Benign Prostate Surgery and QOL and Sexual Function
BEPS
Impact of Prostate Surgery for LUTS on Patients' QOL With Emphasis on Sexual- and Ejaculatory Function
1 other identifier
observational
1,200
1 country
1
Brief Summary
Rationale: A variety of surgical techniques have been described for surgical treatment of male LUTS because of BPH, which has different outcomes and may result in adverse events regarding ejaculatory function and erection, resulting in a negative impact on QOL on short- and mid-term follow-ups. Objective: To compare outcomes of BPH surgery using a conventional versus ejaculation preserving technique on QOL-related aspects with emphasis on ejaculatory and erectile function. Study design: This study is a prospective longitudinal multi-center trial to compare the ejaculatory and erectile function outcomes between conventional and ejaculation preserving BPH surgical procedures/techniques. Baseline characteristics will be recorded, as well as short and mid-term follow-up. Study population: The study population comprises patients who will undergo BPH surgery in the participating centers. Intervention: All patients will undergo BPH surgery (including but not restricted to Monopolar / Bipolar Transurethral resection of the prostate (TURP), photo vaporisation (PVP), Plasmakinetic (PK), Holmium laser enucleation of the prostate (HOLEP) or open prostatectomy (OP)). Main study parameters/endpoints: Primary endpoint is to compare the baseline to the short-term (3 months) and mid-term (6 months) ejaculation function and QoL outcomes. The secondary endpoint is the short and mid-term erection function and QoL outcomes compared to baseline. Nature and extent of the burden and risks associated with participation, benefit, and group relatedness: Patients' burden and risk associated with participating in this trial do not differ among surgical procedures or techniques used. In all groups, patients will undergo a BPH surgery and will be followed for six months at 3 visits.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Sep 2021
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2021
CompletedFirst Submitted
Initial submission to the registry
March 22, 2023
CompletedFirst Posted
Study publicly available on registry
April 24, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
September 30, 2023
CompletedApril 24, 2023
April 1, 2023
1.7 years
March 22, 2023
April 12, 2023
Conditions
Outcome Measures
Primary Outcomes (4)
Preservation of QOL after surgery for BPH
QOL will be assessed before and after by means of validated SF-12 questionnaire
Baseline to 6 months after surgery
Preservation of sexual function after surgery for BPH
Sexual function will be assessed before and after by means of IIEF-5 validated questionnaire
Baseline to 6 months after surgery
Preservation of ejaculatory function after surgery for BPH
Ejaculatory function will be assessed before and after by means of MSHQ-EjD-SF validated questionnaire
Baseline to 6 months after surgery
Preservation of voiding function after ejaculation preserving BPH surgery
LUTS will be assessed before and after by means of IPSS validated questionnaire
Baseline to 6 months after surgery
Secondary Outcomes (4)
Comparison of post-operative complications among the different disobstructive methods
From the day of the operastion up to 90 days
Comparison objective outcomes of uroflowmetry Qmax parameter (ml/sec) in relation to outcomes in preservation of ejaculation and unpreserved surgery
Baseline to 6 months after surgery
Comparison residual urine volumes (Post-voided residual urine, ml) by ultrasound measurement in relation to outcomes in preservation of ejaculation and unpreserved surgery
Baseline to 6 months after surgery
Comparison changes in erectile function between conventional and preserving ejaculatory techniques by using IIEF-5 validated questionnarie
Baseline to 6 months after surgery
Study Arms (1)
Patients required prostate surgery for LUTS
Patients with LUTS attributable to bladder outlet obstruction because BPH
Interventions
Any procedure advised by the EAU guidelines to ovrecome bladder outlet obstruction
Eligibility Criteria
Adult male patients, complaining of LUTS who require surgery because BPH
You may qualify if:
- Has signed informed consent
- Is aged 40 years or older
- With or without erectile function and/or antegrade ejaculation
- No limitation for prostate volume
- Height 150-250 cm
- Weight 40-150 kg
- Age 40-90 years old
- PSA 0.1-30 ng/ml
- Creatinine 0.5-4mg/dl
You may not qualify if:
- History of BPH surgery
- History of pelvic radiation
- History of chronic prostatitis or chronic pelvic pain syndrome
- History of urethral stricture
- History of bladder neck contracture
- Has or has had tumors in the urinary tract
- Has or has had prostate cancer
- Has had previous irradiation of the pelvis
- Has bladder stone
- Has urinary tract infection (UTI)
- Has chronic UTI
- Has neurogenic disorder
- Has conditions associated with a risk of poor protocol compliance
- Has participation in other clinical studies with investigational drugs either concurrently or within the last 30 days
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Istanbul Medipol University Hospitallead
- TC Erciyes Universitycollaborator
- Gaziosmanpasa Research and Education Hospitalcollaborator
- Goztepe Training and Research Hospitalcollaborator
- Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organizationcollaborator
- Ankara Education and Research Hospitalcollaborator
- Uludag Universitycollaborator
- Kırıkkale Universitycollaborator
- SB Istanbul Education and Research Hospitalcollaborator
- Kayseri City Hospitalcollaborator
- Bagcilar Training and Research Hospitalcollaborator
- Ataturk Universitycollaborator
- Sisli Hamidiye Etfal Training and Research Hospitalcollaborator
- Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkeycollaborator
- Haydarpasa Numune Training and Research Hospitalcollaborator
- SBÜ Dr. Sadi Konuk Eğitim ve Araştırma Hastanesicollaborator
- Fatih Sultan Mehmet Training and Research Hospitalcollaborator
- Firat Universitycollaborator
- Recep Tayyip Erdogan Universitycollaborator
- Yuzuncu Yil Universitycollaborator
- Ondokuz Mayıs Universitycollaborator
- Dr. Lutfi Kirdar Kartal Training and Research Hospitalcollaborator
- Ankara City Hospital Bilkentcollaborator
- Izmir Katip Celebi Universitycollaborator
- Haseki Training and Research Hospitalcollaborator
Study Sites (1)
Istanbul Medipol University
Istanbul, 34214, Turkey (Türkiye)
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Johan J de la Rosette, MD PhD
Medipol University
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 6 Months
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor of Urology
Study Record Dates
First Submitted
March 22, 2023
First Posted
April 24, 2023
Study Start
September 1, 2021
Primary Completion
June 1, 2023
Study Completion
September 30, 2023
Last Updated
April 24, 2023
Record last verified: 2023-04
Data Sharing
- IPD Sharing
- Will not share