Chronic Pelvic Pain SyndromeNCT06115083
Effects of Pelvic Floor Training in Male Chronic Pelvic Pain, Correlation Between Subjective and Objective Outcomes
A study testing Pelvic floor re-education using bio-feedback and home training in people with Chronic Pelvic Pain Syndrome and Chronic Prostatitis With Chronic Pelvic Pain Syndrome, run by Region Stockholm at 1 site in Sweden.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Chronic Pelvic Pain Syndrome, Chronic Prostatitis With Chronic Pelvic Pain Syndrome, Chronic Prostatitis
- What is being tested?
- Pelvic floor re-education using bio-feedback and home training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteSweden
- Study dates
- 1 Dec 2023to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 over the age of 18, residents in Sweden, diagnosed with Chronic Primary Pelvic Pain Syndrome (CPPPS) according to the International Statistical Classification of Diseases and Related Health Problems (ICD-10) (N41.1 (chronic prostatitis), N41.9 (Inflammatory disease of prostate, unspecified), N50.8F (Chronic Pelvic Pain Syndrome in men)
Who cannot join
- Cancer in the abdomen or pelvic organs (current or previous)
- Congenital anomalies affecting the pelvic region (Bladder exstrophy, Myelomeningocele etc.)
- Transsexual male, (i.e. at birth biologically female)
- Diseases affecting the nerve function to the pelvic and/or lower extremities, other disease or ongoing treatment that could have an impact on the outcome of the study.
- Incapability to participate in testing or follow training instructions due to mental incapacity, language difficulties etc.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Sweden1 site, 1 recruiting
- Recruiting
Karolinska University Hospital
Stockholm, 141 86
Lotta R Koskela, MD, +46724694888, lotta.renstrom-koskela@sll.se
About this study
Official title: Long Term Effects of Pelvic Floor Re-education in Men With Chronic Pelvic Pain, Using Bio-feedback and Home Training - Subjective Outcomes in Correlation to Objective Measurements of the Lower Urinary Tract and Pelvic Floor
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.
Read the detailed description
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.
- Conditions
- Chronic Pelvic Pain Syndrome, Chronic Prostatitis With Chronic Pelvic Pain Syndrome, Chronic Prostatitis, Pelvic Floor; Relaxation
- Being tested
- Pelvic floor re-education using bio-feedback and home training
- Keywords
- Chronic pelvic pain syndrome, Chronic prostatitis with chronic pelvic pain syndrome, Chronic prostatitis, Pelvic floor muscles, Urodynamics, Physiotherapy, Bio-feedback
- Medical subject headings
- Prostatitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pelvic floor re-education using bio-feedback and home trainingOther
Pelvic floor re-education using bio-feedback and home training
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: Pelvic floor re-education using bio-feedback and home training |
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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: Measured 3, 6 and 12 months after inclusion
Secondary outcomes (7)
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: Measured 3, 6 and 12 months after inclusion
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.
- Normal flow
- Asymmetrical obstructive flow
- Symmetrical low flow
- Irregular curve, straining flow
- Plateau low flow
As described in the International Continence Society good urodynamic practices recommendations 2018 and Urodynamics (third edition) by P. Abrams.
Measured: 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.
- Normal cystometry
- Abnormal sensory input
- Detrusor activity
- Abnormal compliance
- Abnormal bladder capacity
As described in the International Continence Society good urodynamic practices recommendations 2018 and Urodynamics (third edition) by P. Abrams.
Measured: 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.
- Normal flow
- Under-active flow
- Obstructed flow
As described in the International Continence Society good urodynamic practices recommendations 2018 and Urodynamics (third edition) by P. Abrams.
Measured: 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.
- Maximum urethral pressure (cmH2O)
- Maximum urethral closure pressure (cmH2O)
As described in Urodynamics (third edition) by P. Abrams.
Measured: 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
- Assessment of muscle tone
- Decreased / normal / increased
- Assessment of voluntary contraction
- No contraction / correct contraction / contraction only with help from other muscles / uncertain / straining
- Assessment of relaxation post contraction
- Yes / partial or delayed / no
- Assessment of tenderness
- Yes / No
- If yes location is noted and severity of pain is graded according to numeric rating scale, 0-10, with higher value indicatinge more severe pain.
Modified Oxford Scale for assessment of pelvic floor muscle power, graded from 0-5 with higer value indicating stronger power.
Measured: 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: Measured 3, 6 and 12 months after inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2023
- Study start1 Dec 2023
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Pelvic Pain SyndromeStudies of the same condition, open and under way.
- More trials run by Region StockholmThe sponsor's other registered studies.
- 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
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Region Stockholm
- Sponsor type
- Other government
- Collaborators
- Karolinska Institutet
- Responsible party
- Principal investigator, Lotta Renström Koskela, Region Stockholm
- Investigators
- Lotta Renström Koskela, M.D, Principal investigator, Karolinska University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06115083
- Sponsor's protocol ID
- K 2023-4671
- Status last verified
- Apr 2024
- First submitted
- 17 Oct 2023
- Last updated
- 16 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 39496364
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long Term Effects of Pelvic Floor Re-education in Men With Chronic Pelvic Pain, Using Bio-feedback and Home Training - Subjective Outcomes in Correlation to Objective Measurements of the Lower Urinary Tract and Pelvic Floor
- ClinicalTrials.gov ID
- NCT06115083
- Acronym / sponsor ID
- K 2023-4671
- Conditions
- Chronic Pelvic Pain Syndrome, Chronic Prostatitis With Chronic Pelvic Pain Syndrome, Chronic Prostatitis, Pelvic Floor; Relaxation
- Keywords
- Chronic pelvic pain syndrome, Chronic prostatitis with chronic pelvic pain syndrome, Chronic prostatitis, Pelvic floor muscles, Urodynamics, Physiotherapy, Bio-feedback
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Region StockholmOther government
- Collaborators
- Karolinska Institutet
- Study start
- 1 Dec 2023 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 2 Nov 2023 (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 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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Pelvic floor muscle re-education | Experimental | Other: Pelvic floor re-education using bio-feedback and home trainingIntervention 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Men over the age of 18, residents in Sweden, diagnosed with Chronic Primary Pelvic Pain Syndrome (CPPPS) according to the International Statistical Classification of Diseases and Related Health Problems (ICD-10) (N41.1 (chronic prostatitis), N41.9 (Inflammatory disease of prostate, unspecified), N50.8F (Chronic Pelvic Pain Syndrome in men)
Key exclusion criteria (5 listed)
- Cancer in the abdomen or pelvic organs (current or previous)
- Congenital anomalies affecting the pelvic region (Bladder exstrophy, Myelomeningocele etc.)
- Transsexual male, (i.e. at birth biologically female)
- Diseases affecting the nerve function to the pelvic and/or lower extremities, other disease or ongoing treatment that could have an impact on the outcome of the study.
- Incapability to participate in testing or follow training instructions due to mental incapacity, language difficulties etc.
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 |
|---|---|---|
| Pelvic floor re-education using bio-feedback and home trainingPelvic floor re-education using bio-feedback and home training | Other | Pelvic floor muscle re-education |
Primary outcome
Change in symptom score on the National Institute of Health-Chronic Prostatitis Symptom Index questionnaire
Time frame: Measured 3, 6 and 12 months after inclusion
Change in total score, range from 0-43 points. Higher score indicates worse symptoms.
7 secondary outcomes
Change in sub score on the National Institute of Health-Chronic Prostatitis Symptom Index questionnaire
Time frame: Measured 3, 6 and 12 months after inclusion
Changes in global voiding function using free flow non-invasive urodynamic testing
Time frame: Measured 6 and 12 months after inclusion
Changes in global storing function of the bladder using invasive urodynamics, cystometry
Time frame: Measured 6 and 12 months after inclusion
Changes in global voiding function using invasive urodynamics, pressure-flow study
Time frame: Measured 6 and 12 months after inclusion
Changes in urethral pressure using invasive urodynamics, urethral pressure profile
Time frame: 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.
Time frame: Measured 3, 6 and 12 months after inclusion
Correlation between subjective and objective measurements
Time frame: Measured 3, 6 and 12 months after inclusion
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2024.
- Derived from this study: PubMed 39496364Hallencreutz 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.
- Individual participant dataSharing planned: No
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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.
Lotta Renström Koskela, M.D principal investigator
Karolinska University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pelvic floor re-education using bio-feedback and home training in people with Chronic Pelvic Pain Syndrome and Chronic Prostatitis With Chronic Pelvic Pain Syndrome, run by Region Stockholm at 1 site in Sweden.
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 1 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 16 Apr 2024. 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 Sweden. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lotta Renström Koskela, M.D (+46-8-12370000, lotta.renstrom-koskela@regionstockholm.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in symptom score on the National Institute of Health-Chronic Prostatitis Symptom Index questionnaire (time frame: Measured 3, 6 and 12 months after inclusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06115083, which also lists 1 linked publication.
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 16 Apr 2024.