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Study of testosterone treatment to prevent recurrence of urinary passage narrowing after surgery in men with low testosterone

A prospective interventional study on efficacy of testosterone therapy in hypogonadism patients in preventing recurrence after urethral structure treatment. - NIL

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2026/05/110839
Enrollment
170
Registered
2026-05-21
Start date
Unknown
Completion date
Unknown
Last updated
2026-06-01

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

Conditions

Health Condition 1: N358- Other urethral stricture

Interventions

Intervention1: Testosterone supplementation with self calibration: Intervention Details: Testosterone therapy using injectable or transdermal formulations administered in hypogonadal adult male patien

Sponsors

IPGMER and SSKM HOSPITAL
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Adult male patients aged 18 to 80 years with urethral stricture disease and documented low serum testosterone levels planned for definitive treatment including urethroplasty, optical internal urethrotomy, or endoscopic dilatation and willing to provide written informed consent.

Exclusion criteria

Exclusion criteria: Patients with pelvic fracture urethral distraction defect, prior pelvic irradiation, previous testosterone therapy, carcinoma prostate, severe lower urinary tract symptoms unrelated to urethral stricture disease, contraindication to testosterone therapy, or unwillingness to participate in the study.

Design outcomes

Primary

MeasureTime frame
Rate of urethral stricture recurrenceTimepoint: Assessed at 3 months, 6 months, and 12 months following definitive urethral stricture treatment

Secondary

MeasureTime frame
Change in peak urinary flow rate (Qmax)Timepoint: Baseline, 3 months, 6 months, and 12 months;Change in International Prostate Symptom Score (IPSS)Timepoint: Baseline and 12 months;Change in post-void residual urine volumeTimepoint: Baseline, 3 months, 6 months, and 12 months;Safety and adverse effects of testosterone therapy including hematocrit and PSA changesTimepoint: During follow-up up to 12 months;Recurrence-free survival following interventionTimepoint: 12 months post-intervention

Countries

India

Contacts

Public ContactDr Soumya Mondal

IPGMER and SSKM HOSPITAL

dr.soumya.mondal@gmail.com8981222597

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Jun 11, 2026