Incontinence, UrinaryNCT05625048
Urinary Incontinence After Radical Prostatectomy
A study testing Transperinal ultrasound guided instruction in pelvic floor muscle training in people with Incontinence, Urinary and Radical Prostatectomy, run by Regional Hospital West Jutland at 1 site in Denmark.
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… Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Incontinence, Urinary, Radical Prostatectomy
- What is being tested?
- Transperinal ultrasound guided instruction in pelvic floor muscle training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteDenmark
- Study dates
- 12 Oct 2022to Oct 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Major surgery within the last month that may affect pelvic floor function.
- Urinary incontinence prior to surgery
Trial locations and contacts
1 site in 1 country.
Denmark1 site, 1 recruiting
- Recruiting
Regional Hospital Goedstrup
Herning, 7400
Sara Birch, 51540126, sara.birch@goedstrup.rm.dk
About this study
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
- Being tested
- Transperinal ultrasound guided instruction in pelvic floor muscle training
- Medical subject headings
- Urinary Incontinence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transperinal ultrasound guided instruction in pelvic floor muscle trainingOther
The physiotherapists uses transperinal ultrasound as a biofeedback or pedagogical tool to improve the muscle contractions and visualize the muscle work.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 12 month after the operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2022
- Study start12 Oct 2022
- Primary completionOct 2024 (estimated)
- Study completionOct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Incontinence, UrinaryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 66 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Regional Hospital West Jutland
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sara Birch, Regional Hospital West Jutland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05625048
- Sponsor's protocol ID
- 1-10-72-356-21
- Status last verified
- Nov 2022
- First submitted
- 27 Oct 2022
- Last updated
- 22 Nov 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Urinary Incontinence After Radical Prostatectomy
- ClinicalTrials.gov ID
- NCT05625048
- Acronym / sponsor ID
- 1-10-72-356-21
- Conditions
- Incontinence, Urinary, Radical Prostatectomy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- Regional Hospital West JutlandUniversity, hospital or other
- Study start
- 12 Oct 2022 (actual)
- Primary completion
- Oct 2024 (estimated)
- Study completion
- Oct 2025 (estimated)
- First posted
- 22 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Other: Transperinal ultrasound guided instruction in pelvic floor muscle trainingThe 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. |
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (2 listed)
- Major surgery within the last month that may affect pelvic floor function.
- Urinary incontinence prior to surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transperinal ultrasound guided instruction in pelvic floor muscle trainingThe physiotherapists uses transperinal ultrasound as a biofeedback or pedagogical tool to improve the muscle contractions and visualize the muscle work. | Other | Intervention group |
Primary outcome
24-hour pad weigh test
Time frame: 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transperinal ultrasound guided instruction in pelvic floor muscle training in people with Incontinence, Urinary and Radical Prostatectomy, run by Regional Hospital West Jutland at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Birch (51540126, sara.birch@goedstrup.rm.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
24-hour pad weigh test (time frame: 12 month after the operation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Nov 2022.