ホルミウムレーザーによる前立腺核出術後の腹圧性尿失禁を最小限に抑えるための術前骨盤底理学療法
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.
調査の概要
詳細な説明
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.
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
-
-
Ohio
-
Cleveland、Ohio、アメリカ、44195
- Cleveland Clinic
-
-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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.
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：防止
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：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. |
|
介入なし：Postoperative PFPT
This group of patients will be instructed to start pelvic floor physical therapy after surgery (standard of care). |
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Time to continence
時間枠：6 months after surgery
|
Time to recover from transient postoperative stress urinary incontinence |
6 months after surgery
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Uroflow
時間枠：6 months after surgery
|
urine flow rate (milliliters/second) |
6 months after surgery
|
|
Post void residual
時間枠：6 months after surgery
|
Residual urine after voiding (milliliters) |
6 months after surgery
|
|
international prostate symptom score
時間枠：6 months after surgery
|
validated questionnaire on urination symptoms |
6 months after surgery
|
|
operative time
時間枠：day of surgery
|
length of surgery (minutes) |
day of surgery
|
|
length of stay
時間枠：30 days after surgery
|
days of hospitalization after surgery |
30 days after surgery
|
|
catheter duration
時間枠：30 days after surgery
|
days with catheter after surgery |
30 days after surgery
|
|
infectious complications
時間枠：30 days after surgery
|
urinary tract infection complication after surgery |
30 days after surgery
|
|
emergency room visits
時間枠：30 days after surgery
|
number of emergency room visits related to surgery |
30 days after surgery
|
協力者と研究者
スポンサー
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- 23-1128
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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