ストレス性尿失禁に対するレーザー療法と骨盤底筋トレーニング
高周波レーザー療法と骨盤底筋トレーニングがストレス性尿失禁女性に及ぼす効果：プラセボ無作為化比較試験
調査の概要
状態
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究場所
-
-
Konya
-
Meram、Konya、トルコ（Türkiye）、(507) 534-6142
- Physical Therapy Hospital
-
-
参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
対象基準:
- 18歳から65歳の女性、
- ボランティアとして参加し、仕事に専念できる女性、
- 腹圧性尿失禁と診断された女性、
除外基準:
- 妊娠、
- 治療部位における過去12か月以内の手術歴、
- 活動性の性器感染症、
- 悪性腫瘍の存在、
- 過去3か月以内の全身性ステロイド使用、
- 過去7日以内の膣潤滑剤使用、
- 再発性尿路感染症または性器ヘルペス、
- POP-Qスコア3以上
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：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：トリプル
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
プラセボコンパレーター：Plasebo Laser
This group will only receive placebo laser treatment.
The ND: YAG laser system was configured identically, except for the addition of a metal shielding plate to the hand tool to block energy, which had no therapeutic effect, during treatment.
The laser device will be aimed at 6 points in the perineal area .
Assessments will be conducted twice, baseline and post treatment (at 12 weeks).
|
This group will only receive placebo laser treatment.
The ND: YAG laser system was configured identically, except for the addition of a metal shielding plate to the hand tool to block energy, which had no therapeutic effect, during treatment.
The laser device will be aimed at 6 points in the perineal area .
Assessments will be conducted twice, baseline and post treatment (at 12 weeks).
|
|
アクティブコンパレータ：PFME
In this training, patients are taught pelvic floor exercises, which involve slow and fast muscle contractions that train both Type 1 and Type 2 muscle fibers, using vaginal palpation.
During fast contractions, patients are asked to quickly contract and relax their pelvic floor muscles.
The image of "turning the faucet off and on" is used to help patients better understand this exercise.
During slow contractions, patients are asked to slowly tighten their pelvic floor muscles, hold them for 10 seconds, and then slowly relax them.
One set of pelvic floor muscle exercises consists of 10 fast contractions and 10 slow contractions.
According to this program, pelvic floor exercises are performed in weeks 1-2, 2 sets in weeks 3-4, 4 sets in weeks 5-6, 8 sets in weeks 7-8, and 10 sets in weeks 8-12.
Assessments will be conducted twice, baseline and post treatment (at 12 week).
|
In this training, patients are taught pelvic floor exercises, which involve slow and fast muscle contractions that train both Type 1 and Type 2 muscle fibers, using vaginal palpation.
During fast contractions, patients are asked to quickly contract and relax their pelvic floor muscles.
The image of "turning the faucet off and on" is used to help patients better understand this exercise.
During slow contractions, patients are asked to slowly tighten their pelvic floor muscles, hold them for 10 seconds, and then slowly relax them.
One set of pelvic floor muscle exercises consists of 10 fast contractions and 10 slow contractions.
According to this program, pelvic floor exercises are performed in weeks 1-2, 2 sets in weeks 3-4, 4 sets in weeks 5-6, 8 sets in weeks 7-8, and 10 sets in weeks 8-12.
Assessments will be conducted twice, baseline and post treatment (at 12 week).
|
|
実験的：PFME and Laser Therapy
PFMT, patients are taught pelvic floor exercises, which involve slow and fast muscle contractions that train both Type 1 and Type 2 muscle fibers, using vaginal palpation.
During fast contractions, patients are asked to quickly contract and relax their pelvic floor muscles.
The image of "turning the faucet off and on" is used to help patients better understand this exercise.
During slow contractions, patients are asked to slowly tighten their pelvic floor muscles, hold them for 10 seconds, and then slowly relax them.
One set of pelvic floor muscle exercises consists of 10 fast contractions and 10 slow contractions.
Assessments will be conducted twice, baseline and post treatment (at 12 weeks).
Laser was also applied to this group.
Laser application is applied to 6 points in the perineal area.
Continue and biostimulatory mode, intensity 6W, energy density 120J/cm2.
Application time is 2 minutes for each point, and a total of 6 sessions are applied 3 time.
|
PFMT, patients are taught pelvic floor exercises, which involve slow and fast muscle contractions that train both Type 1 and Type 2 muscle fibers, using vaginal palpation. During fast contractions, patients are asked to quickly contract and relax their pelvic floor muscles. The image of "turning the faucet off and on" is used to help patients better understand this exercise. During slow contractions, patients are asked to slowly tighten their pelvic floor muscles, hold them for 10 seconds, and then slowly relax them. One set of pelvic floor muscle exercises consists of 10 fast contractions and 10 slow contractions. According to this program, pelvic floor exercises are performed in weeks 1-2, in weeks 3-4, in weeks 5-6, in weeks 8-12, and in weeks 12. Laser application is applied to 6 points in the perineal area. Continue and biostimulatory mode, intensity 6W, energy density 120J/cm2. Application time is 2 minutes for each point, and a total of 6 sessions are applied 3 time |
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 |
|---|---|---|
|
Urinary incontinence severity
時間枠：baseline, post treatment (at 12 week)
|
The Incontinence Severity Index (ISI): This is a two-question questionnaire that helps calculate the severity of urinary incontinence in patients.
It categorizes incontinence severity into three groups: mild, moderate, and severe.
It is a useful method for monitoring and assessing incontinence severity.
|
baseline, post treatment (at 12 week)
|
|
The impact of urinary incontinence on quality of life
時間枠：baseline, post treatment (at 12 week)
|
The Incontinence Quality of Life Scale (I-QOL) will be used to determine the impact of urinary incontinence on quality of life in women.
It consists of questions under three headings: behavioral, psychological, and social impact.
The questions will be asked of the participants and recorded.
|
baseline, post treatment (at 12 week)
|
|
pelvic floor dysfuntion severity
時間枠：baseline, post treatment (at 12 week)
|
The Global Pelvic Floor Impact Questionnaire (GPTRA): This questionnaire consists of nine questions addressing pelvic floor dysfunction.
A higher total score indicates a greater degree of symptoms.
Participants were asked questions and recorded.
|
baseline, post treatment (at 12 week)
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Sexually Dysfunction
時間枠：baseline, post treatment (at 12 week)
|
The Female Sexual Function Index (FSFI): It consists of nineteen separate questions. It has six subscales: desire, arousal, lubrication, orgasm, general satisfaction, and pain. Questions 3-14 and 15-19 are scored on a 6-point Likert-type scale (0-5), while the remaining questions are scored on a 5-point Likert-type scale (1-5). The scale, which can be applied to those who have had sexual intercourse within the last month, is scored negatively, with higher scores interpreted as indicating no or low sexual dysfunction. The highest possible score is 36.0, and the lowest is 2.0. The cut-off score is 26.55. Scores of 26.55 and below are considered to indicate sexual dysfunction. |
baseline, post treatment (at 12 week)
|
|
pelvic floor muscle function
時間枠：baseline, post treatment (at 12 week)
|
Pelvic floor muscle function will be assessed with EMG biofeedback.
|
baseline, post treatment (at 12 week)
|
協力者と研究者
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
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
- hlaser
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
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。