
- Undergoing open radical prostatectomy
- No preoperative urinary incontinence
- Being body mass index> 30 kg/m2
- Agreeing to participate in the research
- Being literate
Who cannot join
- Having a congenital disorder of the urinary system
- Having neurological disorders
- Having a history of transurethral resection of the prostate
- Having communication and mental impairment
- Inability to do pelvic floor muscle exercises
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Structured Bladder Training Program on Lower Urinary System Symptoms and Quality of Life After Radical Prostatectomy
Radical prostatectomy is the gold standard in the treatment of patients with localized prostate cancer. Urinary incontinence, which is common after surgery, can affect the quality of life of men negatively. There are various attempts to prevent and treat urinary symptoms after radical prostatectomy.The aim of this study is to evaluate the effect of the structured bladder training program on lower urinary tract symptoms and quality of life in patients undergoing radical prostatectomy.
- Being tested
- Bladder Training
- Medical subject headings
- Urinary Incontinence, Lower Urinary Tract Symptoms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bladder TrainingBehavioural
Patients in the structured bladder training group were trained on "lifestyle changes (nutrition, fluid management, exercise), pelvic floor muscle exercises and bladder control techniques".
| Study group | Role | What they receive |
|---|---|---|
| Bladder Training | Experimental | Patients in the structured bladder training group were trained on "lifestyle changes (nutrition, fluid management, exercise), pelvic floor muscle exercises and bladder control techniques". Receives: Behavioral: Bladder Training |
| Control Group | No intervention | Routine patient training was given to the patients in the control group by a nurse working in the clinic. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Urinary incontinence-related quality of life assessed by the International Consultation on Incontinence Questionnaire Short Form (ICIQ-SF)
The primary endpoint of this study was the difference between groups in terms of International Consultation on Incontinence Questionnaire Short Form (ICIQ-SF) scores 3 months after. This scale consists of 6 questions.The range of scores obtained from the scale varies between 0-21 points. High scores on the scale indicate that the quality of urinary incontinence is severely affected.
Measured: 3 months after from baseline (0 month)
Secondary outcomes (1)
Lower urinary tract symptoms assessed by the International Consultation on Incontinence Questionnaire-Male Lower Urinary Tract Symptoms (ICIQ-MLUTS)
The secondary endpoint is the difference between the groups in terms of International Consultation on Incontinence Questionnaire-Male Lower Urinary Tract Symptoms (ICIQ-MLUTS) scores after 3 months. This scale consists of 13 questions. Each question has a 4-point severity scale (0-4) and a 10-point visual analog scale (0-10) measuring quality of life. As the scores obtained from the scale increase, complaints about urinary system symptoms increase and the quality is negatively affected.
Measured: 3 months after from baseline (0 month)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2020
- Study start10 Oct 2019
- Primary completion10 Mar 2020
- Study completion7 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Saglik Bilimleri Universitesi
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elif Gezginci, Saglik Bilimleri Universitesi
- Investigators
- Elif Gezginci, RN, PhD, Principal investigator, Saglik Bilimleri Üniversitesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04628351
- Sponsor's protocol ID
- 19/37
- Status last verified
- Nov 2020
- First submitted
- 7 Nov 2020
- Last updated
- 17 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Tienforti D, Sacco E, Marangi F, D'Addessi A, Racioppi M, Gulino G, Pinto F, Totaro A, D'Agostino D, Bassi P. Efficacy of an assisted low-intensity programme of perioperative pelvic floor muscle training in improving the recovery of continence after radical prostatectomy: a randomized controlled trial. BJU Int. 2012 Oct;110(7):1004-10. doi: 10.1111/j.1464-410X.2012.10948.x. Epub 2012 Feb 14.
PubMed 22332815Jarvis TR, Sandhu JS. Management of urinary incontinence after radical prostatectomy. Curr Urol Rep. 2014 Jul;15(7):421. doi: 10.1007/s11934-014-0421-6.
PubMed 24859671de Lira GHS, Fornari A, Cardoso LF, Aranchipe M, Kretiska C, Rhoden EL. Effects of perioperative pelvic floor muscle training on early recovery of urinary continence and erectile function in men undergoing radical prostatectomy: a randomized clinical trial. Int Braz J Urol. 2019 Nov-Dec;45(6):1196-1203. doi: 10.1590/S1677-5538.IBJU.2019.0238.
PubMed 31808408Hodges P, Stafford R, Coughlin GD, Kasza J, Ashton-Miller J, Cameron AP, Connelly L, Hall LM. Efficacy of a personalised pelvic floor muscle training programme on urinary incontinence after radical prostatectomy (MaTchUP): protocol for a randomised controlled trial. BMJ Open. 2019 May 5;9(5):e028288. doi: 10.1136/bmjopen-2018-028288.
PubMed 31061057Bernardes MFVG, Chagas SC, Izidoro LCR, Veloso DFM, Chianca TCM, Mata LRFPD. Impact of urinary incontinence on the quality of life of individuals undergoing radical prostatectomy. Rev Lat Am Enfermagem. 2019 Mar 10;27:e3131. doi: 10.1590/1518-8345.2757.3131.
PubMed 30916232Chang JI, Lam V, Patel MI. Preoperative Pelvic Floor Muscle Exercise and Postprostatectomy Incontinence: A Systematic Review and Meta-analysis. Eur Urol. 2016 Mar;69(3):460-7. doi: 10.1016/j.eururo.2015.11.004. Epub 2015 Nov 21.
PubMed 26610857
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Structured Bladder Training Program on Lower Urinary System Symptoms and Quality of Life After Radical Prostatectomy
- ClinicalTrials.gov ID
- NCT04628351
- Acronym / sponsor ID
- 19/37
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Saglik Bilimleri UniversitesiUniversity, hospital or other
- Study start
- 10 Oct 2019 (actual)
- Primary completion
- 10 Mar 2020 (actual)
- Study completion
- 7 Nov 2020 (actual)
- First posted
- 13 Nov 2020 (actual)
- 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.
Radical prostatectomy is the gold standard in the treatment of patients with localized prostate cancer. Urinary incontinence, which is common after surgery, can affect the quality of life of men negatively. There are various attempts to prevent and treat urinary symptoms after radical prostatectomy.The aim of this study is to evaluate the effect of the structured bladder training program on lower urinary tract symptoms and quality of life in patients undergoing radical prostatectomy.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bladder Training | Experimental | Behavioral: Bladder TrainingPatients in the structured bladder training group were trained on "lifestyle changes (nutrition, fluid management, exercise), pelvic floor muscle exercises and bladder control techniques". |
| Control Group | No intervention | –Routine patient training was given to the patients in the control group by a nurse working in the clinic. |
Who may qualify
- Ages
- 40 to 85 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Being over the age of 40 years
- Being male
- Being with localized prostate cancer
- Undergoing open radical prostatectomy
- No preoperative urinary incontinence
Key exclusion criteria (5 listed)
- Having a congenital disorder of the urinary system
- Having neurological disorders
- Having a history of transurethral resection of the prostate
- Having communication and mental impairment
- Inability to do pelvic floor muscle exercises
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 |
|---|---|---|
| Bladder TrainingPatients in the structured bladder training group were trained on "lifestyle changes (nutrition, fluid management, exercise), pelvic floor muscle exercises and bladder control techniques". | Behavioural | Bladder Training |
Primary outcome
Urinary incontinence-related quality of life assessed by the International Consultation on Incontinence Questionnaire Short Form (ICIQ-SF)
Time frame: 3 months after from baseline (0 month)
The primary endpoint of this study was the difference between groups in terms of International Consultation on Incontinence Questionnaire Short Form (ICIQ-SF) scores 3 months after. This scale consists of 6 questions.The range of scores obtained from the scale varies between 0-21 points. High scores on the scale indicate that the quality of urinary incontinence is severely affected.
1 secondary outcome
Lower urinary tract symptoms assessed by the International Consultation on Incontinence Questionnaire-Male Lower Urinary Tract Symptoms (ICIQ-MLUTS)
Time frame: 3 months after from baseline (0 month)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2020.
- Background: PubMed 22332815Tienforti D, Sacco E, Marangi F, D'Addessi A, Racioppi M, Gulino G, Pinto F, Totaro A, D'Agostino D, Bassi P. Efficacy of an assisted low-intensity programme of perioperative pelvic floor muscle training in improving the recovery of continence after radical prostatectomy: a randomized controlled trial. BJU Int. 2012 Oct;110(7):1004-10. doi: 10.1111/j.1464-410X.2012.10948.x. Epub 2012 Feb 14.
- Background: PubMed 24859671Jarvis TR, Sandhu JS. Management of urinary incontinence after radical prostatectomy. Curr Urol Rep. 2014 Jul;15(7):421. doi: 10.1007/s11934-014-0421-6.
- Background: PubMed 31808408de Lira GHS, Fornari A, Cardoso LF, Aranchipe M, Kretiska C, Rhoden EL. Effects of perioperative pelvic floor muscle training on early recovery of urinary continence and erectile function in men undergoing radical prostatectomy: a randomized clinical trial. Int Braz J Urol. 2019 Nov-Dec;45(6):1196-1203. doi: 10.1590/S1677-5538.IBJU.2019.0238.
- Background: PubMed 31061057Hodges P, Stafford R, Coughlin GD, Kasza J, Ashton-Miller J, Cameron AP, Connelly L, Hall LM. Efficacy of a personalised pelvic floor muscle training programme on urinary incontinence after radical prostatectomy (MaTchUP): protocol for a randomised controlled trial. BMJ Open. 2019 May 5;9(5):e028288. doi: 10.1136/bmjopen-2018-028288.
- Background: PubMed 30916232Bernardes MFVG, Chagas SC, Izidoro LCR, Veloso DFM, Chianca TCM, Mata LRFPD. Impact of urinary incontinence on the quality of life of individuals undergoing radical prostatectomy. Rev Lat Am Enfermagem. 2019 Mar 10;27:e3131. doi: 10.1590/1518-8345.2757.3131.
- Background: PubMed 26610857Chang JI, Lam V, Patel MI. Preoperative Pelvic Floor Muscle Exercise and Postprostatectomy Incontinence: A Systematic Review and Meta-analysis. Eur Urol. 2016 Mar;69(3):460-7. doi: 10.1016/j.eururo.2015.11.004. Epub 2015 Nov 21.
- Individual participant dataSharing planned: No
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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.
Elif Gezginci, RN, PhD principal investigator
Saglik Bilimleri Üniversitesi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bladder Training in people with Urinary Incontinence and Quality of Life, run by Saglik Bilimleri Universitesi at 1 site in Turkey (Türkiye).
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 8 inclusion and 5 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 17 Nov 2020. 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 Turkey (Türkiye). 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Urinary incontinence-related quality of life assessed by the International Consultation on Incontinence Questionnaire Short Form (ICIQ-SF) (time frame: 3 months after from baseline (0 month)). 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 NCT04628351, which also lists 6 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 17 Nov 2020.