Chronic pelvic pain (CPP) is a common indication for referral to women’s health services, affecting 1 in 4 women (1) and costing up to an estimated £158 million annually to NHS (2). It is a subjective complaint which is difficult to assess and manage but important to be able to measure objectively to measure its burden, impact of quality of life and response to treatments and interventions. The International Continence Society (ICS) has defined CPP as persistent pain lasting longer than 6 months or recurrent episodes of abdominal/pelvic pain, hypersensitivity or discomfort often associated with elimination changes, and sexual dysfunction often in the absence of organic aetiology (3).
There are many pain scales and questionnaires available to assess intensity and impact, however not many have been validated, especially using the evolved and established new definition of pain as a complex condition, rather than a symptom.  The aim of this prospective, cross-sectional, observational study is to produce a validated questionnaire to assess pelvic pain as per the ICS standard for terminology of chronic pelvic pain syndromes. This has not been done yet and will provide a valuable resource as a pain assessment tool in the future clinically and as a research tool.

An original questionnaire was developed for assessment of the pain location, quality and severity, and its impact on quality of life, which can be used for assessment and research purposes.  The content and design were based on ICS standard for terminology in chronic pelvic pain syndromes, literature review of established pain assessment questionnaires currently in use, expert opinion, and patient focus group for content and face validity.
All women attending the urogynaecology outpatient department at a large tertiary centre were asked complete a newly devised questionnaire assessing pelvic pain, its exacerbating factors, and its impact on QoL. The newly devised questionnaire was compared against a validated McGill’s questionnaire and a control group filling in both questionnaires.
The primary study outcome was the validation of the questionnaire. Secondary outcomes included age, BMI, ethnicity, occupational status, allergies, smoking status, pain related diagnosis, co-morbidities, and investigation results.

Statistical analysis was performed using SPSS with the following tests for internal consistency (Cronbach's alpha), criterion validity (comparison with a validated McGill's questionnaire), reliability (Cohen's Kappa coefficient) and reproducibility via test-retest at 1 week. A cut off of p<0.05 being used to test for significance.

A total of one hundred and fifty-three questionnaires were completed, 103 women with chronic pelvic pain as per ICS standard definition, 20 women with no reported pelvic pain. 30 questionnaires were repeated after 1 week for reproducibility by women with CPP.
The mean age of women with CPP was 34.6 years (18-68), with a variation in ethnicity 39% White (British/Irish/Other), 27 % Asian (Indian/Pakistani/Bangladeshi/Other), 15% Black (African/Caribbean/Other), 5% Mixed, and 14 % Other (Not stated/Not known). The mean BMI was 23.6 kg/m2 (18-42).
All the subscales had Kappa of 0.64-0.76 (substantial). Cronbach’s alpha for the questionnaire overall was >0.9 (Excellent Internal consistency) for 20/21 items and 0.86 (Good Internal consistency) for 1 item. The pain location, type and severity were found to be strongly correlated between the proposed questionnaire and McGill’s r =0.63 (strong correlation).

These results show that CPP affects women of a wide range of ages and ethnicities, and it is important to include this diverse group in the validation process of the questionnaire to make it generalisable.  The findings suggest a good convergent and discriminant validity and internal consistency.
The high Cohen’s kappa suggests a ‘substantial’ inter-rater and intra-rater reliability for the qualitative items of the questionnaire.  All items of the questionnaire good or excellent internal consistency suggesting that the items are worded appropriately and asked of an appropriate sample. Within the questionnaire, there are some items which are consistently unfilled as not relevant thus may need to be removed from the final version of the questionnaire which may not be apparent from statistical analysis.
The questionnaire is comparable to a validated pain questionnaire; however, the proposed questionnaire has many different components. Therefore, not all items are comparable as no validated questionnaire exists to encompass all the different components relating pain by use of 1 or more existing questionnaires.

The results suggest that the questionnaire is a reliable and valid measure of CPP in urogynaecology. As the questionnaire was designed by both clinicians and patients, it is clinically relevant and assesses the different aspects of CPP in a patient/user acceptable manner.
Larger number is needed to validate these findings however, the pilot study results are a promising start to the development of a reliable, valid, and useful clinical tool.

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