Preoperatieve bekkenbodemfysiotherapie om stress te minimaliseren Urine-incontinentie na Holmium Laser-enucleatie van de prostaat
The purpose of this study is to allow us to assess the effectiveness (or success) of starting pelvic floor physical therapy (i.e. exercises for your pelvic muscles) prior to HoLEP (holmium laser enucleation of the prostate) surgery for enlarged prostates in order to manage or prevent urinary incontinence (i.e. leaking) after surgery (i.e. post-operatively). Your pelvic floor refers to the muscles under your bladder along your pelvic bones that prevent you from leaking urine or stool. Traditionally, pelvic floor physical therapy is started after surgery and continued until urinary continence (i.e. no leaking of urine) is regained. We want to assess if beginning pelvic floor physical therapy prior to surgery (and continuing afterwards) reduces the time required to regain urinary continence following HoLEP.
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
The incidence of benign prostatic hyperplasia (BPH) in men significantly increases with age and is estimated to impact over 80% of men 70 to 80 years of age. HoLEP is one of many treatments for BPH and associated lower urinary tract symptoms. Compared to other minimally invasive surgical techniques for treatment of BPH, HoLEP has been found to have superior outcomes and is a prostate size-independent procedure with excellent durability, high efficacy, and low complications rates. However, transient stress urinary incontinence (SUI) following HoLEP may last for several months after surgery and can lead to diminished patient quality of life during the recovery period. Measures to prevent or reduce post-operative SUI following HoLEP, including PFPT, may improve patient outcomes.
SUI is also commonly documented after radical prostatectomy (RP) for prostate cancer. The mechanism for incontinence in both RP and HoLEP is thought to at least partially be related to temporary weakness of the external urinary sphincter, which is part of the pelvic floor musculature. While it is unclear if post-operative PFPT alone reduces SUI for patients who have undergone RP, there is evidence that PFPT started pre-operatively and continued post-operatively can decrease SUI following RP.
The utilization of pre-operative PFPT for patients undergoing HoLEP to reduce post-operative SUI is currently not well documented. To date, only one study has demonstrated evidence that PFPT prior to HoLEP may improve continence at 3 months. However, the study included patients with a BMI significantly lower than average in the United States, utilized an unclear PFPT program, and had a relatively small median prostate size (~60 mL), which is important as studies have shown that prostate size can affect post-operative incontinence.
We propose a prospective randomized trial to investigate the efficacy of standardized pre-operative PFPT in reducing SUI and improving patient QoL following HoLEP. This study will help determine the role of pre-operative PFPT in the management of HoLEP associated SUI.
Studietype
Inschrijving (Werkelijk)
Fase
- Niet toepasbaar
Contacten en locaties
Studie Locaties
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Ohio
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Cleveland, Ohio, Verenigde Staten, 44195
- Cleveland Clinic
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
Inclusion Criteria:
- Age: >=18 years of age
- Sex: male sex assigned at birth (needs to have a prostate)
- BMI: all BMI
- Ethnic background: all ethnicities
- Medical history: patients scheduled to undergo HoLEP for BPH/LUTS and associated complications (i.e. gross hematuria, retention, etc.).
Exclusion Criteria:
- Neurological disorders: patients with a history of a neurologic disorder that could affect muscle function, neurogenic bladder, lumbosacral spine pathology
- Specific urologic conditions: patients with pre-operative indwelling catheter, urethral stricture greater than 1 centimeter in length or requiring dilation/incision, indwelling ureteral stent
- History of pelvic radiation: patient with prior pelvic radiation will be excluded
- Patients unable to give consent
- Non-English speaking patients given the need for multiple surveys and telephone follow-ups.
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Preventie
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Experimenteel: Preoperative PFPT
This group of patients will be instructed to start pelvic floor physical therapy 1 month before surgery. |
Pelvic floor physical therapy to start before prostate surgery rather than after surgery. |
|
Geen tussenkomst: Postoperative PFPT
This group of patients will be instructed to start pelvic floor physical therapy after surgery (standard of care). |
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Time to continence
Tijdsspanne: 6 months after surgery
|
Time to recover from transient postoperative stress urinary incontinence |
6 months after surgery
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Uroflow
Tijdsspanne: 6 months after surgery
|
urine flow rate (milliliters/second) |
6 months after surgery
|
|
Post void residual
Tijdsspanne: 6 months after surgery
|
Residual urine after voiding (milliliters) |
6 months after surgery
|
|
international prostate symptom score
Tijdsspanne: 6 months after surgery
|
validated questionnaire on urination symptoms |
6 months after surgery
|
|
operative time
Tijdsspanne: day of surgery
|
length of surgery (minutes) |
day of surgery
|
|
length of stay
Tijdsspanne: 30 days after surgery
|
days of hospitalization after surgery |
30 days after surgery
|
|
catheter duration
Tijdsspanne: 30 days after surgery
|
days with catheter after surgery |
30 days after surgery
|
|
infectious complications
Tijdsspanne: 30 days after surgery
|
urinary tract infection complication after surgery |
30 days after surgery
|
|
emergency room visits
Tijdsspanne: 30 days after surgery
|
number of emergency room visits related to surgery |
30 days after surgery
|
Medewerkers en onderzoekers
Sponsor
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Geschat)
Studie voltooiing (Geschat)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
- Urogenitale ziekten
- Mannelijke urogenitale ziekten
- Urologische ziekten
- Vrouwelijke urogenitale ziekten
- Vrouwelijke urogenitale ziekten en zwangerschapscomplicaties
- Plasstoornissen
- Urologische manifestaties
- Pathologische aandoeningen, tekenen en symptomen
- Tekenen en symptomen
- Lagere urinewegsymptomen
- Urineretentie
Andere studie-ID-nummers
- 23-1128
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
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