- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT01821209
A Study of Intra-operative Autologous Retropubic Urethral Sling on Urinary Control After Robot Assisted Radical Prostatectomy (Sling)
A Randomized Study of Intra-operative Autologous Retropubic Urethral Sling on Urinary Control After Robot Assisted Radical Prostatectomy
Studieoversigt
Status
Intervention / Behandling
Detaljeret beskrivelse
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
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California
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San Francisco, California, Forenede Stater, 94143-1695
- University of California, San Francisco
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- Newly diagnosed patients undergoing robot assisted radical prostatectomy at UCSF
- Histologically defined adenocarcinoma of the prostate
- English or Spanish speaking patients with the ability to provide informed written consent and willingness to comply with the requirements of the protocol
- Age 40-75 year
Exclusion Criteria:
· Patients should not have received any radiation or hormonal therapy prior to surgery for any purpose
- Any prior prostate surgery
- No current or previous history of urinary incontinence requiring chronic pad use or treatments for urinary incontinence
- Patients may not be receiving any other investigational agents
- Any condition that compromises compliance with the objectives and procedures of this protocol, as judged by the principal investigator
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Firedobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Ingen indgriben: Control
Standard robot assisted radical prostatectomy
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Eksperimentel: Sling
Placement of sling at time of robot assisted radical prostatectomy
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Placement of a retropubic urethral sling will involve dissection and harvesting of the right and left vas deferens, which we will be taken out of the body by the bed side assistant who will suture the two vas deferens together in a side to side fashion with the smaller of the two vas deferens placed in the middle of the larger one.
A single 3-0 V-lock suture on a CV23 needle will be placed through one end of the vas sling and then passed into the body by the bed side assistant.
The sling will then be placed on the rectum below the site of the vesicourethral anastamosis and the anastamosis will be completed.
The sling will then be placed around the vesicourethral anastomosis, suspended to the pubic symphysis and tensioned to allow elevation of the vesicourethral anastomosis.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Pad use
Tidsramme: 6 months
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The primary objective of this study is to compare the proportion of people requiring 0 pads per day 6 months after RARP in men with and without sling placement.
Patients will also be assessed at 1 and 3 months.
|
6 months
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Time to zero pads
Tidsramme: 6 months
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Determine if there is a difference in median time to continence defined as not requiring any pad post-surgery between those with and without a sling.
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6 months
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Andre resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Additional pad use outcomes at one and three months
Tidsramme: 3 months
|
2.1 Compare the proportion of patients with and without sling placement who use at most 1 pad per day after RARP. Patients will be assessed to determine the frequency at 1, 3 and 6 months. 2.3 Determine if urinary quality of life as measured by a change from baseline in the Expanded Prostate Cancer Index Composite (EPIC) urinary domain scores differ between sling and non-sling patients at 1, 3 and 6 months 2.4 Determine if urinary obstructive symptoms as measured by a change from baseline in the International Prostate Symptom Score (IPSS) differ between sling and non-sling patients at 1, 3 and 6 months 2.5 Determine if there is a difference in urinary retention at 3 months after surgery between sling and non sling patients. |
3 months
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Samarbejdspartnere og efterforskere
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- SLING2013
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