Comparison of the Effectiveness of Different Conservative Treatment Protocols in Postprostatectomy Urinary Incontinence

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Comparison of the Effectiveness of Different Conservative Treatment Protocols in Individuals With Symptom of Postprostatectomy Urinary Incontinence : a Randomized Controlled Trial

Conditions
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Urinary Incontinence, Prostate Cancer, Urinary Incontinence,Stress, Urinary Incontinence Due to Urethral Sphincter Incompetence

Intervention / Treatment
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* Other: First research arm
* Other: Second research arm
* Other: Third research arm


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Participants older than 18 years of age (with a Mini Mental Test score ≥ 24 for individuals over the ages of 65), who had a complaint of UI after prostatectomy, who did not have any cooperation problems in the evaluations or practices in the study, were included. Exclusion Criteria: Acute disease state (e.g. urinary tract infection, upper respiratory tract infection, interstitial cystitis, bladder or gastrointestinal bleeding), acute surgical condition (occurring within the first 3 weeks after prostatectomy), neurological disease, or participants with neurogenic bladder, participants with complaints of pure urgency urinary incontinence, presence of preoperative incontinence, who have undergone bladder or other prostate surgeries prior to prostatectomy, who did not give consent to the study and who do not have an informed consent form will not be included.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: First research arm (Combined group)<br>Combined group with 8 weeks of pelvic floor muscle training, knack maneuver and lifestyle recommendations. | Other: First research arm<br>* Patients in this group were given 8-week PFMT (including knack maneuver) and lifestyle recommendations for the treatment of urinary incontinence symptoms.<br>* Other names: Combined group;|
| Experimental: Second research arm [PFMT (including knack maneuver) group]<br>Only 8-week PFMT (including knack maneuver) | Other: Second research arm<br>* Patients in this group were given only 8-week PFMT (including knack maneuver) for the treatment of urinary incontinence symptoms.<br>* Other names: PFMT (including knack maneuver) group;|
| Active Comparator: Third research arm (PFMT alone group)<br>It is the control group and patients in this group were given alone8-week PFMT (without knack maneuver). | Other: Third research arm<br>* It is the control group and patients in this group were given alone8-week PFMT (without knack maneuver).<br>* Other names: PFMT alone group;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| International Consultation on Incontinence Modular Questionnaire - Urinary Incontinence short form (ICIQ-UIsf (short form)) | Symptom severity and impact of incontinence on life | In the first evaluation(baseline), during study (at the end of the fourth week), post-treatment evaluation (at the end of the eighth week) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient Global Impression of Severity question | Individual's perception of symptom severity | In the first evaluation(baseline), during study (at the end of the fourth week), post-treatment evaluation (at the end of the eighth week) | 
| 1 hour pad test | Incontinence severity Pad Test assesses urine loss and leakage volume of the participant | In the first evaluation(baseline), during study (at the end of the fourth week), post-treatment evaluation (at the end of the eighth week) | 
| King's Health Questionnaire | Impact of incontinence on quality of life | In the first evaluation(baseline), during study (at the end of the fourth week), post-treatment evaluation (at the end of the eighth week) | 
| Patient Global Impression of Improvement question | Individual's perception of improvement | Post-treatment evaluation (at the end of the eighth week) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Knack maneuver, Pelvic floor muscle training, Lifestyle interventions, Kegel exercises, Prostate cancer, Men's health, Pelvic floor exercises