Comparison of Complications and Clinical Outcomes of Open Transvesical Prostatectomy With or Without Suprapubic Cystostomy in Patients With Benign Prostatic Hyperplasia

Comparison of clinical outcomes and postoperative complications between open transvesical prostatectomy with and without suprapubic cystostomy in patients with benign prostatic hyperplasia

Randomized parallel-group single-blind (assessor and analyst) controlled trial with 114 participants (57 per group). Block randomization (block size 4) using SPSS, allocation concealment with opaque envelopes.

This study will be conducted at Shahid Beheshti Hospital, Hamadan, by a senior urologist. Outcome assessment and data analysis will be performed by blinded individuals, and patients will be followed for 30 days post-surgery.

Inclusion criteria: Confirmed BPH, prostate volume ≥80g, surgical clearance, informed consent. Exclusion: Prostate/bladder malignancy, coagulation disorders, non-discontinuable anticoagulants, active infection, prior prostate/bladder surgery, age >80 with high risk, refusal.

Group 1 (Control): Open transvesical prostatectomy with suprapubic cystostomy. After bladder closure, a suprapubic catheter is inserted through a separate incision above the pubic symphysis, and continuous bladder irrigation is established through a three-way Foley catheter with outflow via the cystostomy. Group 2 (Intervention): Open transvesical prostatectomy without suprapubic cystostomy. Continuous bladder irrigation is established solely through a three-way Foley catheter, with both inflow and outflow through the same catheter.

Hemoglobin drop؛ blood transfusion؛ clot retention؛ early complications (fever, pain, dysuria)؛ cystostomy complications (infection, obstruction, displacement, leakage, hematoma)؛ hospital stay.

Randomization will be performed using block randomization with block sizes of four. The unit of randomization is at the individual level. The random sequence will be generated using SPSS statistical software version 26. For allocation concealment, opaque sealed envelopes with serial numbers will be used, which will be kept closed by an independent person until the time of surgery. After the patient is prepared for surgery and final eligibility is confirmed, the envelope will be opened and the patient will be allocated to one of the two study groups.

In this study, due to the surgical nature of the intervention, blinding of the surgeon, patient, clinical staff, and caregivers is not possible, as the patient and medical team become aware of the type of intervention due to the presence or absence of a suprapubic cystostomy tube. However, to reduce measurement bias in outcome assessment, two groups of individuals will be kept blinded: Outcome Assessor: The individual responsible for collecting data on postoperative outcomes (including hemoglobin drop, need for blood transfusion, clot-related urinary retention, fever, pain, and complications related to cystostomy) will be unaware of patients' group allocation. This person will have access to patients' medical records but will not know the group code, and outcomes will be recorded solely based on predefined clinical criteria. Data Analyst: The individual responsible for statistical analysis of the data will also be blinded to group allocation and will receive coded data (Code A and Code B). Decoding will only be performed after the final analysis is completed. All patients participating in the study have signed informed consent and are aware of their participation. Therefore, blinding does not imply lack of patient awareness about study participation and is conducted in full compliance with ethical standards.

Title: Data and Documentation Sharing Plan for the Clinical Trial Details: All de-identified individual participant data (IPD) will be shared along with the following documents: full study protocol, statistical analysis plan (SAP), informed consent form (ICF), clinical study report (CSR), analytic code (SPSS/R), and the data dictionary.

Data and documents will be available from 3 months after publication of the primary article and will remain accessible for up to 5 years following publication.

Researchers with a valid academic degree in medical sciences or epidemiology who provide a methodologically sound and approved research proposal for using the data.

Purpose: Exclusively for secondary research and scientific analyses with academic purposes, with no commercial use. Conditions: 1. Receiving approval from the local ethics committee. 2. Signing a Data Use Agreement that includes a commitment to maintain confidentiality and not disclose participant identities. 3. Acknowledging the source of data in any resulting publications or presentations.

Requests should be directed to the corresponding author of the article, Dr. Behzad Mohamad Soori. Email: behzad.soori@umsha.ac.ir

1. The applicant submits a project summary (1-2 pages) including objectives, methodology, and proposed analyses, along with academic credentials and a confidentiality commitment, via email. 2. The request is reviewed scientifically and ethically by the corresponding author and an independent expert (if needed). 3. If approved, the applicant signs a Data Use Agreement. 4. After signing, de-identified data will be shared with the applicant through a secure platform (e.g., an encrypted sharing service). 5. The applicant commits to making no attempts to re-identify participants and to properly acknowledge the data source in any resulting publications.

Confidentiality: Patient identities will remain protected, and shared data will be completely de-identified and free of any direct identifiers (e.g., names, national IDs, dates of birth). Intellectual Property: Any use of the data must acknowledge the original source (the primary study authors), and commercial use of the data is strictly prohibited. Regulatory Compliance: This data sharing plan fully complies with the regulations of the Ethics Committee of Hamadan University of Medical Sciences and the ICMJE guidelines.