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Urinary Incontinence After Radical Prostatectomy

Urinary Incontinence After Radical Prostatectomy

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05625048
Enrollment
66
Registered
2022-11-22
Start date
2022-10-12
Completion date
2025-10-31
Last updated
2022-11-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Incontinence, Urinary, Radical Prostatectomy

Brief summary

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.

Interventions

OTHERTransperinal 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.

Sponsors

Regional Hospital West Jutland
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
24-hour pad weigh test12 month after the operationThe 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

Countries

Denmark

Contacts

Primary ContactBirch
sara.birch@goedstrup.rm.dk51540126

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026