Exploratory Study Investigating Urodynamic Parameters During Catheterisation

NCT ID: NCT03337048

Last Updated: 2024-08-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-11-30
• Study Completion Date: 2018-05-29

Brief Summary

The objective of the study is to explore and understand how urodynamic parameters are affected when emptying the bladder with an intermittent catheter.

Detailed Description

The investigation is an explorative open single arm investigation including 30 male subjects. 10 healthy volunteers, 10 patients with SCI and 10 patients with BPH.

The healthy volunteers included into the study will have an information visit and three study visits - an inclusion visit (visit 0), a visit 1 measuring endpoints while spontaneous voiding of the bladder (0-7 days after visit 0) followed by a visit 2 measuring endpoints while emptying the bladder using a standard IC (4-15 days after visit 1). (Visit 0 and visit 1 can be the same day).

The subjects with SCI and enlarged prostate will have an information visit and two study visits. - an inclusion visit (visit 0) where a urine culture is analysed and prophylactic antibiotic is prescribed per the result of the analysis. (Most IC users have bacteria in the urine and to decrease the risk of acquiring a urinary tract infection from the urodynamic examination, urine cultures are performed and prophylactic antibiotics will be prescribed per the result). The second visit (visit 1) is conducted while the patient is on antibiotic treatment measuring all endpoints while emptying the bladder with a standard IC (4-15 days after visit 0 while subject is on prophylaxis antibiotics).

The investigation is conducted at one site and is an explorative study, estimated to last eight (8) months.

Due to the explorative nature of the investigation, no primary endpoint is defined but explorative endpoints are divided into three categories dependent on their relation to bladder, urethra or urine.

Conditions

Spinal Cord Injuries; Enlarged Prostate With Lower Urinary Tract Symptoms

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Measurement of endpoints

In healthy volunteers the endpoint are measured while spontaneous voiding of the bladder and while emptying the bladder using a standard intermittent catheter.

In subjects with spinal cord injury or enlarged prostata the endpoint are measured while emptying the bladder using a standard intermittent catheter.

Group Type: EXPERIMENTAL

SpeediCath

Intervention Type: DEVICE

SpeediCath is a standard intermittent catheter that is on the market.

Interventions

SpeediCath

SpeediCath is a standard intermittent catheter that is on the market.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. Have given written informed consent

2. Be at least 18 years of age and have full legal capacity

3. Be male

4. For healthy volunteers: Willing to comply with not using analgesics up to 24 hours prior to study visit

5. For healthy volunteers: Negative urine multistix (leukocytes and nitrite), or if positive, subsequent negative for bacterial growth in urine culture

6. For SCI and BPH patients: Use intermittent catheter daily and have used intermittent catheters for at least 2 months

Exclusion Criteria

1. Symptoms of urinary tract infections (frequent urination, stinging and pain at urination)

2. Participate in other clinical investigations related to urinary tract system during this investigation (Inclusion → termination)

3. For healthy volunteers: Abnormalities, diseases or surgical procedures performed in the lower urinary tract

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Coloplast A/S

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Nazarena Mazarro

Role: STUDY_DIRECTOR

Vice president Medical Affairs

Locations

Department of Urology, Rigshospitalet

Copenhagen, , Denmark

Countries

Denmark

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

CP277

Identifier Type: -

Identifier Source: org_study_id