Clinical trial NCT05700487: EFFECT ON QUALITY OF LIFE AFTER PROSTATECTOMY
Official title: THE EFFECT OF PELVIC FLOOR EXERCISES ON URINARY INCONTINENCE AND QUALITY OF LIFE AFTER PROSTATECTOMY
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: PROSTATECTOMY
URINARY INCONTINENCE
Keywords: Radical Prostatectomy
Pelvic Floor Exercises
Urinary Incontinence
Quality of life
Lead sponsor: TC Erciyes University
Sponsor class: OTHER
First posted: 2023-01-26
Enrollment: 33
Sex: MALE
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Aim: This study was conducted to determine the effect of pelvic floor exercises (PTE) on urinary incontinence and quality of life (QOL) after radical prostatectomy (RP).

Methods: This randomized controlled, single-blind, experimental study was completed with a total of 33 RP patients, 18 of whom were interventions, and 15 were controls. The intervention group was given pelvic floor exercises (PTE) training in the preoperative period, regular PTE was performed three times a day for six months in the postoperative period, and the continuity of the exercises was checked by telephone. On the other hand, no intervention was applied to the control group other than routine treatment.


Eligibility criteria: Inclusion Criteria:

* Being literate,
* Having the mental competence to understand the questions,
* Radical prostatectomy was performed due to the diagnosis of localized prostate cancer,
* Continuing post-operative follow-up,
* No incontinence problem before surgery,
* Anatomically free of genito-urinary system pathology,
* Those who volunteered to participate in the study were recruited.

Exclusion Criteria:

- With bladder insufficiency (dysfunction),

• Individuals with a different type of incontinence problem such as stress incontinence, neurogenic bladder were not included in the study.

Primary outcomes:
measure: Quality of life Scale(SF-36)
timeFrame: The first measurement was made when the patients were included in the study.
measure: Quality of life Scale(SF-36)
timeFrame: It was performed at the 1st month follow-ups of the patients.
measure: Quality of life Scale(SF-36)
timeFrame: It was performed at the 3st month follow-ups of the patients.
measure: Quality of life Scale(SF-36)
timeFrame: It was performed at the 6st month follow-ups of the patients.
Secondary outcomes:
measure: The Overactive Bladder (OAB-V8 )
timeFrame: The first measurement was made when the patients were included in the study.
measure: The Overactive Bladder (OAB-V8 )
timeFrame: It was performed at the 1st month follow-ups of the patients.
measure: The Overactive Bladder (OAB-V8 )
timeFrame: It was performed at the 3st month follow-ups of the patients.
measure: The Overactive Bladder (OAB-V8 )
timeFrame: It was performed at the 6st month follow-ups of the patients.
Other outcomes:
measure: The Marmara Post-Prostatectomy Incontinence Symptom Score Form
timeFrame: The first measurement was made when the patients were included in the study.
measure: The Marmara Post-Prostatectomy Incontinence Symptom Score Form
timeFrame: It was performed at the 1st month follow-ups of the patients.
measure: The Marmara Post-Prostatectomy Incontinence Symptom Score Form
timeFrame: It was performed at the 3st month follow-ups of the patients.
measure: The Marmara Post-Prostatectomy Incontinence Symptom Score Form
timeFrame: It was performed at the 6st month follow-ups of the patients.
Locations:
city: Kayseri
country: Turkey
facility: ERciyes University
Study officials:
References:
citation: Gacci M, Carini M, Simonato A, Imbimbo C, Gontero P, Briganti A, De Cobelli O, Fulcoli V, Martorana G, Nicita G, Mirone V, Carmignani G. Factors predicting continence recovery 1 month after radical prostatectomy: results of a multicenter survey. Int J Urol. 2011 Oct;18(10):700-8. doi: 10.1111/j.1442-2042.2011.02826.x. Epub 2011 Aug 11.
citation: Almallah YZ, Grimsley SJ. A report of a regional service for post-prostatectomy urinary incontinence: a model for best practice? Ther Adv Urol. 2015 Apr;7(2):69-75. doi: 10.1177/1756287214561625.
citation: Venderbos LDF, Aluwini S, Roobol MJ, Bokhorst LP, Oomens EHGM, Bangma CH, Korfage IJ. Long-term follow-up after active surveillance or curative treatment: quality-of-life outcomes of men with low-risk prostate cancer. Qual Life Res. 2017 Jun;26(6):1635-1645. doi: 10.1007/s11136-017-1507-7. Epub 2017 Feb 6.
citation: Santa Mina D, Matthew AG, Hilton WJ, Au D, Awasthi R, Alibhai SM, Clarke H, Ritvo P, Trachtenberg J, Fleshner NE, Finelli A, Wijeysundera D, Aprikian A, Tanguay S, Carli F. Prehabilitation for men undergoing radical prostatectomy: a multi-centre, pilot randomized controlled trial. BMC Surg. 2014 Nov 13;14:89. doi: 10.1186/1471-2482-14-89.
citation: Lee EW, Kobashi KC. Mixed incontinence: what takes precedence in its management? Curr Urol Rep. 2014 Dec;15(12):461. doi: 10.1007/s11934-014-0461-y.