Effectiveness of Hormonal Intrauterine Device in Treating PCS Compared to Oral Progestin: Randomized Clinical Trial (RCT)

Sponsor

Assiut University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05050357

Collaborator

(none)

104

Enrollment

Location

Arms

Anticipated Duration (Months)

5.8

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The aim of this study is to compare the effectiveness of hormonal intrauterine device (IUD) in treatment of pelvic congestion syndrome in comparison with oral progestins treatment.

Condition or Disease	Intervention/Treatment	Phase
Pelvic Congestion	Device: Hormonal intrauterine device Drug: Progestins Norethindrone	N/A

Detailed Description

Pelvic congestion syndrome (PCS) is a poorly understood association between varicose or dilated pelvic veins and chronic pelvic pain (CPP). It is also called Pelvic venous syndrome, Pelvic venous insufficiency, Pelvic varices and Pelvic vascular dysfunction Chronic pelvic pain is defined as chronic or persistent pain perceived in structures related to the pelvis of either men or women for more than 6 months according to The International Association for the Study of Pain (IASP). In other words, chronic pelvic pain with associated ovarian vein varicosities is termed pelvic congestion syndrome (PCS) and is an important but under-diagnosed condition.

Millions of women worldwide\e may suffer with chronic pelvic pain at some time in their life, and the occurrence may be as high as 39.1%. Chronic pelvic pain may account for 10 to 15% of outpatient gynecologic visits in the United States.The typical age of patients with this condition ranges from 20 to 45 years. It is unclear whether there is any genetic or ethnic predilection.

The etiology of pelvic congestion syndrome is reflux of blood in the ovarian veins due to the absence of functioning valves, resulting in retrograde blood flow and eventual venous dilatation. The cardinal presenting symptom of PCS is pelvic pain, usually described as a dull ache, without evidence of inflammatory disease. Clinical signs may include vulvar varicosities extending onto the medial thigh and long saphenous territory as well as tenderness on deep palpation at the ovarian point; however, such signs are not always present.

For many women with PCS, the road toward a definitive diagnosis has been long and laborious. Certainly the diagnosis of PCS continues to challenge all physicians involved. However, a heightened awareness and clinical suspicion for the specific symptomatology and associated findings may bring about a more rapid progression to the much anticipated treatment. Pelvic ultrasound (US) and/or computed tomography (CT) scan are usually the first imaging modalities in the evaluation of patients with chronic pelvic pain. Both provide excellent resolution of the uterus. Although a CT scan has greater sensitivity for showing varicosities throughout the lower pelvis, Two dimensional ultrasound with Doppler examination provides dynamic information about visualized venous blood flow.

Laparoscopy is often used in patients with chronic pelvic pain in search of a specific diagnosis. This direct visualization is excellent for ruling out other etiologies distinct from PCS such as endometriosis. However, because the examination is done supine and requires insufflation of CO2 gas, there may be compression of varices if present, thereby masking the diagnosis of PCS.Certainly, the diagnostic venogram continues to provide physicians with a reliable minimally invasive gold standard tool in patients with PCS.The diagnostic venogram gives immediate dynamic flow information and measurements of ovarian and pelvic veins with the option of changing patient position.

Many treatment modalities have been proposed. Medical management with hormone analogues and analgesics, surgical ligation of ovarian veins, hysterectomy with or without bilateral salpingo-oophorectomy and transcatheter embolization have been described in the literature as treatment options for patients with PCS today. Medical treatment of PCS includes psychotherapy, progestins, danazol, phlebotonics, gonadotropins receptor agonists (GnRH) with hormone replacement therapy (HRT), dihydroergotamine, and nonsteroidal antiinflammatory drugs (NSAIDS).

To improve clinical efficacy and reduce perioperative and postoperative morbidity, percutaneous pelvic vein embolization therapy has been utilized. Since its introduction in 1993 by Edwards et al, this modality has revolutionized the treatment of PCS. The procedure is usually performed at the time of diagnostic venography using a variety of embolic agents, including sclerosant foam and coils. In several published series in the 1990s, success rates for reduction of chronic pelvic pain ranged from 50 to 80%. With advancements in technique, clinical success is achieved in 70 to 85% of treated patients. It was found taht there was significant improvement in 83% of women in their overall pain perception levels with a mean of 45 months of long-term follow up.

Embolotherapy for PCS is an exciting therapy that has proven to be safer over the past two decades.Chung et al examined the effect of patient stress level on treatment efficacy, directly comparing hysterectomy with oophorectomy versus venous embolization for the treatment of PCS. Analysis of pain scores showed that venous embolization was more effective than hysterectomy, especially for patients who are "typically or moderately highly stressed. It was demonstrated that PCS patients who underwent ovarian and pelvic venous embolization have a more durable result in reduction of their pelvic pain.It was reported that there were no major complications and also did not find any significant changes in the basal follicle-stimulating hormone, luteinizing hormone, or estradiol levels.

Reported complications of embolotherapy are rare (< 4%) and include ovarian vein thrombophlebitis, recurrence of varices, migration of embolic material, and radiation exposure to ovaries. Long-term data shows no demonstrable negative effects on menstrual cycle or fertility from transcatheter embolotherapy, It has proven to be a safe and effective nonsurgical approach in reducing chronic pelvic pain associated with pelvic venous incompetence.

Regarding our study, we hypothesize that levonorgestrel-releasing intrauterine device is better than and more effective than oral progestin in treatment of PCS. Because levonorgestrel-releasing intrauterine device is local treatment and may cause little side effects than the oral treatment. In addition, it has better compliance than oral treatment. Lastly, it contains higher concentration than oral treatment.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

104 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Care Provider)

Primary Purpose:

Treatment

Official Title:

Effectiveness of Hormonal Intrauterine Device in Treating Pelvic Congestion Syndrome Compared to Oral Progestin: A Randomized Controlled Trial

Anticipated Study Start Date :

Oct 1, 2021

Anticipated Primary Completion Date :

Dec 31, 2022

Anticipated Study Completion Date :

Apr 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: hormonal intrauterine device arm	Device: Hormonal intrauterine device insertion of hormonal IUD during menstrual period
Active Comparator: progestin arm	Drug: Progestins Norethindrone oral ethisteron twice daily for three months

Arm

Intervention/Treatment

Active Comparator: hormonal intrauterine device arm

Device: Hormonal intrauterine device

insertion of hormonal IUD during menstrual period

Active Comparator: progestin arm

Drug: Progestins Norethindrone

oral ethisteron twice daily for three months

Outcome Measures

Primary Outcome Measures

The effectiveness of hormonal IUD in reducing pain in patient with pelvic congestion syndrome in comparison to oral progestin [two years]
The primary outcome measure is to compare the degree of pain reduction according to pain scale in pelvic congestion syndrome cases taking hormonal IUD in comparison to those taking oral progestin

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Inclusion Criteria:

Patients with clinical symptoms of pelvic congestion syndrome documented by Trans abdominal and/or transvaginal Doppler ultrasound (dilated ovarian veins with reversed caudal flow, presence of varices , dilated arcuate veins crossing the uterine myometrium, polycystic changes of the ovary and variable duplex waveform during the Valsalva's maneuver).