Hacettepe University
Ankara, 06080, Turkey (Türkiye)
NCT Number: NCT04804839
The main purpose of this study is to reveal the effectiveness of the Knack maneuver and lifestyle recommendations program to be given in addition to the pelvic floor muscle training (PFMT) program, which has been proven to be effective in individuals with urinary incontinence symptoms after prostatectomy. This study is a prospective, controlled, randomized clinical trial. The study includes an 8-week pelvic floor muscle training, Knack maneuver and lifestyle recommendations.
In summary, it is stated in the literature that PFMT and lifestyle recommendations are beneficial in the treatment of urinary incontinence (UI). However, although there is evidence of the effectiveness of the Knack maneuver in stress UI in women, there is no evidence of the Knack maneuver in urinary incontinence after prostatectomy. On the other hand, the literature on the effect of lifestyle recommendations after prostatectomy is very limited.
Therefore, the aim of this study is to reveal the effectiveness of the Knack maneuver and lifestyle recommendations program, which will be given in addition to the PFMT program, which has been demonstrated in individuals with UI complaints after radical prostatectomy, in a randomized controlled design.
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Notify Me18 year and older
Male
Interventional
Not applicable
Ankara, 06080, Turkey (Türkiye)
The main purpose of this study is to reveal the effectiveness of the Knack maneuver and lifestyle recommendations program to be given in addition to the pelvic floor muscle training (PFMT) program, which has been proven to be effective in individuals with urinary incontinence symptoms after prostatectomy. This study is a prospective, controlled, randomized clinical trial. The study includes an 8-week pelvic floor muscle training, Knack maneuver and lifestyle recommendations.
It was planned to enroll 72 individuals with urinary incontinence problems after radical prostatectomy in this randomized controlled clinical study. A physical therapist is responsible for all assessments.
Participants were included in one of three treatment groups (G1: Pelvic floor muscle training + Knack maneuver + lifestyle recommendations; G2: Pelvic floor muscle training + Knack maneuver G3: Pelvic floor muscle training).
In summary, it is stated in the literature that PFMT and lifestyle recommendations are beneficial in the treatment of urinary incontinence (UI). However, although there is evidence of the effectiveness of the Knack maneuver in stress UI in women, there is no evidence of the Knack maneuver in urinary incontinence after prostatectomy. On the other hand, the literature on the effect of lifestyle recommendations after prostatectomy is very limited.
Therefore, the aim of this study is to reveal the effectiveness of the Knack maneuver and lifestyle recommendations program, which will be given in addition to the PFMT program, which has been demonstrated in individuals with UI complaints after radical prostatectomy, in a randomized controlled design.
With this study, the effectiveness of different programs to be applied to individuals suffering from urinary incontinence after prostatectomy will be determined and compared. It will increase the level of evidence for the treatment of urinary incontinence, a common complaint after prostate cancer surgery. In this direction, it will also contribute to the development of public health.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Patients in this group were given 8-week PFMT (including knack maneuver) and lifestyle recommendations for the treatment of urinary incontinence symptoms.
Other names: Combined group
Patients in this group were given only 8-week PFMT (including knack maneuver) for the treatment of urinary incontinence symptoms.
Other names: PFMT (including knack maneuver) group
It is the control group and patients in this group were given alone8-week PFMT (without knack maneuver).
Other names: PFMT alone group
Time frame: In the first evaluation(baseline), during study (at the end of the fourth week), post-treatment evaluation (at the end of the eighth week)
Symptom severity and impact of incontinence on life
Time frame: In the first evaluation(baseline), during study (at the end of the fourth week), post-treatment evaluation (at the end of the eighth week)
Individual's perception of symptom severity
Time frame: In the first evaluation(baseline), during study (at the end of the fourth week), post-treatment evaluation (at the end of the eighth week)
Incontinence severity Pad Test assesses urine loss and leakage volume of the participant
Time frame: In the first evaluation(baseline), during study (at the end of the fourth week), post-treatment evaluation (at the end of the eighth week)
Impact of incontinence on quality of life
Time frame: Post-treatment evaluation (at the end of the eighth week)
Individual's perception of improvement
Time frame: During study (at the end of the fourth week), post-treatment evaluation (at the end of the eighth week)
Compliance with lifestyle change recommendations
Time frame: during study (at the end of the fourth week), post-treatment evaluation (at the end of the eighth week)
Compliance with smoking, alcohol, tea, caffeine, carbonated beverage, water consumption, bowel order management, exercise and physical activity recommendations will be evaluated separately.
Time frame: during study (at the end of the fourth week), post-treatment evaluation (at the end of the eighth week)
Adherence to the home exercise program will be assessed.
Hacettepe University
Other
Comparison of the Effectiveness of Different Conservative Treatment Protocols in Individuals With Symptom of Postprostatectomy Urinary Incontinence : a Randomized Controlled Trial
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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