NCT03874364

Brief Summary

Flexible cystoscopy is routinely performed by urologists. Many patients have concerns to undergo this procedure and expect it to be unpleasant or even painful. Thus, reduction of pain and discomfort during cystoscopy is of great interest, but there is not sufficient evidence regarding the most appropriate conduct of cystoscopy. In this study the impact of lidocaine gel, patient counseling and monitoring regarding pain perception during flexible cystoscopy are investigated.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
280

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

Study Start

First participant enrolled

February 1, 2019

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

March 12, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 14, 2019

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2021

Completed
Last Updated

March 14, 2019

Status Verified

March 1, 2019

Enrollment Period

1.9 years

First QC Date

March 12, 2019

Last Update Submit

March 12, 2019

Conditions

Flexible Cystoscopy

Outcome Measures

Primary Outcomes (1)

  • Pain based on a numeric rating scale

    The pain scale ranging from 0 ("no pain") to 10 ("worst possible pain").

    During flexible cystoscopy

Secondary Outcomes (4)

  • Pain based on a numeric rating scale

    Immediately before flexible cystoscopy

  • Pain based on a numeric rating scale

    10 min after flexible cystoscopy

  • Pain based on a numeric rating scale

    3 days after flexible cystoscopy

  • Pain based on a verbal rating scale

    Immediately after flexible cystoscopy

Study Arms (8)

Lidocaine gel, counselling, monitor

ACTIVE COMPARATOR
Device: Lidocaine gelOther: CounsellingOther: Monitor

Lidocaine gel, counselling, no monitor

ACTIVE COMPARATOR
Device: Lidocaine gelOther: CounsellingOther: No monitor

Lidocaine gel, no counselling, monitor

ACTIVE COMPARATOR
Device: Lidocaine gelOther: MonitorOther: No counselling

Lidocaine gel, no counselling, no monitor

ACTIVE COMPARATOR
Device: Lidocaine gelOther: No counsellingOther: No monitor

Lubricating gel, counselling, monitor

PLACEBO COMPARATOR
Other: CounsellingOther: MonitorDevice: Lubricating gel

Lubricating gel, counselling, no monitor

PLACEBO COMPARATOR
Other: CounsellingDevice: Lubricating gelOther: No monitor

Lubricating gel, no counselling, monitor

PLACEBO COMPARATOR
Other: MonitorDevice: Lubricating gelOther: No counselling

Lubricating gel, no counselling, no monitor

PLACEBO COMPARATOR
Device: Lubricating gelOther: No counsellingOther: No monitor

Interventions

Lidocaine gelDEVICE

10 ml 2% lidocaine gel is instilled with a syringe through the length of the urethra and kept in site at least 5 minutes prior the introduction of the cystoscope.

Lidocaine gel, counselling, monitorLidocaine gel, counselling, no monitorLidocaine gel, no counselling, monitorLidocaine gel, no counselling, no monitor
CounsellingOTHER

Patients receive a brochure in the waiting room explaining the procedure in details.

Lidocaine gel, counselling, monitorLidocaine gel, counselling, no monitorLubricating gel, counselling, monitorLubricating gel, counselling, no monitor
MonitorOTHER

Patients are allowed to view and follow the procedure on a monitor connected to the cystoscope's camera.

Lidocaine gel, counselling, monitorLidocaine gel, no counselling, monitorLubricating gel, counselling, monitorLubricating gel, no counselling, monitor
Lubricating gelDEVICE

10 ml plain lubrificant gel is instilled with a syringe through the length of the urethra and kept in site at least 5 minutes prior the introduction of the cystoscope.

Lubricating gel, counselling, monitorLubricating gel, counselling, no monitorLubricating gel, no counselling, monitorLubricating gel, no counselling, no monitor
No counsellingOTHER

Patients won't receive a brochure in the waiting room explaining the procedure in details.

Lidocaine gel, no counselling, monitorLidocaine gel, no counselling, no monitorLubricating gel, no counselling, monitorLubricating gel, no counselling, no monitor
No monitorOTHER

Patients are not allowed to view and follow the procedure on a monitor connected to the cystoscope's camera.

Lidocaine gel, counselling, no monitorLidocaine gel, no counselling, no monitorLubricating gel, counselling, no monitorLubricating gel, no counselling, no monitor

Eligibility Criteria

Age18 Years - 80 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Men 18 - 80 years
  • Given indication for flexible cystoscopy
  • Written informed consent

You may not qualify if:

  • Allergy to amid anesthetics
  • Urinary tract infection
  • Use of analgesics in the previous 24 hours and chronic intake of analgesics
  • Dementia
  • Presence of a sensory disorder such as or spinal cord injury
  • Indwelling catheter carrier

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Klinik für Urologie, Kantonsspital Luzern

Lucerne, 6000, Switzerland

RECRUITING

MeSH Terms

Interventions

Counseling

Intervention Hierarchy (Ancestors)

Mental Health ServicesBehavioral Disciplines and ActivitiesCommunity Health ServicesHealth ServicesHealth Care Facilities Workforce and Services

Central Study Contacts

Ajet Hyseni, Dr.med.univ.RKS

CONTACT

0+41 41 205 6959ajet.hyseni@luks.ch

Carlo Di Bona

CONTACT

+41 41 205 6308carlo.dibona@luks.ch

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Dr.med.univ.RKS

Study Record Dates

First Submitted

March 12, 2019

First Posted

March 14, 2019

Study Start

February 1, 2019

Primary Completion

January 1, 2021

Study Completion

January 1, 2021

Last Updated

March 14, 2019

Record last verified: 2019-03

Locations

CH(1)