Hypothesis / aims of study
There are some patients who continue to complain of pain and discomfort around the urethral meatus , especially who are Genitourinary Syndrome of Menopause (GSM) and Bladder Pain Syndrome(BPS) even though main symptoms almost cured after treatments. GSM is defined as a collection of symptoms and signs associated with a decrease in estrogen and other sex steroids involving changes to the labia majora/minora, clitoris, vestibule/introitus, vagina, urethra and bladder. The syndrome may include but is not limited to genital symptoms of dryness, burning, and irritation; sexual symptoms of lack of lubrication, discomfort or pain, and impaired function; and urinary symptoms of urgency, dysuria and recurrent urinary tract infections.Women may present with
some or all of the signs and symptoms, which must be bothersome and should not be better accounted for by another diagnosis.1) Interstitial cystitis (IC), including bladder pain syndrome (BPS), is a chronic and debilitating disease that mainly affects women. It is characterized by pelvic pain associated with urinary urgency, frequency, nocturia and negative urine culture, with normal cytology.2)
On the other hand, the area of the urethral meatus and vaginal anterior garden, in which the bartholin gland / skinny gland are opened and are receiving blood supplies different from other vaginal areas and the androgen receptors are more rich from the estrogen receptors in these.3)Therefore we tried the treatment of local testosterone administration for pain and discomfort around the urethral meatus after treatment of GSM or BPS.
Study design, materials and methods
We prospectively studied 26 patients, mean age 66±8 (Median 66, Max79, Min51) between Jan. 2018 and Oct. 2018 at Women’s Clinic LUNA Next Stage. All patients continued to complain of pain and discomfort in the area of the urethral meatus and vaginal anterior garden after treatment for GSM or BPS. GSM patients were treated already by local estrogen therapy and BPS patients were treated already by amitriptyline or duloxetine or pregabalin
Patients used the testosterone cream (1%) for directly the area of the urethral meatus and vaginal anterior garden 0.1g/every two days or 0.05g/every day for one month. And we used the pain scale for judging the efficacy of this treatment and judged “effective” for the patients who recovered their symptoms over 60% after treatment.
This study was approved by the Ethics Committees of Women’s Clinic LUNA Group in 2018 Written informed consent was obtained from all patients.
The success rate of this treatmentwas 73% (19pt /26). The 7 patients(27%) whose symptoms were not recovered contained
1pt of lichen sclerosus et atrophicus, 2 pt. of BPS, 1pt. of GSM,1pt. of clitoris pain, 2 pt. stop by side effect.
Sexually active women were only 5/26(19%). The 2 of 5pt. restarted their coitus.
The main side effects are acne headache, hyperesthesia of the nipple and clitoris early in the administration.There were no characteristic side effects which were genital bleeding, hoarseness, clitoris hypertrophy ,hypertension and body weight gain in this time. Average level of free testosterone was from 0.7 pg/ml to 1.8 pg/ml between before and after treatment.
Interpretation of results
Several randomized, placebo-controlled clinical trials suggest that testosterone therapy improves sexual function and depression in postmenopausal women. But there were few reports which included testosterone therapy for female LUTS and discomfort around perineal area. In this study, local testosterone therapy is estimated to effective for pain and discomfort around the urethral meatus after treatment of Genitourinary Syndrome of Menopause (GSM) and Bladder Pain Syndrome(BPS).And local testosterone therapy for the area of the urethral meatus and vaginal anterior garden is estimated to safe in short time by side effects and their blood concentration.