Effect of 50 and 100 IU Doses of Botox A Toxin Injection in BPH Patients.

NCT02524236 | Completed Early Phase 1

• 1 other identifier: 1 Urology
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

The primary objective of this study is to compare the efficacy and safety of a single injection of 50 U and 100 U doses of BoNT-A for the treatment of BPH-associated LUTS.

Conditions

Benign Prostatic Hyperplasia

Keywords

BPH, OAB, Botox, dose response

Outcome Measures

Primary Outcomes (1)

• IPSS score improvement

  3 months

Secondary Outcomes (1)

• Urinary flow rate

  3 months

Study Arms (2)

Botox 50 IU

ACTIVE COMPARATOR

Intervention: Botox 50 IU vial will be reconstituted with saline 0.9% to a total volume of 5 ml. All patients will receive five injections of 1 mL of the BoNT-A solution, including two injections in each lateral lobe (one proximal and one distal) and one injection in the median lobe. The injection depth will be 7-10 mm. Botox injection in the prostate

Drug: Botox injection in the prostate

Botox 100 IU

ACTIVE COMPARATOR

Intervention: Botox 100 IU vial will be reconstituted with saline 0.9% to a total volume of 5 ml. All patients will receive five injections of 1 mL of the BoNT-A solution, including two injections in each lateral lobe (one proximal and one distal) and one injection in the median lobe. The injection depth will be 7-10 mm. Botox injection in the prostate

Drug: Botox injection in the prostate

Interventions

Botox injection in the prostate DRUG

transrectal access of prostatic injection

Also known as: transrectal injection of the prostate

Botox 100 IU; Botox 50 IU

Eligibility Criteria

• Age: 50 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• persistent moderate to severe LUTS as determined by International Prostatic Symptom Score (IPSS) \>8.
• peak urinary flow rate of less than 12 mL/s.
• an enlarged prostate gland on digital rectal examination.

You may not qualify if:

• history of previous surgery for BPH.
• presence of urethral stenosis.
• urinary tract infection.
• prostate or bladder cancer.
• history of pelvic surgery or radiotherapy.
• neurological diseases.
• urinary retention.
• BPH-associated complications requiring surgical treatment including bladder stone, and bilateral hydronephrosis.

Sponsors & Collaborators

• Beni-Suef University: lead

Study Sites (1)

Beni - Suef University

Banī Suwayf, Beni Suweif Governorate, Egypt

Location

MeSH Terms

Conditions

Prostatic Hyperplasia

Interventions

Botulinum Toxins, Type A

Condition Hierarchy (Ancestors)

Prostatic Diseases; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Botulinum Toxins; Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases; Bacterial Proteins; Proteins; Amino Acids, Peptides, and Proteins; Bacterial Toxins; Toxins, Biological; Biological Factors

Study Officials

• Ahmed M Abdelbary, md

  Beni-Suef University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, FEBU

Study Record Dates

• First Submitted: August 13, 2015
• First Posted: August 14, 2015
• Study Start: August 1, 2015
• Primary Completion: November 1, 2016
• Study Completion: November 1, 2016
• Last Updated: February 20, 2017

Record last verified: 2017-02

Locations

EG (1)