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Not yet recruitingNCT07663097HoLEP and TURPUpdated Jun 26, 2026

Preoperative Anxiety and Surgical Fear in Holmium Laser Enucleation of the Prostate and Transurethral Resection of the Prostate Patients With Benign Prostatic Hyperplasia

An observational study in Benign Prostatic Hyperplasia, sponsored by Hitit University. Not yet recruiting at 1 site in Turkey (Türkiye). Open to male participants aged 50 Years and older. Per ClinicalTrials.gov, last updated 2026-06-26.

Sponsored by Hitit University · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
80
Ages
50 Years and older
Sex
Male
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 39 studies in Prostatic Hyperplasia with a site in Turkey — 14 open to participants now, 15 under way, none of them phase 3. Prostatic Hyperplasia · Turkey.

Planned enrollment
14th of 20
80 · median 200
Started
2026
with 10 others
Observational
20 of 39
8 open now
Primary completion
2027-04
later than 6 of 14 live
Registered
36th of 39
by date
Lead sponsor
2 of 39
Hitit University

Among the 39 studies in Prostatic Hyperplasia with a site in Turkey, this one is the 14th largest by planned enrollment of the 20 observational ones that give a count, is one of 11 that started in 2026, is one of 20 observational ones, reaches primary completion later than 6 of the 14 other live ones, and was the 36th registered.

Prostatic Hyperplasia

827 studies on the registry are indexed under Prostatic Hyperplasia; 179 are open to participants now.

Browse Prostatic Hyperplasia studies →

Open to participants now

14 of the 39 studies in Prostatic Hyperplasia with a site in Turkey are open now. Recruiting first, the newest first:

8 more — sign in →

All 14 open studies →

A study can be open while its sites in Turkey have not opened yet or have stopped. Only those recruiting at a site in Turkey →

Who these studies take

Of the 102 Prostatic Hyperplasia studies recruiting now, 70 (69%) set no upper age limit and 4 (4%) stop at 75 or younger; 7 take children under 18; 7 take healthy volunteers.

This study: 50 Years and older · male · no healthy volunteers.

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02

Study summary

Benign prostatic hyperplasia (BPH) is a common condition in older men and may cause bothersome lower urinary tract symptoms that can negatively affect quality of life. Surgical treatment with Holmium Laser Enucleation of the Prostate (HoLEP) or Transurethral Resection of the Prostate (TURP) is often recommended when medical therapy is insufficient.

This prospective observational study aims to evaluate whether preoperative anxiety, depression, and surgical fear influence postoperative functional outcomes, urinary continence, erectile function, and patient satisfaction in patients undergoing HoLEP or TURP for BPH. Participants will complete validated psychological and functional questionnaires before surgery and during postoperative follow-up visits at 1 and 3 months. The study will also assess changes in psychological status after surgery and compare outcomes between HoLEP and TURP patients.

The findings may help improve preoperative patient counseling and identify patients who could benefit from additional psychological support before surgery.

Read the detailed description

Benign prostatic hyperplasia (BPH) is one of the most common urological conditions affecting aging men and is frequently associated with lower urinary tract symptoms (LUTS) that significantly impair quality of life. Although medical therapy is the first-line treatment for most patients, surgical intervention becomes necessary in cases with severe symptoms, complications, or inadequate response to medication. Transurethral Resection of the Prostate (TURP) has long been considered the standard surgical treatment, while Holmium Laser Enucleation of the Prostate (HoLEP) has emerged as an effective minimally invasive alternative with favorable perioperative and functional outcomes.

Psychological factors such as anxiety, depression, and fear of surgery have been shown to influence recovery, pain perception, treatment satisfaction, and functional outcomes after various surgical procedures. However, the impact of preoperative psychological status on postoperative outcomes in patients undergoing surgery for BPH remains insufficiently investigated.

This prospective, single-center, observational study aims to evaluate the relationship between preoperative anxiety, depression, and surgical fear and postoperative functional outcomes in patients undergoing HoLEP or TURP for BPH. Eighty patients scheduled for surgical treatment of BPH will be enrolled. Patients will be allocated to HoLEP or TURP according to routine clinical practice, surgeon preference, and patient choice. No randomization or study-related intervention will be performed.

Before surgery, participants will complete validated questionnaires assessing lower urinary tract symptoms, erectile function, anxiety, depression, and surgical fear, including the International Prostate Symptom Score (IPSS), International Index of Erectile Function-5 (IIEF-5), State-Trait Anxiety Inventory (STAI), Hospital Anxiety and Depression Scale (HADS), and Surgical Fear Questionnaire (SFQ).

Follow-up assessments will be conducted at postoperative 1 month and 3 months. Functional outcomes, urinary continence, erectile function, psychological status, and patient satisfaction will be evaluated using the same validated instruments. Urinary continence will additionally be assessed using the International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF).

The primary objective is to determine whether preoperative anxiety levels are associated with postoperative functional improvement, measured by changes in IPSS scores. Secondary objectives include evaluating the relationship between psychological status and postoperative urinary incontinence, erectile function, patient satisfaction, and longitudinal changes in anxiety and depression after surgery. Outcomes will also be compared between patients undergoing HoLEP and TURP.

The results of this study may improve understanding of the role of psychological factors in BPH surgery and contribute to the development of targeted perioperative counseling and psychological support strategies for patients undergoing surgical treatment for BPH.

03

Conditions studied

  • Benign Prostatic Hyperplasia

Keywords

  • BPH
  • HOLEP
  • TURP
  • Preoperative anxiety
  • surgical fear
  • depression
  • Patient satisfaction
  • lower urinary tract symptoms
  • urinary incontinence
  • erectile function
04

Who can participate

Ages eligible
50 Years and older
Sexes eligible
Male
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Male patients aged 50 years or older with benign prostatic hyperplasia (BPH) who are scheduled to undergo Holmium Laser Enucleation of the Prostate (HoLEP) or Transurethral Resection of the Prostate (TURP) at Hitit University Erol Olcok Training and Research Hospital and who provide written informed consent.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Male patients aged 50 years or older
  • Diagnosis of benign prostatic hyperplasia (BPH)
  • Scheduled to undergo HoLEP or TURP
  • Ability to understand and complete study questionnaires
  • Provided written

Exclusion criteria

Exclusion Criteria:

  • History of severe psychiatric disorder
  • Active psychiatric treatment
  • Neurogenic bladder or neurologic voiding dysfunction
  • Diagnosis of prostate cancer
  • Previous prostate surgery
  • Inability to comply with study procedures or follow-up visits
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
80 participants (estimated)
Patient registry
No

Groups and cohorts

  • HoLEP Group

    Patients with benign prostatic hyperplasia undergoing HoLEP surgery.

    Procedure: Holmium Laser Enucleation of the Prostate (HoLEP)

  • TURP Group

    Patients with benign prostatic hyperplasia undergoing TURP surgery.

    Procedure: Transurethral Resection of the Prostate (TURP)

Interventions

  • ProcedureHolmium Laser Enucleation of the Prostate (HoLEP)

    Standard HoLEP procedure for treatment of benign prostatic hyperplasia.

  • ProcedureTransurethral Resection of the Prostate (TURP)

    Standard TURP procedure for treatment of benign prostatic hyperplasia.

06

What researchers measure

Primary outcomes

  1. Change in International Prostate Symptom Score (IPSS)

    Association between preoperative anxiety levels and postoperative functional improvement measured by changes in International Prostate Symptom Score (IPSS). IPSS scores range from 0 to 35, with higher scores indicating more severe lower urinary tract symptoms. Change from baseline to postoperative 3 months will be evaluated.

    Time frame: Baseline to 3 months after surgery

Secondary outcomes

  1. Change in IIEF-5 Score

    Change in International Index of Erectile Function-5 (IIEF-5) score. Scores range from 5 to 25, with higher scores indicating better erectile function.

    Time frame: Baseline to 3 months after surgery

  2. Urinary Incontinence Assessed by ICIQ-SF

    Urinary continence assessed using the International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF). Scores range from 0 to 21, with higher scores indicating more severe urinary incontinence.

    Time frame: 1 and 3 months after surgery

  3. Change in HADS Score

    Change in Hospital Anxiety and Depression Scale (HADS) score. Total scores range from 0 to 42, with higher scores indicating greater anxiety and depressive symptoms.

    Time frame: Baseline to 3 months after surgery

  4. Change in STAI Score

    Change in State-Trait Anxiety Inventory (STAI) score. Scores range from 20 to 80, with higher scores indicating greater anxiety levels.

    Time frame: Baseline to 3 months after surgery

  5. Patient Satisfaction Score

    Patient satisfaction will be assessed using a visual analog scale ranging from 0 to 10, with higher scores indicating greater satisfaction with surgical outcomes.

    Time frame: 3 months after surgery

07

Study locations

1 site
08

References and documents

Individual participant data

Plan to share: No — Individual participant data collected during this study will not be made publicly available due to privacy and confidentiality considerations.

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Jun 2026; primary completion for Apr 2027, 9 months later.

Of 59 non-industry observational studies under Prostatic Hyperplasia, half reached primary completion within 33 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 50. This study's planned 9 months is below that.

Counting every sponsor, half of 74 studies reached it within 25 months; a quarter within 12 and three quarters within 50.

How these figures are worked out, and which studies are left out of them.

Registered
Jun 17, 2026
First posted
Jun 23, 2026
StartEst.
Jun 14, 2026
Primary completionEst.
Apr 8, 2027
CompletionEst.
Jun 8, 2027
Last update
Jun 26, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jun 26, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07663097
Lead sponsor
Hitit University
Responsible party
Mustafa Serdar CAGLAYAN (Principal Investigator, Department of Urology, Hitit University) — Principal investigator
First posted
Jun 23, 2026
Start date
Jun 14, 2026 (estimated)
Primary completion
Apr 8, 2027 (estimated)
Completion
Jun 8, 2027 (estimated)
Last update
Jun 26, 2026

Study contacts

Metin Kızgın, Araştırma görevlisi Dr.
Contact
mtnkizgin@gmail.com
+90 507 136 20 45
Mustafa Serdar Caglayan
Contact
serdar.09.09@hotmail.com
05074311951

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.

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