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Completed

NCT Number: NCT04098809

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

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.

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Key information

Conditions

Prostate Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Virginia Mason Medical center

Seattle, Washington, 98101, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

16 French urinary catheter

Device

16 French urinary catheter

20 French urinary catheter

Device

20 French urinary catheter

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Benaroya Research Institute

Other

Registry information

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Sep 23, 2019
Registry last updated
Dec 26, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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