Effect of a modified technique of urinary reconstruction during radical prostatectomy on early continence: a randomized controlled trial
| ISRCTN | ISRCTN65448229 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN65448229 |
| Secondary identifying numbers | CER-CHUQ 2019-4193 |
- Submission date
- 03/07/2024
- Registration date
- 03/07/2024
- Last edited
- 02/08/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Plain English summary of protocol
Background and study aims
The aim of the study was to evaluate whether a modification to the current technique of reconstruction during radical prostatectomy could improve early recovery of urinary continence after surgery.
Who can participate?
All patients undergoing this surgery could participate unless they had conditions that could also impact urinary continence.
What does the study involve?
The study involves adding a suspensory suture to provide additionnal support to the urethra or using the standard technique without this additional suture.
What are the possible benefits and risks of participating?
The possible benefits were an earlier recovery of socially acceptable continence after surgery while the risks were minimal and could in theory include urinary retention and pain after the surgery.
Where is the study run from?
Centre Hospitalier Universitaire de Québec (Canada)
When is the study starting and how long is it expected to run for?
August 2018 to March 2020
Who is funding the study?
Fondation CHU de Québec (Canada)
Who is the main contact?
kaleem.atchia.1@ulaval.ca
Contact information
Public, Scientific, Principal Investigator
11, côte du Palais
Québec
G1R 2J6
Canada
| Phone | +1 4185254444 |
|---|---|
| kaleem.atchia.1@ulaval.ca |
Study information
| Study design | Single center single surgeon single-blinded randomized trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | 45736 PIS v2 19Jun2018.pdf |
| Scientific title | Effect of a modified technique of posterior reconstruction by iliopectineal ligament suspension during robot-assisted laparoscopic radical prostatectomy on early continence: a randomized controlled trial |
| Study objectives | A modified posterior urethral support would aim to recreate a suspensory mechanism to enhance early continence by reducing urethral mobility and restoring a normal urethra-vesical angle during increases in abdominal pressure. |
| Ethics approval(s) |
Approved 26/06/2018, Comité d'éthique de la recherche du CHU de Québec-Université Laval (11, côte du Palais, Québec, G1R 2J6, Canada; +1 4185254444; ethiquedelarecherche@chudequebec.ca), ref: CER-CHUQ 2019-4193 |
| Health condition(s) or problem(s) studied | Prostate cancer |
| Intervention | Posterior reconstruction was done using a standard technique in the control group and was modified for the experimental group by incorporating not only the “Rocco” stitch between Denonvilliers’ fascia and the rhabdosphincter but also the iliopectineal ligaments bilaterally to further improve posterior support with this suspensory ‘hammock’. Both groups of patients were followed for a year with periodic questionnaires and 24-hour pad tests. Randomization: Sealed envelope before surgery, randomised preoperatively by randomisation software. |
| Intervention type | Procedure/Surgery |
| Primary outcome measure | Recovery of continence after prostatectomy measured using Expanded Prostate cancer Index Composite (EPIC-26) questionnaire sent at 1, 3, 6 and 12 months post-operatively |
| Secondary outcome measures | Measured at 1, 3, 6 and 12 months post-operatively: 1. Long term continence measured using Expanded Prostate cancer Index Composite (EPIC-26) questionnaire 2. Erectile function measured using Erectile Function (IIEF-5) 3. Severity of SUI measured using 24-hour pad test at 3, 6 and 12 months |
| Overall study start date | 01/08/2018 |
| Completion date | 31/03/2020 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 40 Years |
| Upper age limit | 85 Years |
| Sex | Male |
| Target number of participants | 200 |
| Total final enrolment | 171 |
| Key inclusion criteria | Localised prostate cancer staged with conventional imaging who chose to be treated with radical prostatectomy |
| Key exclusion criteria | 1. Patients with clinical stage T4 2. Neoadjuvant hormonotherapy 3. Previous history of radiation therapy 4. Endoscopic or open surgeries of the prostate 5. Urethral stricture 6. Urinary incontinence 7. Neurologic disease |
| Date of first enrolment | 01/08/2018 |
| Date of final enrolment | 31/03/2020 |
Locations
Countries of recruitment
- Canada
Study participating centre
Québec
G1R 2J6
Canada
Sponsor information
Hospital/treatment centre
11, côte du Palais
Québec
G1R 2J6
Canada
| Phone | +1 4185254444 |
|---|---|
| chu@chudequebec.ca | |
| Website | https://www.chudequebec.ca/accueil.aspx |
"ROR" |
https://ror.org/006a7pj43 |
Funders
Funder type
Charity
Private sector organisation / Trusts, charities, foundations (both public and private)
- Alternative name(s)
- CHUQ Foundation, Fondation CHUQ
- Location
- Canada
Results and Publications
| Intention to publish date | 15/07/2024 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not expected to be made available |
| Publication and dissemination plan | Planned publication in a peer-reviewed journal |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are not expected to be made available due to limitations from the consent obtained from participants |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | version 2 | 19/06/2018 | 03/07/2024 | No | Yes |
| Protocol file | 03/07/2024 | No | No | ||
| Results article | 21/07/2024 | 02/08/2024 | Yes | No |
Additional files
Editorial Notes
02/08/2024: Publication reference added.
03/07/2024: Trial's existence confirmed by Comité d'éthique de la recherche du CHU de Québec-Université Laval.
