Condition category
Urological and Genital Diseases
Date applied
24/02/2011
Date assigned
31/03/2011
Last edited
24/04/2012
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Mr Mark Rochester

ORCID ID

Contact details

Department of Urology
Norfolk and Norwich University Hospital NHS Foundation Trust
Colney Lane
Norwich
NR4 7UY
United Kingdom
+44 (0)16 0328 6286
mark.rochester@nnuh.nhs.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

2010UROL02

Study information

Scientific title

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

Acronym

SMART-P

Study hypothesis

The main objective of the study is to show that a programme of group-directed cognitive behavioural therapy for men with chronic pelvic pain is more effective than standard therapy (pain relief and coping mechanisms delivered by the pain clinic). This will be evaluated by 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.

Chronic prostatitis is a severe, debilitating chronic illness suffered by a considerable number of men. A universally effective treatment is lacking which can be frustrating for clinicians and distressing for patients. We aim to improve the treatment of these patients by combining cognitive behavioural therapy, which has been shown to be effective for chronic pain conditions including chronic prostatitis, with group-directed self management which has been shown to be effective for a number of other chronic diseases.

We propose to randomise patients to either a self management health and care education programme or to pain clinic referral alone (standard care). We believe that a randomised controlled trial is the most robust method of evaluation of our approach, and will allow us to compare to current available treatment in a scientific manner.

Ethics approval

Norfolk Research Ethics Committee approved on 19th January 2011, ref: 11/H0310/6

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Chronic prostatitis/Chronic pelvic pain syndrome

Intervention

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 treatable bacterial cause for CP/CPPS, referral to pain clinic will be as a result of agreement between clinician and patient. Pharmacological agents such as gabapentin, pregabalin and antidepressants are the mainstay of standard care at present.

Intervention
This group will take part in a course of six weekly small group sessions (five to eight men) developed in conjunction with experts in psychology, pain management and urology, each lasting one hour with a focus on:
1. Understanding physiology of pain
2. Psychological contributors
3. Pain-coping mechanisms
4. Behavioural responses
5. Prevention, rehabilitation and re-enablement
6. Relationships between symptom distress, emotion and pain

We will design the sessions to enable the participants to learn techniques of problem solving and goal setting. Supported self care and ‘co-production’ will be the underlying principles of this programme. The initial session is an introduction to the programme requirements, the rationale and the value of the approach. In early sessions , patients are instructed in the use of the Reaction Record for self-identifying and modifying catastrophic cognition and in understanding how such thinking is associated with greater negative affect, how there is little supportive evidence for such thinking, and how it can lead to poor choices in behavioural coping. During following sessions, patients identify and modify deficits in social support by practicing self-assertion communication exercises with their instructor and then later with significant others in their lives while using the Reaction Record to examine how to better negotiate distressing episodes. Further sessions use the Reaction Record tool to identify and modify illness-focused behavioural coping strategies and also to help re-engage the patient in physical and social activities that they may have abandoned. In the final session, patients are provided with a detailed review of their acquired behavioural modifications. Following this discussion, patients are instructed on continued problem-solving skills and future self-management challenges are discussed.

At 2, 6, and 12 months, clinicians not involved in the conduct of the trial will review participants in the urology outpatient departments and perform NIH-CPPS assessment (a validated pain-score for chronic pelvic pain).

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

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 outcome measures

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.

Overall trial start date

25/03/2011

Overall trial end date

24/03/2012

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Male

Target number of participants

120

Participant 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)

Recruitment start date

25/03/2011

Recruitment end date

24/03/2012

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Department of Urology
Norwich
NR4 7UY
United Kingdom

Sponsor information

Organisation

Norfolk and Norwich University Hospitals NHS FoundationTrust (UK)

Sponsor details

Research and Development
c/o Kathryn Andrews
Norfolk and Norwich University Hospital
Colney Lane
Norwich
NR4 7UY
United Kingdom
+44 (0)16 0328 6611
kathryn.andrews@nnuh.nhs.uk

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Government

Funder name

Health Enterprise East Ltd (UK)-Regional Innovation Fund

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

1. 2011 study protocol in http://www.ncbi.nlm.nih.gov/pubmed/21943084

Publication citations

  1. Study protocol

    Rochester M, Armitage J, Sanders M, Christmas P, Self Management Activation Randomised Trial for Prostatitis (SMART-P): study protocol for a randomised controlled trial., Trials, 2011, 12, 210, doi: 10.1186/1745-6215-12-210.

Additional files

Editorial Notes