Condition category
Surgery
Date applied
03/12/2018
Date assigned
01/05/2019
Last edited
01/05/2019
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

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?
Department of Urology, Sahlgrenska University Hospital, Sahlgrenska Academy at University of Gothenburg. Sweden

When is the study starting and how long is it expected to run for?
January 2015 to December 2020

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

Trial website

Contact information

Type

Scientific

Primary contact

Prof Johan Stranne

ORCID ID

http://orcid.org/0000-0002-4295-6524

Contact details

Bruna Stråket 11B
Gothenburg
41345
Sweden
+46-31-3429007
johan.stranne@vgregion.se

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

Grant ALFGBG-720421

Study information

Scientific title

Incontinence post-robot-assisted radical prostatectomy: anatomical and functional causes

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

Regional ethics review board of Gothenburg (Dnr 131-16), 24/03/2016, Dnr 131-16

Study design

Prospective open non-randomized observational trial

Primary study design

Observational

Secondary study design

Cohort study

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Only in Swedish, not available in web format, please use contact details to request a participant information sheet.

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

Phase

Drug names

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 trial start date

01/01/2015

Overall trial end date

31/12/2020

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

Patients scheduled for robot-assisted laparoscopic radical prostatectomy at Sahlgrenska University Hospital

Participant type

Patient

Age group

Adult

Gender

Male

Target number of participants

200

Participant exclusion criteria

Pre-operative incontinence

Recruitment start date

01/01/2018

Recruitment end date

31/12/2019

Locations

Countries of recruitment

Sweden

Trial participating centre

Dept. of Urology, Sahlgrenska University Hospital
Bruna Stråket 11B
Gothenburg
41645
Sweden

Sponsor information

Organisation

University of Gotheburg

Sponsor details

Box 100
Gothenburg
40530
Sweden

Sponsor type

University/education

Website

https://www.gu.se

Funders

Funder type

Other

Funder name

ALF-medel Västra Götaland

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Prostatacancerförbundet (Swedish Prostate Cancer Association)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Percy Falks Stiftelse för Forskning Beträffande Prostata- och Bröstcancer

Alternative name(s)

Percy Falks Stiftelse

Funding Body Type

private sector organisation

Funding Body Subtype

Trusts, charities, foundations (both publically funded and privately funded)

Location

Sweden

Results and Publications

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 statement
The data sharing plans for the current study are unknown and will be made available at a later date.

Intention to publish date

01/06/2020

Participant level data

To be made available at a later date

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes