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Clinical Efficacy of Transurethral Resection of the Prostate Combined with Oral Anticholinergics or Botulinum Toxin–A Injection to Treat Benign Prostatic Hyperplasia with Overactive Bladder, Randomized Clinical Trial Study

Clinical Efficacy of Transurethral Resection of the Prostate Combined with Oral Anticholinergics or Botulinum Toxin–A Injection to Treat Benign Prostatic Hyperplasia with Overactive Bladder, Randomized Clinical Trial Study

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20201225049827N1
Enrollment
42
Registered
2021-02-16
Start date
2021-02-03
Completion date
Unknown
Last updated
2021-02-22

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

Conditions

LUTS In patients with benign prostatic hyperplasia. Personal history of diseases of genitourinary system

Interventions

Intervention 1: Disport Botox injection of 300 mg diluted with 10 cc of normal saline is injected into the bladder detrusor once after transurethral resection of the prostate. Intervention 2: Control

Sponsors

Shahid Beheshti University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
Male
Age
45 Years to 84 Years

Inclusion criteria

Inclusion criteria: Obstructive symptoms of urinary obstruction defined by IPSS and enlarged prostate on DRE examination Consent to enter the study Existence of LUTS symptoms OAB and DO approval with biodynamics and Eurodynamics study

Exclusion criteria

Exclusion criteria: Patients with neurological diseases such as Parkinson's or stroke Prostate or bladder cancer People who have had bladder or prostate surgery in the past Dissatisfaction with enrollment Allergy to sulifenacin or Botox

Design outcomes

Primary

MeasureTime frame
IPSS(International Prostate Score System) in two groups of botulinum and sulifenacin injection after TURP(Trans Urethral Resection Of Prostate) at 1, 3 and 6 months after treatment. Timepoint: 1, 3 and 6 months after transurethral resection of the prostate are checked. Method of measurement: Based on the International Index of Prostate Symptoms.;Urgent incontinence in the two groups of botulinum and sulifenacin injections after TURP(International Prostate Score System) is performed at 1, 3 and 6 months after treatment. Timepoint: 1, 3 and 6 months after transurethral resection of the prostate are checked. Method of measurement: It is done based on the patient's question.;Prostate volume in the two treatment groups of botulinum and sulifenacin injection after TURP(International Prostate Score System) is done at 1, 3 and 6 months after treatment. Timepoint: 1, 3 and 6 months after transurethral resection of the prostate are checked. Method of measurement: It is done based on ultrasound.;PVR(Post Voiding Residue) is performed in two treatment groups botulinum and sulifenacin injection after TURP(International Prostate Score System) at 1, 3 and 6 months after treatment. Timepoint: 1, 3 and 6 months after transurethral resection of the prostate are checked. Method of measurement: Based on Urodynamic test.;Q MAX(Q maximum) is administered in two treatment groups botulinum and sulifenacin injection after TURP(International Prostate Score System) at 1, 3 and 6 months after treatment. Timepoint: 1, 3 and 6 months after transurethral resection of the prostate are checked. Method of measurement: Based on Urodynamic test.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactSeyed Farzad Allame

Shahid Beheshti University of Medical Sciences

farzadallame@gmail.com+98 21 2271 8003

Outcome results

None listed

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