What causes incontinence after robot-assisted prostate removal in men with prostate cancer?
| ISRCTN | ISRCTN67297115 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN67297115 |
| Secondary identifying numbers | Grant ALFGBG-720421 |
- Submission date
- 03/12/2018
- Registration date
- 01/05/2019
- Last edited
- 02/10/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Ongoing
- Condition category
- Surgery
Plain English Summary
Background and study aims
Prostate cancer is a very common disease and the complete removal of the prostate, radical prostatectomy (RP), is Gold Standard for treating localized disease with 3000 procedures/year in Sweden alone. Robot assisted laparoscopic RP (RALP) constitutes a large and growing part. RALP can cause a number of complications of which urinary incontinence has the largest impact of quality of life (QoL) affecting about 1/5 of the patients. We have identified risk factors for incontinence by analyzing 3000 RALP patients and also also by reviewing a number of films from 800 procedures performed at Sahlgrenska University Hospital. We will use the results from these analyzes in this study study. The aim is to identify what is different in the procedure between a continent and an incontinent patient. We will also record all procedures for further analyses. As a side project we will also with MRT analyze how the prostatic bed changes during RALP to help minimize the field of radiation at potential post-op recurrent disease. To identify and positively affect the factors of the procedure that lead to incontinence would greatly affect a large number of both patients and their kin.
Who can participate?
Patients without pre-operative urinary leakage, planned for radical prostatectomy at Department of Urology, Sahlgrenska University Hospital between 1 Jan 2019 to 31 Dec 2020. The inclusion may be prolonged if accrual is too low.
What does the study involve?
A magnetic resonance tomography (MRT) of the prostate and pelvic floor, a transrectal ultrasound and a urodynamic assessment at the start of the study and at 12 weeks. The radical prostatectomy procedure is also video recorded.
What are the possible benefits and risks of participating?
There are no direct benefits for the participating men. As the investigations are clinical routine in many other conditions the risks for the participants are minimal.
Where is the study run from?
1. Department of Urology, Sahlgrenska University Hospital, Sahlgrenska Academy at University of Gothenburg. Sweden
2. Department of Urology, NU-sjukvården, Uddevalla Hospital, Sweden (added 21/01/2020)
3. Department of Urology, Carlanderska Hospital, Gothenburg, Sweden (added 21/01/2020)
When is the study starting and how long is it expected to run for?
January 2015 to December 2028
Who is funding the study?
1. The Swedish patient prostate cancer society
2. Percy Falks Foundation
3. ALFGBG 720421 VG-Region
Who is the main contact?
Johan Stranne
johan.stranne@vgregion.se
Contact information
Scientific
Bruna Stråket 11B
Gothenburg
41345
Sweden
 ORCID ID |
0000-0002-4295-6524 |
|---|---|
| Phone | +46-31-3429007 |
| johan.stranne@vgregion.se |
Study information
| Study design | Prospective open non-randomized observational trial |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cohort study |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Only in Swedish, not available in web format, please use contact details to request a participant information sheet. |
| Scientific title | Incontinence post-robot-assisted radical prostatectomy: anatomical and functional causes |
| Study acronym | IPA |
| Study hypothesis | This prospective, open-label, non-randomized observational trial seeks to investigate which aspects of robot-assisted radical retropubic prostatectomy leads to post-operative incontinence. |
| Ethics approval(s) | Regional ethics review board of Gothenburg (Dnr 131-16), 24/03/2016, Dnr 131-16 |
| Condition | Incontinence following radical prostatectomy for prostate cancer |
| Intervention | MRT, urodynamics and trans-rectal ultrasound pre-operative and at three months postoperative The plan of study visits is described below. VISIT 1 The assessment of eligibility is done by a urologist. After assessment of eligibility the patient is included and informed consent is signed.The patient will fill in the NPCR PROM-survey and will be scheduled for the urodynamic- and ultrasound-visit at the urological department. A referral for MRT of the prostate (T2) is sent to the radiological department to be performed within 30 days. VISIT 2 To be performed within 30 days of inclusion. MRT (T2) at the radiological department. VISIT 3 To be performed within 30 days of inclusion. Urodynamics is performed as routine. Dynamic transrectal ultrasound at the urological department. VISIT 4 Surgery. Procedure is recorded on hard drive for later analysis. VISIT 5 To be performed at three months after surgery (+/- 2 weeks). MRT at the radiological department. VISIT 6 To be performed at three months after surgery (+/- 2 weeks). Urodynamics, dynamic transrectal/perineal ultrasound at the urological department. Patient answers continence questionnaire at the urological department. |
| Intervention type | Other |
| Primary outcome measure | Urethral length, position of prostate apex, position of bladder neck, position of urethra, thickness of urethra, M. levator ani and M. Pubourethralis/puborectalis and signs of fibrosis of urethra wall, assessed by MRT at baseline and 12 weeks (except for prostate apex at 12 weeks) |
| Secondary outcome measures | 1. Clinical characteristics (comorbidity, medications, BMI, smoking, IPSS, PSA, Gleason score and T-stage) assessed at baseline 2. Urethra pressure profile, sphincter length, function of bladder and bladder outflow tract assessed by urodynamics at baseline and 12 weeks 3. Position and movement of bladder neck and pelvic floor at relaxation and full tension of pelvic floor assessed by ultrasound at baseline and at 12 weeks. 4. Steps of surgery and potential damage of structures around sphincter assessed by video recording at time of surgery |
| Overall study start date | 01/01/2015 |
| Overall study end date | 31/12/2028 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Male |
| Target number of participants | 1000 |
| Participant inclusion criteria | Patients scheduled for robot-assisted laparoscopic radical prostatectomy at Sahlgrenska University Hospital |
| Participant exclusion criteria | Pre-operative incontinence |
| Recruitment start date | 01/01/2018 |
| Recruitment end date | 31/12/2024 |
Locations
Countries of recruitment
- Sweden
Study participating centres
Bruna Stråket 11B
Gothenburg
41645
Sweden
NU-sjukvården
Fjällvägen 9
Uddevalla
SE-451 53
Sweden
-
Sweden
-
Sweden
-
Sweden
Sponsor information
University/education
Box 100
Gothenburg
40530
Sweden
| Website | https://www.gu.se |
|---|---|
"ROR" |
https://ror.org/01tm6cn81 |
Funders
Funder type
Other
No information available
No information available
Private sector organisation / Trusts, charities, foundations (both public and private)
- Alternative name(s)
- Percy Falks Stiftelse
- Location
- Sweden
Results and Publications
| Intention to publish date | 01/06/2020 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| Publication and dissemination plan | Results on causes for post-operative incontinence will be reported in peer-reviewed journal as soon as accrual is complete and data has been analysed. |
| IPD sharing plan | The data sharing plans for the current study are unknown and will be made available at a later date. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | 30/09/2024 | 02/10/2024 | Yes | No |
Editorial Notes
02/10/2024: Publication reference added.
07/11/2023: The following changes were made to the trial record:
1. The target number of participants was changed from 800 to 1000.
2. The study participating centre Carlanderska Hospital was removed and Skåne University Hospital, Karolinska Stockholm, Skövde Hospital were added.
3. The overall end date was changed from 31/12/2025 to 31/12/2028.
06/06/2022: The overall trial end date has been changed from 31/12/2022 to 31/12/2025 and the plain English summary has been updated accordingly.
11/05/2022: Recruitment to this study is no longer paused. The following changes have been made:
1. The recruitment end date has been changed from 31/12/2023 to 31/12/2024.
2. The target number of participants has been changed from 500 to 800 and the total target enrolment has been changed from 500 to 800.
30/04/2020: Due to current public health guidance, recruitment for this study has been paused. The following additional changes have been made:
1. The total target enrolment has been changed from 300 to 500.
2. The recruitment end date has been changed from 31/12/2021 to 31/12/2023.
21/01/2020: The following changes were made to the trial record:
1. The recruitment end date was changed from 31/12/2019 to 31/12/2021.
2. The overall end date was changed from 31/12/2020 to 31/12/2022.
3. The target number of participants was changed from 200 to 300.
4. The trial participating centres Uddevalla Hospital and Carlanderska Hospital were added.
5. The plain English summary was updated to reflect these changes.
17/01/2020: Internal review.
