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

NCT01500603 | Terminated

• 1 other identifier: P100143
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

post-radical prostatectomy; stress urinary incontinence; periurethral Pro-ACT balloons; AdvanceXP retrourethral male sling

Outcome Measures

Primary Outcomes (1)

• 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 management in the year after operation

  12 months after surgical treatment

Secondary Outcomes (2)

• complications

  1, 3 6 and 12 months after surgical treatment

• Cost-effectiveness study of the device

  12 months after surgical treatment

Study Arms (2)

Experimental

EXPERIMENTAL

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

Device: AdvanceXP Male sling device

Active comparator

ACTIVE COMPARATOR

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.

Device: Pro-ACT balloon device

Interventions

AdvanceXP Male sling device 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.

Experimental

Pro-ACT balloon device 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.

Active comparator

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \> 18 years
• Patient presenting mild to moderate stress urinary incontinence (20g \< 72 hours pad-test \< 300g) following radical prostatectomy more than 1 year ago.
• Patient capable of roaming, independent and capable of using toilet without any trouble.
• Patients able to answer to questionnaire and communicate in French
• Informed consent
• Patients with social security

You may not qualify if:

• Uncontrolled prostatic adenocarcinoma or PSA \> 1 ng/ml
• Maximum urinary flow rate \< 15 ml/sec
• Postvoid residual volume \> 150 ml
• Urinated volume in 24h \> 3000 ml
• Uninhibited detrusor contractions associated with leakage during the preoperative urodynamic assessment (realized under anticholinergic if the patient is usually under this medication)
• Severe incontinence (Pad test \> 300g/24h)
• History of artificial urinary sphincter
• Known neurologic bladder dysfunction
• History of neurological disease which can interfere with the urinary symptoms
• Presence of a urethral stenosis or of an anastomotic stricture during the preoperative endoscopy.
• Uncontrolled urinary tract infection
• Patients affected by an infiltrative bladder tumour
• Patients with bladder stones
• Severe constitutional hemorrhagic disease or haemophilia
• Deep depression of immune system

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Service d'urologie, Hôpital Tenon

Paris, 75020, France

Location

MeSH Terms

Conditions

Urinary Incontinence, Stress

Condition Hierarchy (Ancestors)

Urinary Incontinence; Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• François Haab

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 23, 2011
• First Posted: December 28, 2011
• Study Start: March 1, 2013
• Primary Completion: June 1, 2014
• Study Completion: June 1, 2014
• Last Updated: October 8, 2014

Record last verified: 2014-10

Locations

FR (1)