Urinary Incontinence After Radical Prostatectomy

NCT05625048 | Unknown DMC

• 1 other identifier: 1-10-72-356-21
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

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.

Conditions

Incontinence, Urinary; Radical Prostatectomy

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (3)

Intervention group

EXPERIMENTAL

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.

Other: Transperinal ultrasound guided instruction in pelvic floor muscle training

Control group 1

NO INTERVENTION

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

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

Interventions

Transperinal ultrasound guided instruction in pelvic floor muscle training OTHER

The physiotherapists uses transperinal ultrasound as a biofeedback or pedagogical tool to improve the muscle contractions and visualize the muscle work.

Intervention group

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Major surgery within the last month that may affect pelvic floor function.
• Urinary incontinence prior to surgery

Sponsors & Collaborators

• Regional Hospital West Jutland: lead

Study Sites (1)

Regional Hospital Goedstrup

Herning, 7400, Denmark

RECRUITING

MeSH Terms

Conditions

Urinary Incontinence

Condition Hierarchy (Ancestors)

Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Birch

CONTACT

51540126; sara.birch@goedstrup.rm.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: October 27, 2022
• First Posted: November 22, 2022
• Study Start: October 12, 2022
• Primary Completion: October 1, 2024
• Study Completion: October 1, 2025
• Last Updated: November 22, 2022

Record last verified: 2022-11

Locations

DK (1)