Feasibility of Comparing Two Surgical Treatment of Female Urodynamic Stress (SITOT)
Feasibility of Comparing Two Surgical Treatment of Female Urodynamic Stress Incontinence (SITOT)
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
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".
Type d'étude
Inscription (Réel)
Phase
- La phase 1
Contacts et emplacements
Lieux d'étude
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Aberdeenshire
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Aberdeen, Aberdeenshire, Royaume-Uni, AB25 2ZD
- (Grampian) Aberdeen Royal Infermary
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
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
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: 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
|
|
Autre: standared med urethral sling (SMUS)
standard med urethral sling (SMUS)TVT-O, was done as originally described by Deleval et al.
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
• Feasibility of the single incision sub-urethral tape to be done under local anaesthesia
Délai: 1 year
|
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1 year
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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• Patient-reported Success rates
Délai: 1 year
|
Patient-reported Success rates o Assessed by PGI-I "Very Much Improved/ Much Improved." |
1 year
|
Collaborateurs et enquêteurs
Parrainer
Collaborateurs
Les enquêteurs
- Chercheur principal: Mohamed Abdel-Fattah, MRCOG, University of Aberdeen
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- SI-TOT
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