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Completed

NCT Number: NCT02252549

An International Randomized Study to Compare SPIES Versus WLI

This study is a multicenter randomized controlled trial in which the efficacy between SPIES assisted and WLI assisted TURB are compared. Subjects in the experimental arm (Arm A) will undergo SPIES assisted TURB, whereas subjects in the control arm (Arm B) will receive treatment with WLI assisted TURB only. Baseline characteristics will be recorded, as well as short and long-term follow up.

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Key information

Conditions

Bladder Cancer Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Male Urogenital Diseases Neoplasms Neoplasms by Site Urinary Bladder Diseases Urinary Bladder Neoplasms Urogenital Diseases Urogenital Neoplasms Urologic Diseases Urologic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

This study is a multicenter randomized controlled trial in which the recurrence rates of cancer between SPIES assisted and WLI assisted TURB are compared. Randomization is stratified by tumor multiplicity (single or multiple), tumor status (primary or recurrent) and macroscopic findings (papillary or flat, where CIS is scored as flat lesion). Patients randomized into the experimental arm (Arm A) will undergo SPIES and WLI assisted TURB, whereas the patients in the control arm (Arm B) will undergo WLI only assisted TURB. WLI is chosen as control, since it is considered the gold standard for detecting bladder tumors. Short and long term follow up will be recorded in order to evaluate the health gains for patients over a longer period. Perioperative (30 days) complications will be compared between the two treatment arms to evaluate the safety of SPIES.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Has signed informed consent
  • Is scheduled for treatment of a primary or recurrent NMIBC
  • Is aged 18 years or older
  • Has or has had no tumors in the upper urinary tract
  • Has had no previous irradiation of the pelvis

Exclusion criteria

  • Gross haematuria at the time of TURB (i.e. heavy bladder bleeding resulting in marked amounts of blood in the urine which may interfere with cystoscopy)
  • Participation in other clinical studies with investigational drugs either concurrently or within the last 30 days
  • Pregnancy or breast-feeding (all women of child-bearing potential must document a negative serum or urine pregnancy test at screening and are suggested to use the contraceptive pill or an intrauterine device (IUD) during the treatments and for at least one months thereafter)
  • Conditions associated with a risk of poor protocol compliance
  • Has had instillation therapy in the six months prior to the screening visit

Treatment and study plan

SPIES+WLI assisted TURB

Device

WLI assisted TURB

Device

Primary outcomes

  1. To compare the recurrence rate of tumor at 12 months following SPIES assisted TURB (Arm A) with White Light Imaging only assisted TURB (Arm B)

    Time frame: 1 year

Secondary outcomes

  1. 1. To assess the recurrence rate of tumor at short and long term follow up (3 months and 3 years) after SPIES or WLI assisted TURB in patients with NMIBC.

    Time frame: 3 years

  2. 2. To assess the peri-operative morbidity (30 days) between SPIES and WLI assisted TURB by comparing the proportion of adverse events and using the Clavien-Dindo score.

    Time frame: 3 years

Sponsors and collaborators

Lead sponsor

Clinical Research Office of the Endourological Society

Other

Registry information

Official study title

The SPIES Non-Muscle-Invasive Bladder Cancer Study - A Multicenter Randomized Controlled Study; A Multicenter International Randomized Controlled Study to Compare the Outcome Using the Storz Professional Image Enhancement System (SPIES) Versus White Light Imaging (WLI) During TURB of Non-Muscle-Invasive Bladder Cancer (NMIBC).

Important dates

Study start
2015
Primary completion
2020
Study completion
2021
First posted
Sep 30, 2014
Registry last updated
Jul 28, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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