Evaluation of Early Home Return in Patients With Enucleation of Prostate Adenoma

NCT ID: NCT05912764

Last Updated: 2025-11-24

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 440 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-01-26
• Study Completion Date: 2027-08-15

Brief Summary

Prostate adenoma management includes, if necessary, surgical treatments: resection or vaporization by endoscopy or by open surgery in case of a very large prostate. Laser technology is a curative treatment for prostate adenoma. The minimum duration of hospitalization, in the context of enucleation prostatic endoscopy by laser, is estimated at 48 hours.

The Union Clinique has developed an improved rehabilitation care pathway reducing hospitalization duration to 24 hours (one night hospitalization). This care pathway involves patient as an actor in its care but also health professionals, in particular nurses.

This study is based on the hypothesis that the model developed by the Union Clinique can be translated to other healthcare establishments and that home return supervized by nurses allows reducing hospital stay length without increasing the risk of serious complications for patients

Detailed Description

Prostate adenoma management includes first drug treatments and, if necessary, surgical treatments: resection or vaporization by endoscopy or by open surgery in case of a very large prostate. Laser technology is a curative treatment for prostate adenoma. Its objective is to perform endoscopic excision (ablation) of the adenoma, in order to improve patients' quality of life and their urination. The laser energy is transmitted by a guided fiber under endoscopic control through the urethral canal in contact with the adenoma. Several wavelengths of the laser beam, depending on the nature of the generator crystals, are used for their specificity in cutting and tissue cauterization: Greenlight laser, Holmium laser, Thulium laser.

The minimum duration of hospitalization, in the context of an enucleation prostatic endoscopy by laser, is estimated at 48 hours. The Union Clinique has developed an improved rehabilitation care pathway reducing hospitalization duration to 24 hours (one night hospitalization). This care pathway involves patient as an actor in its care but also health professionals, in particular nurses, who will coordinate patients care prior to their intervention and when they leave the Clinics.

This study is based on the hypothesis that the model developed by the Union Clinique can be translated to other healthcare establishments and that home return supervized by health professionals, notably nurses, allows reducing hospital stay length without increasing the risk of serious complications for patients

Conditions

Adenoma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Early home return arm

Nurses will coordinate the patients' care prior to their intervention and when they leave the Clinics.

Group Type: EXPERIMENTAL

Patient support

Intervention Type: OTHER

Patients will be supported by nurses before and after intervention and hospital leave

Standard Of Care arm

Patients will not receive any support before and after intervention and hospital leave

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Patient support

Patients will be supported by nurses before and after intervention and hospital leave

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Patient planned for endoscopic enucleation of prostate adenoma with laser
• Patient with symptomatic benign prostatic hyperplasia and refractory to medical reatment and/or
• Patient with benign prostatic hyperplasia complicated by chronic retention of urine and/or
• Patient with benign prostatic hyperplasia complicated by prostatitis and/or
• Patient with symptomatic benign prostatic hyperplasia

Exclusion Criteria

• Patient living beyond the scope of care by the nurses coordination
• Bedridden patient or WHO clinical condition >2
• Patient requiring curative anticoagulation which cannot be interrupted or relayed at home by heparin
• Patient with double anti-platelet aggregation who cannot be interrupted

• Minimum Eligible Age: 45 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

GCS Ramsay Santé pour l'Enseignement et la Recherche

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Philippe ROUVELLAT, MD

Role: PRINCIPAL_INVESTIGATOR

GCS RAMSAY SANTE

Locations

Clinique de l'Union

Saint-Jean, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Philippe ROUVELLAT, MD

Role: CONTACT

r.rouvellat.union@gmail.com

+ 33 5 61 37 82 93

Facility Contacts

Philippe ROUVELLAT, MD

Role: primary

r.rouvellat.union@gmail.com

+33561378293

Other Identifiers

2023-A00283-42

Identifier Type: -

Identifier Source: org_study_id