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Urinary Incontinence After Radical Prostatectomy

Primary Purpose

Incontinence, Urinary, Radical Prostatectomy

Status
Recruiting
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Transperinal ultrasound guided instruction in pelvic floor muscle training
Sponsored by
Regional Hospital West Jutland
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Incontinence, Urinary

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept 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

Sites / Locations

  • Regional Hospital GoedstrupRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

No Intervention

No Intervention

Arm Label

Intervention group

Control group 1

Control group 2

Arm 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.

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
October 27, 2022
Last Updated
November 14, 2022
Sponsor
Regional Hospital West Jutland
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1. Study Identification

Unique Protocol Identification Number
NCT05625048
Brief Title
Urinary Incontinence After Radical Prostatectomy
Official Title
Urinary Incontinence After Radical Prostatectomy
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
October 12, 2022 (Actual)
Primary Completion Date
October 2024 (Anticipated)
Study Completion Date
October 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Regional Hospital West Jutland

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Incontinence, Urinary, Radical Prostatectomy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
66 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention group
Arm Type
Experimental
Arm 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.
Arm Title
Control group 1
Arm Type
No Intervention
Arm Description
The patients recieve standard care including three physiotherapist sessions; within one week preoperatively, one week postoperatively at catheter removal, and six weeks postoperatively
Arm Title
Control group 2
Arm Type
No Intervention
Arm Description
The patients recieve standard care including three physiotherapist sessions; within one week preoperatively, one week postoperatively at catheter removal, and six weeks postoperatively
Intervention Type
Other
Intervention Name(s)
Transperinal ultrasound guided instruction in pelvic floor muscle training
Intervention Description
The physiotherapists uses transperinal ultrasound as a biofeedback or pedagogical tool to improve the muscle contractions and visualize the muscle work.
Primary Outcome Measure Information:
Title
24-hour pad weigh test
Description
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
Time Frame
12 month after the operation

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Birch
Phone
51540126
Email
sara.birch@goedstrup.rm.dk
Facility Information:
Facility Name
Regional Hospital Goedstrup
City
Herning
ZIP/Postal Code
7400
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sara Birch
Phone
51540126
Email
sara.birch@goedstrup.rm.dk

12. IPD Sharing Statement

Learn more about this trial

Urinary Incontinence After Radical Prostatectomy

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