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Impact of Catheter Size on Peri-Operative Pain After Robotic Assisted Laparoscopic Prostatectomy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04098809
Recruitment Status : Completed
First Posted : September 23, 2019
Results First Posted : December 26, 2019
Last Update Posted : December 26, 2019
Sponsor:
Information provided by (Responsible Party):
Benaroya Research Institute

Brief Summary:
This study is designed to assess the effect of catheter size on postoperative catheter pain, urinary continence, urinary flow rates, post void residuals, International Prostate Symptom Scores (IPSS), and Quality of Life (QoL) score, as well as long term complications after robotic assisted laparoscopic prostatectomy.

Condition or disease Intervention/treatment Phase
Prostate Cancer Device: 16 French urinary catheter Device: 20 French urinary catheter Not Applicable

Detailed Description:
Subjects identified to receive a robotic assisted laparoscopic prostatectomy.were randomized to either a 16 French or 20 French catheter at the completion of the prostatectomy. All prostatectomies were performed by one of three surgeons at the investigator's institution. Preoperative demographics and operative data were recorded for each group. Catheters remained in place for 7-14 days. Subjects were asked on postoperative day 7 to report their catheter-related pain and amount of opioid medication used. Urinary symptoms and quality of life scores and pads per day were recorded at 6 weeks and 12 weeks post-operatively.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 52 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Other
Official Title: Impact of Catheter Size on Peri-Operative Pain After Robotic Assisted Laparoscopic Prostatectomy
Actual Study Start Date : November 9, 2017
Actual Primary Completion Date : November 7, 2018
Actual Study Completion Date : November 7, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Catheter 16 French
16 French urinary catheter
Device: 16 French urinary catheter
16 French urinary catheter

Active Comparator: Catheter 20 French
20 French urinary catheter
Device: 20 French urinary catheter
20 French urinary catheter




Primary Outcome Measures :
  1. Catheter Related Pain: Visual Analog Score Rating [ Time Frame: post-op day 5-7 ]
    Catheter related pain was measured using a visual analog score rating mean post-operative pain on a scale from 1 (no pain) to 10 (worst possible pain). The lower the score the better the outcome.


Secondary Outcome Measures :
  1. Urinary Symptoms [ Time Frame: week 6 ]
    The International Prostate Symptom Score (I-PSS) is based on the answers to seven questions concerning urinary symptoms and one question concerning quality of life. Each question concerning urinary symptoms allows the patient to choose one out of six answers indicating increasing severity of the particular symptom. The answers are assigned points from 0 to 5. The total score can therefore range from 0 to 35 (asymptomatic to very symptomatic).The lower the score the better the outcome.

  2. Quality of Life Score [ Time Frame: Week 6 ]
    Question eight of IPSS refers to the patient's perceived quality of life. The range is from delighted with a score of zero to terrible with a score of 6. The lower the score the better the outcome.

  3. Urinary Symptoms [ Time Frame: week 12 ]

    The International Prostate Symptom Score (I-PSS) is based on the answers to seven questions concerning urinary symptoms and one question concerning quality of life. Each question concerning urinary symptoms allows the patient to choose one out of six answers indicating increasing severity of the particular symptom. The answers are assigned points from 0 to 5. The total score can therefore range from 0 to 35 (asymptomatic to very symptomatic).The lower the score the better the outcome.

    Question eight refers to the patient's perceived quality of life. The range is from delighted with a score of zero to terrible with a score of 6. The lower the score the better the outcome.


  4. Quality of Life Score [ Time Frame: Week 12 ]
    Question eight of the International Prostate Symptom Score (IPSS) refers to the patient's perceived quality of life. The range is from delighted with a score of zero to terrible with a score of 6. The lower the score the better the outcome

  5. Opioid Use [ Time Frame: after discharge until post-op day 7 ]
    Patient reported use of the number of tablets taken from provided prescription of opioids for post-operative pain. This will be converted to a standardized morphine equivalency for comparison. The lower the value the better the outcome.

  6. Home Opioid Use in Standard Morphine Equivalency [ Time Frame: after discharge until post-op day 7 ]
    Patient reported use of the number of tablets taken from provided prescription of opioids for post-operative pain. This will be converted to a standardized morphine equivalency for comparison. The lower the value the better the outcome.

  7. Number of Incontinence Pads Used [ Time Frame: week 6 ]
    Patient reported number of incontinence pads used per day. The lower the number the better the outcome.

  8. Patient Reported Number of Pads Used Per Day. [ Time Frame: Week 12 ]
    Patient reported number of incontinence pads used per day. The lower the number the better the outcome.

  9. Number of Participants Experiencing Bladder Neck Contracture [ Time Frame: week 12 ]
    Number of incidence of participants experiencing bladder neck contracture.

  10. Number of Participants Experiencing Bladder Neck Contracture [ Time Frame: 1 year ]
    Number of Incidence of participants experiencing bladder neck contracture.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Identified as candidate for robotic assisted laparoscopic prostatectomy

Exclusion Criteria:

  • Having filled a prescription for opioid medication in last 2 months.
  • Known latex allergy
  • Known pre-operatively that catheter placement will exceed 14 days
  • History of pelvic radiation
  • Significant deviation from normal operative protocol

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04098809


Locations
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United States, Washington
Virginia Mason Medical center
Seattle, Washington, United States, 98101
Sponsors and Collaborators
Benaroya Research Institute
Investigators
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Principal Investigator: John Corman, MD Virginia Mason Medical Center
  Study Documents (Full-Text)

Documents provided by Benaroya Research Institute:
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Responsible Party: Benaroya Research Institute
ClinicalTrials.gov Identifier: NCT04098809    
Other Study ID Numbers: IRB17-095
First Posted: September 23, 2019    Key Record Dates
Results First Posted: December 26, 2019
Last Update Posted: December 26, 2019
Last Verified: December 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases