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| Name | Class |
|---|---|
| Aberdeen Royal Infirmary | OTHER |
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Aim: The study aim to assess the feasibly a large prospective multi-centre randomised study for comparing the relatively new "Single incision sub-urethral tapes" with the standard surgical treatment of female urodynamic stress incontinence (USI).
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:
Design:
A pilot prospective randomised study within participating urogynaecology units of the "Scottish Pelvic Floor Network".
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single-incision Mini-slings (SIMS- Ajust) | Experimental | 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 |
|
| standared med urethral sling (SMUS) | Other | standard med urethral sling (SMUS)TVT-O, was done as originally described by Deleval et al. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| sub-urethral tape (TVT-O) | Procedure | Tension free vaginal tape vs. single incision sub-urethral tension free vaginal tape |
|
| Measure | Description | Time Frame |
|---|---|---|
| • Feasibility of the single incision sub-urethral tape to be done under local anaesthesia |
| 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| • Patient-reported Success rates | Patient-reported Success rates o Assessed by PGI-I "Very Much Improved/ Much Improved." | 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mohamed Abdel-Fattah, MRCOG | University of Aberdeen | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| (Grampian) Aberdeen Royal Infermary | Aberdeen | Aberdeenshire | AB25 2ZD | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37888839 | Derived | Carter E, Johnson EE, Still M, Al-Assaf AS, Bryant A, Aluko P, Jeffery ST, Nambiar A. Single-incision sling operations for urinary incontinence in women. Cochrane Database Syst Rev. 2023 Oct 27;10(10):CD008709. doi: 10.1002/14651858.CD008709.pub4. |
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| stand standard mid-urethral sling (TVT-O) | Other |
|