Bladder Training in Radical Prostatectomy

NCT04628351 | Completed

• 1 other identifier: 19/37
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Urinary Incontinence; Quality of Life; Lower Urinary Tract Symptoms

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Lower urinary tract symptoms assessed by the International Consultation on Incontinence Questionnaire-Male Lower Urinary Tract Symptoms (ICIQ-MLUTS)

  3 months after from baseline (0 month)

Study Arms (2)

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".

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.

Interventions

Bladder Training BEHAVIORAL

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

Bladder Training

Eligibility Criteria

• Age: 40 Years - 85 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Saglik Bilimleri Universitesi: lead

Study Sites (1)

Elif Gezginci

Istanbul, Turkey (Türkiye)

Location

Related Publications (6)

• 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.

  PMID: 22332815 BACKGROUND

• 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.

  PMID: 24859671 BACKGROUND

• 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.

  PMID: 31808408 BACKGROUND

• 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.

  PMID: 31061057 BACKGROUND

• 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.

  PMID: 30916232 BACKGROUND

• 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.

  PMID: 26610857 BACKGROUND

MeSH Terms

Conditions

Urinary Incontinence; Lower Urinary Tract Symptoms

Condition Hierarchy (Ancestors)

Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Elif Gezginci, RN, PhD

  Saglik Bilimleri Üniversitesi

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: RN, PHD, Asst Prof

Study Record Dates

• First Submitted: November 7, 2020
• First Posted: November 13, 2020
• Study Start: October 10, 2019
• Primary Completion: March 10, 2020
• Study Completion: November 7, 2020
• Last Updated: November 17, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)