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RecruitingNCT05625048Updated Nov 22, 2022

Urinary Incontinence After Radical Prostatectomy

An interventional study of Transperinal ultrasound guided instruction in pelvic floor muscle training in Incontinence, Urinary and Radical Prostatectomy, sponsored by Regional Hospital West Jutland. Recruiting at 1 site in Denmark. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-11-22.

Sponsored by Regional Hospital West Jutland · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Oct 2024, 2 years ago, but the record still lists the study as recruiting.
  • Started Oct 2022; still recruiting 3 years 11 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
66
Allocation
Randomized
Ages
18 Years and older
Sex
Male
01

Study 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.

02

Conditions studied

  • Incontinence, Urinary
  • Radical Prostatectomy
03

In context

Urinary Incontinence

1,363 studies on the registry are indexed under Urinary Incontinence; 228 are open to participants now.

This study's planned enrollment of 66 is close to the median of 66 across 1,011 interventional studies indexed under Urinary Incontinence.

Browse Urinary Incontinence studies →

Lead sponsor

Regional Hospital West Jutland is the lead sponsor of 11 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Male
Accepts healthy volunteers
No

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

Exclusion Criteria:

  • Major surgery within the last month that may affect pelvic floor function.
  • Urinary incontinence prior to surgery
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Investigator, Outcomes assessor)
Enrollment
66 participants (estimated)

Study arms

  • Experimental
    Intervention group

    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

  • No intervention
    Control group 1

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

  • No intervention
    Control group 2

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

Interventions

  • OtherTransperinal 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.

06

What researchers measure

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

    Time frame: 12 month after the operation

07

Study locations

1 of 1 sites recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 22, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05625048
Lead sponsor
Regional Hospital West Jutland
Responsible party
Sara Birch (Principal investigator, Regional Hospital West Jutland) — Principal investigator
First posted
Nov 22, 2022
Start date
Oct 12, 2022
Primary completion
Oct 2024 (estimated)
Completion
Oct 2025 (estimated)
Last update
Nov 22, 2022

Study contacts

Birch
Contact
sara.birch@goedstrup.rm.dk
51540126

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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