Bladder-Adaptive Localized Approach to Neoplasm Care Evaluation (BALANCE Trial)

A Randomized Controlled Trial Comparing Bladder Preservation Therapy (Trimodal Therapy) Versus Radical Cystectomy in Muscle-Invasive Bladder Cancer with a Pragmatic Recruitment Approach

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

PACTR

Registry ID

PACTR202504613623695

Enrollment

200

Registered

2025-04-07

Start date

2025-05-01

Completion date

Unknown

Last updated

2026-09-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cancer Urological and Genital Diseases

Interventions

Open radical cystectomy with pelvic lymph node dissection and urinary diversion

Trimodal therapy and bladder preservation

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients with biopsy proven muscle invasive bladder cancer disease without any evidence of clinical or radiographic metastatic disease (cT2-3N0M0) 2. patients with high risk NMIBC (cT1N0M0) with at least one of the following: A. Multiple T1 tumors B. More than 2cm C. T1 tumor with associated Carcinoma insitu. D. BCG unresponsive disease.

Exclusion criteria

Exclusion criteria: 1. Patients with impaired renal function i.e. createnine clearance < 60 ml/ min. 2. Patients with extension to the prostate, upper urinary tract tumor or the presence of distant metastases. 3. Patients with other malignancy within past 5 years. 4. Patients who underwent any aggressive previous pelvic surgery or pelvic radiation for robotic approach. 5. Patients who are unfit for surgery due to chronic debilitating diseases (e.g. severe hepatic cirrhosis), uncorrectable bleeding diathesis or immunodeficiency syndromes.

Design outcomes

Primary

Measure	Time frame
To assess the feasibility and adherence rates of a pragmatic recruitment model in an RCT comparing Radical Cystectomy (RC) vs. Bladder Preservation Therapy (TMT - Trimodal Therapy).Recruitment and adherence rates (Proportion of patients accepting randomized treatment).	—

Secondary

Measure	Time frame
Compare oncological outcomes between RC and TMT. • Assess patient-reported quality of life (QoL) post-treatment. • Evaluate functional outcomes (urinary function, sexual function). • Determine overall survival (OS), disease-specific survival (DSS), and progression-free survival (PFS). • Analyze rates of salvage cystectomy in the TMT arm.	—

Countries

Egypt

Contacts

Public ContactAhmad Samir Abd Elsamad

Assistant Lecturer of Urology and Urology Specialist

ahmedsamir188288@gmail.com00201273043443

Outcome results

None listed

Source: PACTR (via WHO ICTRP) · Data processed: Sep 19, 2026