Local testosterone therapy for pain and discomfort around the urethral meatus after treatment of Genitourinary Syndrome of Menopause (GSM) and Bladder Pain Syndrome(BPS)

SEKIGUCHI Y1

Research Type

Clinical

Abstract Category

Urethra Male / Female

Abstract 503
Urethra & Prostate
Scientific Podium Short Oral Session 26
Friday 6th September 2019
10:22 - 10:30
Hall G3
Clinical Trial Female Pain, Pelvic/Perineal Painful Bladder Syndrome/Interstitial Cystitis (IC)
1.Women's Clinic LUNA JAPAN
Presenter
Y

Yuki Sekiguchi

Links

Abstract

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.
Results
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.
Concluding message
The  long-term safety profile of testosterone therapy in postmenopausal women is not clear yet. We have done to follow up  local testosterone therapy for long time period.
References
  1. Genitourinary syndrome of menopause: new terminology for vulvovaginal atrophy from the International Society for the Study of Women's Sexual Health and the North American Menopause Society.Portman DJ, Gass ML; Vulvovaginal Atrophy Terminology Consensus Conference Panel. Menopause. 2014 Oct;21(10):1063-8.
  2. Systematic Review of Oral Therapy for the Treatment of Symptoms of Bladder Pain Syndrome: The Brazilian Guidelines. Santos TGD et al. Rev Bras Ginecol Obstet. (2018)
  3. Androgen receptor expression in the human vagina under different physiological and treatment conditions. Baldassarre M et al. Int J Impot Res. (2013)
Disclosures
<span class="text-strong">Funding</span> none <span class="text-strong">Clinical Trial</span> Yes <span class="text-strong">Public Registry</span> No <span class="text-strong">RCT</span> No <span class="text-strong">Subjects</span> Human <span class="text-strong">Ethics Committee</span> Women's Clinic LUNA ethics committee, L07-01 <span class="text-strong">Helsinki</span> Yes <span class="text-strong">Informed Consent</span> Yes