CClinicalTrials.gg
Status unknownNCT03874364Updated Mar 14, 2019

The Effect of Intraurethral Lidocaine Gel on Pain Perception During Flexible Cystoscopy

An interventional study of Lidocaine gel and Counselling in Flexible Cystoscopy, sponsored by Ajet Hyseni. Status unknown at 1 site in Switzerland. Open to male participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2019-03-14.

Sponsored by Ajet Hyseni · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Mar 2019), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
280
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
Male
01

Study 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.

02

Conditions studied

  • Flexible Cystoscopy
03

In context

Lead sponsor

This is the only study on the registry with Ajet Hyseni as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
Male
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • 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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
280 participants (estimated)

Study arms

  • Active comparator
    Lidocaine gel, counselling, monitor

    Device: Lidocaine gel · Other: Counselling · Other: Monitor

  • Active comparator
    Lidocaine gel, counselling, no monitor

    Device: Lidocaine gel · Other: Counselling · Other: No monitor

  • Active comparator
    Lidocaine gel, no counselling, monitor

    Device: Lidocaine gel · Other: Monitor · Other: No counselling

  • Active comparator
    Lidocaine gel, no counselling, no monitor

    Device: Lidocaine gel · Other: No counselling · Other: No monitor

  • Placebo comparator
    Lubricating gel, counselling, monitor

    Other: Counselling · Other: Monitor · Device: Lubricating gel

  • Placebo comparator
    Lubricating gel, counselling, no monitor

    Other: Counselling · Device: Lubricating gel · Other: No monitor

  • Placebo comparator
    Lubricating gel, no counselling, monitor

    Other: Monitor · Device: Lubricating gel · Other: No counselling

  • Placebo comparator
    Lubricating gel, no counselling, no monitor

    Device: Lubricating gel · Other: No counselling · Other: No monitor

Interventions

  • DeviceLidocaine gel

    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.

  • OtherCounselling

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

  • OtherMonitor

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

  • DeviceLubricating gel

    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.

  • OtherNo counselling

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

  • OtherNo monitor

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

06

What researchers measure

Primary outcomes

  1. Pain based on a numeric rating scale

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

    Time frame: During flexible cystoscopy

Secondary outcomes

  1. Pain based on a numeric rating scale

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

    Time frame: Immediately before flexible cystoscopy

  2. Pain based on a numeric rating scale

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

    Time frame: 10 min after flexible cystoscopy

  3. Pain based on a numeric rating scale

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

    Time frame: 3 days after flexible cystoscopy

  4. Pain based on a verbal rating scale

    The pain scale ranging from 0 ("it was not unpleasant") to 5 ("the investigation was almost unbearable").

    Time frame: Immediately after flexible cystoscopy

07

Study locations

1 of 1 sites recruiting
  • Klinik für Urologie, Kantonsspital Luzern
    Lucerne, 6000, Switzerland
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 14, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03874364
Lead sponsor
Ajet Hyseni
Responsible party
Ajet Hyseni (Dr.med.univ.RKS, Luzerner Kantonsspital) — Sponsor-investigator
First posted
Mar 14, 2019
Start date
Feb 1, 2019
Primary completion
Jan 2021 (estimated)
Completion
Jan 2021 (estimated)
Last update
Mar 14, 2019

Study contacts

Ajet Hyseni, Dr.med.univ.RKS
Contact
ajet.hyseni@luks.ch
0+41 41 205 6959
Carlo Di Bona
Contact
carlo.dibona@luks.ch
+41 41 205 6308

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Mar 2019. You cannot join it, but the record below documents what was studied.

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