Periurethral Pro-ACTTM Balloons vs Retrourethral AdvanceXP(TM) Male Sling for Post-prostatectomy Incontinence

Summary

Background: Periurethral Pro-ACT balloons and retrourethral AdvanceXP(TM) male sling have been presented as efficient treatments for management of stress urinary incontinence (SUI) following radical prostatectomy (RP), but no comparative study of these two techniques has been published. The investigators aims were to compare the efficacy of the two devices and provide data about their cost effectiveness.

Hypothesis: The study is based on the superiority hypothesis that AdvanceXP male slings is more efficacious than Pro-ACT balloons at one year follow-up.

Primary objective: The primary objective of this study is to compare the efficacy of the AdvanceXP retrourethral male sling and periurethral Pro-ACT balloons management of SUI after RP at one year follow-up.

Secondary objectives:

* Comprehensive comparative medical evaluation of the two devices in terms of efficacy
* Complete evaluation of the side effects of the two techniques
* Evaluation of the quality of life
* Evaluation of patient satisfaction
* Cost-effectiveness study of the device (total cost over one year of each of the two techniques, differential cost-effectiveness ratio (cost adjusted by QALY), differential cost-effectiveness ratio in terms adjusted to success rate, recommendations that can be made for assessing the potential coverage by the French healthcare system) Population: Patients with history of RP without cancer recurrence, presenting pure SUI on urodynamics (without detrusor overactivity), of mild to moderate degree (24hour pad-test \< 300g).

Study design: This is a prospective, randomized, multicentric (9 tertiary reference centers), comparative trial of the two devices (with a superiority hypothesis). The total number of subjects required is 240 and inclusion period is 12 months. Follow-up consists in 4 visits at 1, 3, 6 and 12 months, with data collection (pad use, uroflowmetry, quality of life validated questionnaires ICIQ-SF and EQ-5D, 24-hr pad test, patient satisfaction with PGI-I and report of any secondary effect). Statistical evaluation is carried out at the end of the follow-up, in intent to treat.

Medical evaluation:

Main criterion:failure of the treatment, defined by reduction of less than 50% of incontinence on 24-hr pad test, explantation of the device or implantation of a new surgical device for SUI.

Secondary outcome criteria

* pad usage per day
* quantitative reduction of the 24hr-pad test
* complications (infection, erosion, hematoma, acute urinary retention)
* number of re-interventions or re-admissions during follow-up
* quality of life measured by the ICIQ-SF questionnaire
* patient satisfaction by the PGI-I questionnaire

Economic evaluation:

* Study of the total cost over one year in each case
* Adjustment of cost of each device to quality of life (QALY evaluation)
* Cost effectiveness study
* Proposals will be made to state at which level the two devices should be covered by the healthcare system.

Conditions

• Stress Urinary Incontinence

Interventions

DEVICE

AdvanceXP Male sling device

Patients will receive AdvanceXP retrourethral male sling (polypropylene mesh) implantation under general or loco-regional anaesthesia, by perineal approach. The sling is placed via transobturator route.

DEVICE

Pro-ACT balloon device

Patients will receive Pro-ACT balloons implantation under general or loco-regional anaesthesia, by perineal approach. The balloons are placed under X-ray control laterally to the urethra, under the bladder neck. The extremity of the device (titanium port), linked to the balloon, is located subcutaneously in the scrotum. During post-operative visits, readjustments of the volume of the balloons will be made under local anaesthesia. The volume will be increased or decreased according to the patients symptoms.

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris

  lead OTHER

Principal Investigators

• François Haab · Assistance Publique - Hôpitaux de Paris

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

MALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2013-03-31

Primary Completion

2014-06-30

Completion

2014-06-30

Countries

• France

Study Locations