Wahl Kate, Orr Natasha L, Parmar Gurkiran, Zhang Sandy X J, MacLeod Rebecca G K, Noga Heather, Albert Arianne, Flannigan Ryan, Brotto Lori A, Yong Paul J
Department of Obstetrics and Gynecology, University of British Columbia, Vancouver, BC V6Z 2K8, Canada.
BC Women's Centre for Pelvic Pain and Endometriosis and UBC Endometriosis and Pelvic Pain Lab, Vancouver, BC V6H 3N1, Canada.
Sex Med. 2024 Aug 31;12(4):qfae049. doi: 10.1093/sexmed/qfae049. eCollection 2024 Aug.
Deep dyspareunia affects 50% of people with endometriosis. The Ohnut is a set of interlocking rings that fit over the penis/insertive object. One or more rings can be used to limit insertion depth and reduce deep dyspareunia.
We conducted a pilot, parallel, open-label randomized controlled trial (RCT) to investigate the feasibility of the study design and the acceptability and preliminary efficacy of the Ohnut.
Participants were recruited from a tertiary center for endometriosis. Eligibility criteria were surgically confirmed endometriosis, age 19-49 years, monogamous sexual relationship with a partner willing to participate in the study, and no comorbid superficial dyspareunia, anxiety, or depression. Couples were randomized into an intervention group or a waitlist control group using a 1:1 allocation ratio. All couples had sex as normal during weeks 1 to 4 (baseline period), and couples in the intervention group used the Ohnut with sex during weeks 5 to 10 (intervention period) while controls had sex as normal. Patient participants used daily diaries to record sexual activity and deep dyspareunia score (0-10) for the 10-week study. Intervention group participants completed an acceptability questionnaire at the end of the study.
The primary outcomes were feasibility of the study and acceptability of the Ohnut. We also assessed differences in deep dyspareunia scores in the participants who used the Ohnut compared to the control participants who did not.
We recruited approximately 5 couples per month of active recruitment. Of 864 potentially eligible participants, we successfully contacted 44.7% (n = 386), of whom 8.0% (n = 31) consented, 64.8% (n = 250) were ineligible, and 27.2% (n = 105) declined. Thirty-one couples were randomly assigned to the intervention or control group, and 17 couples completed the study. Intervention group couples used the Ohnut for an average of 72.4% (32.7%) of sexual encounters during the intervention period. The mean acceptability index score for the Ohnut was 0.83 (0.078) among patients and 0.83 (0.049) among partners (index between 0 and 1). After controlling for baseline deep dyspareunia, there was a significant difference in the intervention period mean deep dyspareunia scores between the control and intervention group (4.69 (2.44) vs 2.46 (1.82), = .012).
We identified preliminary evidence for the acceptability and efficacy of the Ohnut among both patients and partners, suggesting that the Ohnut may be a useful stand-alone or adjuvant management tool for endometriosis-associated deep dyspareunia.
Strengths of this study were the "real-world" use of the Ohnut and data collection from both patients and partners. Limitations of the study design included the strict eligibility criteria that affected feasibility and generalizability.
This pilot RCT indicated that the Ohnut may be an acceptable and effective intervention to reduce endometriosis-associated deep dyspareunia. We identified opportunities to improve design for a larger RCT.
This clinical trial was registered with clinicaltrials.gov (#NCT04370444).
深部性交疼痛影响50%的子宫内膜异位症患者。奥纳特环是一套可套在阴茎/插入物体上的互锁环。可使用一个或多个环来限制插入深度并减轻深部性交疼痛。
我们进行了一项先导性、平行、开放标签随机对照试验（RCT），以研究该研究设计的可行性以及奥纳特环的可接受性和初步疗效。
参与者从一家三级子宫内膜异位症中心招募。纳入标准为经手术确诊的子宫内膜异位症、年龄19 - 49岁、与愿意参与研究的伴侣保持一夫一妻制性关系，且无合并浅表性交疼痛、焦虑或抑郁。夫妻双方以1:1的分配比例随机分为干预组或等待名单对照组。所有夫妻在第1至4周（基线期）正常进行性生活，干预组的夫妻在第5至10周（干预期）性生活时使用奥纳特环，而对照组正常进行性生活。患者参与者使用每日日记记录10周研究期间的性活动和深部性交疼痛评分（0 - 10分）。干预组参与者在研究结束时完成一份可接受性问卷。
主要结果是研究的可行性和奥纳特环的可接受性。我们还评估了使用奥纳特环的参与者与未使用的对照参与者在深部性交疼痛评分上的差异。
在积极招募期间，我们每月大约招募5对夫妻。在864名潜在符合条件的参与者中，我们成功联系到44.7%（n = 386），其中8.0%（n = 31）同意参与，64.8%（n = 250）不符合条件，27.2%（n = 105）拒绝。31对夫妻被随机分配到干预组或对照组，17对夫妻完成了研究。干预组夫妻在干预期平均72.4%（32.7%）的性接触中使用了奥纳特环。奥纳特环的平均可接受性指数评分在患者中为0.83（0.078），在伴侣中为0.83（0.049）（指数范围为0至1）。在控制基线深部性交疼痛后，对照组和干预组在干预期的平均深部性交疼痛评分存在显著差异（4.69（2.44）对2.46（1.82），P = 0.012）。
我们发现了奥纳特环在患者及其伴侣中具有可接受性和疗效的初步证据，表明奥纳特环可能是一种用于子宫内膜异位症相关深部性交疼痛的有用的独立或辅助治疗工具。
本研究的优点是奥纳特环的“实际应用”以及从患者和伴侣双方收集数据。研究设计的局限性包括影响可行性和普遍性的严格纳入标准。
这项先导性RCT表明，奥纳特环可能是一种可接受且有效的干预措施，用于减轻子宫内膜异位症相关的深部性交疼痛。我们确定了在更大规模RCT中改进设计的机会。
本临床试验已在clinicaltrials.gov注册（#NCT04370444）。
