- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT01230450
Feasibility of Comparing Two Surgical Treatment of Female Urodynamic Stress (SITOT)
Feasibility of Comparing Two Surgical Treatment of Female Urodynamic Stress Incontinence (SITOT)
연구 개요
상태
정황
상세 설명
Single incision tension-free sub-urethral vaginal tapes procedures8 have been recently described in an attempt to avoid the blind passage of the trochars through the groin & the adductor muscles and consequently reducing the incidence & severity of postoperative leg pain. The obvious advantages would be shorter hospital stay, early recovery, early resumption of day to day activities & earlier return to work. A number of small prospective audits and case-series have been presented in international conferences reporting on the safety & outcomes for these procedures. However all these studies were for preliminary reports for proof of concept and therefore the studies populations were 15-70 women with short term follow-up of 2-3 month9-11.These studies have shown low perioperative complication rates: bladder injury 0-1%, vaginal erosion 1-3% & one study showing 1.3% pain at 6 weeks follow-up. The patient reported success rates were 77-93% at 2-3 month follow-up9-12.
Objectives:
- Establish the feasibility of the "Single incision sub-urethral tapes" to be done under local anaesthesia.
- The feasibility of randomisation to the standard surgical treatment TVT-O / TVT.
- To compare the surgical approach in this relatively new procedure against the standard procedures as regard: Peri-operative complication rates, Postoperative pain, Time to discharge from the hospital,
- To compare the outcomes as regard: Patient-reported cure rates, Patient satisfaction, Impact on Quality of life (QoL) and sexual function at 3 month & 1 -year follow-up. The objective cure rates will be assessed at 3 month follow-up.
Design:
A pilot prospective randomised study within participating urogynaecology units of the "Scottish Pelvic Floor Network".
연구 유형
등록 (실제)
단계
- 1단계
연락처 및 위치
연구 장소
-
-
Aberdeenshire
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Aberdeen, Aberdeenshire, 영국, AB25 2ZD
- (Grampian) Aberdeen Royal Infermary
-
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- USI
- Mixed incontinence symptoms with predominantly bothering stress component (No DO on UDS).
- Primary Incontinence Surgery.
- BMI < 35
- Ability to understand the information leaflet and sign an informed consent form in English.
- All would have had failed or declined PFMT.
Exclusion Criteria:
- Mixed incontinence with pre-dominant OAB and/or Neurological conditions e.g. MS.
- Detrusor Overactivity on Urodynamics.
- Inability to understand English.
- Un-willing for randomisation.
- Concomitant surgery.
- Patient requiring postoperative hospital-stay for medical or social reasons
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
---|---|
실험적: Single-incision Mini-slings (SIMS- Ajust)
AjustTM has polypropylene fixing anchors (one is fixed and the other adjustable) which are anchored onto the obturator membrane.
The pulley like system enables adjustment of the tension once the arms have been anchored.
Once in place, the anchors rest at right angles to insertion which is claimed to reduce the chances of anchor dislodgment
|
Tension free vaginal tape vs. single incision sub-urethral tension free vaginal tape
|
다른: standared med urethral sling (SMUS)
standard med urethral sling (SMUS)TVT-O, was done as originally described by Deleval et al.
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
• Feasibility of the single incision sub-urethral tape to be done under local anaesthesia
기간: 1 year
|
|
1 year
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
• Patient-reported Success rates
기간: 1 year
|
Patient-reported Success rates o Assessed by PGI-I "Very Much Improved/ Much Improved." |
1 year
|
공동 작업자 및 조사자
수사관
- 수석 연구원: Mohamed Abdel-Fattah, MRCOG, University of Aberdeen
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
여성 복압성 요실금에 대한 임상 시험
-
Goethe UniversityLudwig-Maximilians - University of Munich완전한
sub-urethral tape (TVT-O)에 대한 임상 시험
-
Federal University of São PauloJohnson & Johnson완전한
-
Assiut University아직 모집하지 않음
-
Austrian Urogynecology Working Group (AUWG)완전한
-
South Glasgow University Hospitals NHS TrustHenry Smith Grant알려지지 않은