Investigation of New Intermittent Catheters in Healthy Volunteers
RetentionUrinaryInvestigation of non-CE marked intermittent catheters. The study was a randomized, single blinded, cross-over investigation comparing two new catheters with a comparator catheter in 30 adult healthy volunteers.
Pre-operative Tamsulosin and Time to Spontaneous Void After Hysterectomy
Urinary Retention PostoperativeThe aim of this study is to determine if a one time dose of tamsulosin given pre-operatively decreases the time to void and the time to discharge after minimally invasive hysterectomy.
When is the Best Moment to Remove the Urinary Catheter After Laparoscopic Hysterectomy?
Urinary Tract InfectionBladder RetentionObjective: The aim of this study is to evaluate if direct removal of the urine catheter after an laparoscopic hysterectomy (total laparoscopic hysterectomy and laparoscopic supracervical hysterectomy) is associated with similar (or better) outcomes compared to delayed catheter removal after surgery, which is the current treatment. In addition, we want to investigate patient's experience on this subject. Study design: Randomized Controlled trial, non-inferiority study. Study population: Women older than 18 years old, who are a laparoscopic hysterectomy for benign indication or low-grade malignancy. Intervention: Group A (treatment group): the patients in this group will have their catheter directly removed in the OR after LH. Group B (control group): the patients in the control group will have their catheter removed according to the regular protocol of the hospital (at least 6 hours in place).
A Confirmatory Study Confirming Performance of a New Intermittent Catheter
Urinary RetentionA multi-centre, randomised, controlled crossover design. The total study duration for the individual subject was approximately 9 weeks, consisting of four site visits and two 4-week test periods at home. Visits 0 and 1 could be performed on the same day. For visit 2 and 3, catheterisations were performed in a hospital setting for bladder emptying assessment and collection of urine samples (the latter only in Denmark). Visit 1 and 2 were followed by a home-use test period, followed by visit 3 which terminated the study.
Tissue Bonding Cystostomy(TBC)
Spinal Cord Injury (SCI)Chronic Urinary Retention1 moreSpinal Cord Injured [SCI] patients typically cannot "pee". Injury to the spinal cord disrupts the in-coming and out-going brain signals that coordinate bladder sensation and the emptying of bladder. SCI typically causes chronic retention of urine with uncontrolled leakage of urine. Some form of tube (catheter) is needed to drain the urine except with the mildest forms of SCI. Two types of tubes to drain the urine have been used for many years. These types are the urethral (inserted into the bladder through the opening usually used to empty the bladder) and abdominal, called suprapubic cystostomy tubes (put into the bladder through the abdomen). Bacteria (germs) normally live on our skin. Bacteria have sticky surfaces and so they stick to catheter surfaces. Bacteria reproduce very rapidly from a few dozen to over a million in 24 hours. In a warm liquid environment, like urine, bacteria can reach a density of 10 million per cubic centimeter in 48 hours which causes infection. Oral drugs and antibiotic-coated catheters delay this process by a week or two, but within a month 100% of patients have bacteria in their urine. Existing drugs cannot eliminate these microbial sanctuaries. The TBC is a 'closed access' abdominal drainage tube that has a 'cuff' or 'anchor'. It is permanently placed in the abdominal muscle to bond with the body's tissue. Another catheter is temporarily connected to the TBC that is easily replaceable in the clinic without anesthesia or special instruments. It locks to form a water-tight system. Many parts of the TBC are coated with an antibacterial substance that will delay the growth of bacteria. The TBC has been used with success in multiple animal studies. This is a Phase I human clinical trial in which the TBC will be used 10 spinal cord injured patients, each of whom will be followed for 12 months or longer. Abdominal catheter exit sites will be photographed monthly and tested periodically to document growth of any bacteria. Every three months, patients will complete satisfaction questionnaires and their urine will be tested for bacteria. Urine will also be tested as clinically indicated.
Investigation of Non-CE Marked Intermittent Catheters.
RetentionUrinaryInvestigation of novel non-CE marked intermittent catheters. The study was a randomized, single blinded, cross-over investigation comparing two new catheters for males with a comparator catheter
Investigation of Non-CE Marked Intermittent Catheters for Females
RetentionUrinaryInvestigation of novel non-CE marked intermittent catheters. The study was a randomized, single blinded, cross-over investigation comparing two new catheters for females with a comparator catheter.
Performance of a Single-use Intermittent Micro-hole Zone Catheter
Urinary IncontinenceRetention1 moreThe goal of this randomized, controlled crossover study was to assess the performance of a new micro-hole zone catheter compared to a conventional 2-eyelet catheter in 42 male intermittent catheter users. The main objective of this study was to demonstrate superiority of the micro-hole zone catheter in terms of number of flow-stop episodes and residual volume at first flow-stop, with the catheterization performed by a health care professional in a hospital setting compared to a conventional two-eyelet catheter.
Auriculotherapy for Prevention of Postoperative Urinary Retention
AnalgesiaEpiduralUrinary retention is a common complication of epidural analgesia. Auriculotherapy could prevent this complication. This study will be performed among men receiving thoracic epidural analgesia after thoracic surgery.
When to Perform Bladder Catheterization in Fast-track Hip and Knee Arthroplasty
Postoperative Urinary Retention (POUR)Approximately 40 % of all patients undergoing fast-track total hip or knee arthroplasty needs intermittent bladder catheterization after surgery, as they are transient incapable of voluntary bladder emptying (postoperative urinary retention - POUR). The currently used interventional threshold for urinary bladder catheterization are a bladder volume of approximately 500 ml., but no evidence exists for this threshold. At the same time, the current knowledge suggest, that a bladder volume up to 1000 ml. for 2-4 hours are safe in humans, and as the use of urinary bladder catheterization are increasing the risk of complications, the investigators are hypothesizing that increasing the interventional threshold for urinary bladder catheterization after fast-track total hip or knee arthroplasty, will reduce the number of patients needing urinary bladder catheterization, without increasing the incidence of urological complications - including urinary tract infections.