Dyspareunia Clinical Trial
Official title:
Evaluation of a Novel Female Hygiene Device for Postcoital Discomfort
Previous research has shown that semen deposition in the vagina after intercourse leads to dripping, discomfort, and vaginal odor. This study is evaluating a hygiene device designed to be inserted into the vagina after intercourse to absorb semen deposited into the vaginal canal to determine if there is a reduction in dripping and odor, and to determine the amount of fluids absorbed.
Despite the significant number of sexual dysfunctions in women, physicians often avoid discussing these concerns in the office setting. With recent research on the role of the pelvic floor, and recently approved medical therapies for hypoactive sexual desire disorder, physicians have begun to adapt to questioning patients about libido and pain-related sexual dysfunctions. However, pain-related sexual questionnaires often focus on insertional and penetrational dyspareunia, without asking about discomfort minutes, hours, or even the day following sexual intercourse. One common compliant in ambulatory sexual medicine clinics is the bothersome dripping, odor, and discomfort women experience after sexual activity when no condom is used, and when intravaginal ejaculation occurs. Previous studies have shown the effects of semen on alterations in the vaginal flora. These changes contribute to a multitude of clinical complaints and diagnoses, including malodor, continuous discharge after intercourse, and bacterial vaginosis (BV). The exposure of semen changes the vaginal flora by increasing the pH levels, in turn altering the bacterial growth pattern. This implies the persistent presence of semen in the vagina may be one of the causes of malodor and development of BV. Chvapil utilized gas chromatography and demonstrated that the longer period of time semen was present in the vagina, the more likely it resulted in a strong and unattractive vaginal odor. Gallo showed that an incidental diagnosis of BV was correlated with detection of sperm on gram stain, and frequent coitus with or without condom use. The investigator's goal in this study is to evaluate a novel postcoital consumer health product and its effects on the complaints of continuous seepage of semen and vaginal odor after intercourse. ;
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT03935698 -
Physiotherapy Treatment in Women With Dyspareunia Following Gynecological Cancer: a Pilot Study
|
N/A | |
Recruiting |
NCT03427255 -
CBT Group Treatment for Women With Dyspareunia
|
N/A | |
Completed |
NCT02253173 -
Estradiol Vaginal Softgel Capsules in Treating Symptoms of Vulvar and Vaginal Atrophy in Postmenopausal Women
|
Phase 3 | |
Completed |
NCT03184077 -
Rapidly Absorbing Polyglactin 910 Versus Poliglecaprone 25 for Laceration Repair
|
N/A | |
Recruiting |
NCT05445115 -
The Mollie Study, a Study to Evaluate the Safety and Efficacy of the Mollie Medical Device
|
N/A | |
Withdrawn |
NCT03666819 -
Carbon Dioxide Fractional Laser in Treating Participants With Stage 0-III Hormone Receptor-Positive Breast Cancer With Vulvovaginal Atrophy
|
Phase 2 | |
Active, not recruiting |
NCT03681678 -
Laser Therapy for Treatment of Urogenital Symptoms in Women
|
||
Completed |
NCT04955418 -
Effects of Epi-no Device on Pelvic Floor Dysfunctions
|
N/A | |
Completed |
NCT05834088 -
Effects of Myofascial Release With and Without Thiele Massage
|
N/A | |
Terminated |
NCT03185169 -
GSM (Genitourinary Syndrome Of Menopause) Management In Breast Cancer Survivors
|
Early Phase 1 | |
Completed |
NCT03307044 -
Fractional CO2 Laser Therapy for Survivors of Breast Malignancies
|
N/A | |
Completed |
NCT05617820 -
Study Comparing Estradiol Vaginal Inserts 4mcg To IMVEXXY ® (Estradiol Vaginal Inerts 4 mcg) In The Treatment Of Dyspareunia in Women With Vulvur and Vaginal Atrophy
|
Phase 3 | |
Recruiting |
NCT03714581 -
Laser Therapy Following Radiotherapy for Gynecological Cancer
|
N/A | |
Completed |
NCT04659668 -
Evaluation of the Efficacy and Safety of the Dermal Filler for Female Intimate Area Hydration and Atrophy of the Vagina.
|
N/A | |
Completed |
NCT03199534 -
A Trial of Pelvic Floor Chemodenervation in Patients Undergoing Physical Therapy for High Tone Pelvic Floor Dysfunction
|
Phase 4 | |
Completed |
NCT00318500 -
Study Evaluating the Safety and Efficacy of ERB-041 on Reduction of Symptoms Associated With Endometriosis in Reproductive-Aged Women
|
Phase 2 | |
Recruiting |
NCT05540353 -
Transvaginal Low-level Laser Therapy to Improve Pelvic Pain and Sexual Function in Patients With Endometriosis.
|
N/A | |
Completed |
NCT03178825 -
Hybrid Fractional Laser for Symptoms of Genitourinary Syndrome of Menopause
|
N/A | |
Completed |
NCT04389489 -
Postpartum Sexual Function in Pregnant Women With COVID-19
|
||
Completed |
NCT03372720 -
Fractional CO2 Laser Therapy in Minimizing Genitourinary Syndrome of Menopause in Gynecological Cancer Survivors
|
N/A |