Urinary Incontinence After Radical Prostatectomy

Incontinence, Urinary Clinical Trial

Official title:

Urinary Incontinence After Radical Prostatectomy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05625048
• Other study ID #: 1-10-72-356-21
• Status: Recruiting
• Phase: N/A
• Start date: October 12, 2022
• Est. completion date: October 2025

Study information

• Verified date: November 2022
• Source: Regional Hospital West Jutland
• Contact: Birch
• Phone: 51540126
• Email: sara.birch[@]goedstrup.rm.dk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 66
• Est. completion date: October 2025
• Est. primary completion date: October 2024
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Enuresis
• Incontinence, Urinary
• Radical Prostatectomy
• Urinary Incontinence

Intervention

Other:
• 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.

Locations

Country	Name	City	State
Denmark	Regional Hospital Goedstrup	Herning

Sponsors (1)

Lead Sponsor	Collaborator
Regional Hospital West Jutland

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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