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Comparing Minisling to Tension Free Vaginal Tape in Mangement of Stress Urinary Incontinence

Primary Purpose

Stress Urinary Incontinence

Status

Completed

Phase

Phase 2

Locations

Egypt

Study Type

Interventional

Intervention

single incision minisling

tension free vaginal tape

About this trial

This is an interventional treatment trial for Stress Urinary Incontinence focused on measuring stress urinary incontinence, tension free vaginal tape, single incision minisling, midurethral sling

Eligibility Criteria

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Inclusion Criteria:

Patients with urodynamic stress urinary incontinence, with or without pelvic organ prolapse

Exclusion Criteria:

Patients with overactive bladder on urodynamic study.
Patients with voiding dysfunction.
Patients with intrinsic sphincteric deficiency.
Patients with previous anti-incontinence surgery.
Patients on anti-coagulant therapy.
Immune-compromised patients (DM, patients on corticosteroids treatment).
Refusal of surgery.

Sites / Locations

Ain Shams University, Maternity Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

minisling

tension free vaginal tape

Arm Description

patients in this arm will undergo single incision minisling

patients in this arm will undergo tension free vaginal tape

Outcomes

Primary Outcome Measures

objective cure rate of urinary incontinence at 12 months after surgery

Objective cure is indicated by a negative stress test and the absence of any additional surgical or nonsurgical treatment for stress urinary incontinence

subjective cure rate of urinary incontinence at 12 months after surgery

subjective cure is indicated by an Incontinence Severity Index score of 0 and the absence of any additional surgical or nonsurgical treatment for stress urinary incontinence

Secondary Outcome Measures

Number of participants with short- term complications

short-term complications (less than 6 weeks): post-operative pain, urinary retention, denovo urgency and wound sepsis

Number of participants with long-term complications

long-term complications: erosion, dyspareunia and recurrence

Full Information

NCT ID

NCT02263534

First Posted

August 20, 2014

Last Updated

September 18, 2018

Sponsor

Ain Shams University

1. Study Identification

Unique Protocol Identification Number

NCT02263534

Brief Title

Comparing Minisling to Tension Free Vaginal Tape in Mangement of Stress Urinary Incontinence

Official Title

Randomized Controlled Trial Comparing Minisling to Tension Free Vaginal Tape in Mangement of Stress Urinary Incontinence

Study Type

Interventional

2. Study Status

Record Verification Date

September 2018

Overall Recruitment Status

Completed

Study Start Date

November 10, 2014 (Actual)

Primary Completion Date

June 2017 (Actual)

Study Completion Date

October 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Ain Shams University

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

Based on previous studies the single incision minisling is an easy less invasive procedure with fewer complications and cure rate similar to conventional midurethral slings in the treatment of female stress urinary incontinence. The aim of this study is to test the hypothesis that the single incision mini-sling placed in the "U" position is not inferior to TVT in this patient population.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Stress Urinary Incontinence

Keywords

stress urinary incontinence, tension free vaginal tape, single incision minisling, midurethral sling

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2, Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantOutcomes Assessor

Allocation

Randomized

Enrollment

48 (Actual)

8. Arms, Groups, and Interventions

Arm Title

minisling

Arm Type

Experimental

Arm Description

patients in this arm will undergo single incision minisling

Arm Title

tension free vaginal tape

Arm Type

Sham Comparator

Arm Description

patients in this arm will undergo tension free vaginal tape

Intervention Type

Procedure

Intervention Name(s)

single incision minisling

Intervention Description

midline incision of the vagina at midurethral level dissection of the vagina from perivesical fascia insertion of the tape (polypropylene macropore mesh tape) in the retropubic direction with its end grasped with an artery forceps till level of perineal membrane closure of the vagina 2 sham incisions if the skin only will be made at suprapubic to maintain blindness posterior colpoperneorraphy will be carried out if needed

Intervention Type

Procedure

Intervention Name(s)

tension free vaginal tape

Other Intervention Name(s)

TVT

Intervention Description

midline incision of the vagina at midurethral level dissection of the vagina from perivesical fascia insertion of the tape (polypropylene macropore mesh tape) with the applicators in the retropubic direction and 2 skin incision will be made supra pubic through which the applicators will be passed and removed and the tape will be cut at level just below the skin closure of the vagina posterior colpoperneorraphy will be carried out if needed

Primary Outcome Measure Information:

Title

objective cure rate of urinary incontinence at 12 months after surgery

Description

Objective cure is indicated by a negative stress test and the absence of any additional surgical or nonsurgical treatment for stress urinary incontinence

Time Frame

12 months

Title

subjective cure rate of urinary incontinence at 12 months after surgery

Description

subjective cure is indicated by an Incontinence Severity Index score of 0 and the absence of any additional surgical or nonsurgical treatment for stress urinary incontinence

Time Frame

12 months

Secondary Outcome Measure Information:

Title

Number of participants with short- term complications

Description

short-term complications (less than 6 weeks): post-operative pain, urinary retention, denovo urgency and wound sepsis

Time Frame

12 months

Title

Number of participants with long-term complications

Description

long-term complications: erosion, dyspareunia and recurrence

Time Frame

12 months

10. Eligibility

Sex

Female

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Patients with urodynamic stress urinary incontinence, with or without pelvic organ prolapse Exclusion Criteria: Patients with overactive bladder on urodynamic study. Patients with voiding dysfunction. Patients with intrinsic sphincteric deficiency. Patients with previous anti-incontinence surgery. Patients on anti-coagulant therapy. Immune-compromised patients (DM, patients on corticosteroids treatment). Refusal of surgery.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

ahmed reda, M.Sc

Organizational Affiliation

Ain Shams University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Ain Shams University, Maternity Hospital

City

Cairo

Country

Egypt

12. IPD Sharing Statement

Plan to Share IPD

Undecided

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Comparing Minisling to Tension Free Vaginal Tape in Mangement of Stress Urinary Incontinence

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