Comparison of the Effectiveness of Different Conservative Treatment Protocols in Postprostatectomy Urinary Incontinence
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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N/A |
Detailed Description
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: First research arm (Combined group) Combined group with 8 weeks of pelvic floor muscle training, knack maneuver and lifestyle recommendations. |
Other: First research arm
Patients in this group were given 8-week PFMT (including knack maneuver) and lifestyle recommendations for the treatment of urinary incontinence symptoms.
Other Names:
|
| Experimental: Second research arm [PFMT (including knack maneuver) group] Only 8-week PFMT (including knack maneuver) |
Other: Second research arm
Patients in this group were given only 8-week PFMT (including knack maneuver) for the treatment of urinary incontinence symptoms.
Other Names:
|
| Active Comparator: Third research arm (PFMT alone group) It is the control group and patients in this group were given alone8-week PFMT (without knack maneuver). |
Other: Third research arm
It is the control group and patients in this group were given alone8-week PFMT (without knack maneuver).
Other Names:
|
Outcome Measures
Primary Outcome Measures
- International Consultation on Incontinence Modular Questionnaire - Urinary Incontinence short form (ICIQ-UIsf (short form)) [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
Secondary Outcome Measures
- Patient Global Impression of Severity question [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
- 1 hour pad test [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
- King's Health Questionnaire [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
- Patient Global Impression of Improvement question [Post-treatment evaluation (at the end of the eighth week)]
Individual's perception of improvement
Other Outcome Measures
- International Physical Activity Questionnaire and Likert-type scales. [During study (at the end of the fourth week), post-treatment evaluation (at the end of the eighth week)]
Compliance with lifestyle change recommendations
- Likert-type scales [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.
- Exercise diary [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.
Eligibility Criteria
Criteria
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Hacettepe University | Ankara | Turkey | 06080 |
Sponsors and Collaborators
- Hacettepe University
Investigators
- Principal Investigator: Serap Kaya, Assoc Prof, Hacettepe University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- KA-20081