Actively Recruiting

Phase Not Applicable
Age: 18Years +
MALE
ID06115083

Long Term Effects of Pelvic Floor Re-education in Men With Chronic Pelvic Pain Using Bio-feedback and Home Training Subjective Outcomes Correlated to Objective Measurements

Led by Region Stockholm · Updated on 2024-04-16

40

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

Sponsors

R

Region Stockholm

Lead Sponsor

K

Karolinska Institutet

Collaborating Sponsor

AI-Summary

What this Trial Is About

This research aims to understand the long-term effects of pelvic floor re-education using biofeedback and home training in men with chronic pelvic pain. The study focuses on whether this approach can provide lasting symptom improvement measured by a validated symptom score, the National Institute of Health - Chronic Prostatitis Symptom Index (NIH-CPSI), and if these symptom changes relate to objective pelvic floor function measurements. The trial compares men undergoing pelvic floor training to a control group maintaining their usual treatment. Participants in the intervention group will perform short daily pelvic floor exercises at home for six months, supplemented by four biofeedback sessions during the initial months. They receive personalized instructions based on an initial pelvic floor assessment and report their exercises in a digital diary. The control group will continue their current treatment unchanged for six months, after which they are offered the same pelvic floor training program. Participants will complete symptom questionnaires and undergo pelvic floor muscle assessments and urodynamic evaluations at baseline, three, six, and twelve months. The study measures changes in symptoms, bladder function, and pelvic floor muscle performance over time. The total participation period includes a six-month intervention phase followed by an additional six-month follow-up, allowing researchers to evaluate both early and sustained effects of the training.

CONDITIONS

Brief Title

Effects of Pelvic Floor Training in Male Chronic Pelvic Pain, Correlation Between Subjective and Objective Outcomes

Who Can Participate

Age: 18Years +
MALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Male participants aged 18 years or older
  • Residents of Sweden
  • Diagnosed with Chronic Primary Pelvic Pain Syndrome (CPPPS) based on ICD-10 codes N41.1, N41.9, or N50.8F
Not Eligible

You will not qualify if you...

  • Current or previous cancer in the abdomen or pelvic organs
  • Congenital anomalies affecting the pelvic region such as bladder exstrophy or myelomeningocele
  • Transsexual males (biologically female at birth)
  • Diseases affecting nerve function to the pelvis or lower limbs, or treatments impacting study outcomes
  • Inability to participate in testing or follow training instructions due to mental incapacity or language difficulties

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - 6 months

Participants in the intervention group perform daily pelvic floor muscle training at home for six months combined with four bio-feedback sessions during the first months. Participants receive individual instruction based on baseline assessments and report their training in a digital diary.

4 bio-feedback sessions and daily home training

Follow-up

Duration - 6 months after treatment

Participants are re-evaluated at 3, 6, and 12 months with assessments including symptom scoring and pelvic floor muscle evaluation. Control group participants are offered the treatment after 6 months.

Visits at 3, 6, and 12 months for assessments

Trial Site Locations

Total: 1 location

1

Karolinska University Hospital

Stockholm, Sweden, 141 86

Actively Recruiting

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Research Team

L

Lotta Renström Koskela, M.D

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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Published Research Related To This Trial

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.

Helena Hallencreutz Grape, Birgitta Nordgren, Lotta Renström Koskela

https://pubmed.ncbi.nlm.nih.gov/39496364