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Intra prostatic fossa foley balloon tamponade

The comparison of intra prostatic fossa foley balloon tamponade technique with current simple open prostatectomy procedure

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20180725040589N1
Enrollment
60
Registered
2018-09-03
Start date
2018-02-20
Completion date
Unknown
Last updated
2018-10-11

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

Conditions

Benign Prostatic Hyperplasia (BPH). Enlarged prostate with lower urinary tract symptoms

Interventions

Intervention 1: Intervention group: 30 patients following enucleation of prostate the foley balloon will be inflated and fixed in prostatic fossa and the day after surgery the balloon will be deflated

Sponsors

Kermanshah University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
Male
Age
50 Years to No maximum

Inclusion criteria

Inclusion criteria: Prostate weight more than 75 g Bladder Stone Urinary bladder diverticule Urethral Stricture Orthopedic complications of pelvis

Exclusion criteria

Exclusion criteria: Coagulopathies Prostate cancer Contraindications of surgery due to past medical histories unwilling to do the surgery Incomplete follow up

Design outcomes

Primary

MeasureTime frame
Hemorrhage. Timepoint: the day after surgery and the day of discharge. Method of measurement: Laboratory.;Hb reduction. Timepoint: the day after surgery and the day of discharge. Method of measurement: Laboratory.;The amount of irrigation volume. Timepoint: the day after surgery and the day of discharge. Method of measurement: By a graded container.;Bladder neck contracture. Timepoint: 3 and 6 months following discharge. Method of measurement: Direct observation through cystoscope.;Wound dehiscence. Timepoint: 2 weeks following discharge. Method of measurement: Direct Observation.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactNavid Bahremand Moghaddam

Kermanshah University of Medical Sciences

Bahrehmand@gmail.com+98 83 3427 6326

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026