Less to Hold - A Comparison of Bladder Toxicities (Side Effects) in Patients Undergoing Prostate Radiotherapy Between Patients Treated With Empty Bladder and Those on a Drinking Protocol.

NCT03832803 | Completed

• 1 other identifier: 2113
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Prostate Cancer; Radiotherapy Side Effect

Outcome Measures

Primary Outcomes (1)

• 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.

Secondary Outcomes (2)

• Change in LENT SOMA score

  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

  At time of radiotherapy planning scan which happens at baseline, on day of randomisation.

Study Arms (2)

Empty Bladder

EXPERIMENTAL

Empty bladder prior to treatment.

Behavioral: Empty bladder

Full Bladder

OTHER

Conventional drinking protocol - 200ml water prior to treatment.

Behavioral: Full bladder

Interventions

Empty bladder BEHAVIORAL

No drinking protocol.

Empty Bladder

Full bladder BEHAVIORAL

Followed drinking protocol

Full Bladder

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Prostate cancer receiving radical radiotherapy.

You may not qualify if:

• Not nodal disease.
• Not prostate bed radiotherapy.

Sponsors & Collaborators

• Lancashire Teaching Hospitals NHS Foundation Trust: lead

Study Sites (1)

Lancashire Teaching Hospitals NHS Foundation Trust

Preston, United Kingdom

Location

MeSH Terms

Conditions

Prostatic Neoplasms; Radiation Injuries

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Wounds and Injuries

Study Officials

• Alison Birtle

  Lancashire Teaching Hospitals NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Investigator masking for randomisation purposes only. Masking not possible for intervention whilst on treatment.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: January 29, 2019
• First Posted: February 6, 2019
• Study Start: March 1, 2017
• Primary Completion: March 1, 2018
• Study Completion: January 25, 2019
• Last Updated: February 6, 2019

Record last verified: 2019-02

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)