Urinary Incontinence After Radical Prostatectomy

Study Overview
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Brief Summary
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The aims of this project are; 1) To examine the efficacy of ultrasound-guided pelvic floor muscle training compared to standard care on urinary incontinence in patients undergoing robot assisted radical prostatectomy and 2) To compare physical function, incontinence, and QoL in two groups of patients with low or high function of the pelvic floor muscles respectively before the surgery. This study consists of two parts. The first part is a randomized controlled trial where 44 patients with weak pelvic floor muscle function are randomized to either treatment as usual (control group 1) or ultrasound-guided pelvic floor muscle training (Intervention group). In the second part the patients in control group 1 will be compared with 22 patients with normal/strong pelvic floor muscle function (control group 2). Patients not able to perform the pelvic floor muscle test consisting of 8 repetitions of 4-seconds pelvic floor muscle contraction and 1 repetition of 15-seconds pelvic floor muscle contraction will be randomized to either intervention group or control group 1. Patients able to perform the pelvic floor muscle test will be included in control group 2.

Official Title
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Urinary Incontinence After Radical Prostatectomy

Conditions
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Incontinence, Urinary, Radical Prostatectomy

Intervention / Treatment
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* Other: Transperinal ultrasound guided instruction in pelvic floor muscle training


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Men aged 18 and above Diagnosis of prostatic adenocarcinoma and referred to robot assisted radical prostatectomy No comorbidity that prevents pelvic floor training or effects the function of the pelvic floor Adequacy in written and spoken Danish Performance status 0-1 Able to understand the study procedures and willing to provide written informed consent Exclusion Criteria: Major surgery within the last month that may affect pelvic floor function. Urinary incontinence prior to surgery

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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention group<br>The intervention group receives same treatment as the control groups and in addition transperinal ultrasound guided instruction in pelvic floor muscle training at 2nd and 3rd session. | Other: Transperinal ultrasound guided instruction in pelvic floor muscle training<br>* The physiotherapists uses transperinal ultrasound as a biofeedback or pedagogical tool to improve the muscle contractions and visualize the muscle work.<br>|
| No Intervention: Control group 1<br>The patients recieve standard care including three physiotherapist sessions; within one week preoperatively, one week postoperatively at catheter removal, and six weeks postoperatively | |
| No Intervention: Control group 2<br>The patients recieve standard care including three physiotherapist sessions; within one week preoperatively, one week postoperatively at catheter removal, and six weeks postoperatively | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 24-hour pad weigh test | The patients have to weigh their pads before use and retain them in sealed plastic bags for repeated weight assessment when the 24-hour period has ended. The total increase in weight (gram) of all the pads will be recorded | 12 month after the operation |