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A randomised trial of group-delivered cognitive behavioural therapy versus standard pain clinic treatment for chronic pelvic pain

Self Management Activation Randomised Trial for Prostatitis (SMART-P)

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN21012555
Enrollment
120
Registered
2011-03-31
Start date
2011-03-25
Completion date
Unknown
Last updated
2019-12-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic prostatitis/Chronic pelvic pain syndrome Urological and Genital Diseases Chronic prostatitis

Interventions

Men will be randomised to attend either a self management health and care education programme or to pain clinic referral alone. Standard care After exclusion of a trea

Sponsors

Norfolk and Norwich University Hospitals NHS FoundationTrust (UK)
Lead Sponsor

Eligibility

Sex/Gender
Male

Inclusion criteria

Inclusion criteria: 1. Men with chronic prostatitis (CP)/chronic pelvic pain syndrome (CPPS) refractory to simple pharmacological manipulation from general urology clinics at Norfolk and Norwich University hospitals (NNUH) 2. All patients aged over 18 with a diagnosis of CP/CPPS made by a urologist referred for the first time by their GP 3. Patients must be refractory to antibiotic treatment

Exclusion criteria

Exclusion criteria: 1. Abnormal serum prostate specific antigen (PSA) level 2. Suspected prostate cancer on digital rectal examination 3. Active urinary tract infection 4. Alternative cause for pain found by urologist (e.g. ureteric calculus)

Design outcomes

Primary

MeasureTime frame
1. Changes in the National Institute of Health Chronic Pelvic Pain Score (NIH-CPPS), a validated scoring system for assessing the severity of the condition which will be measured before and after the intervention.

Secondary

MeasureTime frame
1. Assess functional status (Hospital Anxiety and Depression (HAD) and SF-36 score) 2. Changes in requirements for pain-relief medication will also be used as a measure of effectiveness 3. Patients degree of self-management/activation will be assessed by the PAM questionnaire The outcomes will be measured before and after the intervention.

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 28, 2026