Intermittent Catheterization in Spinal Cord Injured Men

NCT02230540 | Terminated Results

• 1 other identifier: CP250
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this investigation is to study how the position of different catheters affect drainage of the bladder.

Conditions

Spinal Cord Injuries

Outcome Measures

Primary Outcomes (1)

• Residual Volume Less Than 100ml

  The primary endpoint was "Residual volume less than 100 ml (Yes/No)" assessed after catheterization when placed at fixed heights (25, 20, 15, 10 and 0 cm) over the wheelchair seat. Prior to the catheterization corresponding to height 25 cm, a solution was instilled into the bladder to ensure a volume equal to 300 ml. The residual volume at height 25 cm was then calculated as 300 ml minus the volume emptied during catheterization. The residual volume corresponding to height 20 cm was calculated as the residual volume corresponding to height 25 minus the additional volume emptied at height 20. The residual volume corresponding to height 15, 10 and 0 cm were derived similarly. Calculated residual volumes were negative, likely due to faulty ultrasound scans performed on subjects in sitting position. Consequently, the changes in bladder volumes, re-worded from "300ml - collected volume \<100ml" to "collected volume \> 200ml", were used to interpret the primary endpoint.

  2-4 hours

Study Arms (2)

Sequence A

EXPERIMENTAL

Catheterization with SelfCath (comparator) followed by measurement of residual urine. Then catheterization with Product A in different positions. Measurement of residual urine at different positions.

Device: SelfCath (comparator); Device: Product A SelfCath and urine bag, Conveen Security+

Sequence B

EXPERIMENTAL

Based on results from sequence A, sequence B may or may not be initiated. Catheterization with SelfCath (comparator) followed by measurement of residual urine. Then catheterization with Product B in different positions. Measurement of residual urine at different positions.

Device: SelfCath (comparator); Device: Product B SelfCath and urine bag, Conveen Contour

Interventions

SelfCath (comparator) DEVICE

Commercially available CE-marked catheter for urinary drainage.

Sequence A; Sequence B

Product A SelfCath and urine bag, Conveen Security+ DEVICE

SelfCath and urine bag, Conveen Security+ (both commercially available CE-marked devices).

Sequence A

Product B SelfCath and urine bag, Conveen Contour DEVICE

SelfCath and urine bag, Conveen Contour (both commercially available CE-marked devices).

Sequence B

Eligibility Criteria

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

You may qualify if:

• Has given written informed consent
• Is at least 18 years of age and has full legal capacity
• Is a male
• Has an Spinal Cord Injury diagnosis

You may not qualify if:

• Participating in other interventional clinical investigations or have previously participated in this investigation
• Known hypersensitivity toward any of the test products
• Serious abdominal scars
• Symptoms of urinary tract infections

Sponsors & Collaborators

• Coloplast A/S: lead

Study Sites (1)

Per Bagi

Copenhagen, 2100, Denmark

Location

MeSH Terms

Conditions

Spinal Cord Injuries

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Results Point of Contact

• Title: Per Bagi, MD
• Organization: Rigshospitalet, Department of Urology

Per.bagi@regionh.dk

+45 3545 8310

Study Officials

• Per Bagi, MD

  Rigshospitalet, Denmark

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 28, 2014
• First Posted: September 3, 2014
• Study Start: September 1, 2014
• Primary Completion: September 1, 2014
• Study Completion: September 1, 2014
• Last Updated: March 15, 2016
• Results First Posted: February 15, 2016

Record last verified: 2016-02

Locations

DK (1)