Urinary Incontinence After Radical Prostatectomy

Not Applicable

Recruiting

• Conditions: Radical Prostatectomy; Incontinence, Urinary
• Interventions: Other: Transperinal ultrasound guided instruction in pelvic floor muscle training

• Registration Number: NCT05625048
• Lead Sponsor: Regional Hospital West Jutland

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-10-12
• Study First Submitted: 2022-10-27
• Status Verified: 2022-11
• Study First Submitted QC: 2022-11-14
• Last Update Submitted: 2022-11-14
• Study First Posted: 2022-11-22
• Last Update Posted: 2022-11-22
• Primary Completion: 2024-10
• Study Completion: 2025-10

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Male
• Target Recruitment: 66

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention group	Transperinal ultrasound guided instruction in pelvic floor muscle training	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.

Primary Outcome Measures

Name	Time	Method
24-hour pad weigh test	12 month after the operation	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

Trial Locations

Locations (1)

Regional Hospital Goedstrup; 🇩🇰 Herning, Denmark