Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
66 participants
INTERVENTIONAL
2022-10-12
2025-10-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Intervention group
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.
Transperinal ultrasound guided instruction in pelvic floor muscle training
The physiotherapists uses transperinal ultrasound as a biofeedback or pedagogical tool to improve the muscle contractions and visualize the muscle work.
Control group 1
The patients recieve standard care including three physiotherapist sessions; within one week preoperatively, one week postoperatively at catheter removal, and six weeks postoperatively
No interventions assigned to this group
Control group 2
The patients recieve standard care including three physiotherapist sessions; within one week preoperatively, one week postoperatively at catheter removal, and six weeks postoperatively
No interventions assigned to this group
Interventions
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Transperinal ultrasound guided instruction in pelvic floor muscle training
The physiotherapists uses transperinal ultrasound as a biofeedback or pedagogical tool to improve the muscle contractions and visualize the muscle work.
Eligibility Criteria
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Inclusion Criteria
* 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
* Urinary incontinence prior to surgery
18 Years
MALE
No
Sponsors
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Regional Hospital West Jutland
OTHER
Responsible Party
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Sara Birch
Principal investigator
Locations
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Regional Hospital Goedstrup
Herning, , Denmark
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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1-10-72-356-21
Identifier Type: -
Identifier Source: org_study_id
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