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Prostate CancerNCT03050996

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

An observational study of Prostate Cancer and Urinary Incontinence, run by Istituto Auxologico Italiano at 1 site in Italy.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 90 years, men only
Conditions the study is for
Prostate Cancer, Urinary Incontinence
What is being tested?
robotic radical prostatectomy
Type of treatment
Surgery or procedure
How many people
50 participants
Where
1 siteItaly
Study dates
1 Jun 2016to 30 Jun 2017
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 90 years
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Study population: Patient affected by prostate cancer, scheduled to undergo robotic assisted radical prostatectomy

Who may be able to join

  • Hystopathologically confirmed prostate cancer

Who cannot join

  • Preoperative urinary incontinence
  • Neurological disorders

Trial locations and contacts

1 site in 1 country.

Andrea Cestari, MD contact

+393472710132

a.cestari@auxologico.it

Italy1 site, 1 recruiting
  • Andrea Cestari

    Milan, 20122

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

    Recruiting

Other trials in Italy

About this study

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

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.

Read the 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).

Being tested
robotic radical prostatectomy
Medical subject headings
Prostatic Neoplasms, Urinary Incontinence

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • robotic radical prostatectomyProcedure or surgery

    Also called Questionnaires

    Urodynamic evaluation during robotic radical prostatectomy

Study groups in NCT03050996
Study groupRoleWhat they receive
robotic radical prostatectomy patientsPatient scheduled to undergo robotic assisted radical prostatectomy
Receives: Procedure: robotic radical prostatectomy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Impact of radical prostatectomy and autologous suburethral placement on sphincteric apparatus and early urinary continence recovery

    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)

    Measured: 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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Feb 2017
  2. Study start1 Jun 2016
  3. Primary completion30 May 2017 (estimated)
  4. Study completion30 Jun 2017 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Prospective
Enrolment
50 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03050996
Sponsor's protocol ID
IAI-URO-RPS-RALP
Status last verified
Feb 2017
First submitted
5 Feb 2017
Last updated
13 Feb 2017
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Prostate Cancer and Urinary Incontinence, run by Istituto Auxologico Italiano at 1 site in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 13 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Andrea Cestari, MD (+393472710132, a.cestari@auxologico.it), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2017.

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