An International Randomized Study to Compare SPIES Versus WLI

Clinical Research Office of the Endourological Society

Status

Completed

Conditions

Bladder Cancer

Treatments

Device: SPIES+WLI assisted TURB

Device: WLI assisted TURB

Study type

Interventional

Funder types

Other

Identifiers

NCT02252549

NL50451.018.14

Details and patient eligibility

About

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.

Full description

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.

Enrollment

700 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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