Non-specified urinary incontinence
Conditions
Interventions
One hundred women will be submitted to a gynecological exam and will be randomized in two groups: 50 for minisling (Solyx) and 50 for transobturator sling (Obtryx II).
It will be collected hemoglobin
Procedure/surgery
Sponsors
Hospital da Mulher José Aristodemo Pinotti
Boston Scientific
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: Women with 18 years and/or older. Positive cough stress test for SUI or positive findings of stress urinary incontinence at urodynamic study (UDS). Post-voiding residue < 100 ml or less 20% of total urinary volume Maximum bladder capacity over 300 ml
Exclusion criteria
Exclusion criteria: Women with overactive bladder or recurrent UTI or previous urogynecological surgeries. Previous pelvic radiotherapy. Presence of pelvic organ prolapse (POP) stage 2 and over. Past or recent history of bladder lithiasis, inferior urinary fistula or diverticulum. Current use of anticoagulants. Previous surgical history of foreign-body reaction like (eg. history of surgery with prosthetic complications).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary outcome 1 Subjective cure: assessment by the improvement in quality of life using PGI-I and KHQ, and presented with absolute scores. There is not a standardization regarding the score mean difference and it is not expected a difference between the groups. They will be measured with 6 and 12 months.;Primary outcome 2 Objective cure (Valsalva´s maneuver) in 6, 12 months: assessment of SUI after 3,6 and 12 months of surgical procedure according to the urodynamic study and categorized in yes or no. It is expected an efficacy rate of 60-80% in both groups, with no difference between them. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcome 10 Thigh pain, defined by the patient a pain in the medial perineal area next in the thigh, categorized into yes or no. It is expected a higher rate of thigh pain in the transobturator group.Assessed at 6 and 12-month postoperative follow-up.;Secondary outcome 11 De novo urgency - a non-expected and quick desire to void that started after the surgery and categorized into yes or no. It is expected a low rate (<1%)with no difference between the groups.Assessed at 6 and 12-month postoperative follow-up.;Secondary outcome 1 Relapse: return of the complaint of urinary incontinence verified after Valsalva maneuver and categorized into yes or no. It is expected a 10% relapse rate in 12 months with no difference between both groups. Assessed at 6 and 12-month postoperative follow-up.;Secondary outcome 2 Pain scale (VAS) - graduates pain in immediate postoperative period - varies from 0 (no pain) to 10 (maximum pain). It is expected a higher VAS for the minisling group.;Secondary outcome 3 Intraoperative bleeding, quantified by the difference between final and initial hemoglobin levels, expressed in absolute values. It is not expected a difference between pre and post op values, neither a difference between groups.;Secondary outcome 4 Need for transfusion, defined as the use of erithrocytes during intraoperative period and categorized in yes or no. It is expected a low rate (<1%)with no difference between the groups.;Secondary outcome 5 Organ lesion (bladder, intestinal or vascular), categorized into yes or no, by physical or imaging exam during ntra and postoperative period. It is expected a low rate (<1%)with no difference between the groups.;Secondary outcome 6 Acute urinary retention, defined as the impossibility to urinate spontaneously after surgery and categorized into yes or no until 15 days after surgery. It is expected a low rate (<10 %)with no difference between the groups.;Secondary outcome 7 Mesh erosion - presence of a dehiscence are | — |
Countries
Brazil
Contacts
Public ContactLuiz Gustavo Brito
Hospital da Mulher José Aristodemo Pinotti
Outcome results
None listed