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| Does local vaginal estrogen after tension-free transobturator vaginal tape reduce overactive bladder symptoms in postmenopausal women? A prospective randomized, controlled study |
Samer Mahmoud Morsya,*( ),Dalia Faroukb,Sara Hassanb,Ahmed Yehia Abdelaziza,Hussein Aly Husseina
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aUrology Department, Kasr Al Ainy Hospital, Cairo University, Cairo, Egypt
bObstetrics and Gynecology Department, Kasr Al Ainy Hospital, Cairo University, Cairo, Egypt |
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Abstract Objective: We aimed to evaluate the efficacy of topical estrogen after transvaginal tension-free vaginal tape-obturator (TVT-O) in the treatment of de novo overactive bladder symptoms that appear after surgery. Methods: This is a prospective randomized controlled study performed in the Urology and Gynecology Departments, Kasr Al Ainy Hospital, Cairo University, Cairo, Egypt. Two hundred and ten postmenopausal females presenting during the period between January 2017 and November 2020 with stress urinary incontinence were included in the study. Patients were divided into two groups, 105 patients in Group A (treatment group) and 105 patients in Group B (control group). Patients in Group A underwent transvaginal TVT-O followed by local vaginal estrogen treatment for 6 months, while patients in Group B underwent transvaginal TVT-O only. The study included any postmenopausal female with urodynamic stress urinary incontinence. All patients had to fulfill a 3-day bladder diary, overactive bladder symptoms score, urine analysis, urodynamic study, and post-voiding residual urine measurement by abdominal ultrasound preoperatively and at 3-month and 6-month follow-ups. Results: At 6-month follow-up, daytime frequency was reduced to 8% in Group A (increased to 21% in Group B) with a statistically significant difference between both groups (p=0.009). At 6-month follow-up, nocturia was 8% in Group A (11% in Group B) with no statistically significant difference between both groups (p=0.469). There was a statistically significant difference between both groups as regards to urinary urgency at 6-month follow-up (p=0.024). There was a statistically significant difference in postoperative wound healing events as regards to cure, hyperemia, gapping, and wound infection 1 week after intervention between both groups (p=0.008). No local or systemic side-effects were reported from local estrogen use. Conclusion: Local vaginal estrogen treatment given to postmenopausal patients after midurethral sling procedures can reduce the symptoms of daytime frequency and urinary urgency. Long-term follow-up is needed.
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Received: 10 October 2021
Available online: 20 January 2024
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Corresponding Authors:
*E-mail address: samermorsy1@gmail.com (S.M. Morsy).
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Participants’ flow diagram. SUI, stress urinary incontinence; TVT-O, tension-free vaginal tape-obturator. Group A, TVT-O and estrogen; Group B, TVT-O only.
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| Variable | Group A | Group B | p-Value | | Age, median (IQR), year | 59.5 (55.0-65.0) | 58.0 (55.0-65.0) | 0.887 | | After menopause, median (IQR), year | 10.5 (4.5-16.0) | 8.5 (3.0-14.0) | 0.060 | | Parity, % | 0.296 | | Nullipara | 3 | 0 | | | Multipara | 97 | 100 | | Frequency, % | 22 | 12 | 0.060 | | Urgency, % | 11 | 12 | 0.825 | | Nocturia, % | 13 | 10 | 0.506 | | UUI, % | 0 | 0 | - | | Intraoperative complication, % | 0.237 | | Vaginal bleeding | 4 | 1 | | | Blood transfusion | 1 | 0 | | Postoperative hemorrhage | 2 | 3 | 1.000 | | One week postoperative wound healing, % | 0.008a | | Cure | 87 | 71 | | | Gapping | 0 | 4 | | Hyperemia | 11 | 16 | | Wound infection | 2 | 9 |
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The patients’ pretreatment clinical data with intraoperative and postoperative events.
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| Variable | 3-month follow-up | 6-month follow-up | | Group A | Group B | p-Value | Group A | Group B | p-Value | | SUI cure | 88% | 87% | 0.831 | 92% | 91% | 0.831 | | Frequency | 12% | 18% | 0.235 | 8% | 21% | 0.009a | | Urgency | 12% | 14% | 0.674 | 6% | 16% | 0.024a | | Nocturia | 7% | 10% | 0.447 | 8% | 11% | 0.469 | | De novo urgency UI | 4% | 5% | 1.000 | 5% | 6% | 0.756 |
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Clinical changes at 3-month and 6-month follow-ups.
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| Episodes per day | Group A | Group B | | Preoperative | 6-month follow-up | p-Value | Preoperative | 6-month follow-up | p-Value | | Daytime frequency | 3.08±6.20 | 1.06±3.85 | <0.001 | 1.80±5.12 | 3.67±7.12 | <0.001 | | Urgency | 0.70±1.93 | 0.40±1.36 | <0.050 | 0.60±1.82 | 0.93±2.32 | <0.050 | | Nocturia | 0.60±1.70 | 0.18±0.72 | <0.050 | 0.54±1.67 | 0.82±2.14 | <0.050 |
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Preoperative and 6-month follow-up clinical findings.
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| Variable | Group A | Group B | | Preoperatively | 7 (2-10) | 0 (0-10) | | After 6 months | 5 (0-7) | 5 (2-10) | | p-Value | 0.015 | <0.001 |
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OAB symptom score preoperatively and at 6-month follow-up.
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| Parameter | Group A | Group B | p-Value | | Preoperative | 6-month follow-up | Preoperative | 6-month follow-up | | Maximal cystometric capacity, mL | 416 (388-453) | 417.5 (378.5-447.5) | 421.0 (389.5-453.0) | 401.5 (383.0-437.0) | 0.202 | | Maximum flow rate, mL/s | 17 (16-19) | 17 (16-19) | 17 (15-19) | 17 (16-19) | 0.854 | | Detrusor pressure at maximum flow, cmH2Oa | 17.0 (16.0-18.5) | 17 (16-19) | 16 (15-18) | 17.0 (15.0-18.5) | 0.367 |
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Preoperative and 6-month follow-up urodynamic findings.
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| Study | Group A | Group B | Patient, n | Inclusion population and follow-up | Clinical change after 6 months follow-up | | This study | TVT-O and estrogen | TVT-O only | 200 | • Postmenopausal females with SUI for 1-, 3-, and 6-month follow-ups | • Improvement of urgency and frequency with a statistically significant difference (p=0.024, p=0.009, respectively)
• OAB symptoms score markedly improved with a statistically significant difference (p=0.015)
• A statistically significant difference in postoperative wound healing (p=0.008) | | Liapis et al., 2010 [6] | TVT-O and estrogen | TVT-O only | 183 | • Postmenopausal females with SUI for 1-, 2-, and 6-month follow-ups | • Improvement of urgency and frequency with a statistically significant difference (p=0.014, p=0.016, respectively)
• OAB symptoms score not assessed
• No statistically significant difference in postoperative wound healing |
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Comparison between this study and the study by Liapis et al. [6].
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