Ignite Creation Date:
2025-12-24 @ 5:08 PM
Ignite Modification Date:
2025-12-27 @ 4:48 AM
Study NCT ID:
NCT01230450
Status:
COMPLETED
Last Update Posted:
2013-01-24
First Post:
2010-10-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Feasibility of Comparing Two Surgical Treatment of Female Urodynamic Stress
Sponsor:
University of Aberdeen
Organization:
Study Overview
Official Title:
Feasibility of Comparing Two Surgical Treatment of Female Urodynamic Stress Incontinence (SITOT)
Status:
COMPLETED
Status Verified Date:
2013-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SITOT
Brief Summary:
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).
Detailed Description:
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:
1. Establish the feasibility of the "Single incision sub-urethral tapes" to be done under local anaesthesia.
2. The feasibility of randomisation to the standard surgical treatment TVT-O / TVT.
3. 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,
4. 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".
Objectives:
1. Establish the feasibility of the "Single incision sub-urethral tapes" to be done under local anaesthesia.
2. The feasibility of randomisation to the standard surgical treatment TVT-O / TVT.
3. 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,
4. 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".
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: