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Retrograde Perfusion Sphinterometry and Autologous Sling to Improve Urinary Continence in Robotic Radical Prostatectomy

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ClinicalTrials.gov Identifier: NCT03050996
Recruitment Status : Unknown
Verified February 2017 by acestari, Istituto Auxologico Italiano.
Recruitment status was:  Recruiting
First Posted : February 13, 2017
Last Update Posted : February 13, 2017
Sponsor:
Information provided by (Responsible Party):
acestari, Istituto Auxologico Italiano

Brief Summary:

Urinary continence recovery remains one of the most bothersome side effect of modern radical prostate surgery and several technical modifications, especially in Robotic assisted radical prostatectomy procedures, have been reported in order to improve early urinary continence recovery.

With the aim to improve the urinary continence recovery after robotic prostatectomy, we evaluate the impact of the use of a 6-branch retropubic suburethral autologous sling, created and placed during the procedure, in association with intraoperative evaluation of the retrograde leak point pressure by means of retrograde perfusion sphincterometry for proper sling tensioning.


Condition or disease Intervention/treatment
Prostate Cancer Urinary Incontinence Procedure: robotic radical prostatectomy

Detailed Description:

Retrograde leak point pressure (RLPP) is intraoperatively evaluated, by means of retrograde perfusion sphinterometry, in patients scheduled to undergo RALP at our Institution, with no patient affected by preoperative urinary incontinence or neurological disorders.

Retrograde Perfusion Sphincterometry (RPS) technique. With the patient under general anaesthesia, with a nasogastric tube and rectal tube to decompress the bowel, properly positioned for RALP procedure (30° of trendelemburg), a graduated fluid supporting pole is positioned in order that the 0 cm position resulted at the level of patient's pubis . At the beginning of the surgical procedure, the indwelling 16ch Foley catheter is inserted and the bladder fully emptied.

The deflated Foley catheter is then retracted to mid urethra/fossa navicularis and inflated with 1.5 cc of Saline in order to prevent fluid extravasation from the external meatus. The catheter is then connected to a 500 cc of Saline perfusate bottle and the bottle is progressively lowered (along the fluid supporting pole) from an eight of 1 meter above the pubis till the fluid stops to flow. The value, in cmH2O, at which the fluid stops to flow into the bladder represents the RLPP.

Six-branch autologous sling surgical technique. Briefly, after bilateral vas deferens harvesting at the time of bladder mobilization during RALP, the sling is prepared on scrub nurse table with six absorbable CT2 needle 0-Vicryl sutures (each measuring 16 cm in length), tight centrally together; the vas deferens are cut in 6 specimens and transfixed with the suture and collected centrally in order to create the bulky central part of the sling .

Before urinary continuity restoration, the sling is introduced into the surgical field and its extremities are fixed bilaterally to the periosteum of the pubic branches at medial (just lateral to the symphysis), lateral and posterior level; the denonvilliers fascia is restored in a double layer fashion in order to separate the urethrovesical anastomosis from the sling. Upon completion of the urethrovesical anastomosis, the sling is tensioned, tightening together the two medial branches first, then the two lateral ones. After subjective proper tension is achieved, the RLPP is evaluated and the tension adjusted accordingly to pre surgery values.

RLPP was respectively evaluated before pneumoperitoneum induction (RLPPb) and after pneumoperitoneum induction (RLPPp). RLPP was then evaluated after urethrovesical anastomosis (RLPPa) and during proper sling tensioning (RLPPs). The aim of sling tensioning was to obtain similar pressures as after pneumoperitoneum induction (RLPPs ≅RLPPp).

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Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Intraoperative Evaluation or Retrograde Leack Point Pressure During Robot Assisted Radical Prostatectomy for Proper Autologous Suburethral Sling Tensioning to Improve Early Urinary Continence Recovery
Actual Study Start Date : June 1, 2016
Estimated Primary Completion Date : May 30, 2017
Estimated Study Completion Date : June 30, 2017

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
robotic radical prostatectomy patients
Patient scheduled to undergo robotic assisted radical prostatectomy
Procedure: robotic radical prostatectomy
Urodynamic evaluation during robotic radical prostatectomy
Other Name: Questionnaires




Primary Outcome Measures :
  1. Impact of radical prostatectomy and autologous suburethral placement on sphincteric apparatus and early urinary continence recovery [ Time Frame: Intraoperative evaluation of sphincteric efficacy with Retrograde Leak Point Pressure evaluation - post operative recovery of urinary continence at catheter removal - 10 and 30 days after catheter removal - 6 and 12 months after surgery ]
    evaluation of sphincteric competence after prostate ablation and sling placement under urodynamic evaluation (Retrograde Leak Point Pressure in cmH2O) and recovery of urinary continence (number of pads used)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patient affected by prostate cancer, scheduled to undergo robotic assisted radical prostatectomy
Criteria

Inclusion Criteria:

  • Hystopathologically confirmed prostate cancer

Exclusion Criteria:

  • Preoperative urinary incontinence
  • Neurological disorders

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03050996


Contacts
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Contact: Andrea Cestari, MD +393472710132 a.cestari@auxologico.it

Locations
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Italy
Andrea Cestari Recruiting
Milano, Italy, 20122
Contact: Andrea Cestari, MD    +393472710132    a.cestari@auxologico.it   
Sponsors and Collaborators
Istituto Auxologico Italiano
Investigators
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Principal Investigator: Andrea Cestari, MD Istituto Auxologico Italiano
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Responsible Party: acestari, Head Department of Urology, Istituto Auxologico Italiano
ClinicalTrials.gov Identifier: NCT03050996    
Other Study ID Numbers: IAI-URO-RPS-RALP
First Posted: February 13, 2017    Key Record Dates
Last Update Posted: February 13, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Urinary Incontinence
Urination Disorders
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms