NCT01295281

Brief Summary

The hypothesis to be investigated is if the tolerability of intermittent catheterization with Polyolefin Based Elastomer (POBE) 2.0 and Polyvinyl Chloride (PVC) is clinically equal - i.e. clinically non-inferior when using POBE 2.0 compared to PVC. Secondary objectives are to evaluate the safety and the subject's perception associated with the use of the catheters, assessed by the recording of adverse events and the ease of handling by means of a subjective assessment scale.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
107

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2011

Shorter than P25 for not_applicable

Geographic Reach
1 country

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 21, 2011

Completed
24 days until next milestone

First Posted

Study publicly available on registry

February 14, 2011

Completed
15 days until next milestone

Study Start

First participant enrolled

March 1, 2011

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2011

Completed
2.8 years until next milestone

Results Posted

Study results publicly available

March 3, 2014

Completed
Last Updated

November 11, 2021

Status Verified

November 1, 2021

Enrollment Period

2 months

First QC Date

January 21, 2011

Results QC Date

November 22, 2013

Last Update Submit

November 10, 2021

Conditions

Catheterization (Clean, Intermittent Urinary Catheterization)

Outcome Measures

Primary Outcomes (1)

  • Number of Participants With Discomfort

    The primary objective of this study is to compare the subject's tolerability, with regards to perceived discomfort, when using two different urinary catheters. Perception of discomfort (yes/ no) will be assessed in patient questionnaire for each subject. The frequency of discomfort will be compared between the treatments.

    At 7 and 14 days after randomization, respectively

Secondary Outcomes (12)

  • Perception of Pain

    At 7 and 14 days after randomization, respectively

  • Perception of Burning Sensation

    At 7 and 14 days after randomization, respectively

  • Presence of Bleeding

    At 7 and 14 days after randomization, respectively

  • Perception of "Other Discomfort"

    At 7 and 14 days after randomization, respectively

  • Perception of Stiffness/ Rigidity

    At 7 and 14 days after randomization, respectively

  • +7 more secondary outcomes

Study Arms (2)

LoFric POBE 2.0 - PVC

EXPERIMENTAL

First period (7 days) use of LoFric POBE 2.0 followed by second period (7 days) use of LoFric PVC

Device: LoFric POBE 2.0Device: LoFric PVC

LoFric PVC - POBE 2.0

EXPERIMENTAL

First period (7 days) use of LoFric PVC followed by second period (7 days) use of LoFric POBE 2.0.

Device: LoFric POBE 2.0Device: LoFric PVC

Interventions

LoFric POBE 2.0DEVICE

To be used at least twice daily, during 7 days. Treatment period 1 and 2 last 7 days, respectively.

LoFric POBE 2.0 - PVCLoFric PVC - POBE 2.0
LoFric PVCDEVICE

To be used at least twice daily, during 7 days. Treatment period 1 and 2 last 7 days, respectively.

LoFric POBE 2.0 - PVCLoFric PVC - POBE 2.0

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Provision of informed consent
  • Males, aged 18 years and over
  • Maintained urethra sensibility
  • Practice intermittent self-catheterization at least 2 times daily
  • Using catheters in the length of 40 cm and size charrière (Ch) 12 or Ch 14
  • Experienced practitioners of intermittent self-catheterization defined as a minimum of three months on therapy
  • Experience of using LoFric catheter within the last 12 months prior to study entry
  • Adults able to read, write and understand information given to them regarding the study

You may not qualify if:

  • Ongoing, symptomatic urinary tract infection (UTI) at enrolment as judged by investigator
  • Known urethral stricture at enrolment as judged by investigator
  • Involvement in the planning and/or conduct of the study (applies to both Astra Tech staff or staff at the study site)
  • Previous enrolment or randomisation of treatment in the present study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Kirurg och Urologmottagningen, Alingsås lasarett

Alingsås, 441 33, Sweden

Location

Urologcentrum

Borås, 501 32, Sweden

Location

Kirurg- och urologmottagningen, Gävle Sjukhus

Gävle, 801 87, Sweden

Location

Urologmottagningen, Lundby Sjukhus

Gothenburg, 417 17, Sweden

Location

Uroterapimottagningen Kärnsjukhuset Skövde

Skövde, 541 85, Sweden

Location

Urologmottagningen Uddevalla sjukhus

Uddevalla, 451 80, Sweden

Location

Results Point of Contact

Title
Dikran Shamoun
Organization
Wellspect HealthCare
dikran.shamoun@wellspect.com
+46313764275

Study Officials

  • Birgit Johansson, Urotherapist

    Kärnsjukhuset Skövde

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
GT60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 21, 2011

First Posted

February 14, 2011

Study Start

March 1, 2011

Primary Completion

May 1, 2011

Study Completion

May 1, 2011

Last Updated

November 11, 2021

Results First Posted

March 3, 2014

Record last verified: 2021-11

Locations

SE(6)