Table 1.
Baseline characteristics of studies on treatment of postradiation pelvic pain
| Interventions (control vs experimental) | N | FU (mo), mean (SD), median (IQR) | Age (yr), mean (SD), median (IQR) | Gender M/F (%) | Type of medical therapy prior to study participation | Duration of symptoms prior to study participation (mo), mean (SD), median (IQR) | Pain assessment (as defined/used by trialist in study) | Quality of life assessment (as defined/used by trialist in study) | Voiding function/bladder capacity (as defined/used by trialist in study) | Bowel symptoms (as defined/used by trialist in study) | Symptom scores (as defined/used by trialist in study) | Outcomes measured | |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Shao et al. (2012) [10]; RCT; China; Nov 2004 to Dec 2008 | Intravesical hyaluronic acid | 16 | 18 | 59 (46–74) |
62/38 | NR | NR | VAS | NA | Urinary frequency | NA | NA | Haematuria/dysuria VAS Urinary frequency Adverse effects |
| Hyperbaric oxygen | 20 | 18 | 60 (39–77) |
60/40 | NR | NR | VAS | NA | Urinary frequency | NA | NA | ||
| Glover et al. (2016) [12]; RCT; UK; Aug 2009 to Oct 2012 | Hyperbaric oxygen | 55 | 12 | 64 (35–81) |
42/58 | NR | NR | LENT SOMA | EORTC QLQ-C30 EORTC QLQ-CR38 |
NA | IBDQ bowel function IBDQ rectal bleeding CTCAE GI scale |
IBDQ LENT SOMA |
IBDQ bowel function IBDQ rectal bleeding score LENT SOMA CTCAE GI scale EORTC QLQ-C30 EORTC QLQ-CR38 Adverse effects |
| Placebo/sham | 29 | 12 | 64 (54–70) |
48/52 | NR | NR | LENT SOMA | NA | |||||
| Guo et al. (2014) [13]; RCT; China; Jan 2009 to Dec 2012 | 10% formalin | 58 | 12 | 49 (26–70) |
0/100 | NR | 13.48 (6–25) |
RPSAS | NA | NA | RPSAS | RPSAS | RPSAS Vienna Rectoscopy Score Adverse effects |
| 4% formalin | 57 | 12 | 50 (25–69) |
0/100 | NR | 11.70 (6–23) |
RPSAS | NA | NA | RPSAS | RPSAS | ||
| Clarke et al. (2008) [11]; RCT; multiple countries | Hyperbaric oxygen | 33 | 60 | NR | 12/88 | NR | NR | LENT SOMA | EPCIC QoL | NA | SOMA LENT | LENT SOMA | LENT SOMA EPCIC QoL Adverse effects |
| Placebo | 39 | 60 | NR | NR | NR | LENT SOMA | EPCIC QoL | NA | LENT SOMA | LENT SOMA |
CTCAE GI = Common Terminology Criteria for Adverse Events gastrointestinal scale; EORTC QLQ-C30 = European Organisation for Research and Treatment of Cancer C30 core quality of life questionnaire; EORTC QLQ-CR38 = European Organisation for Research and Treatment of Cancer C30 core colorectal cancer–specific quality of life questionnaire; EPCIC QoL = Expanded Prostate Cancer Index Composite quality of life; F = female; FU = follow-up; IBDQ = Inflammatory Bowel Disease Questionnaire; IQR = interquartile range; LENT SOMA = Late Effects in Normal Tissues Subjective Objective Management and Analytic scales; M = male; NA = not assessed; NR = not reported; RCT = randomised controlled trial; RPSAS = Radiation Proctopathy System Assessments Scale; SD = standard deviation; VAS = visual analogue scale.