Bladder Training in Radical Prostatectomy

Quality of Life Clinical Trial

Official title:

The Effect of Structured Bladder Training Program on Lower Urinary System Symptoms and Quality of Life After Radical Prostatectomy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04628351
• Other study ID #: 19/37
• Status: Completed
• Phase: N/A
• Start date: October 10, 2019
• Est. completion date: November 7, 2020

Study information

• Verified date: November 2020
• Source: Saglik Bilimleri Universitesi
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: November 7, 2020
• Est. primary completion date: March 10, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 40 Years to 85 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Lower Urinary Tract Symptoms
• Quality of Life
• Urinary Incontinence

Intervention

Behavioral:
• Bladder Training
Patients in the structured bladder training group were trained on "lifestyle changes (nutrition, fluid management, exercise), pelvic floor muscle exercises and bladder control techniques".

Locations

Country	Name	City	State
Turkey	Elif Gezginci	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Saglik Bilimleri Universitesi

Country where clinical trial is conducted

Turkey, 

References & Publications (6)

Bernardes 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. English, Portuguese, Spanish. Erratum in: Rev Lat Am Enfermagem. 2019 Dec 05;27:e3244. — View Citation

Chang 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. Review. — View Citation

de 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. — View Citation

Hodges 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. — View Citation

Jarvis 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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	3 months after from baseline (0 month)
Secondary	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.	3 months after from baseline (0 month)