Bipolar Needlescopic Enucleation Versus Vapoenucleation of BPH

NCT04331301 | Completed

• 1 other identifier: IDIRB2017122601-09
• Study Type: interventional
• Target: 214
• Locations: 1 country
• Sites: 1

Brief Summary

Transurethral resection of the prostate (TURP) is the current standard procedure for men with prostate volume 30-80 gm. In case with large prostate adenoma (\>80 g), the resection time required by TURP is associated with increased risk of TUR syndrome, blood loss and other complications. Many types of minimally invasive surgery exist along with new equipment and techniques. Many types of laser devices such as greenlight laser, thulium laser and holmium laser, are used to enucleate the prostate. Increasing evidence has proven their safety and efficacy However, the use of laser devices is difficult and associated with steep learning curve and high medical expenses. PKEP is a safe and effective procedure for the treatment of bladder obstruction secondary to BPH. This procedure not only improves maximum flow rate at 3 and 12 months after surgery, but it also improves all other recorded parameters (IPSS, QOL, IEFF-5, PVR, PSA). A button electrode can be effectively used to enucleate the prostate because of its powerful vaporisation and strong coagulation (B-TUEP technique) ,such as that with a holmium laser, thulium laser and greenlight laser. However its associated with short term complication as early irritative symptoms, Bulai reported that 16.7% of the patients suffering from early irritative symptoms while Geavlete reported that 11.4% of patient suffering from early irritative symptoms.

Conditions

Prostate Obstruction; Prostatic Hyperplasia; Prostatic Hypertrophy, Benign

Keywords

BPH, IPSS, Bipolar

Outcome Measures

Primary Outcomes (1)

• IPSS

  international prostate symptoms score (range 0 -35, the lower value is better)

  change of IPSS from Basline at 1,3 and 6 months postoperatively

Secondary Outcomes (4)

• QOL

  Change of QOL from Basline at 1,3 and 6 months postoperatively

• Qmax

  Change of Qmax from Basline at 1,3 and 6 months postoperatively

• PVRU

  Change of PVRU from Basline at 1,3 and 6 months postoperatively

• TRUS measured prostate volume

  Change of PV from Basline at 1,3 and 6 months postoperatively

Study Arms (2)

vapoenucleation group

ACTIVE COMPARATOR

Group A

Procedure: Bipolar Vapo-Enucleation of the prostate

needlescopic enucleation

ACTIVE COMPARATOR

group B

Procedure: Bipolar Needlescopic Enucleation of the prostate

Interventions

Bipolar Vapo-Enucleation of the prostate PROCEDURE

group A: Patient will be subjected to bipolar endoscopic enucleation of the prostate by vaporization electrode (vapoenucleation).

Also known as: BVEP

vapoenucleation group

Bipolar Needlescopic Enucleation of the prostate PROCEDURE

group B: Patient will be subjected to bipolar endoscopic enucleation of the prostate by hot knife electrode (Needlescopic Enucleation ).

Also known as: BNEP

needlescopic enucleation

Eligibility Criteria

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

You may qualify if:

• patients with Qmax of less than 15 mL/second due to BPH, severe LUTS/BPH requiring surgical treatment, and International Prostate Symptom Score (IPSS)\>7 due to BPH.

You may not qualify if:

• prostate and/or bladder cancer, bladder diverticula, urethral stricture, active urinary tract infection (UTI), unless treated, and men with neurogenic voiding dysfunction.

Sponsors & Collaborators

• Benha University: lead

Study Sites (1)

Banha University Hospitals

Banhā, Kalubyia, 13511, Egypt

Location

MeSH Terms

Conditions

Prostatic Hyperplasia

Condition Hierarchy (Ancestors)

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

Study Officials

• Waleed El-Shaer

  waleed_elshaer@hotmail.com

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: interventions are blinded to both patients and doctors who 1ry assess and follow-up patients.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 29, 2020
• First Posted: April 2, 2020
• Study Start: January 10, 2017
• Primary Completion: March 1, 2022
• Study Completion: March 10, 2022
• Last Updated: May 2, 2022

Record last verified: 2022-04

Locations

EG (1)