NCT06212453

Brief Summary

The aim of the current study is to evaluate the efficacy of transperineal focal microwave ablation (TMA) of the prostate transition zone as a new treatment for lower urinary tract symptoms (LUTS) due to benign prostatic hyperplasia (BPH) within a prospective single-institutional pilot study.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
22

participants targeted

Target at below P25 for phase_2

Timeline
3mo left

Started Apr 2024

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress90%
Apr 2024Aug 2026

First Submitted

Initial submission to the registry

November 24, 2023

Completed
2 months until next milestone

First Posted

Study publicly available on registry

January 18, 2024

Completed
3 months until next milestone

Study Start

First participant enrolled

April 24, 2024

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2025

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2026

Expected
Last Updated

January 20, 2025

Status Verified

January 1, 2025

Enrollment Period

11 months

First QC Date

November 24, 2023

Last Update Submit

January 17, 2025

Conditions

Benign Prostatic Hyperplasia

Keywords

Benign Prostatic Hyperplasia

Outcome Measures

Primary Outcomes (1)

  • Difference between IPSS score at baseline and at 3 months

    The International Prostate Symptom Score IPSS is a self-questionnaire - It contains seven questions about symptoms related to BPH and one question about the patient's perceived quality of life. The seven questions are scored from 0 to 5. The sum of the 7 items gives the International Prostate Symptom Score in terms of severity (out of 35): 0-7 Mildly symptomatic - 8-19 Moderately symptomatic - 20-35 Severely symptomatic - Efficacy of the intervention with a decrease of at least 6 points on IPSS score between 3 months and baseline.

    3 months

Secondary Outcomes (11)

  • Length of hospital stay

    1 month

  • Need for postoperative bladder catheterization

    1 month

  • Duration of postoperative bladder catheterization

    1 month

  • Postoperative pain

    two hours after surgery

  • Dimensions of transitional zone tissue ablation

    7 days

  • +6 more secondary outcomes

Study Arms (1)

patients with BPH

EXPERIMENTAL

Targeted Microwave Ablation

Procedure: Targeted Microwave Ablation

Interventions

Targeted Microwave AblationPROCEDURE

3D ultrasound-guided focal thermal ablation of the prostate transition zone

patients with BPH

Eligibility Criteria

Age40 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Man over 40 years old
  • Indication of surgical management for BPH
  • Prostate volume ≥30 cc and ≤100 cc as evaluated by ultrasonography
  • IPSS score ≥15
  • Qmax ≤12 ml/s
  • Affiliated to the French national social security system
  • Patient suitable for IV sedation or general anesthesia and focal microwave ablation
  • Wish and able to comply with planned visits
  • Able to express his consent
  • Signed informed consent form

You may not qualify if:

  • Unwillingness to accept the treatment
  • Neurological pathology responsible for micturition disorders
  • History of prostatic surgery
  • History of prostatic arterial embolization
  • Prostate protrusion Index of grade 2 (\>5 mm) or more as evaluated by ultrasonography.
  • Stenosis of the urethra
  • History of prostate cancer
  • History of radiotherapy or pelvic surgery
  • Life expectancy \<2 years
  • Inability to understand the informed consent document, to give consent voluntarily or to complete the study tasks.
  • Participation in another clinical study involving an investigational product within 1 month before study entry.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hôpital Cochin

Paris, 75014, France

RECRUITING

Related Publications (6)

  • Yuan JQ, Mao C, Wong SY, Yang ZY, Fu XH, Dai XY, Tang JL. Comparative Effectiveness and Safety of Monodrug Therapies for Lower Urinary Tract Symptoms Associated With Benign Prostatic Hyperplasia: A Network Meta-analysis. Medicine (Baltimore). 2015 Jul;94(27):e974. doi: 10.1097/MD.0000000000000974.

    PMID: 26166130BACKGROUND

  • Cornu JN, Ahyai S, Bachmann A, de la Rosette J, Gilling P, Gratzke C, McVary K, Novara G, Woo H, Madersbacher S. A Systematic Review and Meta-analysis of Functional Outcomes and Complications Following Transurethral Procedures for Lower Urinary Tract Symptoms Resulting from Benign Prostatic Obstruction: An Update. Eur Urol. 2015 Jun;67(6):1066-1096. doi: 10.1016/j.eururo.2014.06.017. Epub 2014 Jun 25.

    PMID: 24972732BACKGROUND

  • McVary KT, Gange SN, Gittelman MC, Goldberg KA, Patel K, Shore ND, Levin RM, Rousseau M, Beahrs JR, Kaminetsky J, Cowan BE, Cantrill CH, Mynderse LA, Ulchaker JC, Larson TR, Dixon CM, Roehrborn CG. Minimally Invasive Prostate Convective Water Vapor Energy Ablation: A Multicenter, Randomized, Controlled Study for the Treatment of Lower Urinary Tract Symptoms Secondary to Benign Prostatic Hyperplasia. J Urol. 2016 May;195(5):1529-1538. doi: 10.1016/j.juro.2015.10.181. Epub 2015 Nov 22.

    PMID: 26614889BACKGROUND

  • Oelke M, Bachmann A, Descazeaud A, Emberton M, Gravas S, Michel MC, N'dow J, Nordling J, de la Rosette JJ; European Association of Urology. EAU guidelines on the treatment and follow-up of non-neurogenic male lower urinary tract symptoms including benign prostatic obstruction. Eur Urol. 2013 Jul;64(1):118-40. doi: 10.1016/j.eururo.2013.03.004. Epub 2013 Mar 13.

    PMID: 23541338BACKGROUND

  • Gratzke C, Bachmann A, Descazeaud A, Drake MJ, Madersbacher S, Mamoulakis C, Oelke M, Tikkinen KAO, Gravas S. EAU Guidelines on the Assessment of Non-neurogenic Male Lower Urinary Tract Symptoms including Benign Prostatic Obstruction. Eur Urol. 2015 Jun;67(6):1099-1109. doi: 10.1016/j.eururo.2014.12.038. Epub 2015 Jan 19.

    PMID: 25613154BACKGROUND

  • Leonardo C, Lombardo R, Cindolo L, Antonelli A, Greco F, Porreca A, Veneziano D, Pastore A, Dalpiaz O, Ceruti C, Verze P, Borghesi M, Schiavina R, Falabella R, Minervini A; AGILE Group. What is the standard surgical approach to large volume BPE? Systematic review of existing randomized clinical trials. Minerva Urol Nefrol. 2020 Feb;72(1):22-29. doi: 10.23736/S0393-2249.19.03589-6. Epub 2019 Oct 10.

    PMID: 31619035BACKGROUND

MeSH Terms

Conditions

Prostatic Hyperplasia

Condition Hierarchy (Ancestors)

Prostatic DiseasesGenital Diseases, MaleGenital DiseasesUrogenital DiseasesMale Urogenital Diseases

Study Officials

  • Nicolas BARRY DELONGCHAMPS, MD, PhD

    Assistance Publique - Hôpitaux de Paris

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Nicolas BARRY DELONGCHAMPS, MD, PHD

CONTACT

+33 1 58 41 27 64nicolas.barry-delongchamps@aphp.fr

Karima MESBAHI

CONTACT

+33 1 58 41 12 11karima.mesbahi@aphp.fr

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Targeted Microwave Ablation
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 24, 2023

First Posted

January 18, 2024

Study Start

April 24, 2024

Primary Completion

April 1, 2025

Study Completion (Estimated)

August 1, 2026

Last Updated

January 20, 2025

Record last verified: 2025-01

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)