Urinary Incontinence After Radical Prostatectomy

Regional Hospital West Jutland

Status: Enrolling

Conditions: Incontinence, Urinary; Radical Prostatectomy

Treatments: Other: Transperinal ultrasound guided instruction in pelvic floor muscle training

Study type: Interventional

Funder types: Other

Identifiers

NCT05625048

1-10-72-356-21

Details and patient eligibility

About

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.

Enrollment: 66 estimated patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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66 participants in 3 patient groups

Intervention group

Experimental group

Description:

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.

Treatment:

Other: Transperinal ultrasound guided instruction in pelvic floor muscle training

Control group 1

No Intervention group

Description:

The patients recieve standard care including three physiotherapist sessions; within one week preoperatively, one week postoperatively at catheter removal, and six weeks postoperatively

Control group 2

No Intervention group

Description:

The patients recieve standard care including three physiotherapist sessions; within one week preoperatively, one week postoperatively at catheter removal, and six weeks postoperatively