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Radical radiotherapy to the prostate is conventionally treated with a full bladder with the aim of minimising dose to the bladder and small bowel to prevent significant side effects. Tolerance of the bladder filling protocol varies depending on patients' baseline urinary function. It is not uncommon for some men to have "accidents" during treatment causing understandable distress. This can also extend the treatment time and cause knock on delays in the radiotherapy department.
Several United Kingdom (UK) centres report treating with an empty bladder. The investigators carried out a feasibility study comparing treatment with full bladder to empty bladder to ascertain if the investigators can safely change our protocol to that of an empty bladder.
50 patients receiving radical radiotherapy to the prostate were randomised using closed envelope technique 1:1 into 2 groups. Group A followed the conventional drinking protocol at our centre (200ml prior to treatment) and group B were treated with an empty bladder. Baseline, end of treatment and 6 week follow up scores were prospectively collected for International prostate Symptom Score(IPSS), Late Effects Normal Tissue Task Force - Subjective, Objective, Management, Analytic (LENT SOMA) bowel toxicity and quality of life questionnaires. The investigators also looked at bowel and bladder Dose Volume Histogram (DVH) to ensure constraints were met.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Empty Bladder | Experimental | Empty bladder prior to treatment. |
|
| Full Bladder | Other | Conventional drinking protocol - 200ml water prior to treatment. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Empty bladder | Behavioral | No drinking protocol. |
| |
| Full bladder |
| Measure | Description | Time Frame |
|---|---|---|
| Change in IPSS score | IPSS - The International Prostate Symptom Score is a 7 question scale which assesses urinary toxicity. Each question is scored 0-5 totalling a maximum score of 35. A score of 0-7 correlates to mildly symptomatic; 8-19, moderately symptomatic; 20-35, severely symptomatic. | Baseline to end of treatment (4 weeks or 7 and a half weeks depending on radiotherapy schedule); to 6 week follow up; and to 1 year follow up. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in LENT SOMA score | LENT SOMA - The Late Effects in Normal Tissues Subjective, Objective, Management and Analytic Scales. This is a questionnaire that assesses individual bowel symptoms asking initially whether or not they occur and then scoring the frequency, the higher the score, the more frequent the event. Each question has it's own range of score which is explained on the questionnaire. The scores will be compared for individual questions and there will not be any combining of scores between questions. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Alison Birtle | Lancashire Teaching Hospitals NHS Foundation Trust | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lancashire Teaching Hospitals NHS Foundation Trust | Preston | United Kingdom |
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50 patients receiving radical radiotherapy to the prostate were randomised using 1:1 into 2 groups. Group A followed the conventional drinking protocol at our centre (200ml prior to treatment) and group B were treated with an empty bladder. Baseline, end of treatment and 6 week follow up scores were prospectively collected for IPSS, LENT SOMA bowel toxicity and quality of life questionnaires.
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Investigator masking for randomisation purposes only. Masking not possible for intervention whilst on treatment.
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| Behavioral |
Followed drinking protocol |
|
| Baseline to end of treatment (4 weeks or 7 and a half weeks depending on radiotherapy schedule); to 6 week follow up; and to 1 year follow up. |
| Bowel and bladder DVH | Dose to bowel and bladder is calculated and documented if it meets the optimal or mandatory constraints | At time of radiotherapy planning scan which happens at baseline, on day of randomisation. |
| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| D011832 | Radiation Injuries |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
| D014947 | Wounds and Injuries |
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