Urinary Incontinence After Radical Prostatectomy

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: Male
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Denmark
Regional Hospital Goedstrup
RECRUITING
Herning
Contact Information
Primary
Birch
sara.birch@goedstrup.rm.dk
51540126
Time Frame
Start Date: 2022-10-12
Estimated Completion Date: 2025-10
Participants
Target number of participants: 66
Treatments
Experimental: 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.
No_intervention: 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_intervention: 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
Related Therapeutic Areas
Sponsors
Leads: Regional Hospital West Jutland

This content was sourced from clinicaltrials.gov