EPPROSTATECT: Ejaculation Preserving Photoselective Vaporization Versus Plasma Kinetic Vaporization Versus Transurethral Resection Of The Prostate: A RCT

• Sponsor: Mansoura University (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT03589196
• Collaborator: (none)
• Enrollment: 84
• Location: 1
• Arms: 3
• Anticipated Duration (Months): 20.7
• Patients Per Site Per Month: 4.1

Study Details

Study Description

Brief Summary

To Evaluate and compare the outcome and coast of ejaculation sparing management of BPH using 3 different techniques: PVP, PKVP and TURP. Ejaculation sparing TURP group is considered the standard control group. Evaluation will be carried out through a prospective randomized powered trial

Condition or Disease	Intervention/Treatment	Phase
Ejaculation Abnormal; BPH With Urinary Obstruction; Prostatic Hyperplasia; Prostate Disease; Prostate Obstruction	Procedure: Ejaculation Preserving Photoselective Vaporization; Procedure: Ejaculation Preserving Plasma Kinetic Vaporization; Procedure: Ejaculation Preserving Transurethral Resection Of The Prostate	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 84 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Ejaculation Preserving Photoselective Vaporization Versus Plasma Kinetic Vaporization Versus Transurethral Resection Of The Prostate For Management Of Benign Prostatic Enlargement: An Objective Evaluation Through a Prospective Randomized Trial
• Actual Study Start Date: Mar 10, 2018
• Anticipated Primary Completion Date: Jun 1, 2019
• Anticipated Study Completion Date: Dec 1, 2019

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Photoselective Vaporization	Procedure: Ejaculation Preserving Photoselective Vaporization; Ejaculation Preserving Photoselective Vaporization
Active Comparator: Plasma Kinetic Vaporization	Procedure: Ejaculation Preserving Plasma Kinetic Vaporization; Ejaculation Preserving Plasma Kinetic Vaporization
Active Comparator: Transurethral Resection Of The Prostate	Procedure: Ejaculation Preserving Transurethral Resection Of The Prostate; Ejaculation Preserving Transurethral Resection Of The Prostate

Outcome Measures

Primary Outcome Measures

1. estimate and compare the ejaculation preservation effect of the 3 techniques (PKVP, PVP and TURP). [1 years]

   assessed by Male Sexual Health Questionnaire (MSHQ)

Secondary Outcome Measures

1. change in flow rate [1 years]

   measured by uroflowmetery in ml/sec

2. postoperative complication [1 year]

   measured by Clavien-Dindo Classification scale

3. change in patients' symptoms. [1 year]

   measured by International Prostate Symptom Score (I-PSS)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 50 Years and Older
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• 1. Age >50 years 2. Prostate volume (measured by TRUS): 30-80 gm 3. International prostate symptom score (IPSS )>15 and quality of life score (QOL)< 3.

1. Maximum flow rate of uroflometry <10 ml/second 5. Patients with active sexual life (or interested) and having the ability to ejaculate and desire to preserve ejaculation.

2. Failure or intolerance to medical treatment, recurrent urinary infection, urine retention, significant hematuria or deterioration of the upper urinary tract function secondary to BOO.

Exclusion Criteria:

1. Bleeding disorders and patients on anticoagulant treatment

2. Histologically proved cancer prostate

3. Neurogenic voiding dysfunction

4. Lower urinary tract malignancy

5. Preoperative ejaculation or sexual dysfunction

6. Presence of stricture urethra

7. Unfit for spinal anathesia -

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Urology & Nephrology Center	Mansourah		Egypt

Sponsors and Collaborators

• Mansoura University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Mansoura University
• ClinicalTrials.gov Identifier: NCT03589196
• Other Study ID Numbers: MS/18.02.30
• First Posted: Jul 17, 2018
• Last Update Posted: Jul 17, 2018
• Last Verified: Mar 1, 2018

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Prostatic Hyperplasia; Prostatic Diseases; Hyperplasia

Study Results

No Results Posted as of Jul 17, 2018