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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02524236
Recruitment Status : Completed
First Posted : August 14, 2015
Last Update Posted : February 20, 2017
Sponsor:
Information provided by (Responsible Party):
Ahmed Abdelbary, Beni-Suef University

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.

Condition or disease Intervention/treatment Phase
Benign Prostatic Hyperplasia Drug: Botox injection in the prostate Early Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Studying the Dose Response of 50 and 100 IU of Botox A Toxin Injection in the Prostates of BPH Patients.
Study Start Date : August 2015
Actual Primary Completion Date : November 2016
Actual Study Completion Date : November 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Botox

Arm Intervention/treatment
Active Comparator: Botox 50 IU

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
transrectal access of prostatic injection
Other Name: transrectal injection of the prostate

Active Comparator: Botox 100 IU

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
transrectal access of prostatic injection
Other Name: transrectal injection of the prostate




Primary Outcome Measures :
  1. IPSS score improvement [ Time Frame: 3 months ]

Secondary Outcome Measures :
  1. Urinary flow rate [ Time Frame: 3 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02524236


Locations
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Egypt
Beni - Suef University
Beni Suef, Egypt
Sponsors and Collaborators
Beni-Suef University
Investigators
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Principal Investigator: Ahmed M Abdelbary, md Beni-Suef University
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Responsible Party: Ahmed Abdelbary, MD, FEBU, Beni-Suef University
ClinicalTrials.gov Identifier: NCT02524236    
Other Study ID Numbers: 1 Urology
First Posted: August 14, 2015    Key Record Dates
Last Update Posted: February 20, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Ahmed Abdelbary, Beni-Suef University:
BPH, OAB, Botox, dose response
Additional relevant MeSH terms:
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Prostatic Hyperplasia
Hyperplasia
Pathologic Processes
Prostatic Diseases