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| Name | Class |
|---|---|
| Karolinska Institutet | OTHER |
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The goal of this randomized controlled study is to establish the long-term effect of pelvic floor re-education using biofeedback and home training for men with chronic pelvic pain. The main questions it aims to answer are if pelvic floor re-education using bio-feedback and home training will give a long-lasting improvement in symptoms, assessed with a validated symptom score (the National Institute of Health - Chronic Prostatitis Symptom Index) and if an improvement in symptoms can be correlated to objective measurements of pelvic floor function. Participants will be asked to do pelvic floor exercises daily during six months with additional sessions of bio-feedback training. The control group will have no changes in their on-going treatment for their chronic pelvic pain and will be offered to enter the treatment group after six months.
At baseline all included study subjects will fill in a validated symptom score, the National Institute of Health - Chronic Prostatitis Symptom Index (NIH-CPSI) and have an assessment of their pelvic floor muscles and undergo a urodynamic evaluation.
The intervention group will perform short daily session of pelvic floor muscle training at home during six months in combination with four bio-feedback sessions during the first months. The study subjects will receive an individual instruction based on the pelvic floor assessment from the baseline visit. The study subjects will report their training in a digital diary.
A reevaluation will be done at three, six and twelve months. At six and 12 months repeating the baseline tests. At three months a renewed assessment of muscle function and the NIH-CPSI questionnaire.
The control group will be instructed not to engage in any new treatment for their chronic pelvic pain during the study period. After the six months evaluation all participants in the control group will be offered to be enrolled in the treatment group, with the same set-up and follow-up as the treatment group.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pelvic floor muscle re-education | Experimental | Intervention with pelvic floor re-education using bio-feedback and home training for 6 months, with a follow up visit after an additional period of 6 months |
|
| Standard Care | No Intervention | No intervention during 6 months after inclusion. After the 6 month follow-up evaluation the study subjects are offered to participate in the interventional arm. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pelvic floor re-education using bio-feedback and home training | Other | Pelvic floor re-education using bio-feedback and home training |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in symptom score on the National Institute of Health-Chronic Prostatitis Symptom Index questionnaire | Change in total score, range from 0-43 points. Higher score indicates worse symptoms. | Measured 3, 6 and 12 months after inclusion |
| Measure | Description | Time Frame |
|---|---|---|
| Change in sub score on the National Institute of Health-Chronic Prostatitis Symptom Index questionnaire | Sub score according to the domains; pain 0-21, urological symptoms 0-10 points and quality of life impact 0-12 points. Higher score indicates worse symptoms in all three domains. | Measured 3, 6 and 12 months after inclusion |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lotta Renström Koskela, M.D | Contact | +46-8-12370000 | lotta.renstrom-koskela@regionstockholm.se |
| Name | Affiliation | Role |
|---|---|---|
| Lotta Renström Koskela, M.D | Karolinska University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Karolinska University Hospital | Recruiting | Stockholm | 141 86 | Sweden |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39496364 | Derived | Hallencreutz Grape H, Nordgren B, Renstrom Koskela L. Long-term effects of pelvic floor training in male chronic pelvic pain, correlation between subjective and objective outcomes: a study protocol for a randomised controlled trial. BMJ Open. 2024 Nov 4;14(11):e087620. doi: 10.1136/bmjopen-2024-087620. |
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A randomized controlled single blinded clinical study with a study period of 12 months from inclusion until completion. The study subjects are then randomly assigned in a 1:1 ratio either to treatment or control group. After 6 months the study subjects in the control group are offered to be included in the intervention group.
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The interpreter of the urodynamic evaluations will be blinded regarding intervention/control group
| Changes in global voiding function using free flow non-invasive urodynamic testing |
Changes in global voiding function using free flow non-invasive urodynamic testing with electromyogram. Global assessment where combined results from maximum urinary flow rate, voided volume, post voiding residual volume, pelvic floor activity during voiding and the shape of the curve are used to define types of voiding patterns.
As described in the International Continence Society good urodynamic practices recommendations 2018 and Urodynamics (third edition) by P. Abrams. |
| Measured 6 and 12 months after inclusion |
| Changes in global storing function of the bladder using invasive urodynamics, cystometry | Changes in global bladder function using invasive urodynamics with cystometry with electromyogram. Global assessment where combined results from sensory input, cystometric capacity, detrusor activity, compliance and pelvic floor activity are combined to define different patterns.
As described in the International Continence Society good urodynamic practices recommendations 2018 and Urodynamics (third edition) by P. Abrams. | Measured 6 and 12 months after inclusion |
| Changes in global voiding function using invasive urodynamics, pressure-flow study | Changes in global voiding function using invasive urodynamics, pressure-flow study with electromyogram. Global assessment where combined results from detrusor contractility, urinary flow and pelvic floor activity are combined to define different patterns.
As described in the International Continence Society good urodynamic practices recommendations 2018 and Urodynamics (third edition) by P. Abrams. | Measured 6 and 12 months after inclusion |
| Changes in urethral pressure using invasive urodynamics, urethral pressure profile | Changes in urethral pressure using invasive urodynamics, urethral pressure profile.
As described in Urodynamics (third edition) by P. Abrams. | Measured 6 and 12 months after inclusion |
| Changes in pelvic floor muscle assessment according to test specifics by Frawley et al 2021 and the modified Oxford Scale according to Laycock et al 2001. | Pelvic floor muscle assessment according to test specifics by Frawley et al 2021
Modified Oxford Scale for assessment of pelvic floor muscle power, graded from 0-5 with higer value indicating stronger power. | Measured 3, 6 and 12 months after inclusion |
| Correlation between subjective and objective measurements | Correlation between subjective measurements using the National Institute of Health-Chronic Prostatitis Symptom Index questionnaire and objective findings on urodynamic testing and pelvic floor assessment. | Measured 3, 6 and 12 months after inclusion |
| ID | Term |
|---|---|
| D011472 | Prostatitis |
| ID | Term |
|---|---|
| D011469 | Prostatic Diseases |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
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