ClinicalTrials.gg
RecruitingNCT05912764PRECODOMUpdated Nov 24, 2025

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

An interventional study of Patient support in Adenoma, sponsored by GCS Ramsay Santé pour l'Enseignement et la Recherche. Recruiting at 1 site in France. Open to male participants aged 45 Years and older. Per ClinicalTrials.gov, last updated 2025-11-24.

Sponsored by GCS Ramsay Santé pour l'Enseignement et la Recherche · Not applicable, Interventional, and Supportive care

From the registry’s dates

  • Started Jan 2024; still recruiting 2 years 9 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
440
Allocation
Randomized
Ages
45 Years and older
Sex
Male
01

Study 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

Read the 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

02

Conditions studied

  • Adenoma

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03

In context

Adenoma

182 studies on the registry are indexed under Adenoma; 28 are open to participants now.

This study's planned enrollment of 440 is above the median of 372 across 127 interventional studies indexed under Adenoma.

Browse Adenoma studies →

Lead sponsor

GCS Ramsay Santé pour l'Enseignement et la Recherche is the lead sponsor of 207 studies on the registry; 99 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
45 Years and older
Sexes eligible
Male
Accepts healthy volunteers
No

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

  • Patient planned for endoscopic enucleation of prostate adenoma with laser
  • Patient with symptomatic benign prostatic hyperplasia and 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

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- aggregation who cannot be interrupted
Terms in these criteria, in plain language(2)

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.

Relapsed and refractory

Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.

Platelets

Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.

05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
440 participants (estimated)

Study arms

  • Experimental
    Early home return arm

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

    Other: Patient support

  • No intervention
    Standard Of Care arm

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

Interventions

  • OtherPatient support

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

06

What researchers measure

Primary outcomes

  1. Re-hospitalizations and/or hospitalization extensions rate

    the percentage of re-hospitalizations and/or hospitalization extensions

    Time frame: 2 weeks

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

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

Started Jan 2024 (actual). Primary completion is estimated for Aug 2027, 42 months after the start.

Of 44 non-industry interventional studies with no phase under Adenoma, half reached primary completion within 37 months of starting (the median), counting those still running; a quarter within 19 and three quarters within 50. This study's planned 42 months is above that.

Counting every sponsor, half of 50 studies reached it within 34 months; a quarter within 19 and three quarters within 50.

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

Registered
Jun 12, 2023
First posted
Jun 22, 2023
StartActual
Jan 26, 2024
Primary completionEst.
Aug 15, 2027
CompletionEst.
Aug 15, 2027
Last update
Nov 24, 2025
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 Nov 24, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05912764
Responsible party
Sponsor
First posted
Jun 22, 2023
Start date
Jan 26, 2024
Primary completion
Aug 15, 2027 (estimated)
Completion
Aug 15, 2027 (estimated)
Last update
Nov 24, 2025

Study contacts

Philippe ROUVELLAT, MD
Contact
r.rouvellat.union@gmail.com
+ 33 5 61 37 82 93
Philippe ROUVELLAT, MD
principal investigator · GCS RAMSAY SANTE

Oversight

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

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