Benign Prostate Surgery and QOL and Sexual Function

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.

Conditions

• Quality of Life
• Sexual Dysfunction
• Ejaculatory Dysfunction
• Lower Urinary Tract Symptoms
• Erectile Dysfunction
• Incontinence

Interventions

PROCEDURE

Monopolar / Bipolar Transurethral resection of prostate (TURP), photovaporisation (PVP), Plasmakinetic (PK), Holmium laser enucleation of the prostate (HOLEP) or open prostatectomy (OP)).

Any procedure advised by the EAU guidelines to ovrecome bladder outlet obstruction

Sponsors & Collaborators

• TC Erciyes University

  collaborator OTHER

• Gaziosmanpasa Research and Education Hospital

  collaborator OTHER_GOV

• Goztepe Training and Research Hospital

  collaborator OTHER

• Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization

  collaborator OTHER

• Ankara Education and Research Hospital

  collaborator OTHER_GOV

• Uludag University

  collaborator OTHER

• Kırıkkale University

  collaborator OTHER

• SB Istanbul Education and Research Hospital

  collaborator OTHER

• Kayseri City Hospital

  collaborator OTHER_GOV

• Bagcilar Training and Research Hospital

  collaborator OTHER_GOV

• Ataturk University

  collaborator OTHER

• Sisli Hamidiye Etfal Training and Research Hospital

  collaborator OTHER

• Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey

  collaborator OTHER

• Haydarpasa Numune Training and Research Hospital

  collaborator OTHER

• SBÜ Dr. Sadi Konuk Eğitim ve Araştırma Hastanesi

  collaborator OTHER

• Fatih Sultan Mehmet Training and Research Hospital

  collaborator OTHER

• Firat University

  collaborator OTHER

• Recep Tayyip Erdogan University

  collaborator OTHER

• Yuzuncu Yıl University

  collaborator OTHER

• Ondokuz Mayıs University

  collaborator OTHER

• Dr. Lutfi Kirdar Kartal Training and Research Hospital

  collaborator OTHER_GOV

• Ankara City Hospital Bilkent

  collaborator OTHER

• Izmir Katip Celebi University

  collaborator OTHER

• Haseki Training and Research Hospital

  collaborator OTHER

• Istanbul Medipol University Hospital

  lead OTHER

Principal Investigators

• Johan J de la Rosette, MD PhD · Medipol University

Eligibility

Min Age

40 Years

Max Age

90 Years

Sex

MALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-09-01

Primary Completion

2023-06-01

Completion

2023-09-30

Countries

• Turkey (Türkiye)

Study Locations