스트레스성 요실금을 위한 레이저 요법과 골반저 근육 훈련
고주파 레이저 치료와 골반저근 운동이 스트레스성 요실금 여성에게 미치는 영향: 위약 대조 무작위 대조 시험
연구 개요
상태
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Konya
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Meram, Konya, 터키 (Türkiye), (507) 534-6142
- Physical Therapy Hospital
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참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
포함 기준:
- 18-65세 여성,
- 자발적으로 참여하고 일할 의사가 있는 여성,
- 스트레스성 요실금 진단을 받은 여성,
제외 기준:
- 임신,
- 치료 부위에 대한 12개월 이내의 이전 수술,
- 활성 생식기 감염,
- 악성 종양의 존재,
- 지난 3개월 이내의 전신 스테로이드 사용,
- 지난 7일 이내의 질 윤활제 사용,
- 재발성 요로 감염 또는 생식기 포진,
- POP-Q 점수 3 이상
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 삼루타
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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위약 비교기: 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).
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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).
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활성 비교기: 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).
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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).
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실험적: 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.
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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 |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Urinary incontinence severity
기간: baseline, post treatment (at 12 week)
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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.
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baseline, post treatment (at 12 week)
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The impact of urinary incontinence on quality of life
기간: baseline, post treatment (at 12 week)
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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.
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baseline, post treatment (at 12 week)
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pelvic floor dysfuntion severity
기간: baseline, post treatment (at 12 week)
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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.
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baseline, post treatment (at 12 week)
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Sexually Dysfunction
기간: baseline, post treatment (at 12 week)
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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)
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pelvic floor muscle function
기간: baseline, post treatment (at 12 week)
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Pelvic floor muscle function will be assessed with EMG biofeedback.
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baseline, post treatment (at 12 week)
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공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- hlaser
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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