Effects of Extracorporeal Shockwave Therapy Versus Pulsed Electromagnetic Field Therapy in Females With Sexual Dysfunction.
2026年5月14日 更新者：Mahmoud Hamada Mohamed、Benha University
Effects of Extracorporeal Shockwave Therapy Versus Pulsed Electromagnetic Field Therapy in Females With Sexual Dysfunction: a Randomized Controlled Trial
This is a prospective, three-arm, parallel-group, assessor-blinded randomized controlled trial designed to compare the effectiveness of extracorporeal shockwave therapy (ESWT) combined with pelvic floor muscle training (PFMT), pulsed electromagnetic field stimulation (PEMF) combined with PFMT, and PFMT alone in Females with sexual dysfunction.
Participants will be randomly allocated in a 1:1:1 ratio, and the study duration is 16 weeks, including an 8-week intervention period and an 8-week follow-up period.
調査の概要
状態
募集
詳細な説明
Female sexual dysfunction is a multifactorial condition involving physiological, vascular, neuromuscular, and psychosocial components, and pelvic floor dysfunction and impaired genital blood flow are recognized contributing factors. Therefore, this trial integrates both neuromuscular rehabilitation and non-invasive energy-based modalities to target different underlying mechanisms of FSD.
A total of 90 women diagnosed with FSD based on a Female Sexual Function Index (FSFI) score < 26.55 will be recruited and randomly assigned in a 1:1:1 ratio to one of three groups. The ESWT + PFMT group will receive low-intensity radial extracorporeal shockwave therapy once weekly for 8 weeks, applied to the perineum and pelvic floor trigger points, in addition to a standardized pelvic floor muscle training program performed three times weekly under supervision. The PEMF + PFMT group will receive pulsed electromagnetic field stimulation three times weekly for 8 weeks, combined with the same standardized PFMT protocol. The PFMT-only group will perform identical supervised pelvic floor muscle training without adjunct device-based therapy.
Randomization will be performed using a computer-generated sequence with block randomization, and allocation will be ensured using sealed opaque envelopes. Outcome assessors will be blinded to group allocation to reduce assessment bias.
研究の種類
介入
入学 (推定)
90
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究連絡先
- 名前：Mahmoud Hamada Mohamed Associate Professor, Ph.D
- 電話番号：01096968910
- メール：mahmoud.mohamed@fpt.bu.edu.eg
研究場所
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Banī Suwayf、エジプト
- 募集
- Outpatient clinic, faculty of Physical Therapy, Beni Suef University
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コンタクト：
- Marwa Elsayed Mohamed Lecturer, Ph.D
- 電話番号：01141825442
- メール：Marwa.elsayed@pt.bsu.edu.eg
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コンタクト：
- Marwa Elsayed Mohamed Lecturer, Ph.D
- メール：Marwa.elsayed@pt.bsu.edu.eg
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-
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 大人
健康ボランティアの受け入れ
いいえ
説明
Inclusion Criteria:
- Female participants aged 20-50 years diagnosed with female sexual dysfunction (FSFI score <26.55), reporting symptoms of reduced sexual desire, arousal dysfunction, orgasmic dysfunction, or dyspareunia.
- Premenopausal women in a stable sexual relationship for at least 6 months and sexually active during the previous month.
- Symptoms persisting for at least 3 months before enrollment.
- Ability to understand study procedures and provide written informed consent.
- Willingness to refrain from initiating any additional treatment for sexual dysfunction during the study period
Exclusion Criteria:
- Pregnancy or planned pregnancy during the study period.
- Pelvic surgery within the previous 6 months.
- Active pelvic inflammatory disease, genital infection, or unexplained vaginal bleeding.
- Neurological disorders affecting pelvic floor or sexual function.
- Severe pelvic organ prolapse, severe urinary incontinence, or significant pelvic anatomical abnormalities.
- Current hormonal therapy or use of medications known to affect sexual function, including antidepressants or antipsychotics.
- Severe psychiatric disorders or cognitive impairment limiting participation.
- Menopause or perimenopausal status.
- Uncontrolled systemic diseases such as diabetes mellitus, hypertension, cardiovascular disease, or thyroid disorders.
- Presence of malignancy, pelvic radiation history, or severe chronic pelvic pain disorders.
- Contraindications to ESWT or PEMF including cardiac pacemakers or implanted electronic devices, coagulation disorders, anticoagulant therapy, epilepsy, or metal implants in the pelvic region.
- Current participation in another clinical trial or receipt of physiotherapy for sexual dysfunction within the previous 3 months.
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：ESWT + PFMT
Participants will receive low-intensity extracorporeal shockwave therapy and participants will perform a standardized pelvic floor muscle training program
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Extracorporeal shockwave therapy will be delivered using a low-intensity radial shockwave device, administered once weekly for 8 weeks, with each session delivering 1500-2000 shockwave pulses at an energy flux density of 0.05-0.10
mJ/mm² and a frequency of 5-8 Hz.
The application will target the perineum and pelvic floor trigger points using a standardized treatment probe with appropriate coupling gel to ensure optimal energy transmission.
Each session will last approximately 7 minutes, and intensity will be adjusted based on patient tolerance without exceeding the recommended energy threshold for soft tissue application
pelvic floor exercises will be performed for 45 minutes per day, three days per week, over an eight-week period.
Prior to beginning participant will be directed to void the bladder and be supine lying with flexed knees and mildly abducted hips.
She was then will be guided to contract the PFMs maximally, holding each contraction for 10 seconds.
This will be performed 15 times with a 10-second rest interval within contractions.
Each session will be consisted of three exercise sets, with each set performed for 15 minutes.
Home exercises were prescribed twice daily, providing a total of 45 minutes of training each day
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アクティブコンパレータ：PEMF + PFMT
Participants will receive pulsed electromagnetic stimulation combined with the same standardized pelvic floor muscle training program
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pelvic floor exercises will be performed for 45 minutes per day, three days per week, over an eight-week period.
Prior to beginning participant will be directed to void the bladder and be supine lying with flexed knees and mildly abducted hips.
She was then will be guided to contract the PFMs maximally, holding each contraction for 10 seconds.
This will be performed 15 times with a 10-second rest interval within contractions.
Each session will be consisted of three exercise sets, with each set performed for 15 minutes.
Home exercises were prescribed twice daily, providing a total of 45 minutes of training each day
Pulsed electromagnetic field stimulation (PEMF) will be applied to the pelvic floor region for 20-minute sessions, three times weekly day after day for 8 consecutive weeks.
Stimulation parameters will include a frequency of 10 Hz, magnetic field intensity of 200 μT, and pulse duration of 250 μs.
Treatment sessions will be administered under therapist supervision with participants positioned comfortably in supine crook-lying.
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他の：PFMT (Control)
Participants will receive a standardized pelvic floor muscle training program
|
pelvic floor exercises will be performed for 45 minutes per day, three days per week, over an eight-week period.
Prior to beginning participant will be directed to void the bladder and be supine lying with flexed knees and mildly abducted hips.
She was then will be guided to contract the PFMs maximally, holding each contraction for 10 seconds.
This will be performed 15 times with a 10-second rest interval within contractions.
Each session will be consisted of three exercise sets, with each set performed for 15 minutes.
Home exercises were prescribed twice daily, providing a total of 45 minutes of training each day
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Female Sexual Function Index (FSFI) Total Score
時間枠：Baseline, Week 8. Week 16
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Female sexual function will be assessed using the Female Sexual Function Index (FSFI), a validated self-reported 19-item questionnaire designed to evaluate six domains of female sexual function, including desire, arousal, lubrication, orgasm, satisfaction, and pain.
Individual domain scores are calculated and summed to obtain a total score ranging from 2 to 36, with higher scores indicating better sexual function, while scores below 26.55 are considered indicative of female sexual dysfunction.
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Baseline, Week 8. Week 16
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Sexual Quality of Life Scale
時間枠：Baseline, week 8, and week 16
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Sexual quality of life will be assessed using the Sexual Quality of Life-Female Questionnaire (SQOL-F), a validated self-administered questionnaire designed to evaluate the impact of female sexual dysfunction on psychosocial well-being and intimate relationships.
The questionnaire consists of 18 items covering domains of sexual confidence, emotional well-being, relationship satisfaction, self-esteem, and psychosexual functioning.
Each item is scored on a 6-point Likert scale, and the total score is transformed to a 0-100 scale, with higher scores indicating better sexual quality of life.
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Baseline, week 8, and week 16
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Pelvic floor muscle strength
時間枠：Baseline, week 6 and week 16
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Pelvic floor muscle strength will be objectively assessed before and after the intervention using the XFT-0010 Pelvic Floor Assessment System.
The system consists of an appropriately sized intravaginal pressure probe connected to the main recording unit via a flexible catheter, enabling quantitative measurement of pelvic floor muscle contraction strength.
Participants will be assessed in the crook-lying position under standardized conditions and instructed to perform three maximal voluntary pelvic floor muscle contractions, each separated by a standardized rest interval to minimize fatigue.
The highest recorded contraction value will be used for statistical analysis.
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Baseline, week 6 and week 16
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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
スポンサー
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (実際)
2026年5月14日
一次修了 (推定)
2026年12月15日
研究の完了 (推定)
2027年1月15日
試験登録日
最初に提出
2026年5月7日
QC基準を満たした最初の提出物
2026年5月7日
最初の投稿 (実際)
2026年5月13日
学習記録の更新
投稿された最後の更新 (実際)
2026年5月18日
QC基準を満たした最後の更新が送信されました
2026年5月14日
最終確認日
2026年5月1日
詳しくは
本研究に関する用語
その他の研究ID番号
- ESWT VS PEMF in FSD 2026
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
未定
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
いいえ
米国FDA規制機器製品の研究
いいえ
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