Salvage Radiotherapy After Radical Prostatectomy

NCT02597725 | Unknown

• 1 other identifier: Urodynamics in prostate cancer
• Study Type: observational
• Target: 70
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to describe the urinary morbidity as a result surgery and radiation therapy, in patients treated for prostate cancer. All the patients will undergo a Urodynamic examination to verify the grade of Urinary morbidity.

Conditions

Prostate Cancer

Keywords

Urodynamics; Late effects; Urinary Incontinence

Outcome Measures

Primary Outcomes (4)

• Spontaneous urinary flow

  The patients load the water at a special flow toilet

  2 minutes

• Biomechanical properties of urethra

  Evaluation of biomechanical wall properties by measuring luminal cross-sectional area and pressure.

  10 minutes

• Cystometri

  The bladder is filled with saline with a flow rate of 60 mL/minute.

  20 minutes

• Uretal pressure profile

  To evaluate the uretal pressure profile. The water pump perfused saline at a flow rate of 1 mL, while the catheter. attached to an automatic pulling device, was pulled out of the urethra at 2 mm/s.

  10 minutes

Study Arms (1)

Urodynamics

There is no intervention in this study.

Eligibility Criteria

• Age: 50 Years - 90 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The patients in this cohort had surgery for prostate cancer in the period from 1999-2009. Because of a locale disease relapse the patients were treated with Salvage radiation therapy in the period from 2006-2010.

You may qualify if:

• Patients treated with salvage radiotherapy at Aarhus University hospital in the period from 2006-2010.

You may not qualify if:

• Other cancer types
• Severe comorbidity

Sponsors & Collaborators

• University of Aarhus: lead

MeSH Terms

Conditions

Prostatic Neoplasms; Urinary Incontinence

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Michael Borre, Professor

  University of Aarhus

  STUDY CHAIR

• Morten Høyer, Professor

  University of Aarhus

  STUDY CHAIR

Central Study Contacts

Maria Ervandian, MD

CONTACT

004523392309; mservandian@ki.au.dk

Helene Nørrelund

CONTACT

hwn@clin.au.dk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 7, 2015
• First Posted: November 5, 2015
• Study Start: November 1, 2015
• Primary Completion: July 1, 2016
• Study Completion: July 1, 2016
• Last Updated: November 5, 2015

Record last verified: 2015-10