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

Prostate Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04804839
• Other study ID #: KA-20081
• Status: Completed
• Phase: N/A
• Start date: April 1, 2021
• Est. completion date: March 1, 2022

Study information

• Verified date: March 2024
• Source: Hacettepe University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: March 1, 2022
• Est. primary completion date: March 1, 2022
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Enuresis
• Prostate Cancer
• Prostatic Neoplasms
• Urinary Incontinence
• Urinary Incontinence Due to Urethral Sphincter Incompetence
• Urinary Incontinence, Stress
• Urinary Incontinence,Stress

Intervention

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.
• Second research arm
Patients in this group were given only 8-week PFMT (including knack maneuver) for the treatment of urinary incontinence symptoms.
• Third research arm
It is the control group and patients in this group were given alone8-week PFMT (without knack maneuver).

Locations

Country	Name	City	State
Turkey	Hacettepe University	Ankara

Sponsors (1)

Lead Sponsor	Collaborator
Hacettepe University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	International Physical Activity Questionnaire and Likert-type scales.	Compliance with lifestyle change recommendations	During study (at the end of the fourth week), post-treatment evaluation (at the end of the eighth week)
Other	Likert-type scales	Compliance with smoking, alcohol, tea, caffeine, carbonated beverage, water consumption, bowel order management, exercise and physical activity recommendations will be evaluated separately.	during study (at the end of the fourth week), post-treatment evaluation (at the end of the eighth week)
Other	Exercise diary	Adherence to the home exercise program will be assessed.	during study (at the end of the fourth week), post-treatment evaluation (at the end of the eighth week)
Primary	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	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)
Secondary	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)
Secondary	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)
Secondary	Patient Global Impression of Improvement question	Individual's perception of improvement	Post-treatment evaluation (at the end of the eighth week)